The whole relaxation at Christmas thing. Completely agree it's a dumb idea. But as a point of principle if we can't trust the populace to do the right thing with all the evidence in front of them should we be allowing them to vote? Asking for a friend. Myself hoping that common sense will prevail and people will self-regulate.
Also need to consider keeping schools 'online only' for first half term 2021 ie up to late Feb, I know it's not ideal.
We might as well just give up and tell everyone to repeat the academic year.
I do expect the government to announce that A Levels / GCSEs for 2021 will be assessed purely on teachers assessment/coursework in due course even though they won't say that at the moment. On that basis the loss of the 6 weeks to Feb 2021 should not make too much difference.
Also need to consider keeping schools 'online only' for first half term 2021 ie up to late Feb, I know it's not ideal.
We might as well just give up and tell everyone to repeat the academic year.
I do expect the government to announce that A Levels / GCSEs for 2021 will be assessed purely on teachers assessment/coursework in due course even though they won't say that at the moment. On that basis the loss of the 6 weeks to Feb 2021 should not make too much difference.
It's more the actual cumulative disruption on the education itself that concerns me than it is the effect on the examination element, particularly for increasingly younger kids.
Does anyone have any idea why the EU has not approved the Pfizer vaccine?
They are following the procedures for 'provisional' authorisation, which are more onerous and take longer than those required for the 'emergency' authorisation we used.
Seems pretty daft to me - if this isn't an emergency, what is? They'll have lost a month.
The delay will cost lives, clearly the vaccine is safe, Covid in old and ill people is deadly. Its complete madness.
It looks to me that the difference between the UK and the EU is in the management of adverse effects. The Pfizer vaccine is safe to use in general, but there will be a small proportion of adverse effects, allergies and so on. The EU wants a proper management and reporting plan in place before giving the go-ahead; the UK will deal with these as ad-hoc events. Arguably, the UK and other countries get a free ride from the EU doing this work, but actually it's fine. Vaccines are an international effort.
A management plan surely can be devised months in advance. Why wait until the vaccine has been submitted?
I think the risk management plan can only be fully fleshed out once the basis for the decision it's safe to use is fully determined. Any authorisation is conditional on the attributes of the drug. Background infohere.
I should also say that while the UK will benefit from the EU's risk management plans, these in turn will be informed by early data from the UK rollout.
The attributes of the drug being the results of the phase three trials, not some management plan that could be planned for months in advance.
Not necessarily. You can't assess the risks unless you know what the risks are. If you get the basic authorisation out the way as soon as possible, that assessment will follow on after.
Anyway this is the set of bullet points that the EMA identify as the difference between Emergency Use Authorisation (under which the UK has released the Pfizer vaccine) and the full EMA authorisation:
info on the group of people to be given the vaccine;
the vaccine's pharmaceutical quality and purity;
manufacturing and controls of batches;
compliance with international requirements for laboratory testing and conduct of clinical trials;
types of immune responses;
side effects e.g. with regard to older people, or pregnant women;
labelling and package leaflet;
the way risks will be managed and monitored once the vaccine is authorised.
Reference the link above.
I think risk assessment is highly overrated, particularly where risks cannot be calculated with high degrees of precision or confidence. Risk management does not rely upon risk calculation, but on hazard identification, and upon eliminating or mitigating down to acceptable levels the impacts of the risks associated with those hazards.
That list identifies hazards. You don't need to calculate the risks to put in place risk controls for them.
Possibly. I think effects on pregnant women are worth knowing, given they are vaccinating women of childbearing age from the off. Also it's worth knowing if there are age-specific risks, given the main demographic for this vaccine. And these plus other emerging risks will feed into those plans.
Basically the EMA is going through more hoops. Is it worth it, bearing in mind speed is of the essence? I don't think there is an objective answer to that. My impression is that Germany in particular changed its mind on going with Emergency Authorisation and decided to wait for full authorisation. I can guess their reasons for doing so are (1) that Germany (and some other European counties) have high levels of vaccine sceptics, so any shortcuts to the process will be jumped on, and (2) it won't make much difference to the speed of immunisation given Christmas and a relatively low initial availability of the vaccine, so why not wait a couple of weeks and do it properly?
Seems like all the disputed states (disputed in the mind of Trump that is) bar Michigan have announced their results. I very much hope Betfraud are going to face some consequences.
If they keep this market open after Biden has won the actual EC vote, Betfair and any bookies following suit will imo have become a part of Trump's black ops fascist fantasy role play. Which is a very bad look indeed.
Worse than that - they will have destroyed their good name as a reliable place to bet.
Yes. They HAVE to settle it on the EC vote. Last chance saloon for them.
I`ve just complained to BF for a second time - using Nigelb`s wording (below): the winner is more than just projected; the winner has been declared by the electoral college.
Do they declare the winner? I thought that was when the vote was certified in the House.
Which is Jan 6th. Becomes the next peg if they miss this one. Then nothing until Inauguration.
A viable market would be which happens first - Betfair settling POTUS or a Deal with the EU.
Also need to consider keeping schools 'online only' for first half term 2021 ie up to late Feb, I know it's not ideal.
We might as well just give up and tell everyone to repeat the academic year.
I do expect the government to announce that A Levels / GCSEs for 2021 will be assessed purely on teachers assessment/coursework in due course even though they won't say that at the moment. On that basis the loss of the 6 weeks to Feb 2021 should not make too much difference.
It's more the actual cumulative disruption on the education itself that concerns me than it is the effect on the examination element, particularly for increasingly younger kids.
It's a nightmare for younger kids as well.
They really do miss not physically seeing their friends.
I also feel tremendously sad for university students, my deepest and longest lasting friendships were formed at university.
As much as you can do online, nothing quite forges a friendship as seeing one of your friends getting absolutely sloshed at university, feeling so sick, that he decides to ring his mother 250 miles away at 3am to ask her to come look after him and make egg and soldiers.
If you really believed that Betfair have now changed their market to be the actual next president, and were allowed to do so, then surely it wouldn't be possible to make 37 million quid by betting on Nancy Pelosi. She and Kamala Harris would be making up all the spare possibility rather than Trump (I'm assuming that that the House would not permit Trump, which seems more like a trillion to one possibility).
If it should go to a contigent election, then the House would elect Trump as there would be sufficient Republican-majority state delegations in the new House.
That requires the Democrat House to vote against the electoral college. The senate alone may be able to prevent Biden winning. It cannot force any other outcome, hence Pelosi takes office as next in line.
Each state's delegates cast one bloc vote. I think the GOP have the highest number of states in the House.
I think that only happens in the case that a candidate fails to get to 270, otherwise it's just a normal House session for confirming the Electoral College count.
Also need to consider keeping schools 'online only' for first half term 2021 ie up to late Feb, I know it's not ideal.
We might as well just give up and tell everyone to repeat the academic year.
I do expect the government to announce that A Levels / GCSEs for 2021 will be assessed purely on teachers assessment/coursework in due course even though they won't say that at the moment. On that basis the loss of the 6 weeks to Feb 2021 should not make too much difference.
It's more the actual cumulative disruption on the education itself that concerns me than it is the effect on the examination element, particularly for increasingly younger kids.
Yes a fair call. The spread of infection appears to be a greater problem in the secondary schools, perhaps leave the primary schools open?
Does anyone have any idea why the EU has not approved the Pfizer vaccine?
They are following the procedures for 'provisional' authorisation, which are more onerous and take longer than those required for the 'emergency' authorisation we used.
Seems pretty daft to me - if this isn't an emergency, what is? They'll have lost a month.
The delay will cost lives, clearly the vaccine is safe, Covid in old and ill people is deadly. Its complete madness.
It looks to me that the difference between the UK and the EU is in the management of adverse effects. The Pfizer vaccine is safe to use in general, but there will be a small proportion of adverse effects, allergies and so on. The EU wants a proper management and reporting plan in place before giving the go-ahead; the UK will deal with these as ad-hoc events. Arguably, the UK and other countries get a free ride from the EU doing this work, but actually it's fine. Vaccines are an international effort.
A management plan surely can be devised months in advance. Why wait until the vaccine has been submitted?
I think the risk management plan can only be fully fleshed out once the basis for the decision it's safe to use is fully determined. Any authorisation is conditional on the attributes of the drug. Background infohere.
I should also say that while the UK will benefit from the EU's risk management plans, these in turn will be informed by early data from the UK rollout.
The attributes of the drug being the results of the phase three trials, not some management plan that could be planned for months in advance.
Not necessarily. You can't assess the risks unless you know what the risks are. If you get the basic authorisation out the way as soon as possible, that assessment will follow on after.
Anyway this is the set of bullet points that the EMA identify as the difference between Emergency Use Authorisation (under which the UK has released the Pfizer vaccine) and the full EMA authorisation:
info on the group of people to be given the vaccine;
the vaccine's pharmaceutical quality and purity;
manufacturing and controls of batches;
compliance with international requirements for laboratory testing and conduct of clinical trials;
types of immune responses;
side effects e.g. with regard to older people, or pregnant women;
labelling and package leaflet;
the way risks will be managed and monitored once the vaccine is authorised.
Reference the link above.
I think risk assessment is highly overrated, particularly where risks cannot be calculated with high degrees of precision or confidence. Risk management does not rely upon risk calculation, but on hazard identification, and upon eliminating or mitigating down to acceptable levels the impacts of the risks associated with those hazards.
That list identifies hazards. You don't need to calculate the risks to put in place risk controls for them.
Possibly. I think effects on pregnant women are worth knowing, given they are vaccinating women of childbearing age from the off. Also it's worth knowing if there are age-specific risks, given the main demographic for this vaccine. And these plus other emerging risks will feed into those plans.
Basically the EMA is going through more hoops. Is it worth it, bearing in mind speed is of the essence? I don't think there is an objective answer to that. My impression is that Germany in particular changed its mind on going with Emergency Authorisation and decided to wait for full authorisation. I can guess their reasons for doing so are (1) that Germany (and some other European counties) have high levels of vaccine sceptics, so any shortcuts to the process will be jumped on, and (2) it won't make much difference to the speed of immunisation given Christmas and a relatively low initial availability of the vaccine, so why not wait a couple of weeks and do it properly?
So the UK is kindly running a phase 4 trial for the EU?
Does anyone have any idea why the EU has not approved the Pfizer vaccine?
They are following the procedures for 'provisional' authorisation, which are more onerous and take longer than those required for the 'emergency' authorisation we used.
Seems pretty daft to me - if this isn't an emergency, what is? They'll have lost a month.
The delay will cost lives, clearly the vaccine is safe, Covid in old and ill people is deadly. Its complete madness.
It looks to me that the difference between the UK and the EU is in the management of adverse effects. The Pfizer vaccine is safe to use in general, but there will be a small proportion of adverse effects, allergies and so on. The EU wants a proper management and reporting plan in place before giving the go-ahead; the UK will deal with these as ad-hoc events. Arguably, the UK and other countries get a free ride from the EU doing this work, but actually it's fine. Vaccines are an international effort.
A management plan surely can be devised months in advance. Why wait until the vaccine has been submitted?
I think the risk management plan can only be fully fleshed out once the basis for the decision it's safe to use is fully determined. Any authorisation is conditional on the attributes of the drug. Background infohere.
I should also say that while the UK will benefit from the EU's risk management plans, these in turn will be informed by early data from the UK rollout.
The attributes of the drug being the results of the phase three trials, not some management plan that could be planned for months in advance.
Not necessarily. You can't assess the risks unless you know what the risks are. If you get the basic authorisation out the way as soon as possible, that assessment will follow on after.
Anyway this is the set of bullet points that the EMA identify as the difference between Emergency Use Authorisation (under which the UK has released the Pfizer vaccine) and the full EMA authorisation:
info on the group of people to be given the vaccine;
the vaccine's pharmaceutical quality and purity;
manufacturing and controls of batches;
compliance with international requirements for laboratory testing and conduct of clinical trials;
types of immune responses;
side effects e.g. with regard to older people, or pregnant women;
labelling and package leaflet;
the way risks will be managed and monitored once the vaccine is authorised.
Reference the link above.
I think risk assessment is highly overrated, particularly where risks cannot be calculated with high degrees of precision or confidence. Risk management does not rely upon risk calculation, but on hazard identification, and upon eliminating or mitigating down to acceptable levels the impacts of the risks associated with those hazards.
That list identifies hazards. You don't need to calculate the risks to put in place risk controls for them.
Possibly. I think effects on pregnant women are worth knowing, given they are vaccinating women of childbearing age from the off. Also it's worth knowing if there are age-specific risks, given the main demographic for this vaccine. And these plus other emerging risks will feed into those plans.
Basically the EMA is going through more hoops. Is it worth it, bearing in mind speed is of the essence? I don't think there is an objective answer to that. My impression is that Germany in particular changed its mind on going with Emergency Authorisation and decided to wait for full authorisation. I can guess their reasons for doing so are (1) that Germany (and some other European counties) have high levels of vaccine sceptics, so any shortcuts to the process will be jumped on, and (2) it won't make much difference to the speed of immunisation given Christmas and a relatively low initial availability of the vaccine, so why not wait a couple of weeks and do it properly?
Are there many pregnant 80+ women out there?
And "doing it properly", implying the process other countries have gone through is not proper.
Just imagine if the Dems didn’t hold the House then effectively the election could have been stolen for Trump,.
The USA is in a terrible state where one party is becoming fascist and where the polarization makes the Brexit divide in the UK look like a love in .
How would it have been stolen had the GOP taken the House? The electoral votes would have been the same and the certification process would have just been a formality by the VP.
See here, if they had a majority in the House and Senate they could pull this off.
Trump Allies Eye Long-Shot Election Reversal in Congress, Testing Pence
Some House Republicans plan to try to use Congress’s tallying of electoral results on Jan. 6 to tip the election to President Trump. The attempt will put Republicans in a pinch.
Seems like the longest of long shots, especially with several GOP senators already saying they would never countenance such an idea.
No chance they would win but I can see a few Republican Senators looking at 2024 voting for it.
Personally, I think their main aim is to keep the issue in the spotlight rather than fade away, and then hope something comes else out in the same nature as the Hunter Biden investigation. They still wouldn't win but it would tar Biden's Presidency.
I think that's absolutely right.
It's not a zero risk strategy though for the Republicans. Indeed, it's a bit of a "this'll help me in the Primaries" play that may dent the Republicans chances in the midterms. Especially as Biden is likely to get a little bit of an economic tailwind from CV19 fading into the distance.
It could also be to energise the base for the Georgia Senate elections as well, although it's a double-edged sword.
Re the economic tailwind, I'm inclining more and more to the view the next 18 months will be tough because the damage caused has been so great and because - unless there is 100% faith in the vaccines and their efficiency - consumers and small businesses may be fearful of spending in case there is another outbreak. I hope I am wrong (for the sake of the US) but I am a bit more gloomy.
I think I might pass. I'm depressed enough as it is.
The link did not work for me, but then I am not signed up to Parler.
apologies - It's not a link - it's a twitter address. It won't depress you - it's documenting people on Parler's meltdowns as they meet the real world.
Maybe they'll wait till, oh, the 23rd and then announce Christmas is off, for maximum lolz.
Eid was crasser than that, wasn't it?
We'll get to December 24th, a large chunk of the nation will be halfway to where they were going... and then people will be told to Remain Indoors.
2020 must be the first year in a decade that I've not set foot in a mosque.
I am way ahead of you on that one
Ah but I'm a good* Muslim.
*If you ignore my constant gambling and whoring.
Have you embraced Bacon Butties or is that still beyond the pale? (You can always take the 5th on that question )
Back in my days of cultural innocence. I cooked my new Muslim neighbour a lovely pork chop dinner. He laughed, handed me the chop and ate everything else whilst enlightening me to my blunder over beer and wine....
Does anyone have any idea why the EU has not approved the Pfizer vaccine?
They are following the procedures for 'provisional' authorisation, which are more onerous and take longer than those required for the 'emergency' authorisation we used.
Seems pretty daft to me - if this isn't an emergency, what is? They'll have lost a month.
The delay will cost lives, clearly the vaccine is safe, Covid in old and ill people is deadly. Its complete madness.
It looks to me that the difference between the UK and the EU is in the management of adverse effects. The Pfizer vaccine is safe to use in general, but there will be a small proportion of adverse effects, allergies and so on. The EU wants a proper management and reporting plan in place before giving the go-ahead; the UK will deal with these as ad-hoc events. Arguably, the UK and other countries get a free ride from the EU doing this work, but actually it's fine. Vaccines are an international effort.
A management plan surely can be devised months in advance. Why wait until the vaccine has been submitted?
I think the risk management plan can only be fully fleshed out once the basis for the decision it's safe to use is fully determined. Any authorisation is conditional on the attributes of the drug. Background infohere.
I should also say that while the UK will benefit from the EU's risk management plans, these in turn will be informed by early data from the UK rollout.
The attributes of the drug being the results of the phase three trials, not some management plan that could be planned for months in advance.
Not necessarily. You can't assess the risks unless you know what the risks are. If you get the basic authorisation out the way as soon as possible, that assessment will follow on after.
Anyway this is the set of bullet points that the EMA identify as the difference between Emergency Use Authorisation (under which the UK has released the Pfizer vaccine) and the full EMA authorisation:
info on the group of people to be given the vaccine;
the vaccine's pharmaceutical quality and purity;
manufacturing and controls of batches;
compliance with international requirements for laboratory testing and conduct of clinical trials;
types of immune responses;
side effects e.g. with regard to older people, or pregnant women;
labelling and package leaflet;
the way risks will be managed and monitored once the vaccine is authorised.
Reference the link above.
I think risk assessment is highly overrated, particularly where risks cannot be calculated with high degrees of precision or confidence. Risk management does not rely upon risk calculation, but on hazard identification, and upon eliminating or mitigating down to acceptable levels the impacts of the risks associated with those hazards.
That list identifies hazards. You don't need to calculate the risks to put in place risk controls for them.
Possibly. I think effects on pregnant women are worth knowing, given they are vaccinating women of childbearing age from the off. Also it's worth knowing if there are age-specific risks, given the main demographic for this vaccine. And these plus other emerging risks will feed into those plans.
Basically the EMA is going through more hoops. Is it worth it, bearing in mind speed is of the essence? I don't think there is an objective answer to that. My impression is that Germany in particular changed its mind on going with Emergency Authorisation and decided to wait for full authorisation. I can guess their reasons for doing so are (1) that Germany (and some other European counties) have high levels of vaccine sceptics, so any shortcuts to the process will be jumped on, and (2) it won't make much difference to the speed of immunisation given Christmas and a relatively low initial availability of the vaccine, so why not wait a couple of weeks and do it properly?
Are there many pregnant 80+ women out there?
And "doing it properly", implying the process other countries have gone through is not proper.
As far as priority vaccinations go there are probably many pregnant women who work in care homes or the NHS.
Does anyone have any idea why the EU has not approved the Pfizer vaccine?
They are following the procedures for 'provisional' authorisation, which are more onerous and take longer than those required for the 'emergency' authorisation we used.
Seems pretty daft to me - if this isn't an emergency, what is? They'll have lost a month.
The delay will cost lives, clearly the vaccine is safe, Covid in old and ill people is deadly. Its complete madness.
It looks to me that the difference between the UK and the EU is in the management of adverse effects. The Pfizer vaccine is safe to use in general, but there will be a small proportion of adverse effects, allergies and so on. The EU wants a proper management and reporting plan in place before giving the go-ahead; the UK will deal with these as ad-hoc events. Arguably, the UK and other countries get a free ride from the EU doing this work, but actually it's fine. Vaccines are an international effort.
No, the EU gets a free ride by being slow because there will be actual events in the UK, Canada and the US over the next couple of months. Are you so deluded that you can't admit that the EU has ever made a mistake?
Does anyone have any idea why the EU has not approved the Pfizer vaccine?
They are following the procedures for 'provisional' authorisation, which are more onerous and take longer than those required for the 'emergency' authorisation we used.
Seems pretty daft to me - if this isn't an emergency, what is? They'll have lost a month.
The delay will cost lives, clearly the vaccine is safe, Covid in old and ill people is deadly. Its complete madness.
It looks to me that the difference between the UK and the EU is in the management of adverse effects. The Pfizer vaccine is safe to use in general, but there will be a small proportion of adverse effects, allergies and so on. The EU wants a proper management and reporting plan in place before giving the go-ahead; the UK will deal with these as ad-hoc events. Arguably, the UK and other countries get a free ride from the EU doing this work, but actually it's fine. Vaccines are an international effort.
A management plan surely can be devised months in advance. Why wait until the vaccine has been submitted?
I think the risk management plan can only be fully fleshed out once the basis for the decision it's safe to use is fully determined. Any authorisation is conditional on the attributes of the drug. Background infohere.
I should also say that while the UK will benefit from the EU's risk management plans, these in turn will be informed by early data from the UK rollout.
The attributes of the drug being the results of the phase three trials, not some management plan that could be planned for months in advance.
Not necessarily. You can't assess the risks unless you know what the risks are. If you get the basic authorisation out the way as soon as possible, that assessment will follow on after.
Anyway this is the set of bullet points that the EMA identify as the difference between Emergency Use Authorisation (under which the UK has released the Pfizer vaccine) and the full EMA authorisation:
info on the group of people to be given the vaccine;
the vaccine's pharmaceutical quality and purity;
manufacturing and controls of batches;
compliance with international requirements for laboratory testing and conduct of clinical trials;
types of immune responses;
side effects e.g. with regard to older people, or pregnant women;
labelling and package leaflet;
the way risks will be managed and monitored once the vaccine is authorised.
Reference the link above.
I think risk assessment is highly overrated, particularly where risks cannot be calculated with high degrees of precision or confidence. Risk management does not rely upon risk calculation, but on hazard identification, and upon eliminating or mitigating down to acceptable levels the impacts of the risks associated with those hazards.
That list identifies hazards. You don't need to calculate the risks to put in place risk controls for them.
Possibly. I think effects on pregnant women are worth knowing, given they are vaccinating women of childbearing age from the off. Also it's worth knowing if there are age-specific risks, given the main demographic for this vaccine. And these plus other emerging risks will feed into those plans.
Basically the EMA is going through more hoops. Is it worth it, bearing in mind speed is of the essence? I don't think there is an objective answer to that. My impression is that Germany in particular changed its mind on going with Emergency Authorisation and decided to wait for full authorisation. I can guess their reasons for doing so are (1) that Germany (and some other European counties) have high levels of vaccine sceptics, so any shortcuts to the process will be jumped on, and (2) it won't make much difference to the speed of immunisation given Christmas and a relatively low initial availability of the vaccine, so why not wait a couple of weeks and do it properly?
Are there many pregnant 80+ women out there?
And "doing it properly", implying the process other countries have gone through is not proper.
The process in some other countries has not been as thorough as it should be. Given the pandemic, it is reasonable to claim speed is more important then thoroughness, but it is a judgement call.
Does anyone have any idea why the EU has not approved the Pfizer vaccine?
They are following the procedures for 'provisional' authorisation, which are more onerous and take longer than those required for the 'emergency' authorisation we used.
Seems pretty daft to me - if this isn't an emergency, what is? They'll have lost a month.
The delay will cost lives, clearly the vaccine is safe, Covid in old and ill people is deadly. Its complete madness.
It looks to me that the difference between the UK and the EU is in the management of adverse effects. The Pfizer vaccine is safe to use in general, but there will be a small proportion of adverse effects, allergies and so on. The EU wants a proper management and reporting plan in place before giving the go-ahead; the UK will deal with these as ad-hoc events. Arguably, the UK and other countries get a free ride from the EU doing this work, but actually it's fine. Vaccines are an international effort.
A management plan surely can be devised months in advance. Why wait until the vaccine has been submitted?
I think the risk management plan can only be fully fleshed out once the basis for the decision it's safe to use is fully determined. Any authorisation is conditional on the attributes of the drug. Background infohere.
I should also say that while the UK will benefit from the EU's risk management plans, these in turn will be informed by early data from the UK rollout.
The attributes of the drug being the results of the phase three trials, not some management plan that could be planned for months in advance.
Not necessarily. You can't assess the risks unless you know what the risks are. If you get the basic authorisation out the way as soon as possible, that assessment will follow on after.
Anyway this is the set of bullet points that the EMA identify as the difference between Emergency Use Authorisation (under which the UK has released the Pfizer vaccine) and the full EMA authorisation:
info on the group of people to be given the vaccine;
the vaccine's pharmaceutical quality and purity;
manufacturing and controls of batches;
compliance with international requirements for laboratory testing and conduct of clinical trials;
types of immune responses;
side effects e.g. with regard to older people, or pregnant women;
labelling and package leaflet;
the way risks will be managed and monitored once the vaccine is authorised.
Reference the link above.
I think risk assessment is highly overrated, particularly where risks cannot be calculated with high degrees of precision or confidence. Risk management does not rely upon risk calculation, but on hazard identification, and upon eliminating or mitigating down to acceptable levels the impacts of the risks associated with those hazards.
That list identifies hazards. You don't need to calculate the risks to put in place risk controls for them.
Possibly. I think effects on pregnant women are worth knowing, given they are vaccinating women of childbearing age from the off. Also it's worth knowing if there are age-specific risks, given the main demographic for this vaccine. And these plus other emerging risks will feed into those plans.
Basically the EMA is going through more hoops. Is it worth it, bearing in mind speed is of the essence? I don't think there is an objective answer to that. My impression is that Germany in particular changed its mind on going with Emergency Authorisation and decided to wait for full authorisation. I can guess their reasons for doing so are (1) that Germany (and some other European counties) have high levels of vaccine sceptics, so any shortcuts to the process will be jumped on, and (2) it won't make much difference to the speed of immunisation given Christmas and a relatively low initial availability of the vaccine, so why not wait a couple of weeks and do it properly?
Are there many pregnant 80+ women out there?
And "doing it properly", implying the process other countries have gone through is not proper.
As far as priority vaccinations go there are probably many pregnant women who work in care homes or the NHS.
Admittedly true, but the vaccine can be authorised for use on a subset of people. It doesn't need to be held up until absolutely everyone can have it.
Reports tonight that Merkel is in some difficulty especially over the delay in the vaccine while apparently the first German to be vaccinated has been in the UK
Europe is in a gathering crisis as member states see the roll out of the vaccine both here, in Canada and the US but not in the EU
I think the virus is spreading via aerosolised form in pubs and restaurants.
I think it is the shops.
Thought about going to Sheffield city centre today, saw the crowds, and went back home.
On the island we seem to have the problem of people from Tier two Portsmouth making day trips on the catamaran and hovercraft to go shopping and boozing. If you look at the map the only sub zone that figures for cases now is Ryde, where they dock.
Does anyone have any idea why the EU has not approved the Pfizer vaccine?
They are following the procedures for 'provisional' authorisation, which are more onerous and take longer than those required for the 'emergency' authorisation we used.
Seems pretty daft to me - if this isn't an emergency, what is? They'll have lost a month.
The delay will cost lives, clearly the vaccine is safe, Covid in old and ill people is deadly. Its complete madness.
It looks to me that the difference between the UK and the EU is in the management of adverse effects. The Pfizer vaccine is safe to use in general, but there will be a small proportion of adverse effects, allergies and so on. The EU wants a proper management and reporting plan in place before giving the go-ahead; the UK will deal with these as ad-hoc events. Arguably, the UK and other countries get a free ride from the EU doing this work, but actually it's fine. Vaccines are an international effort.
A management plan surely can be devised months in advance. Why wait until the vaccine has been submitted?
I think the risk management plan can only be fully fleshed out once the basis for the decision it's safe to use is fully determined. Any authorisation is conditional on the attributes of the drug. Background infohere.
I should also say that while the UK will benefit from the EU's risk management plans, these in turn will be informed by early data from the UK rollout.
The attributes of the drug being the results of the phase three trials, not some management plan that could be planned for months in advance.
Not necessarily. You can't assess the risks unless you know what the risks are. If you get the basic authorisation out the way as soon as possible, that assessment will follow on after.
Anyway this is the set of bullet points that the EMA identify as the difference between Emergency Use Authorisation (under which the UK has released the Pfizer vaccine) and the full EMA authorisation:
info on the group of people to be given the vaccine;
the vaccine's pharmaceutical quality and purity;
manufacturing and controls of batches;
compliance with international requirements for laboratory testing and conduct of clinical trials;
types of immune responses;
side effects e.g. with regard to older people, or pregnant women;
labelling and package leaflet;
the way risks will be managed and monitored once the vaccine is authorised.
Reference the link above.
I think risk assessment is highly overrated, particularly where risks cannot be calculated with high degrees of precision or confidence. Risk management does not rely upon risk calculation, but on hazard identification, and upon eliminating or mitigating down to acceptable levels the impacts of the risks associated with those hazards.
That list identifies hazards. You don't need to calculate the risks to put in place risk controls for them.
Possibly. I think effects on pregnant women are worth knowing, given they are vaccinating women of childbearing age from the off. Also it's worth knowing if there are age-specific risks, given the main demographic for this vaccine. And these plus other emerging risks will feed into those plans.
Basically the EMA is going through more hoops. Is it worth it, bearing in mind speed is of the essence? I don't think there is an objective answer to that. My impression is that Germany in particular changed its mind on going with Emergency Authorisation and decided to wait for full authorisation. I can guess their reasons for doing so are (1) that Germany (and some other European counties) have high levels of vaccine sceptics, so any shortcuts to the process will be jumped on, and (2) it won't make much difference to the speed of immunisation given Christmas and a relatively low initial availability of the vaccine, so why not wait a couple of weeks and do it properly?
Are there many pregnant 80+ women out there?
And "doing it properly", implying the process other countries have gone through is not proper.
The process in some other countries has not been as thorough as it should be. Given the pandemic, it is reasonable to claim speed is more important then thoroughness, but it is a judgement call.
Thee requirements laid down in the law regarding use authorisation were not met?
Does anyone have any idea why the EU has not approved the Pfizer vaccine?
They are following the procedures for 'provisional' authorisation, which are more onerous and take longer than those required for the 'emergency' authorisation we used.
Seems pretty daft to me - if this isn't an emergency, what is? They'll have lost a month.
The delay will cost lives, clearly the vaccine is safe, Covid in old and ill people is deadly. Its complete madness.
It looks to me that the difference between the UK and the EU is in the management of adverse effects. The Pfizer vaccine is safe to use in general, but there will be a small proportion of adverse effects, allergies and so on. The EU wants a proper management and reporting plan in place before giving the go-ahead; the UK will deal with these as ad-hoc events. Arguably, the UK and other countries get a free ride from the EU doing this work, but actually it's fine. Vaccines are an international effort.
A management plan surely can be devised months in advance. Why wait until the vaccine has been submitted?
I think the risk management plan can only be fully fleshed out once the basis for the decision it's safe to use is fully determined. Any authorisation is conditional on the attributes of the drug. Background infohere.
I should also say that while the UK will benefit from the EU's risk management plans, these in turn will be informed by early data from the UK rollout.
The attributes of the drug being the results of the phase three trials, not some management plan that could be planned for months in advance.
Not necessarily. You can't assess the risks unless you know what the risks are. If you get the basic authorisation out the way as soon as possible, that assessment will follow on after.
Anyway this is the set of bullet points that the EMA identify as the difference between Emergency Use Authorisation (under which the UK has released the Pfizer vaccine) and the full EMA authorisation:
info on the group of people to be given the vaccine;
the vaccine's pharmaceutical quality and purity;
manufacturing and controls of batches;
compliance with international requirements for laboratory testing and conduct of clinical trials;
types of immune responses;
side effects e.g. with regard to older people, or pregnant women;
labelling and package leaflet;
the way risks will be managed and monitored once the vaccine is authorised.
Reference the link above.
I think risk assessment is highly overrated, particularly where risks cannot be calculated with high degrees of precision or confidence. Risk management does not rely upon risk calculation, but on hazard identification, and upon eliminating or mitigating down to acceptable levels the impacts of the risks associated with those hazards.
That list identifies hazards. You don't need to calculate the risks to put in place risk controls for them.
Possibly. I think effects on pregnant women are worth knowing, given they are vaccinating women of childbearing age from the off. Also it's worth knowing if there are age-specific risks, given the main demographic for this vaccine. And these plus other emerging risks will feed into those plans.
Basically the EMA is going through more hoops. Is it worth it, bearing in mind speed is of the essence? I don't think there is an objective answer to that. My impression is that Germany in particular changed its mind on going with Emergency Authorisation and decided to wait for full authorisation. I can guess their reasons for doing so are (1) that Germany (and some other European counties) have high levels of vaccine sceptics, so any shortcuts to the process will be jumped on, and (2) it won't make much difference to the speed of immunisation given Christmas and a relatively low initial availability of the vaccine, so why not wait a couple of weeks and do it properly?
Are there many pregnant 80+ women out there?
And "doing it properly", implying the process other countries have gone through is not proper.
Healthcare workers are being vaccinated in this round and may potentially be going through pregnancy. MHRA exclude women who are knowingly pregnant from their authorisation, but it would be good to know what the effects are, just in case. Ostensibly that's a difference between the two authorisations.
"Doing it properly". The EMA is doing more, but is it necessary? That's not a fully objective decision in my view. Personally, I am happy to get vaccinated on the MHRA authorisation, but no public health policy will be accepted by the public on my risk appetite or those of politicians etc. If the public require a gold plated authorisation instead of a silver plated good-enough authorisation, you will go for the gold.
Reports tonight that Merkel is in some difficulty especially over the delay in the vaccine while apparently the first German to be vaccinated has been in the UK
Europe is in a gathering crisis as member states see the roll out of the vaccine both here, in Canada and the US but not in the EU
It'll be even more of a crisis when they spend months authorising a vaccine for which they have millions of vials ready to be distributed, unlike for Pfizer.
Also need to consider keeping schools 'online only' for first half term 2021 ie up to late Feb, I know it's not ideal.
We might as well just give up and tell everyone to repeat the academic year.
I do expect the government to announce that A Levels / GCSEs for 2021 will be assessed purely on teachers assessment/coursework in due course even though they won't say that at the moment. On that basis the loss of the 6 weeks to Feb 2021 should not make too much difference.
It's more the actual cumulative disruption on the education itself that concerns me than it is the effect on the examination element, particularly for increasingly younger kids.
Yes a fair call. The spread of infection appears to be a greater problem in the secondary schools, perhaps leave the primary schools open?
But it's not ideal.
Yeah it's probably the least worst compromise outcome, although I get the feeling that once the secondary schools shut the teachers in the primary schools are not going to quietly just carry on themselves. But I'm very likely doing them a massive disservice.
Does anyone have any idea why the EU has not approved the Pfizer vaccine?
They are following the procedures for 'provisional' authorisation, which are more onerous and take longer than those required for the 'emergency' authorisation we used.
Seems pretty daft to me - if this isn't an emergency, what is? They'll have lost a month.
The delay will cost lives, clearly the vaccine is safe, Covid in old and ill people is deadly. Its complete madness.
It looks to me that the difference between the UK and the EU is in the management of adverse effects. The Pfizer vaccine is safe to use in general, but there will be a small proportion of adverse effects, allergies and so on. The EU wants a proper management and reporting plan in place before giving the go-ahead; the UK will deal with these as ad-hoc events. Arguably, the UK and other countries get a free ride from the EU doing this work, but actually it's fine. Vaccines are an international effort.
A management plan surely can be devised months in advance. Why wait until the vaccine has been submitted?
I think the risk management plan can only be fully fleshed out once the basis for the decision it's safe to use is fully determined. Any authorisation is conditional on the attributes of the drug. Background infohere.
I should also say that while the UK will benefit from the EU's risk management plans, these in turn will be informed by early data from the UK rollout.
The attributes of the drug being the results of the phase three trials, not some management plan that could be planned for months in advance.
Not necessarily. You can't assess the risks unless you know what the risks are. If you get the basic authorisation out the way as soon as possible, that assessment will follow on after.
Anyway this is the set of bullet points that the EMA identify as the difference between Emergency Use Authorisation (under which the UK has released the Pfizer vaccine) and the full EMA authorisation:
info on the group of people to be given the vaccine;
the vaccine's pharmaceutical quality and purity;
manufacturing and controls of batches;
compliance with international requirements for laboratory testing and conduct of clinical trials;
types of immune responses;
side effects e.g. with regard to older people, or pregnant women;
labelling and package leaflet;
the way risks will be managed and monitored once the vaccine is authorised.
Reference the link above.
I think risk assessment is highly overrated, particularly where risks cannot be calculated with high degrees of precision or confidence. Risk management does not rely upon risk calculation, but on hazard identification, and upon eliminating or mitigating down to acceptable levels the impacts of the risks associated with those hazards.
That list identifies hazards. You don't need to calculate the risks to put in place risk controls for them.
Possibly. I think effects on pregnant women are worth knowing, given they are vaccinating women of childbearing age from the off. Also it's worth knowing if there are age-specific risks, given the main demographic for this vaccine. And these plus other emerging risks will feed into those plans.
Basically the EMA is going through more hoops. Is it worth it, bearing in mind speed is of the essence? I don't think there is an objective answer to that. My impression is that Germany in particular changed its mind on going with Emergency Authorisation and decided to wait for full authorisation. I can guess their reasons for doing so are (1) that Germany (and some other European counties) have high levels of vaccine sceptics, so any shortcuts to the process will be jumped on, and (2) it won't make much difference to the speed of immunisation given Christmas and a relatively low initial availability of the vaccine, so why not wait a couple of weeks and do it properly?
Are there many pregnant 80+ women out there?
And "doing it properly", implying the process other countries have gone through is not proper.
Healthcare workers are being vaccinated in this round and may potentially be going through pregnancy. MHRA exclude women who are knowingly pregnant from their authorisation, but it would be good to know what the effects are, just in case. Ostensibly that's a difference between the two authorisations.
"Doing it properly". The EMA is doing more, but is it necessary? That's not a fully objective decision in my view. Personally, I am happy to get vaccinated on the MHRA authorisation, but no public health policy will be accepted by the public on my risk appetite or those of politicians etc. If the public require a gold plated authorisation instead of a silver plated good-enough authorisation, you will go for the gold.
That's a stupid reason to delay the roll out. Just don't vaccinate pregnant women in the first round.
Also need to consider keeping schools 'online only' for first half term 2021 ie up to late Feb, I know it's not ideal.
We might as well just give up and tell everyone to repeat the academic year.
I do expect the government to announce that A Levels / GCSEs for 2021 will be assessed purely on teachers assessment/coursework in due course even though they won't say that at the moment. On that basis the loss of the 6 weeks to Feb 2021 should not make too much difference.
It's more the actual cumulative disruption on the education itself that concerns me than it is the effect on the examination element, particularly for increasingly younger kids.
Yes a fair call. The spread of infection appears to be a greater problem in the secondary schools, perhaps leave the primary schools open?
If you really believed that Betfair have now changed their market to be the actual next president, and were allowed to do so, then surely it wouldn't be possible to make 37 million quid by betting on Nancy Pelosi. She and Kamala Harris would be making up all the spare possibility rather than Trump (I'm assuming that that the House would not permit Trump, which seems more like a trillion to one possibility).
The problem is, John, that if Betfair are not prepared to settle in accordance with their published rules how do you know who they will settle on and why?
They are making it up as they go along. You could have a very good bet on Nancy Pelosi, for example, only to find they have alighted on a completely different basis for settling.
I see where you are coming from, and you are making sense. Betfair are not. You would be risking money with a capricious market maker.
My advice is that if you try to exploit their unpredictability, keep your stakes small and be prepared for disappointment.
It’s more than making it up as they go along - they have changed wholesale the basis on which they said they’d settle the market. There is zero case for them not to settle tomorrow. The winner is more than just projected; the winner has been declared by the electoral college
They put in their terms that death wouldn't affect the market and then as soon as Trump fell ill they suspended the market.
And the winning party market, after I had smugly warned people to bet on that instead of the Next President market.
If you really believed that Betfair have now changed their market to be the actual next president, and were allowed to do so, then surely it wouldn't be possible to make 37 million quid by betting on Nancy Pelosi. She and Kamala Harris would be making up all the spare possibility rather than Trump (I'm assuming that that the House would not permit Trump, which seems more like a trillion to one possibility).
If you really believed that Betfair have now changed their market to be the actual next president, and were allowed to do so, then surely it wouldn't be possible to make 37 million quid by betting on Nancy Pelosi. She and Kamala Harris would be making up all the spare possibility rather than Trump (I'm assuming that that the House would not permit Trump, which seems more like a trillion to one possibility).
The problem is, John, that if Betfair are not prepared to settle in accordance with their published rules how do you know who they will settle on and why?
They are making it up as they go along. You could have a very good bet on Nancy Pelosi, for example, only to find they have alighted on a completely different basis for settling.
I see where you are coming from, and you are making sense. Betfair are not. You would be risking money with a capricious market maker.
My advice is that if you try to exploit their unpredictability, keep your stakes small and be prepared for disappointment.
It’s more than making it up as they go along - they have changed wholesale the basis on which they said they’d settle the market. There is zero case for them not to settle tomorrow. The winner is more than just projected; the winner has been declared by the electoral college
They put in their terms that death wouldn't affect the market and then as soon as Trump fell ill they suspended the market.
And the winning party market, after I had smugly warned people to bet on that instead of the Next President market.
If you really believed that Betfair have now changed their market to be the actual next president, and were allowed to do so, then surely it wouldn't be possible to make 37 million quid by betting on Nancy Pelosi. She and Kamala Harris would be making up all the spare possibility rather than Trump (I'm assuming that that the House would not permit Trump, which seems more like a trillion to one possibility).
If you really believed that Betfair have now changed their market to be the actual next president, and were allowed to do so, then surely it wouldn't be possible to make 37 million quid by betting on Nancy Pelosi. She and Kamala Harris would be making up all the spare possibility rather than Trump (I'm assuming that that the House would not permit Trump, which seems more like a trillion to one possibility).
The problem is, John, that if Betfair are not prepared to settle in accordance with their published rules how do you know who they will settle on and why?
They are making it up as they go along. You could have a very good bet on Nancy Pelosi, for example, only to find they have alighted on a completely different basis for settling.
I see where you are coming from, and you are making sense. Betfair are not. You would be risking money with a capricious market maker.
My advice is that if you try to exploit their unpredictability, keep your stakes small and be prepared for disappointment.
It’s more than making it up as they go along - they have changed wholesale the basis on which they said they’d settle the market. There is zero case for them not to settle tomorrow. The winner is more than just projected; the winner has been declared by the electoral college
They put in their terms that death wouldn't affect the market and then as soon as Trump fell ill they suspended the market.
And the winning party market, after I had smugly warned people to bet on that instead of the Next President market.
Still furious about that.
It is further evidence, if any were needed, that the current farce is due to incompetence rather than scheming or mischief-making.
It is however incompetence on an epic scale and if the chat on Betfair Community is anything to go by the number of customers they are going to lose may be significant.
I would be shocked if Johnson rowed back on Christmas. His libertarian instincts would make cancelling Christmas a big ask.
Who says anything about cancelling it? Smaller, yes. And a good excuse not to have the in-laws around.
I think Boris will stick with the Christmas arrangements although on the face of it, it is not a good idea.
A lot of people will be minimising arrangements, well within the guidance.
I am expecting a lockdown from 28 Dec, harder than the one we have just had, and we may need to keep it in place until end Feb. By end Feb hopefully a large proportion of the 65+ will have had their second vaccine so the exposure to deaths/hospitalisations will be much lower from March.
Also need to consider keeping schools 'online only' for first half term 2021 ie up to late Feb, I know it's not ideal.
There is not a politician in the land who is in charge and who is willing to close schools.
It is insane shibboleth. Secondary teachers are close to total revolt.
I think the virus is spreading via aerosolised form in pubs and restaurants.
I think it is the shops.
Thought about going to Sheffield city centre today, saw the crowds, and went back home.
I think it is shops too, primarily because they are one of the few places people can actually go to when they aren't working.
Anecdata from my region was that when another region nearby was in tier 4 and the shops were shut (non-essential excepted), the shopping centres in my tier 3 area was considerably busier, as folk basically travelled to where the open shops were. Not hugely surprising, but, y'know.
Does anyone have any idea why the EU has not approved the Pfizer vaccine?
They are following the procedures for 'provisional' authorisation, which are more onerous and take longer than those required for the 'emergency' authorisation we used.
Seems pretty daft to me - if this isn't an emergency, what is? They'll have lost a month.
The delay will cost lives, clearly the vaccine is safe, Covid in old and ill people is deadly. Its complete madness.
It looks to me that the difference between the UK and the EU is in the management of adverse effects. The Pfizer vaccine is safe to use in general, but there will be a small proportion of adverse effects, allergies and so on. The EU wants a proper management and reporting plan in place before giving the go-ahead; the UK will deal with these as ad-hoc events. Arguably, the UK and other countries get a free ride from the EU doing this work, but actually it's fine. Vaccines are an international effort.
A management plan surely can be devised months in advance. Why wait until the vaccine has been submitted?
I think the risk management plan can only be fully fleshed out once the basis for the decision it's safe to use is fully determined. Any authorisation is conditional on the attributes of the drug. Background infohere.
I should also say that while the UK will benefit from the EU's risk management plans, these in turn will be informed by early data from the UK rollout.
The attributes of the drug being the results of the phase three trials, not some management plan that could be planned for months in advance.
Not necessarily. You can't assess the risks unless you know what the risks are. If you get the basic authorisation out the way as soon as possible, that assessment will follow on after.
Anyway this is the set of bullet points that the EMA identify as the difference between Emergency Use Authorisation (under which the UK has released the Pfizer vaccine) and the full EMA authorisation:
info on the group of people to be given the vaccine;
the vaccine's pharmaceutical quality and purity;
manufacturing and controls of batches;
compliance with international requirements for laboratory testing and conduct of clinical trials;
types of immune responses;
side effects e.g. with regard to older people, or pregnant women;
labelling and package leaflet;
the way risks will be managed and monitored once the vaccine is authorised.
Reference the link above.
I think risk assessment is highly overrated, particularly where risks cannot be calculated with high degrees of precision or confidence. Risk management does not rely upon risk calculation, but on hazard identification, and upon eliminating or mitigating down to acceptable levels the impacts of the risks associated with those hazards.
That list identifies hazards. You don't need to calculate the risks to put in place risk controls for them.
Possibly. I think effects on pregnant women are worth knowing, given they are vaccinating women of childbearing age from the off. Also it's worth knowing if there are age-specific risks, given the main demographic for this vaccine. And these plus other emerging risks will feed into those plans.
Basically the EMA is going through more hoops. Is it worth it, bearing in mind speed is of the essence? I don't think there is an objective answer to that. My impression is that Germany in particular changed its mind on going with Emergency Authorisation and decided to wait for full authorisation. I can guess their reasons for doing so are (1) that Germany (and some other European counties) have high levels of vaccine sceptics, so any shortcuts to the process will be jumped on, and (2) it won't make much difference to the speed of immunisation given Christmas and a relatively low initial availability of the vaccine, so why not wait a couple of weeks and do it properly?
So the UK is kindly running a phase 4 trial for the EU?
It is. While the UK will benefit from the EU's risk management plans, these in turn will be informed by early data from the UK rollout. Vaccines are an international effort.
I would be shocked if Johnson rowed back on Christmas. His libertarian instincts would make cancelling Christmas a big ask.
Who says anything about cancelling it? Smaller, yes. And a good excuse not to have the in-laws around.
I think Boris will stick with the Christmas arrangements although on the face of it, it is not a good idea.
A lot of people will be minimising arrangements, well within the guidance.
I am expecting a lockdown from 28 Dec, harder than the one we have just had, and we may need to keep it in place until end Feb. By end Feb hopefully a large proportion of the 65+ will have had their second vaccine so the exposure to deaths/hospitalisations will be much lower from March.
Also need to consider keeping schools 'online only' for first half term 2021 ie up to late Feb, I know it's not ideal.
There is not a politician in the land who is in charge and who is willing to close schools.
It is insane shibboleth. Secondary teachers are close to total revolt.
It's one of those inconvienient truths that the virus spreads very nicely indeed round schools.
Also need to consider keeping schools 'online only' for first half term 2021 ie up to late Feb, I know it's not ideal.
We might as well just give up and tell everyone to repeat the academic year.
I do expect the government to announce that A Levels / GCSEs for 2021 will be assessed purely on teachers assessment/coursework in due course even though they won't say that at the moment. On that basis the loss of the 6 weeks to Feb 2021 should not make too much difference.
It's more the actual cumulative disruption on the education itself that concerns me than it is the effect on the examination element, particularly for increasingly younger kids.
Yes a fair call. The spread of infection appears to be a greater problem in the secondary schools, perhaps leave the primary schools open?
But it's not ideal.
Yeah it's probably the least worst compromise outcome, although I get the feeling that once the secondary schools shut the teachers in the primary schools are not going to quietly just carry on themselves. But I'm very likely doing them a massive disservice.
I think they would as long as they were not expected to teach full classes. If there was some kind of rolling system, or secondary teachers were drafted in to help primaries (which could be managed in academy chains) I don’t think they would object.
Bear in mind, we all went into teaching to teach. But this term has been horrible and ridiculous. Next half term will be worse, for many reasons, and the virus looks set to surge as well. I just do not see how this is sustainable. If they try, there will be even more teachers than normal quitting in the summer. We’ve already had multiple notices of retirement.
Does anyone have any idea why the EU has not approved the Pfizer vaccine?
They are following the procedures for 'provisional' authorisation, which are more onerous and take longer than those required for the 'emergency' authorisation we used.
Seems pretty daft to me - if this isn't an emergency, what is? They'll have lost a month.
The delay will cost lives, clearly the vaccine is safe, Covid in old and ill people is deadly. Its complete madness.
It looks to me that the difference between the UK and the EU is in the management of adverse effects. The Pfizer vaccine is safe to use in general, but there will be a small proportion of adverse effects, allergies and so on. The EU wants a proper management and reporting plan in place before giving the go-ahead; the UK will deal with these as ad-hoc events. Arguably, the UK and other countries get a free ride from the EU doing this work, but actually it's fine. Vaccines are an international effort.
A management plan surely can be devised months in advance. Why wait until the vaccine has been submitted?
I think the risk management plan can only be fully fleshed out once the basis for the decision it's safe to use is fully determined. Any authorisation is conditional on the attributes of the drug. Background infohere.
I should also say that while the UK will benefit from the EU's risk management plans, these in turn will be informed by early data from the UK rollout.
The attributes of the drug being the results of the phase three trials, not some management plan that could be planned for months in advance.
Not necessarily. You can't assess the risks unless you know what the risks are. If you get the basic authorisation out the way as soon as possible, that assessment will follow on after.
Anyway this is the set of bullet points that the EMA identify as the difference between Emergency Use Authorisation (under which the UK has released the Pfizer vaccine) and the full EMA authorisation:
info on the group of people to be given the vaccine;
the vaccine's pharmaceutical quality and purity;
manufacturing and controls of batches;
compliance with international requirements for laboratory testing and conduct of clinical trials;
types of immune responses;
side effects e.g. with regard to older people, or pregnant women;
labelling and package leaflet;
the way risks will be managed and monitored once the vaccine is authorised.
Reference the link above.
I think risk assessment is highly overrated, particularly where risks cannot be calculated with high degrees of precision or confidence. Risk management does not rely upon risk calculation, but on hazard identification, and upon eliminating or mitigating down to acceptable levels the impacts of the risks associated with those hazards.
That list identifies hazards. You don't need to calculate the risks to put in place risk controls for them.
Possibly. I think effects on pregnant women are worth knowing, given they are vaccinating women of childbearing age from the off. Also it's worth knowing if there are age-specific risks, given the main demographic for this vaccine. And these plus other emerging risks will feed into those plans.
Basically the EMA is going through more hoops. Is it worth it, bearing in mind speed is of the essence? I don't think there is an objective answer to that. My impression is that Germany in particular changed its mind on going with Emergency Authorisation and decided to wait for full authorisation. I can guess their reasons for doing so are (1) that Germany (and some other European counties) have high levels of vaccine sceptics, so any shortcuts to the process will be jumped on, and (2) it won't make much difference to the speed of immunisation given Christmas and a relatively low initial availability of the vaccine, so why not wait a couple of weeks and do it properly?
So the UK is kindly running a phase 4 trial for the EU?
It is. While the UK will benefit from the EU's risk management plans, these in turn will be informed by early data from the UK rollout. Vaccines are an international effort.
Pity in the meantime EU citizens lives are at risk as they delay the vaccination
Reports tonight that Merkel is in some difficulty especially over the delay in the vaccine while apparently the first German to be vaccinated has been in the UK
Europe is in a gathering crisis as member states see the roll out of the vaccine both here, in Canada and the US but not in the EU
Germany was largely untouched in the first wave. Their numbers in the second wave are going to be deeply unsettling as Germany has to come to terms with not having as much of a magic defence as it previously thought.
Maybe they'll wait till, oh, the 23rd and then announce Christmas is off, for maximum lolz.
Eid was crasser than that, wasn't it?
We'll get to December 24th, a large chunk of the nation will be halfway to where they were going... and then people will be told to Remain Indoors.
2020 must be the first year in a decade that I've not set foot in a mosque.
I am way ahead of you on that one
Ah but I'm a good* Muslim.
*If you ignore my constant gambling and whoring.
Have you embraced Bacon Butties or is that still beyond the pale? (You can always take the 5th on that question )
Back in my days of cultural innocence. I cooked my new Muslim neighbour a lovely pork chop dinner. He laughed, handed me the chop and ate everything else whilst enlightening me to my blunder over beer and wine....
As it happens I am about to donate a home baked bacon loaf to my ICU nurse neighbour as a treat for the pressure period over the next weeks.
Children are both veggies, so it makes sure she gets it .
I think the virus is spreading via aerosolised form in pubs and restaurants.
I think it is the shops.
Thought about going to Sheffield city centre today, saw the crowds, and went back home.
Pubs and restaurants have social distancing. Shops do not. Although offset against masks.
Pubs and restaurants also have the QR code thingy so if the virus is being spread there, it should have been detected. I've not seen anything on the news but then again, I've not looked. The restrictions do not make much sense. Why is eating a substantial meal prophylactic against booze-induced infection, and why only before 10pm or 6pm?
Shops do have social distancing, at least round here.
I think the virus is spreading via aerosolised form in pubs and restaurants.
I think it is the shops.
Thought about going to Sheffield city centre today, saw the crowds, and went back home.
Pubs and restaurants have social distancing. Shops do not. Although offset against masks.
I a shop if you are near to someone else it is not for long. In a pub or restaurant, you are sharing the same air with the staff and customers for one or two hours. So even if you are socially distancing, there is still a risk.
I would be shocked if Johnson rowed back on Christmas. His libertarian instincts would make cancelling Christmas a big ask.
Who says anything about cancelling it? Smaller, yes. And a good excuse not to have the in-laws around.
I think Boris will stick with the Christmas arrangements although on the face of it, it is not a good idea.
A lot of people will be minimising arrangements, well within the guidance.
I am expecting a lockdown from 28 Dec, harder than the one we have just had, and we may need to keep it in place until end Feb. By end Feb hopefully a large proportion of the 65+ will have had their second vaccine so the exposure to deaths/hospitalisations will be much lower from March.
Also need to consider keeping schools 'online only' for first half term 2021 ie up to late Feb, I know it's not ideal.
There is not a politician in the land who is in charge and who is willing to close schools.
It is insane shibboleth. Secondary teachers are close to total revolt.
What’s especially annoying is the blame us for things not working.
And then, when they cancel assessments and fail to put anything in place so we have another train crash, they will blame us for that.
I would be shocked if Johnson rowed back on Christmas. His libertarian instincts would make cancelling Christmas a big ask.
Who says anything about cancelling it? Smaller, yes. And a good excuse not to have the in-laws around.
I think Boris will stick with the Christmas arrangements although on the face of it, it is not a good idea.
A lot of people will be minimising arrangements, well within the guidance.
I am expecting a lockdown from 28 Dec, harder than the one we have just had, and we may need to keep it in place until end Feb. By end Feb hopefully a large proportion of the 65+ will have had their second vaccine so the exposure to deaths/hospitalisations will be much lower from March.
Also need to consider keeping schools 'online only' for first half term 2021 ie up to late Feb, I know it's not ideal.
There is not a politician in the land who is in charge and who is willing to close schools.
It is insane shibboleth. Secondary teachers are close to total revolt.
It's one of those inconvienient truths that the virus spreads very nicely indeed round schools.
I mean, it is fairly clear that Primary Schools are not super spreader locations but Secondary schools are just the pits.
The insane thing is that the secondary teachers I have spoken too are confident that the kids are getting a worse education being back full time than they would be 50/50 because the total lack of interaction the Covid restrictions bring just destroys the point of being in full time.
Also need to consider keeping schools 'online only' for first half term 2021 ie up to late Feb, I know it's not ideal.
We might as well just give up and tell everyone to repeat the academic year.
I do expect the government to announce that A Levels / GCSEs for 2021 will be assessed purely on teachers assessment/coursework in due course even though they won't say that at the moment. On that basis the loss of the 6 weeks to Feb 2021 should not make too much difference.
It's more the actual cumulative disruption on the education itself that concerns me than it is the effect on the examination element, particularly for increasingly younger kids.
Yes a fair call. The spread of infection appears to be a greater problem in the secondary schools, perhaps leave the primary schools open?
But it's not ideal.
Yeah it's probably the least worst compromise outcome, although I get the feeling that once the secondary schools shut the teachers in the primary schools are not going to quietly just carry on themselves. But I'm very likely doing them a massive disservice.
You do realise that closing the schools does not mean that the teachers stop working. If any thing they work longer because they have to chop and change between presence and online teaching at short notice.
I would be shocked if Johnson rowed back on Christmas. His libertarian instincts would make cancelling Christmas a big ask.
Who says anything about cancelling it? Smaller, yes. And a good excuse not to have the in-laws around.
I think Boris will stick with the Christmas arrangements although on the face of it, it is not a good idea.
A lot of people will be minimising arrangements, well within the guidance.
I am expecting a lockdown from 28 Dec, harder than the one we have just had, and we may need to keep it in place until end Feb. By end Feb hopefully a large proportion of the 65+ will have had their second vaccine so the exposure to deaths/hospitalisations will be much lower from March.
Also need to consider keeping schools 'online only' for first half term 2021 ie up to late Feb, I know it's not ideal.
There is not a politician in the land who is in charge and who is willing to close schools.
It is insane shibboleth. Secondary teachers are close to total revolt.
It's one of those inconvienient truths that the virus spreads very nicely indeed round schools.
Well, closing schools to keep the pubs open doesn't sound like a vote winner overall.
Of course, if closing everything else apart from essential shops isn't enough, secondary schools are next.
Also need to consider keeping schools 'online only' for first half term 2021 ie up to late Feb, I know it's not ideal.
We might as well just give up and tell everyone to repeat the academic year.
I do expect the government to announce that A Levels / GCSEs for 2021 will be assessed purely on teachers assessment/coursework in due course even though they won't say that at the moment. On that basis the loss of the 6 weeks to Feb 2021 should not make too much difference.
It's more the actual cumulative disruption on the education itself that concerns me than it is the effect on the examination element, particularly for increasingly younger kids.
Yes a fair call. The spread of infection appears to be a greater problem in the secondary schools, perhaps leave the primary schools open?
But it's not ideal.
Yeah it's probably the least worst compromise outcome, although I get the feeling that once the secondary schools shut the teachers in the primary schools are not going to quietly just carry on themselves. But I'm very likely doing them a massive disservice.
I think they would as long as they were not expected to teach full classes. If there was some kind of rolling system, or secondary teachers were drafted in to help primaries (which could be managed in academy chains) I don’t think they would object.
Bear in mind, we all went into teaching to teach. But this term has been horrible and ridiculous. Next half term will be worse, for many reasons, and the virus looks set to surge as well. I just do not see how this is sustainable. If they try, there will be even more teachers than normal quitting in the summer. We’ve already had multiple notices of retirement.
Also need to consider keeping schools 'online only' for first half term 2021 ie up to late Feb, I know it's not ideal.
We might as well just give up and tell everyone to repeat the academic year.
I do expect the government to announce that A Levels / GCSEs for 2021 will be assessed purely on teachers assessment/coursework in due course even though they won't say that at the moment. On that basis the loss of the 6 weeks to Feb 2021 should not make too much difference.
It's more the actual cumulative disruption on the education itself that concerns me than it is the effect on the examination element, particularly for increasingly younger kids.
Yes a fair call. The spread of infection appears to be a greater problem in the secondary schools, perhaps leave the primary schools open?
But it's not ideal.
Yeah it's probably the least worst compromise outcome, although I get the feeling that once the secondary schools shut the teachers in the primary schools are not going to quietly just carry on themselves. But I'm very likely doing them a massive disservice.
I think they would as long as they were not expected to teach full classes. If there was some kind of rolling system, or secondary teachers were drafted in to help primaries (which could be managed in academy chains) I don’t think they would object.
Bear in mind, we all went into teaching to teach. But this term has been horrible and ridiculous. Next half term will be worse, for many reasons, and the virus looks set to surge as well. I just do not see how this is sustainable. If they try, there will be even more teachers than normal quitting in the summer. We’ve already had multiple notices of retirement.
@ydoethur You always present reasonable alternatives and potential work-arounds to this issue, which is to your credit, and you are doing a difficult job in extremely trying circumstances. Your suggestions there are eminently sensible.
I think people would understand that kind of rationale. I think often the problem seems to be - intentionally or not, and may well be the issue is the media here rather than anything else - the school issue tends to become a binary "are they open or are they closed (hence "blended") learning", and no attempt to try and recover the lost time or consider alternative options ever seems to come from the discussion. The focus is always on the exams and not on somehow trying to recover the lost teaching time, especially when we can guess that for a significant proportion of kids "blended" learning or predominantly online learning equates to minimal or no learning.
But yes - I can imagine it's not the most appealing career right now!
I would be shocked if Johnson rowed back on Christmas. His libertarian instincts would make cancelling Christmas a big ask.
Who says anything about cancelling it? Smaller, yes. And a good excuse not to have the in-laws around.
I think Boris will stick with the Christmas arrangements although on the face of it, it is not a good idea.
A lot of people will be minimising arrangements, well within the guidance.
I am expecting a lockdown from 28 Dec, harder than the one we have just had, and we may need to keep it in place until end Feb. By end Feb hopefully a large proportion of the 65+ will have had their second vaccine so the exposure to deaths/hospitalisations will be much lower from March.
Also need to consider keeping schools 'online only' for first half term 2021 ie up to late Feb, I know it's not ideal.
There is not a politician in the land who is in charge and who is willing to close schools.
It is insane shibboleth. Secondary teachers are close to total revolt.
It's one of those inconvienient truths that the virus spreads very nicely indeed round schools.
I mean, it is fairly clear that Primary Schools are not super spreader locations but Secondary schools are just the pits.
The insane thing is that the secondary teachers I have spoken too are confident that the kids are getting a worse education being back full time than they would be 50/50 because the total lack of interaction the Covid restrictions bring just destroys the point of being in full time.
Not just that, but it’s a hell of a lot more disruptive. Far easier to put decent lessons online when you’re not trying to still teach half their classmates. Then they com back, the other half goes, you get chaos...
Just imagine if the Dems didn’t hold the House then effectively the election could have been stolen for Trump,.
The USA is in a terrible state where one party is becoming fascist and where the polarization makes the Brexit divide in the UK look like a love in .
How would it have been stolen had the GOP taken the House? The electoral votes would have been the same and the certification process would have just been a formality by the VP.
See here, if they had a majority in the House and Senate they could pull this off.
Trump Allies Eye Long-Shot Election Reversal in Congress, Testing Pence
Some House Republicans plan to try to use Congress’s tallying of electoral results on Jan. 6 to tip the election to President Trump. The attempt will put Republicans in a pinch.
Seems like the longest of long shots, especially with several GOP senators already saying they would never countenance such an idea.
No chance they would win but I can see a few Republican Senators looking at 2024 voting for it.
Personally, I think their main aim is to keep the issue in the spotlight rather than fade away, and then hope something comes else out in the same nature as the Hunter Biden investigation. They still wouldn't win but it would tar Biden's Presidency.
I think that's absolutely right.
It's not a zero risk strategy though for the Republicans. Indeed, it's a bit of a "this'll help me in the Primaries" play that may dent the Republicans chances in the midterms. Especially as Biden is likely to get a little bit of an economic tailwind from CV19 fading into the distance.
It could also be to energise the base for the Georgia Senate elections as well, although it's a double-edged sword.
Re the economic tailwind, I'm inclining more and more to the view the next 18 months will be tough because the damage caused has been so great and because - unless there is 100% faith in the vaccines and their efficiency - consumers and small businesses may be fearful of spending in case there is another outbreak. I hope I am wrong (for the sake of the US) but I am a bit more gloomy.
I think the virus is spreading via aerosolised form in pubs and restaurants.
I think it is the shops.
Thought about going to Sheffield city centre today, saw the crowds, and went back home.
Yes. I had to go into Boro a week last Saturday for non-Christmas shopping reasons. It was bloody horrible. Too many people, no distancing, patchy mask compliance. Nobody seemed to care.
Despite 2020 being a big pile of poo.... the premier league table is a joy to behold.
For now.
Thank you.
I'm trying to bet on the double.
Spurs win the PL and Arsenal get relegated.
Am I right in thinking Arsenal are the only club never to have been relegated from the current Premier League?
If we're talking the Premier League era post 92, Liverpool, Everton, Spurs and Man Utd are also ever presents. Arsenal are the only team never relegated since WW2, if my memory serves.
Does anyone have any idea why the EU has not approved the Pfizer vaccine?
They are following the procedures for 'provisional' authorisation, which are more onerous and take longer than those required for the 'emergency' authorisation we used.
Seems pretty daft to me - if this isn't an emergency, what is? They'll have lost a month.
The delay will cost lives, clearly the vaccine is safe, Covid in old and ill people is deadly. Its complete madness.
It looks to me that the difference between the UK and the EU is in the management of adverse effects. The Pfizer vaccine is safe to use in general, but there will be a small proportion of adverse effects, allergies and so on. The EU wants a proper management and reporting plan in place before giving the go-ahead; the UK will deal with these as ad-hoc events. Arguably, the UK and other countries get a free ride from the EU doing this work, but actually it's fine. Vaccines are an international effort.
A management plan surely can be devised months in advance. Why wait until the vaccine has been submitted?
I think the risk management plan can only be fully fleshed out once the basis for the decision it's safe to use is fully determined. Any authorisation is conditional on the attributes of the drug. Background infohere.
I should also say that while the UK will benefit from the EU's risk management plans, these in turn will be informed by early data from the UK rollout.
The attributes of the drug being the results of the phase three trials, not some management plan that could be planned for months in advance.
Not necessarily. You can't assess the risks unless you know what the risks are. If you get the basic authorisation out the way as soon as possible, that assessment will follow on after.
Anyway this is the set of bullet points that the EMA identify as the difference between Emergency Use Authorisation (under which the UK has released the Pfizer vaccine) and the full EMA authorisation:
info on the group of people to be given the vaccine;
the vaccine's pharmaceutical quality and purity;
manufacturing and controls of batches;
compliance with international requirements for laboratory testing and conduct of clinical trials;
types of immune responses;
side effects e.g. with regard to older people, or pregnant women;
labelling and package leaflet;
the way risks will be managed and monitored once the vaccine is authorised.
Reference the link above.
I think risk assessment is highly overrated, particularly where risks cannot be calculated with high degrees of precision or confidence. Risk management does not rely upon risk calculation, but on hazard identification, and upon eliminating or mitigating down to acceptable levels the impacts of the risks associated with those hazards.
That list identifies hazards. You don't need to calculate the risks to put in place risk controls for them.
Possibly. I think effects on pregnant women are worth knowing, given they are vaccinating women of childbearing age from the off. Also it's worth knowing if there are age-specific risks, given the main demographic for this vaccine. And these plus other emerging risks will feed into those plans.
Basically the EMA is going through more hoops. Is it worth it, bearing in mind speed is of the essence? I don't think there is an objective answer to that. My impression is that Germany in particular changed its mind on going with Emergency Authorisation and decided to wait for full authorisation. I can guess their reasons for doing so are (1) that Germany (and some other European counties) have high levels of vaccine sceptics, so any shortcuts to the process will be jumped on, and (2) it won't make much difference to the speed of immunisation given Christmas and a relatively low initial availability of the vaccine, so why not wait a couple of weeks and do it properly?
Are there many pregnant 80+ women out there?
And "doing it properly", implying the process other countries have gone through is not proper.
As far as priority vaccinations go there are probably many pregnant women who work in care homes or the NHS.
Admittedly true, but the vaccine can be authorised for use on a subset of people. It doesn't need to be held up until absolutely everyone can have it.
Obviously which has been done. I believe it's not being given to pregnant ladies at this stage but I'm not 100% sure.
Also need to consider keeping schools 'online only' for first half term 2021 ie up to late Feb, I know it's not ideal.
We might as well just give up and tell everyone to repeat the academic year.
I do expect the government to announce that A Levels / GCSEs for 2021 will be assessed purely on teachers assessment/coursework in due course even though they won't say that at the moment. On that basis the loss of the 6 weeks to Feb 2021 should not make too much difference.
It's more the actual cumulative disruption on the education itself that concerns me than it is the effect on the examination element, particularly for increasingly younger kids.
Yes a fair call. The spread of infection appears to be a greater problem in the secondary schools, perhaps leave the primary schools open?
But it's not ideal.
Yeah it's probably the least worst compromise outcome, although I get the feeling that once the secondary schools shut the teachers in the primary schools are not going to quietly just carry on themselves. But I'm very likely doing them a massive disservice.
I think they would as long as they were not expected to teach full classes. If there was some kind of rolling system, or secondary teachers were drafted in to help primaries (which could be managed in academy chains) I don’t think they would object.
Bear in mind, we all went into teaching to teach. But this term has been horrible and ridiculous. Next half term will be worse, for many reasons, and the virus looks set to surge as well. I just do not see how this is sustainable. If they try, there will be even more teachers than normal quitting in the summer. We’ve already had multiple notices of retirement.
What's the infection rate for teachers?
I honestly don’t know. Apart from anything else, it’s difficult to say with certainty where they caught it.
What’s causing major issues though is that simultaneously we are being told we’re not able to be infected by pupils or colleagues and having huge numbers of people either infected or isolating elsewhere.
Reports tonight that Merkel is in some difficulty especially over the delay in the vaccine while apparently the first German to be vaccinated has been in the UK
Europe is in a gathering crisis as member states see the roll out of the vaccine both here, in Canada and the US but not in the EU
If the Germans are unhappy with Merkel, and looking enviously across the Channel, can we do a contra deal with Germany please? Johnson for Mrs Merkel.
Also need to consider keeping schools 'online only' for first half term 2021 ie up to late Feb, I know it's not ideal.
We might as well just give up and tell everyone to repeat the academic year.
I do expect the government to announce that A Levels / GCSEs for 2021 will be assessed purely on teachers assessment/coursework in due course even though they won't say that at the moment. On that basis the loss of the 6 weeks to Feb 2021 should not make too much difference.
It's more the actual cumulative disruption on the education itself that concerns me than it is the effect on the examination element, particularly for increasingly younger kids.
Yes a fair call. The spread of infection appears to be a greater problem in the secondary schools, perhaps leave the primary schools open?
But it's not ideal.
Yeah it's probably the least worst compromise outcome, although I get the feeling that once the secondary schools shut the teachers in the primary schools are not going to quietly just carry on themselves. But I'm very likely doing them a massive disservice.
You do realise that closing the schools does not mean that the teachers stop working. If any thing they work longer because they have to chop and change between presence and online teaching at short notice.
I realise that, yes. Like I say I may be doing them a disservice, but I just get the feeling that if secondary schools close the next pressure point will be desire to close the primary schools. My own personal belief is that particularly for primary school kids the predominantly online learning model should be avoided at all costs.
Does anyone have any idea why the EU has not approved the Pfizer vaccine?
They are following the procedures for 'provisional' authorisation, which are more onerous and take longer than those required for the 'emergency' authorisation we used.
Seems pretty daft to me - if this isn't an emergency, what is? They'll have lost a month.
The delay will cost lives, clearly the vaccine is safe, Covid in old and ill people is deadly. Its complete madness.
It looks to me that the difference between the UK and the EU is in the management of adverse effects. The Pfizer vaccine is safe to use in general, but there will be a small proportion of adverse effects, allergies and so on. The EU wants a proper management and reporting plan in place before giving the go-ahead; the UK will deal with these as ad-hoc events. Arguably, the UK and other countries get a free ride from the EU doing this work, but actually it's fine. Vaccines are an international effort.
A management plan surely can be devised months in advance. Why wait until the vaccine has been submitted?
I think the risk management plan can only be fully fleshed out once the basis for the decision it's safe to use is fully determined. Any authorisation is conditional on the attributes of the drug. Background infohere.
I should also say that while the UK will benefit from the EU's risk management plans, these in turn will be informed by early data from the UK rollout.
The attributes of the drug being the results of the phase three trials, not some management plan that could be planned for months in advance.
Not necessarily. You can't assess the risks unless you know what the risks are. If you get the basic authorisation out the way as soon as possible, that assessment will follow on after.
Anyway this is the set of bullet points that the EMA identify as the difference between Emergency Use Authorisation (under which the UK has released the Pfizer vaccine) and the full EMA authorisation:
info on the group of people to be given the vaccine;
the vaccine's pharmaceutical quality and purity;
manufacturing and controls of batches;
compliance with international requirements for laboratory testing and conduct of clinical trials;
types of immune responses;
side effects e.g. with regard to older people, or pregnant women;
labelling and package leaflet;
the way risks will be managed and monitored once the vaccine is authorised.
Reference the link above.
I think risk assessment is highly overrated, particularly where risks cannot be calculated with high degrees of precision or confidence. Risk management does not rely upon risk calculation, but on hazard identification, and upon eliminating or mitigating down to acceptable levels the impacts of the risks associated with those hazards.
That list identifies hazards. You don't need to calculate the risks to put in place risk controls for them.
Possibly. I think effects on pregnant women are worth knowing, given they are vaccinating women of childbearing age from the off. Also it's worth knowing if there are age-specific risks, given the main demographic for this vaccine. And these plus other emerging risks will feed into those plans.
Basically the EMA is going through more hoops. Is it worth it, bearing in mind speed is of the essence? I don't think there is an objective answer to that. My impression is that Germany in particular changed its mind on going with Emergency Authorisation and decided to wait for full authorisation. I can guess their reasons for doing so are (1) that Germany (and some other European counties) have high levels of vaccine sceptics, so any shortcuts to the process will be jumped on, and (2) it won't make much difference to the speed of immunisation given Christmas and a relatively low initial availability of the vaccine, so why not wait a couple of weeks and do it properly?
So the UK is kindly running a phase 4 trial for the EU?
It is. While the UK will benefit from the EU's risk management plans, these in turn will be informed by early data from the UK rollout. Vaccines are an international effort.
Pity in the meantime EU citizens lives are at risk as they delay the vaccination
Yes. On the other hand the extra steps the EMA are going through may save some lives, if not this time, then with another medication. And if people don't have confidence in the vaccine and its certification and don't take it, that will also have an effect that can be measured in lives. Almost all certification activity is a waste of time, but there is a reason why you are required to do it. The cost/benefit on specific certification activities isn't a straightforward calculation.
Also need to consider keeping schools 'online only' for first half term 2021 ie up to late Feb, I know it's not ideal.
We might as well just give up and tell everyone to repeat the academic year.
I do expect the government to announce that A Levels / GCSEs for 2021 will be assessed purely on teachers assessment/coursework in due course even though they won't say that at the moment. On that basis the loss of the 6 weeks to Feb 2021 should not make too much difference.
It's more the actual cumulative disruption on the education itself that concerns me than it is the effect on the examination element, particularly for increasingly younger kids.
Yes a fair call. The spread of infection appears to be a greater problem in the secondary schools, perhaps leave the primary schools open?
But it's not ideal.
Yeah it's probably the least worst compromise outcome, although I get the feeling that once the secondary schools shut the teachers in the primary schools are not going to quietly just carry on themselves. But I'm very likely doing them a massive disservice.
You do realise that closing the schools does not mean that the teachers stop working. If any thing they work longer because they have to chop and change between presence and online teaching at short notice.
I realise that, yes. Like I say I may be doing them a disservice, but I just get the feeling that if secondary schools close the next pressure point will be desire to close the primary schools. My own personal belief is that particularly for primary school kids the predominantly online learning model should be avoided at all costs.
Well, it doesn’t work. You might as well not bother.
Edit - that is, with online lessons for primary school age children, in case that was misunderstood.
Maybe they'll wait till, oh, the 23rd and then announce Christmas is off, for maximum lolz.
Eid was crasser than that, wasn't it?
We'll get to December 24th, a large chunk of the nation will be halfway to where they were going... and then people will be told to Remain Indoors.
2020 must be the first year in a decade that I've not set foot in a mosque.
I am way ahead of you on that one
Ah but I'm a good* Muslim.
*If you ignore my constant gambling and whoring.
Have you embraced Bacon Butties or is that still beyond the pale. (You can always take the 5th on that question )
No I've not eaten anything that cheweth the cud, or of them that divide the cloven hoof.
It is curious the parts of Islam I've followed and the ones I've not.
Pretty much all my friends love bacon, so I've been often told about the joys of eating pig related products.
I thought Lamb and/or Goat was OK?
My education continues....
Industry friend of mine does a lot of business with the highly successful British Asian wholesale sector. Eats a lot of curries and always orders King Prawns - apparently guaranteed to not offend anyone.
Does anyone have any idea why the EU has not approved the Pfizer vaccine?
They are following the procedures for 'provisional' authorisation, which are more onerous and take longer than those required for the 'emergency' authorisation we used.
Seems pretty daft to me - if this isn't an emergency, what is? They'll have lost a month.
The delay will cost lives, clearly the vaccine is safe, Covid in old and ill people is deadly. Its complete madness.
It looks to me that the difference between the UK and the EU is in the management of adverse effects. The Pfizer vaccine is safe to use in general, but there will be a small proportion of adverse effects, allergies and so on. The EU wants a proper management and reporting plan in place before giving the go-ahead; the UK will deal with these as ad-hoc events. Arguably, the UK and other countries get a free ride from the EU doing this work, but actually it's fine. Vaccines are an international effort.
A management plan surely can be devised months in advance. Why wait until the vaccine has been submitted?
I think the risk management plan can only be fully fleshed out once the basis for the decision it's safe to use is fully determined. Any authorisation is conditional on the attributes of the drug. Background infohere.
I should also say that while the UK will benefit from the EU's risk management plans, these in turn will be informed by early data from the UK rollout.
The attributes of the drug being the results of the phase three trials, not some management plan that could be planned for months in advance.
Not necessarily. You can't assess the risks unless you know what the risks are. If you get the basic authorisation out the way as soon as possible, that assessment will follow on after.
Anyway this is the set of bullet points that the EMA identify as the difference between Emergency Use Authorisation (under which the UK has released the Pfizer vaccine) and the full EMA authorisation:
info on the group of people to be given the vaccine;
the vaccine's pharmaceutical quality and purity;
manufacturing and controls of batches;
compliance with international requirements for laboratory testing and conduct of clinical trials;
types of immune responses;
side effects e.g. with regard to older people, or pregnant women;
labelling and package leaflet;
the way risks will be managed and monitored once the vaccine is authorised.
Reference the link above.
I think risk assessment is highly overrated, particularly where risks cannot be calculated with high degrees of precision or confidence. Risk management does not rely upon risk calculation, but on hazard identification, and upon eliminating or mitigating down to acceptable levels the impacts of the risks associated with those hazards.
That list identifies hazards. You don't need to calculate the risks to put in place risk controls for them.
Possibly. I think effects on pregnant women are worth knowing, given they are vaccinating women of childbearing age from the off. Also it's worth knowing if there are age-specific risks, given the main demographic for this vaccine. And these plus other emerging risks will feed into those plans.
Basically the EMA is going through more hoops. Is it worth it, bearing in mind speed is of the essence? I don't think there is an objective answer to that. My impression is that Germany in particular changed its mind on going with Emergency Authorisation and decided to wait for full authorisation. I can guess their reasons for doing so are (1) that Germany (and some other European counties) have high levels of vaccine sceptics, so any shortcuts to the process will be jumped on, and (2) it won't make much difference to the speed of immunisation given Christmas and a relatively low initial availability of the vaccine, so why not wait a couple of weeks and do it properly?
So the UK is kindly running a phase 4 trial for the EU?
It is. While the UK will benefit from the EU's risk management plans, these in turn will be informed by early data from the UK rollout. Vaccines are an international effort.
Pity in the meantime EU citizens lives are at risk as they delay the vaccination
Yes. On the other hand the extra steps the EMA are going through may save some lives, if not this time, then with another medication. And if people don't have confidence in the vaccine and its certification and don't take it, that will also have an effect that can be measured in lives. Almost all certification activity is a waste of time, but there is a reason why you are required to do it. The cost/benefit on specific certification activities isn't a straightforward calculation.
Another medication? In case you hadn't noticed we are in the middle of a pandemic. Unless you are suggesting that the MHRA is less rigorous in general than the EMA?
I would be shocked if Johnson rowed back on Christmas. His libertarian instincts would make cancelling Christmas a big ask.
Who says anything about cancelling it? Smaller, yes. And a good excuse not to have the in-laws around.
I think Boris will stick with the Christmas arrangements although on the face of it, it is not a good idea.
A lot of people will be minimising arrangements, well within the guidance.
I am expecting a lockdown from 28 Dec, harder than the one we have just had, and we may need to keep it in place until end Feb. By end Feb hopefully a large proportion of the 65+ will have had their second vaccine so the exposure to deaths/hospitalisations will be much lower from March.
Also need to consider keeping schools 'online only' for first half term 2021 ie up to late Feb, I know it's not ideal.
There is not a politician in the land who is in charge and who is willing to close schools.
It is insane shibboleth. Secondary teachers are close to total revolt.
It's one of those inconvienient truths that the virus spreads very nicely indeed round schools.
I mean, it is fairly clear that Primary Schools are not super spreader locations but Secondary schools are just the pits.
The insane thing is that the secondary teachers I have spoken too are confident that the kids are getting a worse education being back full time than they would be 50/50 because the total lack of interaction the Covid restrictions bring just destroys the point of being in full time.
Is it clear? My daughter is in one local primary school and my wife works at another. Covid has ripped through both schools - at least half of each school's bubbles have been off at one time or another with half a dozen or so teachers.
Does anyone have any idea why the EU has not approved the Pfizer vaccine?
They are following the procedures for 'provisional' authorisation, which are more onerous and take longer than those required for the 'emergency' authorisation we used.
Seems pretty daft to me - if this isn't an emergency, what is? They'll have lost a month.
The delay will cost lives, clearly the vaccine is safe, Covid in old and ill people is deadly. Its complete madness.
It looks to me that the difference between the UK and the EU is in the management of adverse effects. The Pfizer vaccine is safe to use in general, but there will be a small proportion of adverse effects, allergies and so on. The EU wants a proper management and reporting plan in place before giving the go-ahead; the UK will deal with these as ad-hoc events. Arguably, the UK and other countries get a free ride from the EU doing this work, but actually it's fine. Vaccines are an international effort.
A management plan surely can be devised months in advance. Why wait until the vaccine has been submitted?
I think the risk management plan can only be fully fleshed out once the basis for the decision it's safe to use is fully determined. Any authorisation is conditional on the attributes of the drug. Background infohere.
I should also say that while the UK will benefit from the EU's risk management plans, these in turn will be informed by early data from the UK rollout.
The attributes of the drug being the results of the phase three trials, not some management plan that could be planned for months in advance.
Not necessarily. You can't assess the risks unless you know what the risks are. If you get the basic authorisation out the way as soon as possible, that assessment will follow on after.
Anyway this is the set of bullet points that the EMA identify as the difference between Emergency Use Authorisation (under which the UK has released the Pfizer vaccine) and the full EMA authorisation:
info on the group of people to be given the vaccine;
the vaccine's pharmaceutical quality and purity;
manufacturing and controls of batches;
compliance with international requirements for laboratory testing and conduct of clinical trials;
types of immune responses;
side effects e.g. with regard to older people, or pregnant women;
labelling and package leaflet;
the way risks will be managed and monitored once the vaccine is authorised.
Reference the link above.
I think risk assessment is highly overrated, particularly where risks cannot be calculated with high degrees of precision or confidence. Risk management does not rely upon risk calculation, but on hazard identification, and upon eliminating or mitigating down to acceptable levels the impacts of the risks associated with those hazards.
That list identifies hazards. You don't need to calculate the risks to put in place risk controls for them.
Possibly. I think effects on pregnant women are worth knowing, given they are vaccinating women of childbearing age from the off. Also it's worth knowing if there are age-specific risks, given the main demographic for this vaccine. And these plus other emerging risks will feed into those plans.
Basically the EMA is going through more hoops. Is it worth it, bearing in mind speed is of the essence? I don't think there is an objective answer to that. My impression is that Germany in particular changed its mind on going with Emergency Authorisation and decided to wait for full authorisation. I can guess their reasons for doing so are (1) that Germany (and some other European counties) have high levels of vaccine sceptics, so any shortcuts to the process will be jumped on, and (2) it won't make much difference to the speed of immunisation given Christmas and a relatively low initial availability of the vaccine, so why not wait a couple of weeks and do it properly?
So the UK is kindly running a phase 4 trial for the EU?
It is. While the UK will benefit from the EU's risk management plans, these in turn will be informed by early data from the UK rollout. Vaccines are an international effort.
Pity in the meantime EU citizens lives are at risk as they delay the vaccination
Yes. On the other hand the extra steps the EMA are going through may save some lives, if not this time, then with another medication. And if people don't have confidence in the vaccine and its certification and don't take it, that will also have an effect that can be measured in lives. Almost all certification activity is a waste of time, but there is a reason why you are required to do it. The cost/benefit on specific certification activities isn't a straightforward calculation.
But in the court of public opinion Germans (and the rest of Europe) seeing the UK actually actively vaccinating against covid while the EU delays is going to cause considerable friction
Could you even start to imagine if the situation was reversed just how angry the UK citizens would be
Does anyone have any idea why the EU has not approved the Pfizer vaccine?
They are following the procedures for 'provisional' authorisation, which are more onerous and take longer than those required for the 'emergency' authorisation we used.
Seems pretty daft to me - if this isn't an emergency, what is? They'll have lost a month.
The delay will cost lives, clearly the vaccine is safe, Covid in old and ill people is deadly. Its complete madness.
It looks to me that the difference between the UK and the EU is in the management of adverse effects. The Pfizer vaccine is safe to use in general, but there will be a small proportion of adverse effects, allergies and so on. The EU wants a proper management and reporting plan in place before giving the go-ahead; the UK will deal with these as ad-hoc events. Arguably, the UK and other countries get a free ride from the EU doing this work, but actually it's fine. Vaccines are an international effort.
A management plan surely can be devised months in advance. Why wait until the vaccine has been submitted?
I think the risk management plan can only be fully fleshed out once the basis for the decision it's safe to use is fully determined. Any authorisation is conditional on the attributes of the drug. Background infohere.
I should also say that while the UK will benefit from the EU's risk management plans, these in turn will be informed by early data from the UK rollout.
The attributes of the drug being the results of the phase three trials, not some management plan that could be planned for months in advance.
Not necessarily. You can't assess the risks unless you know what the risks are. If you get the basic authorisation out the way as soon as possible, that assessment will follow on after.
Anyway this is the set of bullet points that the EMA identify as the difference between Emergency Use Authorisation (under which the UK has released the Pfizer vaccine) and the full EMA authorisation:
info on the group of people to be given the vaccine;
the vaccine's pharmaceutical quality and purity;
manufacturing and controls of batches;
compliance with international requirements for laboratory testing and conduct of clinical trials;
types of immune responses;
side effects e.g. with regard to older people, or pregnant women;
labelling and package leaflet;
the way risks will be managed and monitored once the vaccine is authorised.
Reference the link above.
I think risk assessment is highly overrated, particularly where risks cannot be calculated with high degrees of precision or confidence. Risk management does not rely upon risk calculation, but on hazard identification, and upon eliminating or mitigating down to acceptable levels the impacts of the risks associated with those hazards.
That list identifies hazards. You don't need to calculate the risks to put in place risk controls for them.
Possibly. I think effects on pregnant women are worth knowing, given they are vaccinating women of childbearing age from the off. Also it's worth knowing if there are age-specific risks, given the main demographic for this vaccine. And these plus other emerging risks will feed into those plans.
Basically the EMA is going through more hoops. Is it worth it, bearing in mind speed is of the essence? I don't think there is an objective answer to that. My impression is that Germany in particular changed its mind on going with Emergency Authorisation and decided to wait for full authorisation. I can guess their reasons for doing so are (1) that Germany (and some other European counties) have high levels of vaccine sceptics, so any shortcuts to the process will be jumped on, and (2) it won't make much difference to the speed of immunisation given Christmas and a relatively low initial availability of the vaccine, so why not wait a couple of weeks and do it properly?
So the UK is kindly running a phase 4 trial for the EU?
It is. While the UK will benefit from the EU's risk management plans, these in turn will be informed by early data from the UK rollout. Vaccines are an international effort.
Pity in the meantime EU citizens lives are at risk as they delay the vaccination
Yes. On the other hand the extra steps the EMA are going through may save some lives, if not this time, then with another medication. And if people don't have confidence in the vaccine and its certification and don't take it, that will also have an effect that can be measured in lives. Almost all certification activity is a waste of time, but there is a reason why you are required to do it. The cost/benefit on specific certification activities isn't a straightforward calculation.
Another medication? In case you hadn't noticed we are in the middle of a pandemic. Unless you are suggesting that the MHRA is less rigorous in general than the EMA?
The MHRA is less rigorous in this specific instance than the EMA. That's not the question. The question is whether the MHRA is rigorous enough.
As far as my personal willingness to be vaccinated is concerned, it is. My view is irrelevant however.
The German Health Minister complains about the delay in the EMA giving full authorisation, but he's not prepared to go on Emergency Authorisation, which he would be on the hook for. Read into that what you will.
* I should add the question is also whether the EMA is too rigorous, given time is of the essence.
Comments
We'll get to December 24th, a large chunk of the nation will be halfway to where they were going... and then people will be told to Remain Indoors.
Basically the EMA is going through more hoops. Is it worth it, bearing in mind speed is of the essence? I don't think there is an objective answer to that. My impression is that Germany in particular changed its mind on going with Emergency Authorisation and decided to wait for full authorisation. I can guess their reasons for doing so are (1) that Germany (and some other European counties) have high levels of vaccine sceptics, so any shortcuts to the process will be jumped on, and (2) it won't make much difference to the speed of immunisation given Christmas and a relatively low initial availability of the vaccine, so why not wait a couple of weeks and do it properly?
I see one guy is saying that the only mistake that Trump has made is approving the vaccine
A viable market would be which happens first - Betfair settling POTUS or a Deal with the EU.
Opens at 50/50?
Vanilla thinks @ links are to vanilla users of that name.
They really do miss not physically seeing their friends.
I also feel tremendously sad for university students, my deepest and longest lasting friendships were formed at university.
As much as you can do online, nothing quite forges a friendship as seeing one of your friends getting absolutely sloshed at university, feeling so sick, that he decides to ring his mother 250 miles away at 3am to ask her to come look after him and make egg and soldiers.
But it's not ideal.
https://madison.com/wsj/news/local/govt-and-politics/wisconsin-supreme-court-rejects-donald-trumps-election-challenge-electors-vote-for-joe-biden/article_d82d99c1-25a5-53ad-bd55-e0998efd86a5.html
*If you ignore my constant gambling and whoring.
And "doing it properly", implying the process other countries have gone through is not proper.
Re the economic tailwind, I'm inclining more and more to the view the next 18 months will be tough because the damage caused has been so great and because - unless there is 100% faith in the vaccines and their efficiency - consumers and small businesses may be fearful of spending in case there is another outbreak. I hope I am wrong (for the sake of the US) but I am a bit more gloomy.
Thought about going to Sheffield city centre today, saw the crowds, and went back home.
This is the link
https://twitter.com/parlertakes?lang=en
Back in my days of cultural innocence. I cooked my new Muslim neighbour a lovely pork chop dinner. He laughed, handed me the chop and ate everything else whilst enlightening me to my blunder over beer and wine....
It is curious the parts of Islam I've followed and the ones I've not.
Pretty much all my friends love bacon, so I've been often told about the joys of eating pig related products.
Europe is in a gathering crisis as member states see the roll out of the vaccine both here, in Canada and the US but not in the EU
(Why do we still not know just how airborne this thing is?)
"Doing it properly". The EMA is doing more, but is it necessary? That's not a fully objective decision in my view. Personally, I am happy to get vaccinated on the MHRA authorisation, but no public health policy will be accepted by the public on my risk appetite or those of politicians etc. If the public require a gold plated authorisation instead of a silver plated good-enough authorisation, you will go for the gold.
The first non teacher I’ve come across who really gets the situation.
For now.
Thank you.
They are making it up as they go along. You could have a very good bet on Nancy Pelosi, for example, only to find they have alighted on a completely different basis for settling.
I see where you are coming from, and you are making sense. Betfair are not. You would be risking money with a capricious market maker.
My advice is that if you try to exploit their unpredictability, keep your stakes small and be prepared for disappointment.
It’s more than making it up as they go along - they have changed wholesale the basis on which they said they’d settle the market.
There is zero case for them not to settle tomorrow. The winner is more than just projected; the winner has been declared by the electoral college
They put in their terms that death wouldn't affect the market and then as soon as Trump fell ill they suspended the market.
And the winning party market, after I had smugly warned people to bet on that instead of the Next President market.
Still furious about that. It is further evidence, if any were needed, that the current farce is due to incompetence rather than scheming or mischief-making.
It is however incompetence on an epic scale and if the chat on Betfair Community is anything to go by the number of customers they are going to lose may be significant.
Spurs win the PL and Arsenal get relegated.
It is insane shibboleth. Secondary teachers are close to total revolt.
Anecdata from my region was that when another region nearby was in tier 4 and the shops were shut (non-essential excepted), the shopping centres in my tier 3 area was considerably busier, as folk basically travelled to where the open shops were. Not hugely surprising, but, y'know.
My education continues....
Bear in mind, we all went into teaching to teach. But this term has been horrible and ridiculous. Next half term will be worse, for many reasons, and the virus looks set to surge as well. I just do not see how this is sustainable. If they try, there will be even more teachers than normal quitting in the summer. We’ve already had multiple notices of retirement.
Children are both veggies, so it makes sure she gets it
Shops do have social distancing, at least round here.
And then, when they cancel assessments and fail to put anything in place so we have another train crash, they will blame us for that.
The insane thing is that the secondary teachers I have spoken too are confident that the kids are getting a worse education being back full time than they would be 50/50 because the total lack of interaction the Covid restrictions bring just destroys the point of being in full time.
Of course, if closing everything else apart from essential shops isn't enough, secondary schools are next.
I think people would understand that kind of rationale. I think often the problem seems to be - intentionally or not, and may well be the issue is the media here rather than anything else - the school issue tends to become a binary "are they open or are they closed (hence "blended") learning", and no attempt to try and recover the lost time or consider alternative options ever seems to come from the discussion. The focus is always on the exams and not on somehow trying to recover the lost teaching time, especially when we can guess that for a significant proportion of kids "blended" learning or predominantly online learning equates to minimal or no learning.
But yes - I can imagine it's not the most appealing career right now!
Do you mean never to have been relegated from the top division?
What’s causing major issues though is that simultaneously we are being told we’re not able to be infected by pupils or colleagues and having huge numbers of people either infected or isolating elsewhere.
This article is damning:
https://www.theguardian.com/education/2020/dec/14/covid-stress-takes-toll-on-teachers-in-england
Edit - that is, with online lessons for primary school age children, in case that was misunderstood.
https://en.wikipedia.org/wiki/List_of_unrelegated_association_football_clubs#Never_relegated
Could you even start to imagine if the situation was reversed just how angry the UK citizens would be
I was just quoting the Old Testament.
As far as my personal willingness to be vaccinated is concerned, it is. My view is irrelevant however.
The German Health Minister complains about the delay in the EMA giving full authorisation, but he's not prepared to go on Emergency Authorisation, which he would be on the hook for. Read into that what you will.
* I should add the question is also whether the EMA is too rigorous, given time is of the essence.