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This sort of bollox does no good whatsoever in my book, how this bloke has still got his Cabinet job is beyond me'
https://www.theguardian.com/society/...an-all-of-them
Pfizer has applied to the FDA for "emergency use authorization", and the hearing was granted for December 10th. The hearing for the Moderna vaccine is on the 17th. I'm not defending the government, but it's not like you get on Zoom and someone says "well' what do you lot reckon? Shall we do it?". Regulations are a pain in the ass, but they serve a purpose. And it's the law.
A pertinent point made here at 9 minutes and 30 seconds in this video by Dr John Campbell.
https://youtu.be/FhUh7FWDPMQ
I was just about to say the same thing
Years ago politicians who did or said something similar would have died by the sword. These days, especially with so much going on, they seem to survive just because the focus and headlines shift elsewhere. Cummings, Patel and Hancock would never have kept their jobs under previous PM's.
The source of my information, which you have rather grandly pronounced to be ‘misinformed opinion’, is Guido Rasi. No doubt you know that until 3 weeks ago he was the Executive Director of the EMA. Referring to the MHRA’s authorisation he said “If you evaluate only the partial data as they are doing they also take a minimum of risk. Personally I would have expected a robust review of all available data, which the British government has not done to be able to say that without Europe you come first.”
Now I know you are the board’s self-appointed expert on regulatory affairs but on this occasion I’m going to defer to his expertise over yours.
https://www.theguardian.com/world/20...says-eu-agency
According to the MHRA press conference yesterday Pfizer have been feeding them all the available data for months so that the Agency would be in a position to reach a quick decision. In other words the MHRA had all the data, had been looking at it for months meaning this partial data argument is inaccurate. Of course, some might say the MHRA person could have been withholding the truth but I doubt that very much.
First Im not the boards self appointed expert, but I do have a good idea of how the system works. You suggest that Rasi is as good as his word because he used to head up the EMA, but you may not have considered that there could be a touch of bias in his comments. It's a bit like asking our Cardiff Manager why Swansea are doing better then us this season and expecting a neutral reply.
Further, do you really think that Pfizer would hold back data from either of the regulatory boards? No way. They both get the full data for analysis.
The MHRA is one of the most rigorous and respected regulatory authorities in the world. Th fact that the EMA used London as its base until very recently speaks volumes for UK expertise in this area.
To my mind the reason the MHRA worked night and day on this was not to score points but to meet an urgent unmet medical need. It's the politicians who are making capital out of it.
Maybe the delay in the USA , was partly due to the election , it does seem strange that weren't first at the starting line, they love that stuff ??
One thing to add to my previous post. Rasi suggested that UK went for approval for emergency use only where the EMA is looking at things in a more timely and comprehensive way.
What he knows but didn’t say is the MHRA has only got the authority currently to get medicines approved to be used in emergencies. That is the case until the end of the year when Brexit is done. All other regulatory approval in UK is through the EMA until year end.
In practice that probably means that if we wait on EMA approval as EU members and they approve it after 1 Jan when we are no longer members, then their approval would have no legal status in UK and we would have had to start-the process from scratch delaying availability in UK. The MHRA took the only course of action available to it, and did well
Apologies. This thread is so active I missed your earlier post. I heard a discussion on Sky News at about the same time as the MHRA press conference where various "experts" were discussing the roll out of the vaccine, safety and the speed at which MHRA were able to act.
As the EMA indicate they have most of the relevant data, we do not know whether they have the full information which the MHRA imply they have. If not why not? And if they have all the available data why do they have to wait until the end of the month to "look at it" or even make a decision? I don't know the answer, no one does.
There is obviously a lot going on and I don't presume to know the full facts. All I know is what I heard when it was stated the EMA would "look at it at the end of the month"
Is it true that each Member State of the EU has to independently give it the go ahead after it’s been approved by the EMA as well?
For prescription medicines the EMA approves them for use in all EU countries. Once approved individual countries decide whether to allow them onto the market or not. Pricing and reimbursement are decided by the individual country, and in UK for example bodies like NICE make recommendations on the use of new medicines.