What does the UK think of the EU and the US taking the lead in authorizing Pfizer's new crown vaccine?

The Department of Health and Social Security said the provisional approval came after "months of rigorous clinical trials and a thorough analysis of the data by MHRA experts in the UK, which concluded that the vaccine met strict standards of safety, quality and effectiveness."
" trial data show that the BNT-162b2 vaccine is up to 95% effective in preventing COVID-19.
MHRA has been conducting a rolling review of the vaccine to evaluate the available data on that basis, rather than waiting until clinical trials are over.
Health Minister Matt Hancock said earlier this month that using the method meant the MHRA could judge clinical safety "within days of the formal submission of the permit application."
" vaccine was authorised for emergency supply under section 174 of the UK's drug laws.
the legislation allows for temporary supply of new drugs before they are officially licensed in response to a public health emergency before the Brexit transition is over.
, the MHRA's interim interim director, said the MHRA made the recommendations "after an extremely thorough and scientifically rigorous review of all the evidence for the safety, importance and quality of the vaccine."
press conference on December 2nd, Raine sought to allay any concerns about the rush of the authorization process, saying the teams had been working in parallel to assess the vaccine data and were "absolutely not stealing."
MHRA said on November 23rd that it had received "more data" from Pfizer and BioNTech.
Pfizer executive Ralf Rene Rainert said at a news conference on Wednesday that he was receiving emails from other countries that were considering seeking faster authorization under the UK leadership.
," he said, "the world is watching britain right now".
did not name the countries.
Pfizer and its partner BioNTech's team worked around the clock with their MHRA counterparts to answer each question and provide additional customized data if necessary, according to people familiar with the matter.
said the MHRA had been sending questions to the company until the weekend.
said the MHRA sometimes responds quickly to the data it sends in as little as ten minutes.
BioNTech, said UK regulators had raised issues as detailed as other international regulators.
What this approval means for the MHRA after Brexit The UK's provisional approval of the vaccine has another special significance, namely that the UK's Brexit transition will end on 31 December, after which the MHRA will become an independent regulator with primary responsibility for licensing drugs used in the UK, freeing it from the restrictions imposed by the EMA over the past 16 years.
Evans, professor of drug epidemiology at the London School of Hygiene and Tropical Medicine, said: "The MHRA's big motivation is to make sure that starting in 2021, companies will provide them with new drugs and vaccines.
," he said, "it's a rehearsal, the world is watching, and the MHRA's message is, "We're going to do it fast."
advantage of the MHRA is that it was a mainse of the EMA before Brexit and could assess a large part of the group's new drugs.
EMA headquarters moved from London to Amsterdam last year after the UK decided to brexit.
, the EMA distributed the UK MHRA's vast portfolio of drug reviews to other EU countries.
EMA said the 370 drugs that were part of the UK's responsibilities at the time had been redistributed among 27 EU countries, as well as Iceland and Norway.
Evans, said the MHRA's work was "relatively inadequate" as the workload declined.
this provides the MHRA with additional "bandwidth" to act quickly.
-based MHRA has also acquired experienced staff to stay in London as a result of the relocation of EMA headquarters.
, UK regulators and ministers no longer need to go through the European Commission system.
is a small advantage," said George Freeman, a former uk life sciences minister who oversaw MHRA changes to speed up drug reviews.
MHRA was founded in 2003 by a merger of the UK's drug and medical device regulators and is not a household name even in the UK, with 1,320 employees.
EMA has approximately 900 employees, but it does not review medical devices or supervise clinical trials, which are the responsibility of each EU member state.
FDA has approximately 17,000 employees.
to give the vaccine the green light, the UK government has used its long-standing powers to authorise drugs in emergency situations and even allow the MHRA to review drugs outside the EMA framework even before the end of the Brexit transition period.
all other EU member states have the same powers, but none has publicly announced plans to exercise them.
the EU and the US, but European regulators and lawmakers disagreed with the UK's speed, criticising the move as "hasty and hasty".
FDA and the European Union EMA defended its slower approach.
both agencies are expected to make decisions on the Pfizer/BioNTech vaccine this month.
FDA will hold a vaccine expert meeting on December 10 to discuss the emergency use authorization (EUA) for the Pfizer vaccine, and another vaccine expert meeting on December 17 to discuss the EUA for another mRNA vaccine, Moderna.
meetings are designed to increase confidence in the regulatory process.
say experts may help address people's hesitations about getting vaccinated.
FDA Director Stephen Hahn was called to the White House on Tuesday to explain why Pfizer's vaccine had not been approved quickly, a move that caused shock in the industry and further concerns about the FDA's independence.
to act as soon as possible because it is a state of emergency, but we will make sure that our scientists take the time to make the right decisions," Hahn later told the media.
our work is correct and we will make the right decisions about the safety and effectiveness of the vaccine.
EMA has a more appropriate procedure that will take longer because more evidence needs to be considered and more checks involved, the EMA said in a statement to Reuters on Wednesday.
EMA is looking for a wider licensing category, which will be broader and more durable than the UK's decision.
EMA officials said EU law did not allow the EMA to meet the temporary emergency use authorization sought by the UK.
, they need more evidence and assurance that production controls will remain in place after licensing.
EMA spokesman said , " These are essential elements to ensure a high level of protection for citizens in mass vaccinations . "
" EMA will announce its decision on the Pfizer vaccine on December 29 and the Moderna vaccine on January 12.
in each case, the EMA must convene its high-level Scientific Committee on Drug Use before it can make a decision.
EMA has slowed due to data format issues and software compatibility , according to people familiar with the matter .
EMA said last week that it would consider ways to speed up its systems and ask pharmaceutical companies for advice .
-Aspen