FDA confirms Pfizer vaccine is effective and safe as it prepares to green light the shot Thursday – nearly one week behind the UK
- A panel of scientists from the FDA posted their first analysis of the vaccine online
- That analysis will now be reviewed by a panel of independent scientists
- That will happen on Thursday and if they agree, the vaccine will finally get official approval and be distributed across the US from Dec 15
- 20million doses are expected this year but most won’t come until next summer
- It is down to the Trump administration declining an offer to buy additional doses earlier this year
- The New York Times reports that now, the US may not get most of its doses until June 2021 because of the decision
- The UK started giving out the first vaccinations on Tuesday
FDA scientists say the Pfizer vaccine meets all safety and efficacy requirements in their first analysis of it that will now be reviewed by an independent panel before it is approved.
The Food and Drug Administration posted its analysis online on Tuesday morning as across the Atlantic, Britain on Tuesday began vaccinating its oldest citizens with the shots. An independent panel of experts still has to review it before it can be approved.
The earliest that will happen is on Thursday and then vaccine roll out won’t begin until December 15 at least, much to the chagrin of US officials and citizens who are watching impatiently while the UK gives out its first vaccines.
Once approved, the US has a reported 100million doses of the vaccine from Pfizer which is enough to inoculate 50million people – around 15 percent of the population.
The briefing documents say that while there were no ‘meaningful imbalances’ but four people in the trial suffered facial paralysis – otherwise known as Bells palsy.
The 92-page document will be reviewed on Thursday when the panel of experts convenes
The FDA scientists’ conclusion towards the end of the report that the vaccine meets safety and efficacy standards
The UK approved the vaccine last week and started giving it out today. Above, Margaret Keenan, 90, becomes the first person in the world to receive it. She was given the vaccine on Tuesday morning in Coventry, England
The New York Times reports that the Trump administration was offered the chance to buy more doses of the vaccine in the summer but that they passed.
Now, Pfizer has entered manufacturing deals with other countries which the Times says could make it more difficult for the US to get all of the vaccines they need.
On a call with reporters, a senior administration official said the Times’ report was ‘false.’
But the official did not address what was ‘false’ and said: ‘We feel absolutely confident we will get the vaccine doses for which we’ve contracted and will have sufficient number of doses to vaccinate all Americans who desire one before the end of second quarter 2021.’
Pfizer and Moderna both snubbed a vaccine summit at the White House that will take place on Tuesday.
STAT reported Monday that Pfizer CEO Albert Bourla and Moderna CEO Stéphane Bancel had been invited to appear in Washington and declined.
The White House is claiming that it decided instead to have Dr. Peter Marks, the leader of the Food and Drug Administration’s biologics center, as its guest and that he declined to appear at the event while Pfizer and Moderna’s vaccines were both still under review.
Trump’s camp had accused both Pfizer and Moderna of withholding how effective their vaccines were until after the election in an attempt to thwart his chances of success.
They both denied it, saying there was nothing political about either announcement.
President Donald Trump was incensed after good news on the coronavirus vaccine front came after the November 3 presidential election
The White House invited Psizer CEO Albert Bourla (left) and Moderna CEO Stéphane Bancel to Tuesday’s ‘Vaccine Summit,’ an invitation they both declined, according to STAT
Last week, the FDA was slammed for taking so long to approve the vaccine when it had already been approved in the UK.
Commissioner Steve Hahn defended the process, saying it was the safes and most ‘robust’ of any country in the world.
The first to get the vaccine, once approved, will be nursing home residents and healthcare workers.
Then, it will be down to the states to determine who goes next.
The vaccine is, according to the pharmaceutical firm’s research, 95 percent effective.
It’s still unclear how long protection lasts and some side effects have been reported like mild flu symptoms and headaches.
The briefing documents from the FDA encourage people to continue participating in the study so that can be examined.
One nurse who took it said she experienced the highest fever of her life afterwards.