FDA scientists give Pfizer vaccine the green light in first analysis – but it’s STILL not approved

FDA scientists say the Pfizer vaccine is effective and have recommended it for approval in the first piece of analysis before it will be officially green-lit.  

Documents released by U.S. regulators Tuesday confirmed that Pfizer and BioNTech´s COVID-19 vaccine was strongly protective against COVID-19 — offering the world´s first detailed look at the evidence behind the shots.

The Food and Drug Administration posted its analysis online even as across the Atlantic, Britain on Tuesday began vaccinating its oldest citizens with the Pfizer-BioNTech 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 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. 

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  

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. 

One nurse who took it said she experienced the highest fever of her life afterwards. 

Studies in children as young as 12 are just beginning.