President Donald Trump raged at the FDA for taking so long to approve Pfizer’s COVID vaccine on Friday morning and ordered them to ‘stop playing games and start saving lives’ as Health and Human Services Secretary Alex Azar said official approval may still take ‘a couple of days’.
A panel of 23 independent scientists voted in favor of the vaccine on Thursday and recommended it to the FDA after a day of long, drawn-out talks over whether or not it is safe.
But the FDA still has not officially given it approval and the first doses haven’t been distributed yet, even though the UK and Canada have both given it the green light.
Health and Human Services Alex Azar says the FDA has told
‘In the next couple of days probably as we work to negotiate with Pfizer the information doctors need to prescribe appropriately, we should be seeing the authorization and we’ll be working with Pfizer to get that shipped out so we could be seeing people getting vaccinated Monday, Tuesday of next week.’
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Speaking on Good Morning America, Health and Human Services Alex Azar says the FDA has told Pfizer it ‘intends to approve’ its COVID vaccine after an excruciating two-and-a-half week wait but inexplicably, it still hasn’t
The first shots in the arm in the US won’t be until Monday or Tuesday at the very earliest. Above, someone getting the vaccine in the UK on December 8
Once distributed to the states, each state must set up its own schedule and plan for distributing it among the people.
TIMELINE ON PFIZER VACCINE
November 18: Pfizer announces its vaccine is 94% effective
November 23: Pfizer submits trial data to FDA for emergency approval
December 3: UK approves Pfizer vaccine
December 7: First doses are given in England
December 8: FDA releases preliminary analysis saying vaccine is safe and effective but still doesn’t approve it
December 9: Canada approves the vaccine
December 9: Deadliest day for US with 3,045 deaths
December 10: FDA advisory committee meets to discuss the vaccine
The FDA released a statement on Friday morning claiming it was working to approve the vaccine quickly.
‘Following yesterday’s positive advisory committee meeting outcome regarding the Pfizer-BioNTech COVID-19 vaccine, the U.S. Food and Drug Administration has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization.
‘The agency has also notified the U.S. Centers for Disease Control and Prevention and Operation Warp Speed, so they can execute their plans for timely vaccine distribution,’ Commissioner Steve Hahn said in a statement on Friday morning.
In New York, for example, Governor Cuomo says he’ll start dishing out the shots on December 15, starting with nursing home staff, residents and healthcare workers.
Azar said the first shots in the arm would be December 14 or 15.
‘We’re looking at 20million Americans being vaccinated in the next couple weeks, 50million by the end of January.
‘We believe we could have 100million vaccinations in arm by the end of February.
‘The products just keep rolling out, especially if we get to add AstraZeneca and Johnson & Johnson to our arsenal,’ he said.
By that timeline, optimistically, that would mean less than a third of the US population would be vaccinated by the end of February.
All the experts however say at least 75 percent of population needs to be vaccinated for life to return to pre-pandemic levels and there’s no telling how long that will take or if it ever will.
Pfizer submitted to the FDA for emergency approval on November 23. This is how many people have died since then from COVID
There remains a huge amount of skepticism surrounding the vaccine that scientists are trying now to fight against.
On Friday morning, former CDC Director Dr. Rich Besser told Today: ‘There was an overwhelming feeling that this is a very safe and effective vaccine, and that the FDA should approve it.
The scientists at yesterday’s panel also all voted that the vaccine was safe.
‘An EUA is a starting point but in all likelihood, the FDA will request the company will continue to do additional studies.
‘There was overwhelming feeling that this is a very safe and effective vaccine and that the FDA should approve it,’ he said.
He went on to say there was concern over the fact that it had been rolled out quickly and said the FDA will likely ask Pfizer to keep studying trial participants to get more information.
‘We’ve never had a vaccine approved this quickly and that will raise a lot of concerns for many people. Those concerns have to be addressed.
‘You’re not going to be able to address those concerns by just putting out ads saying “everyone get this vaccine.”
‘It’s going to take fedeal dollars so that communities and states can work with everybody to understand what are people’s concerns, who are the trusted leaders in each community, what needs to be done.
‘This is being approved base on two months of safety data which isn’t a lot and as we saw in the UK they were detecting issues in people who had severe allergic reactions.’