A panel of expert advisors to the Food and Drug Administration (FDA) will met tomorrow to discuss whether to recommend that the agency authorize the second shot to be given to Americans.
‘Tomorrow, the FDA will hopefully make a decision regarding whether or not the Moderna messenger RNA vaccine will get an emergency use authorization,’ Dr Fauci told CNBC.
Pfizer‘s shot was not given the green light for more than 24 hours after the same panel recommended its approval at the end of last Thursday’s meeting.
That drew anger and frustration from Americans, including the President, whose chief of staff Mark Meadows allegedly threatened Commissioner Dr Stephen Hahn’s job if Pfizer’s vaccine wasn’t approved by Friday.
Dr Fauci’s comments suggest that the FDA, with one approval and the preparations for distribution of a COVID-19 vaccine under its belt, might move more quickly on Moderna’s shot.
Dr Anthony Fauci said on CNBC that the FDA will ‘hopefully’ approve Moderna’s COVID-19 jab as early as tomorrow, following an expert meeting to discuss the shot
‘A couple of days ago…2.9 billion doses were sent out to 145 locations, and over the next few days to weeks, there’ll be more and more doses to ultimately, we hope, with a combination of Pfizer and Moderna, if Moderna gets the EUA, which I hope they will, that by the time you get to the end of December, have 40 million doses for 20 million people, to be able to administer,’ Dr Fauci explained.
His comments come as the first doses of a coronavirus vaccine – Pfizer’s – are distributed across the nation.
It’s an historic and anxious step toward curbing the pandemic in the U.S., where more than 3,000 Americans died Tuesday alone.
On Wednesday, one of the first 96 people given the jab in Alaska developed a severe reaction to it.
Two UK health care workers had similar reactions, going into anaphylactic shock, after getting Pfizer’s shot on the first day of its rollout there.
The Alaskan woman, Juneau, Alaska, had no known history of drug allergies – unlike the two UK cases – triggering worry over the shot.
Dr Fauci was not surprised by the emergence of these reactions – or that they didn’t come up in trials for Pfizer’s shot.
‘Well, that’s the reason why I think people need to understand that the issue of the safety goes well beyond the confines of a clinical trial,’ Dr Fauci told CNBC.
‘Because when you’re in a clinical trial, you’re giving it for example, the Pfizer trial was 44,000 people.
‘Once you decide to dispense the vaccine widely, you’re talking about millions and tens of millions and ultimately hundreds of millions of doses. So you may see reactions that you didn’t see in the clinical trial…you may see reactions that you didn’t see in the clinical trial.’
In the UK, the official advice is that people who have a history of severe allergies not get Pfizer’s shot.
The U.S. has not issued any similar official warnings, but Dr Fauci said this might be cause for Americans with allergies to skip this shot and wait for another, or make sure the location where they choose to get vaccinated has treatments for bad reactions, like EpiPens, available.
Severe allergic reactions weren’t reported in Moderna’s trial either, but are likely to come up in the FDA’s Thursday discussion since the firm’s shot is the same type as Pfizer’s, an mRNA vaccine.