Breaking: Pfizer to file today for emergency-use approval for COVID-19 vaccine

Merry Vaccine-mas, everyone! Pfizer has broken the tape first with the FDA, or will within hours or even minutes with its emergency-use authorization request. If granted, Pfizer says it will only take hours to start shipping its COVID-19 vaccine, and they believe that high-risk groups will get access before Christmas:

The drugmaker Pfizer said it plans to submit an application to the Food and Drug Administration on Friday for emergency use authorization of its coronavirus vaccine. That would set in motion an accelerated regulatory process that could allow the first Americans to get a vaccine by the middle of December. …

An emergency authorization would allow limited groups of Americans to get the vaccines before the F.D.A. has completed the typical monthslong approval process, but agency officials have made clear through new guidelines that their bar for emergency authorization will be high.

On the other hand, the FDA is also cognizant of the study data already. Plus, Pfizer’s track record on safety and the urgent need for the vaccine will tilt the process toward expediting their approval. However, the emergency-use approval is not a full green light:

If there’s an emergency green light, “that vaccine is still deemed investigational. It’s not approved yet,” Dr. Marion Gruber, chief of FDA’s vaccine office, told the National Academy of Medicine this week.

That means anyone offered an emergency vaccination must get a “fact sheet” describing potential benefits and risks before going through with the shot, she said.

There will be a lot of unknowns. For example, the 95% protection rate is based on people who developed symptoms and then were tested for the virus. Can the vaccinated get infected but have no symptoms, able to spread the virus? How long does protection last?

That’s why the 44,000-person study needs to keep running — something difficult considering ethically, participants given dummy shots at some point must be offered real vaccine, complicating the search for answers.

Some groups might be excluded from the vaccine due to the structure of the Phase 3 testing done. Pfizer’s testing did not include pregnant women, which means additional safety testing will have to be performed before they can access it. Moderna’s test groups didn’t include children, while Pfizer included children age 12 and above in its testing. Children aren’t considered high-risk for COVID-19 anyway, but just the same, the testing will have to include them for any vaccinations to be approved.

Speaking of Moderna, they’re expected to follow suit shortly with their request. Their vaccine is as effective but more easily stored and distributed. That will help in the first quarter of next year but probably not before Christmas, unless the FDA moves fast on both requests.

We’re not out of the tunnel yet, and it’s still going to be a while before we are. This might be the brightest light yet that we’ve seen at the end of it, however, and it’s not going to be as long as we feared eight months ago.

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