Breaking: FDA told Pfizer to expect immediate emergency-use authorization for vaccine, says Azar

“Good news”? It’s great news, even if it is anything but unexpected. Health and Human Services Secretary Alex Azar announced on Good Morning America that the FDA has informed Pfizer of its intent to issue an emergency-use authorization (EUA) for its COVID-19 vaccine. That means that vaccinations in the US could start as soon as Monday.

Plus, the FDA will come back and do this all over again on December 17th with the Moderna vaccine:

The New York Times wondered whether the FDA would get bogged down any further in its bureaucracy after the advisory panel’s vote yesterday to recommend the EUA. Azar’s announcement removes the remaining doubt:

Since the panel’s vote on Thursday was only advisory, the vaccine must now secure the authorization of the federal Food and Drug Administration. That’s ordinarily a long and laborious process.

But that is highly unlikely to be the case this time. Barring last-minute snags, the F.D.A. is expected to issue an emergency authorization on Saturday.

And that means the first Covid-19 vaccinations to be administered in the U.S. outside the confines of an experiment are likely to begin early next week. First in line to get it are health care workers and nursing home residents.

“We could see people getting vaccinated Monday, Tuesday of next week,” Alex Azar, the secretary of health and human services, said on ABC’s “Good Morning America” on Friday.

Azar explicitly told George Stephanopoulos that the FDA had told Pfizer of its intent to act immediately. They would need to inform Pfizer of that intent in order to get the wheels of distribution turning as fast as possible. Regulations prevented Pfizer from moving the vaccines to providers until the FDA issued its EUA. To get vaccines started by Monday, Pfizer needs to start moving its inventory to its end users ASAP.

But are they approving it because it’s safe and effective, or because they’re desperate? Or for *ahem* some other reason?

Definitely the former, previous CDC director Rich Besser told Savannah Guthrie on NBC’s Today. Besser watched the advisory-panel meeting yesterday and came away impressed. The FDA will want more studies on subdemos that might not have gotten enough participation in the Phase 3 trials, but overall the data was comprehensive and impressive. Americans should have high confidence in the Pfizer vaccine, Besser says:

Next up: Moderna on the 17th. Based on the time frame of this approval process, we might end up with two EUAs for COVID-19 vaccines by Christmas. Congratulations to everyone who made this happen.

Update: Azar says that a setback for Sanofi will have no impact on projected vaccinations. They’re still looking at 50 million vaccinations by the end of January.