Never has reading between the lines been made so easy, suggests Business Insider. The Food and Drug Administration meets with its panel of independent experts today to conduct a final review of data from Pfizer’s COVID-19 trials. The FDA could issue an emergency-use authorization that would roll out millions of doses for the first US vaccinations in the pandemic.
That’s if the FDA gets support from its experts and considers it safe, commissioner Stephen Hahn told NBC’s Savannah Guthrie on Today:
“Our plan is to take their recommendations into account… and make a decision shortly thereafter. We intend to act quickly.” – FDA Commissioner Stephen Hahn on today’s meeting with an outside panel to discuss the approval of Pfizer’s coronavirus vaccine pic.twitter.com/1CqJWu9GxH
— TODAY (@TODAYshow) December 10, 2020
Come on, man, writes Anna Medaris Miller. Everyone knows that the FDA has little choice but to roll out the vaccine, especially since the same vaccinations have already begun in the UK and will start in Canada shortly:
FDA Commissioner Dr. Stephen Hahn said the outcome is already predictable, and that the agency intends to act on the advisory panel’s advice immediately.
“We’ll have to see what the scientific and medical discussion is today. But our plan is to take their recommendations into account for our decision making and make a decision shortly thereafter … We intend to act quickly,” he told Savannah Guthrie live on NBC News’ TODAY before the advisory committee convened.
The head of the FDA assured, “our initial assessment is that this is a vaccine that does meet our criteria … But we do want to hear from the vaccine advisory committee.”
It’s not as if there aren’t some open questions. The UK discovered that people with “significant” histories of allergic reactions might have to wait for a different vaccine. There are also questions about long-term impacts of the vaccine that can’t be answered at this time, but as one epidemiologist told me on Monday, the long term impact of no vaccine is pretty much continued isolation and its health impacts.
Besides, the FDA can’t back down now that the UK and Canada have launched the Pfizer vaccine. The US hit a new record for daily deaths yesterday at over 3,000, and thanks to the holiday season that might not yet be the peak. They need to start dragging the transmission rate down pronto, and emergency deployments of effective vaccines will do that. Especially at the efficacy level promised by Pfizer and Moderna — 95% in a two-stage dosing regimen.
In other words, this is almost certainly a mere formality. That prompts the question, though, why the FDA didn’t just call its panel last week and skip the formalities. A week’s head start would have been helpful if this was a done deal all along.
The FDA hearing is being streamed on YouTube. It’s all pretty technical, and there seems to be no real suspense in the ending. It’s sometimes amusing to watch the smartest minds in the world not knowing how to unmute themselves, but let every person who never did their own Zoom version of Silent Movie cast the first stone.