FDA committee votes to OK Pfizer's coronavirus vaccine for EUA

[PeteS in CA]

https://www.foxnews.com/health/fda-committee-votes-ok-pfizers-coronavirus-vaccine-eua

FDA committee votes to OK Pfizer's coronavirus vaccine for EUA

A U.S. Food and Drug Administration advisory committee on Thursday voted to approve Pfizer and BioNTech’s emergency use authorization (EUA) application for its coronavirus vaccine candidate, the first COVID-19 jab to win such approval in the U.S.

The vote was 17-4. One committee member abstained.

The committee was charged with voting on the following question: "Based on the totality of scientific evidence available, do the benefits of the Pfizer-BioNTech COVID-19 Vaccine outweigh its risk for use in individuals 16 years of age and older?"
...
The highly anticipated meeting included members of the FDA’s Center for Biologics Evaluation and Research advisory committee, outside vaccine experts and Pfizer representatives. The U.S. follows behind Canada, the United Kingdom and Bahrain to approve the emergency use of Pfizer and BioNTech’s coronavirus vaccine. 

Albeit significant, it’s important to note that the committee’s vote in favor of the EUA is not final; the vote now has to be reviewed by the officials with the Center for Biologics Evaluation and Research, which will confirm the decision.

[PeteS in CA]

https://hotair.com/archives/ed-morrissey/2020/12/11/breaking-fda-told-pfizer-expect-immediate-emergency-use-authorization-vaccine-says-azar/

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:

Since whatever Pfizer has produced and shipped to the US is already staged around the country, this might be more pertinent to US distribution channels and administration sites (e.g. pharmacies and community clinics). OTOH, maybe Pfizer has more in its shipment pipeline it's been holding pending approval or maybe Pfizer's US and EU production facilities aren't operating at full capacity.

As the article said, next week, Moderna, and unlike Pfizer's vaccine which needs to be stored at dry ice temperatures, Moderna's can be stored at ordinary freezer temperatures (= easier handling and storage).