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FDA Officially Approves Pfizer Booster For 65 & Up, High-Risk Categories; 3rd Shot For Others Still On Ice – Update

Dominic Patten
·5-min read

UPDATED, 5:08 PM: Less than a week after an advisory panel to Food and Drug Administration rejected an application for wide-spread booster shots of of Pfizer’s Covid-19 vaccine, but gave the thumbs up for those 65 and older and those in high risk categories, the federal agency officially signed off. on the latter.

Coming two days after what the Biden administration had earmarked as the start of a new round of vaccination shots, the FDA this afternoon laid out what the new state of affairs actually is

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Expected for seniors, the more vulnerable and those in frontline occupations like healthcare workers, teachers and grocery store staff who had their second jab six months or more ago, the booster still has at least one more hoop to jump through. An independent panel advising the Centers for Disease Control and Prevention will meet tomorrow to analyze data and offer their own recommendations on who should get a third shot.

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Though the advisory panel nods are not binding on the FDA or CDC, it is unlikely either will choose to contradict them …and no word on when Americans 16 – 65 will be getting their next Pfizer jab.

PREVIOUSLY, SEPT 17 PM: A month after Joe Biden laid out a plan for Americans to get a vaccine booster shot to help contain the coronavirus pandemic and the deadly Delta variant, a pivotal advisory panel to the Food and Drug Administration today kicked a lot of the legs out from the President’s proposal.

In a whirlwind of mixed messages, the 18-member scientific committee voted 16-2 against distribution of a third shot of Pfizer’s Covid-19 vaccine for those 16 and older. Specifically the question on the pharmaceutical giant’s application poised to the group of outside experts on Friday was: “Do the safety and effectiveness data from clinical trial C4591001 support approval of a COMIRNATY booster dose administered at least 6 months after completion of the primary series for use in individuals 16 years of age and older?”

As well as viewing the booster data in question from Israel as lacking the parameters to be pertinent in the United States, with its far larger and diverse population, Friday’s initial decision was based on concerns about safety in the general population with an additional jab.

Then, following a day of public debate over the measure in front of the Vaccines and Related Biological Products Advisory Committee, the same panel voted unanimously later Friday to give Pfizer booster shots to Americans 65 and older, as well as those in “high risk” categories.

Needless to say, coming just days before the September 20 rollout of the administration’s third shot strategy, Friday’s non-binding but influential vote is a real kneecapping to the White House. Whether the FDA will abide by the panel’s vote is still TBD. However, if precedent is any indication, they very well might.

National Institute of Allergy and Infectious Diseases Director & White House Chief Medical Advisor Dr. Anthony Fauci tried to put the best face on the situation in an interview with CNBC this afternoon. “There’s still a lot ahead even though we have one element of the decision, not the decision but the recommendation, and the vote which as I mentioned it’s not totally surprising,” Dr. Fauci told Closing Bell’s Meg Tirrelll today. “I think the critical issue is at what age will be the cut off, if any.”

Putting the realpolitik calendar in an even tighter vice, the Centers of Disease Control and Prevention had set a two-day gathering beginning on September 22 of some of its top inside and outside scientists to look at plans for a third shot. Based on protocol and facts of life, those meetings were in anticipation that today’s FDA panel votes would give the Pfizer booster the green light — which was not entirely the case.

Today’s votes also follow a published review of scientific data last week by the likes of two senior Food and Drug Administration officials and the World Health Organization, that suggested now is not the time for a third shot for many. Basically, the conclusion was while the vaccine’s refuting of mild disease may weaken in a few months, the effectiveness against harsher ailments remains strong.

Pfizer stock was flat in after-hours trading after slipping 1% during the regular trading day to close at $43.89.

The company’s shares have risen 8% since the FDA granted emergency use authorization for the vaccine last December. Late last month, in a boost (no pun intended) to pro-vaxxers and to take away one of the main arguments of anti-vax crowd, the FDA officially approved the Pfizer-BioNTech Covid-19 Vaccine. The order said the vaccine would now formally be known and marketed “as ‘Comirnaty’ for the prevention of COVID-19 disease in individuals 16 years of age and older.”

Maybe.

Deadline’s Jill Goldsmith contributed to this report.

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