FDA decision on Pfizer's COVID-19 vaccine booster mixed: What to know

Pfizer-BioNTech booster shot down by FDA for ages 16 and older

An independent committee advising the Food and Drug Administration voted in support of Pfizer’s COVID-19 vaccine booster shot at least six months following the second dose for people ages 65 and older and for those at high risk of occupational exposure and severe COVID-19.

The vote was 18-0. The vote will now go before the FDA to issue a final decision. 

The panel earlier Friday afternoon voted to reject licensure of Pfizer's booster vaccine in people ages 16 and older, at a vote of 2-16.

The country’s plan for a booster shot rollout among the larger U.S. population remains mired with conflicting views from experts, including two senior FDA advisers stepping down over the issue, arguing that data don't support administration of a booster shot for most Americans. 

Top health officials last month issued a plan to begin offering boosters developed by Moderna and Pfizer starting the week of Sept. 20, but what happens now remains unclear. 

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The booster debate also is taking place in the context of global vaccine equity issues, as roughly half of the population around the world remains unvaccinated, and leaders at the World Health Organization have urged wealthier countries to halt booster shot rollout until at least the end of the year.

Here is a FOX Business rundown of what you need to know. 

FDA

During the deliberations, panel members suggested older, vulnerable populations may benefit from boosters, but noted insufficient data among younger groups and concerns over potential increased risk for heart inflammation, particularly among males ages 16-17.

The meeting included members of the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC), as well as officials from the Centers for Disease Control and Prevention, lsrael’s Health Ministry, vaccine experts and Pfizer representatives.

In a briefing document released ahead of Friday’s vote, the agency struck a neutral tone over the issue, writing: "Some observational studies have suggested declining efficacy of COMIRNATY [Pfizer’s approved shot] over time against symptomatic infection or against the Delta variant, while others have not." It also noted that the current vaccines remain effective in preventing severe COVID-19 disease and death.

"There are many potentially relevant studies, but FDA has not independently reviewed or verified the underlying data or their conclusions," the document continues. "It should be recognized that while observational studies can enable understanding of real-world effectiveness, there are known and unknown biases that can affect their reliability."

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Pfizer-BioNTech

Pfizer did not immediately comment following the decision late Friday. 

Ahead of the decision, Pfizer continued to push for booster shots, citing a gradual decline in vaccine efficacy after six months. According to recent findings, within two months after the second dose, efficacy peaked at about 96%, sliding to about 90% by four months before further declining to approximately 84% by the data cutoff date. However, the jab remained protective against severe disease, at 96.7%.

"I believe the right thing, based on our scientific analysis, it is that boosters are needed," Pfizer CEO Albert Bourla said Sept. 14 at a Research! America National Health Research forum.

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Moderna

Massachusetts-based biotech company Moderna has also cited a need for a booster dose to maintain protection. The company released new data on Sept. 15, finding that breakthrough COVID-19 infections nearly doubled among those vaccinated last year versus study participants who received shots eight months ago.

"It is promising to see clinical and real-world evidence adding to the growing body of data on the effectiveness of the Moderna COVID-19 vaccine," Stéphane Bancel, CEO of Moderna, said in a related statement. "The increased risk of breakthrough infections in COVE study participants who were vaccinated last year compared to more recently illustrates the impact of waning immunity and supports the need for a booster to maintain high levels of protection. We hope these findings are helpful as health authorities and regulators continue to assess strategies for ending this pandemic."

Bancel spoke with FOX Business about boosters last month.