FDA Panel Votes Against Approval Of Pfizer/BioNTech's COVID-19 Booster Shot For General Public

Pfizer, Inc. PFE-BioNTech SE BNTX shares are sliding after a Food and Drug Administration panel voted against recommending a third dose of their COVID-19 vaccine, Comirnaty, to the general population.

What Happened: FDA's Vaccines and Related Biological Products Advisory Committee met Friday to discuss Pfizer-BioNTech's supplemental biologics license application for Comirnaty for the administration of a third dose, or "booster" dose, of the COVID-19 vaccine, in individuals 16 years of age and older.

For the question "whether the safety and effectiveness data for Comirnaty support approval of a booster dose administered six months after the primary series in individuals 16 years and older," 16 members voted "no" and two members voted "yes."

This could prove to be a setback for the Biden administration's drive to begin administering booster doses, beginning next week, to the general population, who have been vaccinated at least eight months ago.

FDA's stance doesn't come as a total surprise, as a new review co-authored by scientists, including top FDA vaccine regulators, published in the Lancet earlier this week said booster doses may not be warranted at this point of time.

During Friday's livestreamed meeting, FDA's Center for Biologics Evaluation and Research, Dr. Peter Marks, said, "committee members should focus on "the science" of Pfizer's application for approval of a booster dose, and not issues like equity of global vaccine distribution."

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For a second voting question on whether the booster dose could be authorized for emergency use in individuals 65 years of age and older and individuals at high risk of severe COVID-19, all 18 voting members gave "yes" votes.

"It's likely beneficial, in my opinion, for the elderly, and may eventually be indicated for the general population. I just don't think we're there yet in terms of the data," Dr. Ofer Levy, a vaccine and infectious disease specialist at Boston Children's Hospital, said in the comments in the run up to the voting.

What's Next: The Adcom recommendation is non-binding, as the FDA customarily takes into account the panel's discussion and recommendation but is not bound to toe in line.

A Centers for Disease Control and Prevention advisory panel will meet next week to discuss recommendations for who should receive a booster dose.

Reacting to the outcome, Pfizer shares closed down 1.33% at $43.88 and were losing an incremental 0.32% in after-hours trading. BioNTech fell 3.61% to $359.19.

Moderna, Inc. MRNA, which is also sponsoring a booster dose fell 2.41% to $430.05 in regular trading. The stock was down an incremental 1.11% to $425.26 in after-hours trading.