A committee comprising outside advisers to the United States Food and Drug Administration (FDA), on December 10, voted overwhelmingly to endorse emergency use of Pfizer’s COVID-19 vaccine candidate. This paves the way for the FDA to grant authorisation for the vaccine to be given to the general public in the US.
The panel called Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 17 to 4 in support of the USFDA granting Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine. There was one member of the Committee whose vote is not included in the 17 to 4 vote decision.
Pfizer’s vaccine is already approved in the UK, Bahrain and Canada. Pfizer has filed for emergency use approval of the vaccine in India.
Pfizer said VRBPAC based its recommendation on the totality of scientific evidence shared by the companies, including data from a pivotal Phase 3 clinical study announced last month and published today in The New England Journal of Medicine.
“The Phase 3 data demonstrated a vaccine efficacy rate of 95 percent in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from 7 days after the second dose,” Pfizer said in a statement.
“The Data Monitoring Committee for the study has not reported any serious safety concerns related to the vaccine. Efficacy was consistent across age, gender, race and ethnicity demographics. All trial participants will continue to be monitored for an additional two years after their second dose to assess long-term protection and safety,” the statement added.
Under an EUA, the USFDA has the authority to allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions during a declared public health emergency when there are no adequate, approved, and available alternatives.