FDA decision on US authorization of Pfizer COVID-19 vaccine expected within days

By Jane Byrne

- Last updated on GMT

© GettyImages/Ildo Frazao
© GettyImages/Ildo Frazao

Related tags COVID-19 Vaccine Pfizer

The FDA is set to make a decision on Emergency Use Authorization (EUA) in the coming days for the mRNA COVID-19 vaccine candidate, BNT162b2, from drug makers, Pfizer and BioNTech.

If authorized, BNT162b2 would be the first COVID-19 vaccine available in the US.

Yesterday [December 10] saw a positive endorsement of the US FDA advisory body, the Vaccines and Related Biological Products Advisory Committee (VRBPAC), of the safety and efficacy of that vaccine. The committee voted 17 to 4 in support of the FDA granting the EUA for the shot.

The US Food and Drug Administration (FDA) will take the group’s recommendation into consideration when it makes a final determination.

Canada’s health regulator gave the green light to BioNTech and Pfizer’s vaccine on Wednesday, with the country set to launch its inoculation campaign next week.

The vaccine has already been authorized for emergency use by the UK and Bahrain.

Scientific evidence 

VRBPAC’s vote was based on the totality of scientific evidence presented by the companies, including Phase 3 efficacy and safety data announced last month and published yesterday in The New England Journal of Medicine, ​said Pfizer and BioNTech.

That Phase 3 data demonstrated a vaccine efficacy rate of 95% 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 seven days after the second dose.

The companies said 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 Data Monitoring Committee for the study has not reported any serious safety concerns related to the vaccine, added the sponsors.

Pfizer 'standing at the ready'

“We have been looking forward to presenting our robust data package to the committee of vaccine experts for the US government since we began our efforts to develop a novel COVID-19 vaccine earlier this year,”​ said Dr Albert Bourla, Pfizer chairman and CEO. “We are pleased with the committee’s strong majority vote, and if the FDA issues an authorization, stand at the ready to bring this vaccine to people in the US in an effort to help combat this devastating pandemic.”

FDA advisory committees provide non-binding recommendations, with the final decision on approval or authorization to be made by the FDA.

Under an EUA, the FDA 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.

Phase 2/3 studies 

The companies said that the ongoing Phase 3 clinical trial of BNT162b2, which is based on BioNTech’s proprietary mRNA technology, has enrolled more than 44,000 participants, the vast majority of whom have received their second dose. A breakdown of the diversity of clinical trial participants can be found here​ from more than 150 clinical trials sites in the US, Germany, Turkey, South Africa, Brazil and Argentina.

The Phase 3 trial is designed as a 1:1 vaccine candidate to placebo, randomized, observer-blinded study to obtain safety, immune response, and efficacy data needed for regulatory review. The trial’s primary endpoints are prevention of COVID-19 in those who have not been infected by SARS-CoV-2 prior to immunization, and prevention of COVID-19 regardless of whether participants have previously been infected by SARS-CoV-2. 

Secondary endpoints include prevention of severe COVID-19 in those groups. The study also will explore prevention of infection by SARS-CoV-2, the virus that causes COVID-19. Data from this study, including longer term safety, comprehensive information on duration of protection, efficacy against asymptomatic SARS-CoV-2 infection, and safety and immunogenicity in adolescents 12-17 years of age will be gathered in the months ahead, said the developers.

Additional studies are planned to evaluate BNT162b2 in pregnant women, children younger than 12 years, and those in special risk groups, such as the immunocompromised, they added.

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