FDA Grants Priority Review to Pfizer, BioNTech COVID-19 Vaccine

Officials with the FDA have granted priority review to Pfizer and BioNTech’s biologics license application (BLA) for their mRNA COVID-19 vaccine in patients 16 years of age and older, according to a press release from BioNTech.¹

The companies completed the rolling submission of their application in May 2021, and the Prescription Drug User Fee Act goal date for a decision is in January 2022. The application is supported by clinical data from the pivotal phase 3 trial of the vaccine, which observed the efficacy and safety of the vaccine for up to 6 months after the second dose.¹

Data supporting the original emergency use authorization (EUA) demonstrated a vaccine efficacy of 95% in trial participants without prior SARS-CoV-2 infection, as well as in participants with and without prior SARS-CoV-2 infection. For those without prior infection, the analysis was based on 170 cases of COVID-19. The efficacy in adults 65 years of age and older was more than 94%, with consistency across age, gender, race, and ethnicity demographics.²

The vaccine has been authorized for emergency use since December 2020 for the prevention of COVID-19 caused by SARS-CoV-2. This EUA was expanded to include individuals 12 through 15 years of age on May 10, 2021, and the companies plan to submit a supplemental BLA for licensure of the vaccine in this age group once they have the required data 6 months following the second dose.¹

The priority review designation is reserved for drugs that would provide significant improvements in the safety and efficacy of the treatment, diagnosis, or prevention of serious conditions compared to currently available treatments. It signals that the FDA plans to take action on the application within 6 months compared to 10 months under standard review.³

REFERENCES

1. US FDA Grants Priority Review for the Biologics License Application for Pfizer-BioNTech COVID-19 Vaccine. News release. BioNTech. July 16, 2021. Accessed July 16, 2021. https://investors.biontech.de/news-releases/news-release-details/us-fda-grants-priority-review-biologics-license-application

2. FDA Grants Historic Emergency Use Authorization to COVID-19 Vaccine from Pfizer and BioNTech. Pharmacy Times. December 12, 2020. Accessed July 16, 2021. https://www.pharmacytimes.com/view/fda-grants-historic-emergency-use-authorization-to-covid-19-vaccine-from-pfizer-and-biontech

3. FDA. Priority Review. Updated January 4, 2018. Accessed July 16, 2021. https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/priority-review