Pfizer/BioNTech’s mRNA Vaccine Comirnaty Receives FDA Priority Review for Use in Individuals Aged 16 and Older Amid Global COVID-19 Cases Surpassing 190 Million

July 18, 2021 /BioonBIOON/ -- According to Baidu's 《Real-time Novel Coronavirus Pneumonia EpidemicBig DataReport》, as of 00:00 on July 18, 2021,Global cumulative confirmed cases have exceeded 190 million (190.59 million), with deaths surpassing 4.09 million.

Recently,Pfizer(Pfizer) and BioNTech jointly announced that the U.S. Food and Drug Administration (FDA) has granted itCOVID-19 mRNA vaccine Comirnaty (BNT162b2)Biologics License Application (BLA) Priority Review designation (PRD). This mRNA vaccineFor active immunization to prevent COVID-19 in individuals 16 years of age and older.FDAThe Prescription Drug User Fee Act (PDUFA) target date for the BLA has been set for January 2022.

Pfizer and BioNTech completed the rolling submission of the BLA in May 2021. The application included data from the pivotal Phase 3 trial of Comirnaty, with results demonstrating that the vaccine maintained efficacy and a favorable safety profile within 6 months following the second dose.

Specifically, analysis of the 927 confirmed symptomatic COVID-19 cases observed in this pivotal Phase 3 trial showed that,The efficacy of Comirnaty in preventing COVID-19 was 91.3% from 7 days to 6 months after the second dose.According to the definition of the U.S. Centers for Disease Control and Prevention (CDC), Comirnaty has an efficacy rate of 100% in preventing severe COVID-19 disease; according to the U.S.FDAdefinition, the efficacy against severe COVID-19 disease was 95.3%. Safety data from this Phase 3 study, collected from more than 12,000 vaccine recipients with at least 6 months of follow-up after the second dose, demonstrated that Comirnaty has a favorable safety and tolerability profile.

Comirnaty vaccine (Image source: haber7.net)

May 10, 2021,FDAThe Emergency Use Authorization (EUA) for the Pfizer/BioNTech COVID-19 mRNA vaccine, Comirnaty, has been expanded to include adolescents aged 12 to 15 years. Once the required data from six months following the second dose are available, both companies intend to submit a supplemental Biologics License Application (BLA) to support the approval of this mRNA vaccine for adolescents aged 12 to 15 years.

The Pfizer/BioNTech COVID-19 vaccine is based on BioNTech's proprietary mRNA technology and was jointly developed by BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the European Union and holds Emergency Use Authorization (EUA) or equivalent authorizations in the United States (together with Pfizer), the United Kingdom, Canada, and other countries, prior to planned applications for full marketing authorization in these countries.

Currently, the Comirnaty vaccine has not yet been approved or licensed by the U.S. FDA, but has receivedFDA's Emergency Use Authorization (EUA): For active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals aged ≥12 years. (Bioon.com)

Original Source:U.S. FDA Grants Priority Review for the Biologics License Application for Pfizer-BioNTech COVID-19 Vaccine