Pharma majors Pfizer Inc. and BioNTech SE have successfully attained US FDA’s Biologics License Application (BLA) approval for COMIRNATY® (COVID-19 Vaccine, mRNA) for preventing COVID-19 in individuals aged above 16 years.
COMIRNATY is the very first COVID-19 vaccine which the FDA has approved. The vaccine was made available in the US in December 2020 under Emergency Use Authorization (EUA).
After receiving initial data from the pivotal Phase 3 clinical trial, the EUA approved vaccine went through necessary distribution across the United States to help offer protection during the COVID-19 public health emergency.
Pfizer and BioNTech submitted an all-inclusive data package that contained longer-term follow-up data from the Phase 3 trial. The vaccine’s high efficiency and favorable safety profile were detected and observed for up to six months after the second dose.
This submission data packages also included the facilities and manufacturing data required for licensing. Pfizer and BioNTech submitted the data in May 2021, and the BLA received Priority Review in July 2021.
Albert Bourla, Chairman and Chief Executive Officer of Pfizer, said that the longer-term follow-up data and the FDA approval assures the effectiveness and safety profile of its vaccine, especially at a time when it is urgently required.
Mr. Bourla claims that approximately 60% of Americans are fully vaccinated, and the death rates, infections and hospitalizations rates continue to increase among the people who are not vaccinated in the country. Pfizer hopes that this approval will boost public confidence in the vaccine, as immunization is still the key tool for saving lives and achieving herd immunity.
Since December 2020, hundreds of millions of vaccine doses have been provided in the United States and Pfizer looks forward to working with the government to reach even more Americans now that the FDA has approved its vaccine.