COMIRNATY is the first Covid-19 vaccine to be granted FDA approval Approval is based on a comprehensive submission package.
Pfizer Inc and BioNTech SE developed vaccine get approval based six-month efficacy, safety data after the second dose
More than 1.2 billion Pfizer-BioNTech doses have been delivered to more than 120 countries or territories around the world since December 2020
San Francisco, NFAPost: Pfizer Inc and BioNTech SE announced that the US Food and Drug Administration (FDA) approved the Biologics License Application (BLA) for COMIRNATY (Covid-19 Vaccine, mRNA) to prevent Covid-19 in individuals 16 years of age and older. COMIRNATY is the first Covid-19 vaccine to be granted approval by the FDA.
The vaccine has been available in the United States under Emergency Use Authorization (EUA) since December 11, 2020 (as the Pfizer-BioNTech COVID-19 vaccine). The EUA permitted essential rollout of vaccine doses across the United States to help provide protection during the COVID-19 public health emergency, based on initial data from the pivotal Phase 3 clinical trial.
For FDA approval, Pfizer and BioNTech submitted a comprehensive data package that included longer-term follow-up data from the Phase 3 trial, where the vaccine’s high efficacy and favorable safety profile were observed up to six months after the second dose.
The BLA submission package also included the manufacturing and facilities data required for licensure. Pfizer and BioNTech completed submission of the BLA in May 2021, and the BLA was granted Priority Review in July 2021.
Pfizer Chairman and Chief Executive Officer Albert Bourla said based on the longer-term follow-up data that the company submitted, the decision by the FDA affirms the efficacy and safety profile of the vaccine at a time when it is urgently needed.
“About 60% of eligible Americans are fully vaccinated, and infection, hospitalization and death rates continue to rise rapidly among unvaccinated populations across the country,” said Albert Bourla.
Albert Bourla said he is hopeful this approval will help increase confidence in our vaccine, as vaccination remains the best tool the company has to help protect lives and achieve herd immunity.
“Hundreds of millions of doses of our vaccine already have been administered in the United States since December 2020, and we look forward to continuing to work with the U.S. government to reach more Americans now that we have FDA approval, said Albert Bourla.
BioNTech Cofounder Managing Director and CEO Ugur Sahin said today’s full approval by the FDA underlines the vaccine’s high efficacy and favorable safety profile.
“Our companies have shipped more than one billion doses worldwide, and we will continue to work tirelessly to broaden the access to our vaccine and to be prepared for potential emerging escape variants,” said Ugur Sahin.
As announced on August 16, Pfizer and BioNTech plan to seek licensure of a third, or booster, dose of COMIRNATY in individuals 16 years of age and older via a supplemental BLA. The companies also intend to submit a supplemental BLA to support potential full FDA approval of COMIRNATY in individuals 12 through 15 years of age once the required data out to six months after the second vaccine dose are available.
In the meantime, the vaccine remains available to 12- to 15-year-olds under the Emergency Use Authorization (EUA) granted by the FDA on May 10, 2021. For individuals at least 12 years of age who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise, a third dose of the vaccine also remains available under EUA following an amendment by the FDA on August 12.
COMIRNATY, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union and the United Kingdom, and the holder of emergency use authorisations or equivalents in the United States (jointly with Pfizer), Canada and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.
Indication & Authorized Use
COMIRNATY® (COVID-19 vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech.
It is approved as a 2-dose series for prevention of COVID-19 in individuals 16 years of age and olderIt is also authorised under Emergency Use Authorization (EUA) to be administered for emergency use to: prevent COVID-19 in individuals 12 through 15 years, andprovide a third dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise
The Pfizer-BioNTech Covid-19 vaccine has received EUA from FDA to:
prevent Covid-19 in individuals 12 years of age and older, andprovide a third dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise
The FDA-approved COMIRNATY® (Covid-19 vaccine, mRNA) and the EUA-authorized Pfizer-BioNTech Covid-19 vaccine have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series. An individual may be offered either COMIRNATY® (Covid-19 vaccine, mRNA) or the Pfizer-BioNTech COVID-19 vaccine to prevent coronavirus disease 2019 (Covid-19) caused by SARS-CoV-2.
EUA Statement
This emergency use of the product has not been approved or licensed by FDA, but has been authorized by FDA under an Emergency Use Authorisation (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 12 years of age and older; and the emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.
