Pfizer (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the U.S. 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.

“Based on the longer-term follow-up data that we submitted, today’s decision by the FDA affirms the efficacy and safety profile of our vaccine at a time when it is urgently needed. About 60 percent 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, Chairman and Chief Executive Officer, Pfizer. “I am hopeful this approval will help increase confidence in our vaccine, as vaccination remains the best tool we have 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.”

“Today's full approval by the FDA underlines the vaccine's high efficacy and favorable safety profile,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “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.”

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 authorizations 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 older
• It is also authorized under Emergency Use Authorization (EUA) to be administered for emergency use to:
  • prevent COVID-19 in individuals 12 through 15 years, and
  • provide 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, and
• provide 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 Authorization (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.

Important Safety Information

Individuals should not get the Pfizer-BioNTech COVID-19 vaccine if they:

• had a severe allergic reaction after a previous dose of this vaccine
• had a severe allergic reaction to any ingredient of this vaccine

Individuals should tell the vaccination provider about all of their medical conditions, including if they:

• have any allergies
• have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart)
• have a fever
• have a bleeding disorder or are on a blood thinner
• are immunocompromised or are on a medicine that affects the immune system
• are pregnant, plan to become pregnant, or are breastfeeding
• have received another COVID-19 vaccine
• have ever fainted in association with an injection

The vaccine may not protect everyone.

Side effects reported with the vaccine include:

• There is a remote chance that the vaccine could cause a severe allergic reaction
  • A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose of the vaccine. For this reason, vaccination providers may ask individuals to stay at the place where they received the vaccine for monitoring after vaccination
  • Signs of a severe allergic reaction can include difficulty breathing, swelling of the face and throat, a fast heartbeat, a bad rash all over the body, dizziness, and weakness
  • If an individual experiences a severe allergic reaction, they should call 9-1-1 or go to the nearest hospital
• Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received the vaccine. In most of these people, symptoms began within a few days following receipt of the second dose of the vaccine. The chance of having this occur is very low. Individuals should seek medical attention right away if they have any of the following symptoms after receiving the vaccine:
  • chest pain
  • shortness of breath
  • feelings of having a fast-beating, fluttering, or pounding heart
• Side effects that have been reported with the vaccine include:
  • severe allergic reactions; non-severe allergic reactions such as rash, itching, hives, or swelling of the face; myocarditis (inflammation of the heart muscle); pericarditis (inflammation of the lining outside the heart); injection site pain; tiredness; headache; muscle pain; chills; joint pain; fever; injection site swelling; injection site redness; nausea; feeling unwell; swollen lymph nodes (lymphadenopathy); diarrhea; vomiting; arm pain
• These may not be all the possible side effects of the vaccine. Serious and unexpected side effects may occur. The vaccine is still being studied in clinical trials. Call the vaccination provider or healthcare provider about bothersome side effects or side effects that do not go away

There is no information on the use of the vaccine with other vaccines.

Patients should always ask their healthcare providers for medical advice about adverse events. Individuals are encouraged to report negative side effects of vaccines to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Visit http://www.vaers.hhs.gov or call 1‐800‐822‐7967. In addition, side effects can be reported to Pfizer Inc. at www.pfizersafetyreporting.com or by calling 1-800-438-1985.

Please click here for full Prescribing Information (16+ years of age) and Recipient and Caregiver Fact Sheet (12+ years of age).