First emergency use authorization in the United States for a COVID-19 vaccine booster in adolescents 12 through 15 years of age
Today’s FDA action also reduces time between completion of primary series and booster dose for all eligible individuals, and authorizes a third primary series dose for individuals 5through 11 years of age with certain kinds of immunocompromise
Pfizer and BioNTech fulfill their goal to deliver 1 billion doses of their COVID-19 vaccine to low- and middle-income countries in 2021
NEW YORK & MAINZ, Germany--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the U.S. Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) of a booster dose of the Pfizer-BioNTech COVID-19 Vaccine to include individuals 12 years of age and older. The booster dose is the same dosage strength (30-µg) as the dose approved in the primary series.

A booster dose of the Pfizer-BioNTech COVID-19 Vaccine was previously authorized by the FDA for emergency use after completion of a primary series in individuals 16 years of age and older. The vaccine is also authorized for eligible individuals 18 and older who have completed primary vaccination with a different authorized COVID-19 vaccine.

“The recent rise in COVID-19 cases is concerning to all and today’s decision by the FDA to further expand the Emergency Use Authorization of a booster dose of our vaccine is critical to help us ultimately defeat this pandemic,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “We continue to believe that broad use of boosters is essential to preserving a high level of protection against this disease and reducing the rate of hospitalizations.”

“The booster vaccination increases the level of immunity and improves protection against COVID-19 across all age groups that have been authorized to receive one,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “In the current situation, it is important to offer all eligible individuals a booster, particularly against the backdrop of the newly-emerging variants such as Omicron.”

Real world evidence from the Ministry of Health of Israel on the administration of over 4.1 million third doses of the Pfizer-BioNTech COVID-19 Vaccine given at least 5 months after the primary series revealed no new safety concerns in adolescents 12 through 17 years of age.1

Additional EUA Amendments

Separately, the FDA is also amending the existing EUA to reduce the time for administration of a booster dose from at least six months to at least five months following completion of the primary series for individuals 12 years of age and older. The reduction of time between the primary series is supported by real world evidence from the Ministry of Health of Israel on the administration of third doses of the Pfizer-BioNTech COVID-19 Vaccine given at least 5 months after the primary series, which revealed no new safety concerns in adults.1

Finally, the FDA has expanded the current Emergency Use Authorization to include administration of a third primary series dose at least 28 days following the second dose for individuals 5 through 11 years of age who have who have been determined to have certain kinds of immunocompromise. This authorization is based on information extrapolated from an independent report evaluating safety and effectiveness of a third dose in adults who received solid organ transplants. A third primary dose of the Pfizer-BioNTech vaccine was previously authorized for administration to individuals at least 12 years of age who have been determined to have certain kinds of immunocompromise.

The companies continue to supply the vaccine, including booster doses, under their existing supply agreement with the U.S. government, which continues through April 2022. The companies do not expect that today’s news will impact the existing supply agreements in place with governments and international health organizations around the world. As of December 29, 2021, Pfizer and BioNTech have delivered 1 billion doses of the Pfizer-BioNTech COVID-19 Vaccine to low- and middle-income countries. The companies expect to deliver an additional 1 billion doses to these nations in 2022. These doses are part of Pfizer and BioNTech’s previously announced pledge to provide 2 billion doses of the COVID-19 vaccine to low- and middle-income countries between 2021 and 2022.

The Pfizer-BioNTech COVID-19 Vaccine, 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, the United Kingdom, Canada and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.

U.S. Indication & Authorized Use

HOW IS THE VACCINE GIVEN?

The vaccine will be given as an injection into the muscle.

Primary Series:

In individuals 5 years of age and older, the vaccine is administered as a 2-dose series, 3 weeks apart. In individuals 5 years of age and older, a third primary series dose may be administered at least 28 days after the second dose to individuals who are determined to have certain kinds of immunocompromise.

Booster Dose:

A single booster dose of the vaccine may be administered at least 5 months after completion of a primary series of the Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA) to individuals 12 years of age and older
A single booster dose of the vaccine may be administered to individuals 18 years of age and older who have completed primary vaccination with a different authorized COVID-19 vaccine. Individuals should check with their healthcare provider regarding timing of the booster dose
WHAT IS THE INDICATION AND AUTHORIZED USE?

The Pfizer-BioNTech COVID-19 Vaccine has received EUA from FDA to provide:

a 2-dose primary series to individuals 5 years of age and older
a third primary series dose to individuals 5 years of age and older who have been determined to have certain kinds of immunocompromise
a single booster dose to individuals 12 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA)
a single booster dose to individuals 18 years of age and older who have completed primary vaccination with a different authorized COVID-19 vaccine. The booster schedule is based on the labeling information of the vaccine used for the primary series
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 EUA to provide:
a 2-dose primary series to individuals 12 through 15 years of age
a third primary series dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise
a single booster dose to individuals 12 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA)
a single booster dose to individuals 18 years of age and older who have completed primary vaccination with a different authorized COVID-19 vaccine. The booster schedule is based on the labeling information of the vaccine used for the primary series
EUA Statement

Emergency uses of the vaccine have not been approved or licensed by FDA, but have been authorized by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in individuals 5 years of age and older. The emergency uses are 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. Please see EUA Fact Sheets at www.cvdvaccine-us.com.

IMPORTANT SAFETY INFORMATION

Individuals should not get the 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 1 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, more commonly in males under 40 years of age than among females and older males. 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
Additional 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); decreased appetite; diarrhea; vomiting; arm pain; fainting in association with injection of the vaccine
These may not be all the possible side effects of the vaccine. Serious and unexpected side effects may occur. The possible side effects of the vaccine are 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
Data on administration of this vaccine at the same time as other vaccines have not yet been submitted to FDA. Individuals considering receiving this vaccine with other vaccines, should discuss their options with their healthcare provider.

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 https://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.