- Doses expected to be delivered by April 2022

NEW YORK & MAINZ, Germany--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the U.S. government has purchased 50 million more doses of the companies’ COVID-19 vaccine. The U.S. will receive these additional doses to continue to support preparedness for pediatric vaccinations, including securing vaccines for children under 5 years of age, should they receive regulatory authorization. The companies expect to deliver all these doses by April 30, 2022.

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With this order, the U.S. government has exercised its final purchase option under its existing U.S. supply agreement with the companies, bringing the total number of Pfizer-BioNTech COVID-19 Vaccine doses secured under the agreement since the start of the pandemic to 600 million – spanning doses for adults and adolescents, and children. Separately, Pfizer and BioNTech have agreed to provide a total of 1 billion doses to the U.S. government at a not-for-profit price for donation to low- and lower-middle-income countries.

“We are extremely proud to provide enough doses of our vaccine to help protect every U.S. child under 12 from COVID-19, if authorized by the FDA,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “As we await the agency’s review of our application for emergency use of the vaccine in children 5 to under 12 years of age, and clinical trial results in children under 5, we are working with the U.S. government to help ensure communities across the country have access to pediatric doses as soon as possible. The introduction of doses for young children will be another critical milestone in addressing this public health crisis.”

“From the very beginning, it has been our goal to provide access to a highly effective vaccine to as many people as possible. This supply agreement will help to offer a vaccine to all children younger than 12 years of age in the United States,” said Ugur Sahin, CEO and Co-founder of BioNTech. “We would like to thank the U.S. government for its trust in us and our vaccine.”

Pfizer and BioNTech submitted a request earlier this month to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization of their COVID-19 vaccine in children 5 to <12 years of age. The dosage strength for this age group (10 µg) was carefully selected as the preferred dose for safety, tolerability and immunogenicity, and differs from the dosage strength for individuals 12 years and older (30 µg). If authorized and subsequently recommended by the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP), the companies expect to then begin shipping 10-µg pediatric doses immediately, as directed by the U.S. government. Eligible U.S. residents will continue to receive the vaccine for free, consistent with the U.S. government’s commitment to free access to COVID-19 vaccines.

In addition to the U.S. FDA, the companies have submitted data to the European Medicines Agency to support the vaccination of children 5 to <12 years of age. Further submissions for this age group are planned or underway with other regulatory agencies around the world. Initial data from the other two age cohorts in the ongoing Pfizer-BioNTech clinical trial in children – those 2 to <5 years of age and those 6 months to <2 years of age – are expected as soon as fourth quarter 2021 or early first quarter 2022.

Commitment to Global Vaccine Access

In total, Pfizer and BioNTech expect to manufacture 3 billion doses of their COVID-19 vaccine worldwide in 2021, which includes pediatric doses. In 2022, the companies expect to manufacture 4 billion doses of the Pfizer-BioNTech COVID-19 Vaccine worldwide, which also includes pediatric doses. The companies do not expect the introduction of pediatric doses in the U.S. to impact the existing supply agreements in place with governments and international health organizations around the world.

To date, Pfizer and BioNTech have shipped more than 1.8 billion COVID-19 vaccine doses to 149 countries and territories. The companies are firmly committed to working toward equitable and affordable access for COVID-19 vaccines and have pledged to provide 2 billion doses to low- and middle-income countries in 2021 and 2022 – at least 1 billion each year.

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 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 or ongoing.

U.S INDICATION & AUTHORIZED USE

HOW IS THE VACCINE GIVEN?

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

Primary Series: The vaccine is administered as a 2-dose series, 3 weeks apart. A third dose may be administered at least 4 weeks 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 6 months after completion of a primary series to individuals:
65 years of age and older
18 through 64 years of age at high risk of severe COVID-19
18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2
A single booster dose of the vaccine may be administered to certain individuals who have completed primary vaccination with a different authorized COVID-19 vaccine. Individuals should check with their healthcare provider regarding eligibility for, and timing of, the booster dose.
WHAT IS THE INDICATION AND AUTHORIZED USE?

The FDA-approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the FDA-authorized Pfizer-BioNTech COVID-19 Vaccine under Emergency Use Authorization (EUA) have the same formulation and can be used interchangeably to provide the COVID-19 primary vaccination series or a booster dose.

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 two-dose primary series in individuals 12 through 15 years
a third primary series dose in individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise
a single booster dose to the following individuals who have completed a primary series with Pfizer BioNTech COVID-19 Vaccine or COMIRNATY®:
65 years of age and older
18 through 64 years of age at high risk of severe COVID-19
18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2
a single booster dose to eligible individuals who have completed primary vaccination with a different authorized COVID-19 vaccine. Booster eligibility and schedule are based on the labeling information of the vaccine used for the primary series.
The Pfizer-BioNTech COVID-19 Vaccine has received EUA from FDA to provide:

a two-dose primary series in individuals 12 years of age and older
a third primary series dose for individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise
a single booster dose to the following individuals who have completed a primary series with Pfizer BioNTech COVID-19 Vaccine or COMIRNATY®:
65 years of age and older
18 through 64 years of age at high risk of severe COVID-19
18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2
a single booster dose to eligible individuals who have completed primary vaccination with a different authorized COVID-19 vaccine. Booster eligibility and schedule are 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 12 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 Sheet 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 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); 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 has 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 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). Please click here for Fact Sheet for Vaccination Providers (12+ years of age). Please click here for the Recipients and Caregivers Fact Sheet (12+ years of age).

About Pfizer: Breakthroughs That Change Patients’ Lives

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

Pfizer Disclosure Notice

The information contained in this release is as of October 28, 2021. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. etc. etc.

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