Pfizer and BioNTech Receive First U.S. FDA Emergency Use Authorization of Covid Vaccine Booster

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the U.S. Food and Drug Administration (FDA) has authorized for emergency use a booster dose of the Pfizer-BioNTech COVID-19 Vaccine for individuals 65 years of age and older, individuals 18 through 64 years of age at high risk of severe COVID-19, and individuals 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19. The booster dose is to be administered at least six months after completion of the primary series, and is the same formulation and dosage strength as the doses in the primary series.

“This first FDA authorization of a COVID-19 vaccine booster is a critical milestone in the ongoing fight against this disease,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “Over the last year and a half, we have aimed to stay vigilant as the pandemic has evolved – including evaluating the impact of a booster dose. We believe boosters have an important role to play in addressing the continued threat of this disease, alongside efforts to increase global access and uptake among the unvaccinated. Today’s FDA action is an important step in helping the most vulnerable among us remain protected from COVID-19.”

“Today’s emergency use authorization is supported by clinical data underlining that a booster induces a strong immune response against tested variants of concern and can address a current public health need. We will continue to monitor new SARS-CoV-2 strains, to be prepared for potential emerging escape variants,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “We and our collaboration partner have submitted booster data to other regulatory agencies around the world. We are simultaneously working to expand access to our vaccines globally.”

The FDA based this EUA on the totality of scientific evidence shared by the companies and reviewed by the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC),including data from the Pfizer-BioNTech clinical program evaluating the safety, tolerability and immunogenicity of a booster dose of the COVID-19 vaccine. A booster dose of the vaccine elicited significantly higher neutralizing antibody titers against the initial SARS-CoV-2 virus (wild type), as well as the Beta and Delta variants, when compared with the levels observed after the two-dose primary series. The reactogenicity profile within seven days after the booster dose was typically mild to moderate, and the frequency of reactions was similar to or lower than after dose two. The adverse event profile was generally consistent with other clinical safety data for the vaccine.

As a next step, the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) will meet to discuss a potential recommendation for the use and rollout of boosters to Americans.

Pfizer and BioNTech continue to supply the vaccine, including sufficient volume for boosters, under their existing supply agreement with the U.S. government, which continues through April 2022. The companies do not expect the introduction of booster doses in the U.S. to impact the existing supply agreements in place with governments and international health organizations around the world. Pfizer and BioNTech have pledged to provide two billion doses to low- and middle-income countries in 2021 and 2022 – at least one billion doses each year.

Under the EUA in the U.S., a third dose of the vaccine was previously authorized for individuals at least 12 years of age who have undergone solid organ transplant, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise. This authorization of a third dose for immunocompromised individuals – administered at least 28 days following the second dose – is separate and distinct from the booster dose authorized today. The third dose for immunocompromised individuals is meant to address the fact that these individuals sometimes do not build enough protection after two doses of the vaccine. In contrast, the booster dose authorized today refers to an additional dose of the vaccine that is given to those who have built enough protection after the primary vaccination series, but may have decreased protection over time due to waning of immunity.

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.

Indication & Authorized Use

HOW IS THE VACCINE GIVEN?

The vaccine will be given to you 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 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 whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID‑19

WHAT IS THE INDICATION AND AUTHORIZED USE?

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. Although they may be manufactured in different facilities, the products offer the same safety and effectiveness.

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 be administered 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; and
  • a single booster dose in 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 whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID‑19

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; and
  • a single booster dose in 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 whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID‑19

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 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); 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 your healthcare provider if you have any side effects that bother you or 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 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.

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.

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