Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced today that the U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously to recommend the FDA grant Emergency Use Authorization (EUA) for a booster dose of COMIRNATY® (COVID-19 Vaccine, mRNA) in individuals 65 years of age and older and individuals at high risk of severe COVID-19. The committee recommended that the additional dose be administered at least six months after the two-dose series. The panel also agreed that healthcare workers and others at high risk for occupational exposure should be included in this EUA.
VRBPAC is made up of independent experts who advise the FDA on scientific and regulatory matters, including the evaluation of vaccine safety and efficacy.
At this time, VRBPAC did not vote in favor of approval of a booster dose for the full population for which Pfizer and BioNTech submitted their supplemental Biologics License Application, which was individuals 16 and older. The same data have recently been submitted to the European Medicines Agency (EMA) and will be filed with other regulatory authorities in the coming weeks. The companies remain vigilant and continue to generate relevant COMIRNATY booster dose data for evaluation for future licensure in further groups as well as to address emerging variants of concern.
The FDA is expected to make its decision in the coming days. This decision could allow COMIRNATY to be the first COVID-19 vaccine with a booster authorized in the U.S.
"Today the VRBPAC reviewed data from our clinical program showing a favorable safety profile and strong immune responses against SARS-CoV-2 after a booster dose of our vaccine. These data, and the larger body of scientific evidence presented at the meeting, underscore our belief that boosters can be a critical tool in the ongoing effort to control the spread of this virus," said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development, Pfizer. "We thank the committee for their thoughtful review of the data and will work with the FDA following today's meeting to address the committee's questions, as we continue to believe in the benefits of a booster dose for a broader population."
"We are committed to support the ongoing efforts to reduce infections and COVID-19 cases. The data we submitted to the FDA, EMA and other regulatory authorities underline that a booster induces a strong immune response against all tested variants of concern and may contribute to address a public health need," said Özlem Türeci, M.D., Co-founder and Chief Medical Officer of BioNTech.
VRBPAC based its recommendation on the totality of scientific evidence shared by the companies, including data from their clinical program evaluating the safety, tolerability and immunogenicity of a booster dose of COMIRNATY. 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 COMIRNATY.
Real-world surveillance data also were presented to the VRBPAC by the Israel Ministry of Health, providing further support for the public health impact of boosters. The data presented from Israel included an analysis published this week in The New England Journal of Medicine. The analysis comprised approximately 1.1 million individuals ages 60 years and older who were eligible for a booster dose of the vaccine between July 30 through August 31, 2021. No new safety signals were observed, and reported adverse events were lower than those observed after dose two. The analysis showed that a booster dose restored very high levels of protection against COVID-19 infections and severe disease in this period when Delta was the dominant strain. Individuals who received the booster dose were less likely by a factor of 11.3 (95% CI: 10.4, 12.3) to develop a confirmed infection and less likely by a factor of 19.5 (95% CI: 12.9, 29.5) to develop severe illness compared to those who were previously fully vaccinated but did not receive a booster dose. The additional protection after receiving a booster translated to vaccine effectiveness comparable to levels seen early in the country's vaccine rollout (an estimated 95%), when the Alpha variant was predominant.
Under the EUA of the Pfizer-BioNTech vaccine in the U.S., a third dose 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 is separate and distinct from the booster dose reviewed by VRBPAC 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 recommended today by VRBPAC for EUA refers to an additional dose of the vaccine that is given to those who have built enough protection after the primary two-dose vaccination series, but may have decreased protection over time due to waning of immunity.
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, 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.
U.S. 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). Please click here for Fact Sheet for Vaccination Providers (12+ years of age).
