NEW YORK and MAINZ, GERMANY, DECEMBER 17, 2021 — Pfizer Inc. (NYSE: PFE) and
BioNTech SE (Nasdaq: BNTX) today shared that following a routine review by the external independent Data Monitoring Committee (DMC), the companies will amend the clinical study evaluating the safety, tolerability, and immunogenicity of the Pfizer-BioNTech COVID-19 Vaccine in children 6 months to under 5 years of age. The study will now include evaluating a third dose of 3 µg at least two months after the second dose of the two-dose series to provide high levels of protection in this young age group.
While the study is ongoing and remains blinded, a pre-specified immunogenicity analysis was conducted on a subset of the study population one month following the second dose. Compared to the 16- to 25-year-old population in which high efficacy was demonstrated, non-inferiority was met for the 6- to 24-month-old population but not for the 2- to under 5-year-old population in this analysis. No safety concerns were identified and the 3 µg dose demonstrated a favorable safety profile in children 6 months to under 5 years of age.
The decision to evaluate a third dose of 3 µg for children 6 months to under 5 years of age reflects the companies’ commitment to carefully select the right dose to maximize the risk-
benefit profile. If the three-dose study is successful, Pfizer and BioNTech expect to submit data to regulators to support an Emergency Use Authorization (EUA) for children 6 months to under 5 years of age in the first half of 2022.
Pfizer and BioNTech also plan to evaluate a third dose of the 10 µg formulation in children 5 to under 12 years of age.
Furthermore, the companies have initiated a low dose sub-study of a third dose of 10 µg or 30 µg in approximately 600 adolescents aged 12- to 17, to assess safety and immunogenicity.
These updates were informed by the effectiveness data for three doses of the vaccine for people 16 years and older, and the early laboratory data observed with Delta and other variants of concern, including Omicron, which suggest that people vaccinated with three doses of a COVID- 19 vaccine may have a higher degree of protection.
These changes have been endorsed by and agreed upon with the U.S. Food and Drug Administration and the European Medicines Agency.
About the Phase 1/2/3 Trial in Children
The Phase 1/2/3 trial initially enrolled up to 4,500 children ages 6 months to under 12 years of age in the United States, Finland, Poland, and Spain from more than 90 clinical trial sites. It was
designed to evaluate the safety, tolerability, and immunogenicity of the Pfizer -BioNTech vaccine on a two-dose schedule (approximately 21 days apart) in three age groups: ages 5 to under 12 years; ages 2 to under 5 years; and ages 6 months to under 2 years. Based on the Phase 1 dose- escalation portion of the trial, children ages 5 to under 12 years received a two-dose schedule of 10 µg each while children under age 5 received a lower 3 µg dose for each injection in the Phase 2/3 study. The trial enrolled children with or without prior evidence of SARS-CoV-2 infection.
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 12 years of age and older, a third primary series dose may be administered at least 4 weeks after the second dose to individuals who are determined to have certain kin ds 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 18 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 12 years of age and older who have been determined to have certain kinds of immunocompromise
• a single booster dose to individuals 16 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY®
• a single booster dose to individuals 16 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:
o a 2-dose primary series to individuals 12 through 15 years of age
o a third primary series dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise
o a single booster dose to individuals 16 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY®
o a single booster dose to individuals 16 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
o 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
o 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
o 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:
o chest pain
o shortness of breath
o feelings of having a fast-beating, fluttering, or pounding heart
• Additional side effects that have been reported with the vaccine include:
o 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.
Click for
Fact Sheets and Prescribing Information for individuals 12 years of age and older
Full Prescribing Information (16 years of age and older)
EUA Fact Sheet for Vaccination Providers (12 years of age and older), Purple Cap
EUA Fact Sheet for Vaccination Providers (12 years of age and older), Gray Cap Recipients and Caregivers Fact Sheet (12 years of age and older)
Fact Sheets for individuals 5 through 11 years of age
EUA Fact Sheet for Vaccination Providers (5 through 11 years of age), Orange Cap
Recipients and Caregivers Fact Sheet (5 through 11 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 December 17, 2021. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or etc. etc.
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