Based on topline data, three doses of the Pfizer-BioNTech COVID-19 Vaccine met all immunobridging criteria required for Emergency Use Authorization
The third 3-µg dose was well tolerated among 1,678 children under 5 years of age with a safety profile similar to placebo
Vaccine efficacy of 80.3% was observed in descriptive analysis of three doses during a time when Omicron was the predominant variant
The 3-µg dose level, which is one-tenth the dose for adults, was selected for children under 5 years of age based on safety, tolerability and immunogenicity
NEW YORK & MAINZ, Germany--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced topline safety, immunogenicity and vaccine efficacy data from a Phase 2/3 trial evaluating a third 3-µg dose of the Pfizer-BioNTech COVID-19 Vaccine in children 6 months to under 5 years of age. Following a third dose in this age group, the vaccine was found to elicit a strong immune response, with a favorable safety profile similar to placebo.

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Vaccine efficacy, a secondary endpoint in this trial, was 80.3% in children 6 months to under 5 years of age. This descriptive analysis was based on 10 symptomatic COVID-19 cases identified from seven days after the third dose and accrued as of April 29, 2022. The trial protocol specifies a formal analysis will be performed when at least 21 cases have accrued from seven days after the third dose. Final vaccine efficacy data will be shared once available.

“Our COVID-19 vaccine has been studied in thousands of children and adolescents, and we are pleased that our formulation for the youngest children, which we carefully selected to be one-tenth of the dose strength for adults, was well tolerated and produced a strong immune response,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “These topline safety, immunogenicity and efficacy data are encouraging, and we look forward to soon completing our submissions to regulators globally with the hope of making this vaccine available to younger children as quickly as possible, subject to regulatory authorization.”

“The study suggests that a low 3-ug dose of our vaccine, carefully selected based on tolerability data, provides young children with a high level of protection against the recent COVID-19 strains,” said Prof. Ugur Sahin, M.D., CEO and co-founder of BioNTech. “We are preparing the relevant documents and expect completing the submission process to the FDA this week, with submissions to EMA and other regulatory agencies to follow within the coming weeks.”

In the Phase 2/3 trial, 1,678 children received a third dose of the 3-µg formulation at least two months after the second dose at a time when Omicron was the predominant variant. The immunogenicity analysis of geometric mean titer (GMT) ratio and seroresponse rate was conducted on a subset of study participants one month following the third dose in children 6 months to under 5 years of age, compared to the second dose in the 16- to 25-year-old population. Non-inferiority was met for both the 6- to 24-month-old population and the 2- to under 5-year-old population for both co-primary endpoints. Three 3-µg doses of the Pfizer-BioNTech COVID-19 Vaccine was well-tolerated in this age group, and no new safety signals were identified. The majority of adverse events were mild or moderate.

Studies in adults, adolescents, and children over 5 years of age continue to indicate that three doses of the Pfizer-BioNTech COVID-19 Vaccine enhances protection compared to two doses. The safety, immunogenicity and vaccine efficacy data for three doses of the vaccine in children under 5 years of age are consistent with the data seen in adults, suggesting that a third dose will provide similar benefit in children.

In February 2022, the companies initiated a rolling submission for Emergency Use Authorization (EUA) of their COVID-19 vaccine in children 6 months to under 5 years of age, following a request by the U.S. Food and Drug Administration (FDA). At that time, a two-dose series was determined to be well-tolerated in this age group. Pfizer and BioNTech plan to submit these new safety, immunogenicity, and vaccine efficacy data on three doses to the rolling U.S. EUA application this week, with submissions to regulators worldwide to follow.

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.

About the Phase 1/2/3 Trial in Children

The Phase 1/2/3 trial has enrolled more than 10,000 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. The trial evaluated the safety, tolerability, and immunogenicity of three doses of the Pfizer-BioNTech COVID-19 Vaccine 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.

U.S. Indication & Authorized Use

Pfizer-BioNTech COVID-19 Vaccine is FDA authorized under Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 5 years of age and older.

Pfizer-BioNTech COVID-19 Vaccine is FDA authorized to provide:

Primary Series

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 with certain kinds of immunocompromise
Booster Series

a single booster dose to individuals 5 through 11 years of age who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine
a first 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 first booster dose to individuals 18 years of age and older who have completed primary vaccination with a different authorized or approved COVID-19 vaccine. The booster schedule is based on the labeling information of the vaccine used for the primary series
a second booster dose to individuals 50 years of age and older who have received a first booster dose of any authorized or approved COVID-19 vaccine
a second booster dose to individuals 12 years of age and older with certain kinds of immunocompromise and who have received a first booster dose of any authorized or approved COVID-19 vaccine
COMIRNATY®INDICATION

COMIRNATY® (COVID-19 Vaccine, mRNA) is a vaccine approved for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older.

COMIRNATY® is administered as a 2-dose primary series
COMIRNATY® AUTHORIZED USES

COMIRNATY® (COVID-19 Vaccine, mRNA) is FDA authorized under Emergency Use Authorization (EUA) to provide:

Primary Series

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 with certain kinds of immunocompromise
Booster Dose

a first booster dose to individuals 12 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY®
a first booster dose to individuals 18 years of age and older who have completed primary vaccination with another authorized or approved COVID-19 vaccine. The booster schedule is based on the labeling information of the vaccine used for the primary series
a second booster dose to individuals 50 years of age and older who have received a first booster dose of any authorized or approved COVID-19 vaccine
a second booster dose to individuals 12 years of age and older with certain kinds of immunocompromise and who have received a first booster dose of any authorized or approved COVID-19 vaccine
Emergency Use Authorization

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 either individuals 12 years of age and older, or in individuals 5 through 11 years of age, as appropriate. 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.

INTERCHANGEABILITY

FDA-approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine FDA authorized for Emergency Use Authorization (EUA) for individuals 12 years of age and older can be used interchangeably by a vaccination provider when prepared according to their respective instructions for use.

The formulation of the Pfizer-BioNTech COVID-19 Vaccine authorized for use in children 5 through 11 years of age differs from the formulations authorized for individuals 12 years of age and older and should therefore not be used interchangeably. The Pfizer-BioNTech COVID-19 Vaccine authorized for use in children 5 through 11 years of age should not be used interchangeably with COMIRNATY® (COVID-19 Vaccine, mRNA).

IMPORTANT SAFETY INFORMATION

Tell your vaccination provider about all of your medical conditions, including if you:

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
Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA) may not protect all vaccine recipients
You should not receive Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA) if you have had a severe allergic reaction to any of its ingredients or had a severe allergic reaction to a previous dose of Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY®
There is a remote chance that Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA) 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, your vaccination provider may ask you to stay at the place where you received the vaccine for monitoring after vaccination. If you experience a severe allergic reaction, call 9-1-1 or go to the nearest hospital
Seek medical attention right away if you have any of the following symptoms:

difficulty breathing, swelling of the face and throat, a fast heartbeat, a bad rash all over the body, dizziness, and weakness
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
Seek medical attention right away if you 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
Fainting can happen after getting injectable vaccines, including Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA). Sometimes people who faint can fall and hurt themselves. For this reason, your vaccination provider may ask you to sit or lie down for 15 minutes after receiving the vaccine
Some people with weakened immune systems may have reduced immune responses to Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA)
Additional side effects include rash, itching, hives, swelling of the face, 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, and fainting in association with injection of the vaccine
These may not be all the possible side effects of the vaccine. Call the vaccination provider or healthcare provider about bothersome side effects or side effects that do not go away.

You should always ask your healthcare providers for medical advice about adverse events. Report vaccine side effects to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1?800?822?7967 or report online to www.vaers.hhs.gov/reportevent.html. You can also report side effects to Pfizer Inc. at www.pfizersafetyreporting.com or by calling 1-800-438-1985
Click for Fact Sheets and Prescribing Information for individuals 5 years of age and older:

Recipients and Caregivers Fact Sheet (5 through 11 years of age)
Recipients and Caregivers Fact Sheet (12 years of age and older)
COMIRNATY® Full Prescribing Information (16 years of age and older), DILUTE BEFORE USE, Purple Cap
COMIRNATY® Full Prescribing Information (16 years of age and older), DO NOT DILUTE, Gray Cap
EUA Fact Sheet for Vaccination Providers (5 through 11 years of age), DILUTE BEFORE USE, Orange Cap
EUA Fact Sheet for Vaccination Providers (12 years of age and older), DILUTE BEFORE USE, Purple Cap
EUA Fact Sheet for Vaccination Providers (12 years of age and older), DO NOT DILUTE, Gray Cap

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 May 23, 2022. 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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