Pfizer-BioNTech Announce Positive Topline Results of Pivotal COVID-19 Vaccine Study in Adolescents
Pfizer-BioNTech COVID-19 Vaccine Shows 100% Efficacy in Adolescents Aged 12–15
[2021 Update] – Pfizer Inc. and BioNTech SE announced positive topline results from a Phase 3 clinical trial evaluating the safety and efficacy of their COVID-19 vaccine, BNT162b2, in adolescents aged 12 to 15. The trial demonstrated 100% efficacy and a robust antibody response in this age group, exceeding levels observed in vaccinated participants aged 16 to 25 in earlier analyses. The vaccine was also well tolerated in adolescents.
The randomized, placebo-controlled trial enrolled 2,260 participants in the United States. Among them, 18 cases of COVID-19 occurred in the placebo group (n=1,129), and none in the vaccinated group (n=1,131). In a subset of vaccinated adolescents, the geometric mean titer (GMT) of neutralizing antibodies reached 1,239.5, compared to 705.1 GMT in the 16–25 age group, confirming non-inferiority and strong immunogenicity.
““We share the urgency to expand the authorization of our vaccine to younger populations and are encouraged by the data from adolescents aged 12 to 15,” said Albert Bourla, Chairman and CEO of Pfizer. “We plan to submit these data to the FDA as a proposed amendment to our Emergency Use Authorization in the coming weeks and to other regulators around the world, with the hope of starting to vaccinate this age group before the start of the next school year.””
““Across the globe, we are longing for a normal life. This is especially true for our children,” added Ugur Sahin, CEO and Co-founder of BioNTech. “The initial results suggest that children are particularly well protected by vaccination, which is encouraging given recent trends in the spread of the B.1.1.7 (UK) variant. It’s crucial to enable them to return to everyday school life while protecting them and their families.””
Regulatory Plans
Pfizer and BioNTech plan to submit the trial data to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) as part of a request to expand both the Emergency Use Authorization (EUA) in the U.S. and the EU Conditional Marketing Authorization for COMIRNATY®, the brand name for BNT162b2. All participants will continue to be monitored for long-term safety and protection for an additional two years after their second dose. The companies also intend to submit the data for peer-reviewed publication.
Update on Pediatric Studies (Ages 6 Months to 11 Years)
Pfizer and BioNTech also announced progress on their global Phase 1/2/3 trial evaluating BNT162b2 in children aged 6 months to 11 years. The study will assess safety, tolerability, and immunogenicity on a two-dose schedule, approximately 21 days apart, across three age cohorts:
5 to 11 years – dosing began last week
2 to 5 years – dosing expected to start next week
6 months to 2 years – to follow
Regulatory Status and Background
At the time of this announcement, BNT162b2 had not yet been fully approved or licensed by the FDA but was authorized for emergency use under an EUA to prevent COVID-19 in individuals 16 years of age and older. This emergency use remains in effect under the declaration issued pursuant to Section 564(b)(1) of the FD&C Act, unless terminated or revoked earlier.
For full EUA Prescribing Information and the Fact Sheet for Healthcare Providers Administering the Vaccine, visit: www.cvdvaccine.com
BNT162b2 is based on BioNTech’s proprietary mRNA technology and was developed jointly by BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the European Union and the holder of emergency use authorizations in the United States, United Kingdom, Canada, and several other countries. Full marketing authorization submissions were in progress at the time.
IMPORTANT SAFETY INFORMATION
From U.S. FDA Emergency Use Authorization Prescribing Information for the Pfizer-BioNTech COVID-19 Vaccine
Contraindication:
Do not administer the Pfizer-BioNTech COVID-19 Vaccine to individuals with a known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine.
Preparedness for Allergic Reactions:
Appropriate medical treatment for managing acute allergic reactions must be immediately available in the event of an anaphylactic reaction following administration.
Monitoring Guidelines:
Vaccine recipients should be monitored for immediate adverse reactions in accordance with Centers for Disease Control and Prevention (CDC) guidelines:
https://www.cdc.gov/vaccines/covid-19/
Immunocompromised Individuals:
People with compromised immune systems, including those undergoing immunosuppressant therapy, may have a diminished immune response to the vaccine.
Effectiveness:
The Pfizer-BioNTech COVID-19 Vaccine may not protect all recipients.
Observed Side Effects (Ages 16+) in Clinical Trials:
Pain at injection site: 84.1%
Fatigue: 62.9%
Headache: 55.1%
Muscle pain: 38.3%
Chills: 31.9%
Joint pain: 23.6%
Fever: 14.2%
Injection site swelling: 10.5%
Injection site redness: 9.5%
Nausea: 1.1%
Malaise: 0.5%
Lymphadenopathy: 0.3%
Post-Marketing Experience:
Severe allergic reactions, including anaphylaxis, have been reported during mass vaccination campaigns outside clinical trials. Additional adverse reactions—some potentially serious—may emerge with broader use.
Use in Pregnancy and Breastfeeding:
Available data on vaccine administration during pregnancy are insufficient to determine associated risks.
Data on the vaccine’s effects on breastfed infants or on milk production/excretion are not available.
Vaccine Interchangeability:
There are no data supporting the interchangeability of the Pfizer-BioNTech COVID-19 Vaccine with other COVID-19 vaccines. Individuals should receive both doses of the Pfizer-BioNTech vaccine to complete the series.
Adverse Event Reporting:
Vaccination providers must report adverse events to the Vaccine Adverse Event Reporting System (VAERS):
Phone: 1-800-822-7967
Please include the description: “Pfizer-BioNTech COVID-19 Vaccine EUA” in all reports.
Provider Responsibilities:
Providers must review the EUA Fact Sheet for:
Information to Provide to Recipients/Caregivers
Mandatory Requirements for Vaccine Administration
Access the Fact Sheet and full EUA Prescribing Information at: www.cvdvaccine-us.com
Further Information:
For a full discussion of risks and uncertainties, refer to BioNTech’s Annual Report on Form 20-F for the year ended December 31, 2020, filed with the SEC on March 30, 2021: www.sec.gov