(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the Conditional Marketing Authorization (CMA) for COMIRNATY® in the European Union (EU) has been expanded to include individuals 12 to 15 years of age. This follows the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) positive opinion to authorize the vaccine in this age group. The extended indication for the CMA for COMIRNATY is valid in all 27 EU member states.
COMIRNATY was the first COVID-19 vaccine to receive authorization in the EU and is the first to have its CMA extended to adolescents. Distribution and administration of COMIRNATY by the EU member states will continue to be determined according to the populations identified in the EU and per national guidance.
"Today's extension of our COVID-19 vaccine authorization in the European Union is another critical milestone in our collective effort to broaden vaccination programs to as many people as possible," said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. "Making vaccines available to adolescents will help re-open schools, and support the return to a normal day-to-day life."
"This is a meaningful moment for adolescents, parents and entire families who are seeking protection from this virus and a return to normalcy," said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. "We appreciate the agency's thorough and efficient review of the data from our clinical trial, and look forward to seeing more people across Europe immunized as a result of today's decision."
The EU decision is based on data from a pivotal Phase 3 clinical trial, which enrolled 2,260 participants aged 12 to 15 years. Participants received two 30 μg doses of the COVID-19 vaccine. Results from this trial, which were published in The New England Journal of Medicine on May 27, 2021, showed a vaccine efficacy of 100% in participants with or without prior SARS-CoV-2 infection and robust antibody responses. In the trial, the vaccine was also generally well tolerated. Participants will continue to be monitored for long-term protection and safety for an additional two years after their second dose.
In addition, the pediatric study evaluating the safety and efficacy of the COVID-19 vaccine in children 6 months to 11 years of age is ongoing. Pfizer and BioNTech expect to have definitive readouts and, subject to the data generated, submit for an Emergency Use Authorization (e.g., in the U.S.) or a variation to Conditional Marketing Authorizations (e.g., in the EU) for two cohorts, including children 2-5 years of age and 5-11 years of age, in September. The readout and submission for the cohort of children 6 months to 2 years of age are expected in the fourth quarter.
The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the European Union, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer), United Kingdom, Canada and other countries in advance of a planned application for full marketing authorizations in these countries.
The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) for use in individuals 12 years of age and older. 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. Please see Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and Full EUA Prescribing Information available at www.cvdvaccine-us.com.
AUTHORIZED USE IN THE U.S.:
The Pfizer-BioNTech COVID19 Vaccine is authorized for use under an 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 12 years of age and older.
IMPORTANT SAFETY INFORMATION FROM U.S. FDA EMERGENCY USE AUTHORIZATION PRESCRIBING INFORMATION:
- Do not administer Pfizer‑BioNTech COVID-19 Vaccine to individuals with known history of a severe allergic reaction (eg, anaphylaxis) to any component of the Pfizer‑BioNTech COVID-19 Vaccine
- Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Pfizer‑BioNTech COVID-19 Vaccine
Monitor Pfizer-BioNTech COVID-19 Vaccine recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control and Prevention guidelines (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-…)
- Syncope (fainting) may occur in association with administration of injectable vaccines, in particular in adolescents. Procedures should be in place to avoid injury from fainting
- Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer‑BioNTech COVID-19 Vaccine
- The Pfizer‑BioNTech COVID-19 Vaccine may not protect all vaccine recipients
- In clinical studies, adverse reactions in participants 16 years of age and older included pain at the 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%), and lymphadenopathy (0.3%)
- In a clinical study, adverse reactions in adolescents 12 through 15 years of age included pain at the injection site (90.5%), fatigue (77.5%), headache (75.5%), chills (49.2%), muscle pain (42.2%), fever (24.3%), joint pain (20.2%), injection site swelling (9.2%), injection site redness (8.6%), lymphadenopathy (0.8%), and nausea (0.4%)
- Severe allergic reactions, including anaphylaxis, and other hypersensitivity reactions, diarrhea, vomiting, and pain in extremity (arm) have been reported following administration of the Pfizer-BioNTech COVID-19 Vaccine outside of clinical trials
Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Pfizer-BioNTech COVID-19 Vaccine
- Available data on Pfizer‑BioNTech COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy
- Data are not available to assess the effects of Pfizer‑BioNTech COVID-19 Vaccine on the breastfed infant or on milk production/excretion
- There are no data available on the interchangeability of the Pfizer‑BioNTech COVID‑19 Vaccine with other COVID-19 vaccines to complete the vaccination series. Individuals who have received one dose of Pfizer‑BioNTech COVID-19 Vaccine should receive a second dose of Pfizer‑BioNTech COVID-19 Vaccine to complete the vaccination series
- Vaccination providers must report Adverse Events in accordance with the Fact Sheet to VAERS online at https://vaers.hhs.gov/reportevent.html
