COMIRNATY® is the first and only COVID‐19 vaccine to be granted FDA approval for adolescents 12 years and older, following emergency use authorization in May 2021.
Approval of the two‐dose primary series is based on the totality of data through six months post‐dose 2 in individuals 12 through 15 years of age.
Favorable safety profile observed across more than 2,200 adolescents who participated in the clinical trial.
On July 8 the U.S. Food and Drug Administration (FDA) approved the companies' supplemental Biologics License Application (sBLA) for their COVID‐19 vaccine, known as COMIRNATY® (COVID‐19 Vaccine, mRNA), to include individuals 12 through 15 years of age. The vaccine was previously made available to this age group in the U.S. under emergency use authorization (EUA), and to date more than 9 million 12‐ to 15‐year‐old adolescents in the U.S. have completed a primary series.
The approval is based on data from a Phase 3 clinical trial of 2,260 participants 12 through 15 years of age. A two‐dose primary series of the vaccine (30‐µg dose) elicited SARS‐CoV‐2–neutralizing antibody geometric mean titers (GMTs) of 1,239.5, demonstrating strong immunogenicity in a subset of adolescents one month after the second dose. This compared well (was non‐inferior) to GMTs elicited by participants aged 16 to 25 years old (705.1 GMTs) in an earlier analysis. In the trial, a two‐dose primary series of the vaccine (30‐µg dose) was also 100% effective (95% confidence interval [CI, 87.5, 100.0]) in preventing COVID‐19, measured between a week and more than four months after the second dose. During this time, all 30 cases of confirmed symptomatic COVID‐19 were in the placebo group (N=1,109) and no cases were in the COMIRNATY group (N=1,119). The only SARS‐CoV‐2 variant of concern identified from the confirmed COVID‐19 cases in this age group was Alpha as the efficacy analysis was conducted between November 2020 and May 2021, which was before the Delta and Omicron surges. No cases of severe disease occurred in either the COMIRNATY or placebo group. The adverse event profile was generally consistent with other clinical data for the vaccine, with a favorable safety profile observed across 6 months of safety follow‐up data after the second dose.
Pfizer and BioNTech also filed these data with the European Medicines Agency (EMA) and other regulatory authorities around the world.
COMIRNATY is now the only COVID‐19 vaccine approved by the FDA as a two‐dose primary series for individuals 12 years and older. An EUA for a primary series in U.S. adolescents ages 12 through 15 years was previously granted in May 2021 based on initial data from the same pivotal Phase 3 clinical trial. Longer‐term follow‐up data, announced in November 2021, confirmed the safety and effectiveness of COMIRNATY in adolescents 12–15 years of age and were required for licensure. In the European Union the conditional marketing authorization in this age group was granted by EMA in August 2021.
COMIRNATY was previously FDA approved for individuals 16 years and older in August 2021. Pfizer and BioNTech have also submitted a sBLA to the U.S. FDA to extend the approval of COMIRNATY to include booster doses for individuals ages 16 years and older, who are currently authorized under EUA.
Indications
Pfizer‐BioNTech COVID‐19 Vaccine is FDA authorized under EUA for active immunization to prevent coronavirus disease 2019 (COVID‐19) caused by severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) in individuals 6 months of age and older. Pfizer‐BioNTech COVID‐19 Vaccine is FDA authorized to provide:
Primary Series
A 3‐dose primary series to individuals 6 months through 4 years of age.
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.
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.
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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:
in people 12 through 15 years of age, the most common side effects (≥8%) were pain at the injection site, fatigue, headache, chills, muscle pain, fever, joint pain, injection site swelling, and injection site redness;
in people 16 through 55 years of age, the most common side effects (≥10%) were pain at the injection site, fatigue, headache, muscle pain, chills, joint pain, fever, and injection site swelling;
in people 56 years of age and older, the most common side effects (≥10%) were pain at the injection site, fatigue, headache, muscle pain, chills, joint pain, injection site swelling, fever, and injection site redness.
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. There may also be allergic reactions.
Individuals should always ask their 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
Currently, many Americans are hoping that a new vaccine which is effective against the BA 5 variant will be released soon.