Comirnaty Gets Full FDA Approval for COVID-19 Prevention in Adolescents



The Food and Drug Administration (FDA) has granted full approval of Comirnaty® (COVID-19 Vaccine, mRNA; Pfizer and BioNTech) for active immunization to prevent COVID-19 in adolescents 12 through 15 years of age.

The approval of Comirnaty was based on data from a randomized, placebo-controlled phase 3 trial which included 2260 participants 12 to 15 years of age enrolled in the US. Participants were randomly assigned to receive either a 2-dose series (30µg per dose) of the Comirnaty vaccine or placebo.

Findings demonstrated that the vaccine was 100% effective (95% CI, 87.5-100.0) against COVID-19, measured 7 days through over 4 months after the second dose. There were 30 confirmed symptomatic cases of COVID-19 reported in the placebo group (n=1109) and 0 cases in the vaccine group (n=1119), with no cases of severe disease occurring in either treatment group. 


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Findings also showed the 2-dose primary series in this patient population elicited SARS-CoV-2 neutralizing antibody geometric mean titers (GMTs) that were noninferior to GMTs elicited in participants 16 to 25 years of age.

The safety profile of the vaccine was consistent with that reported in other clinical safety data, with a favorable profile across 6 months of follow-up after the second dose.

Comirnaty is now approved as a 2-dose primary series for the prevention of COVID-19 in individuals 12 years of age and older. The Pfizer-BioNTech COVID-19 vaccine is also currently authorized for emergency use as:

  • A 3-dose primary series for individuals 6 months of age through 4 years.
  • A 2-dose primary series for individuals 5 through 11 years of age.
  • A third primary series dose for individuals 5 years of age and older who have been determined to have certain kinds of immunocompromise.
  • A single booster dose for individuals 5 through 11 years of age who have completed a primary series with Pfizer-BioNTech COVID-19 vaccine.
  • A first booster dose for 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 for individuals 18 years of age and older who have completed primary vaccination with a different authorized or approved COVID-19 vaccine.
  • A second booster dose for 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 for 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. 

Reference

Pfizer and BioNTech announce US FDA approval of their COVID-19 Vaccine Comirnaty® for adolescents 12 through 15 years of age. News release. Pfizer Inc. and BioNTech SE. July 8, 2022. Accessed July 11, 2022. https://www.pfizer.com/news/announcements/pfizer-and-biontech-announce-us-fda-approval-their-covid-19-vaccine-comirnatyr

This article originally appeared on MPR




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