FDA Approves Pfizer/BioNTech’s COVID-19 Vaccine for 5- to 11-Year-Olds

Last Friday, Pfizer and BioNTech SE announced that the FDA has approved their COVID-19 vaccine Comirnaty for emergency use in children 5 through 11 years of age. With this, Comirnaty becomes the first COVID-19 vaccine in the US to be authorized for administration in this age group.

“This is a day so many parents, eager to protect their young children from this virus, have been waiting for,” said Albert Bourla, Chairman and CEO of Pfizer. “Over 6 million children in the US have been diagnosed with COVID-19 since the start of this pandemic, and a high number of young people continue to be infected every week. With this FDA authorization, we have achieved another key marker in our ongoing effort to help protect families and communities, and to get this disease under control.”

Encouraging Phase2/3 Trial Data

The emergency approval is based on the Phase 2/3 trial that showed that a two-dose regimen of 10 μg administered 21 days apart was well tolerated in young children. The 10-µg dose level was carefully selected based on safety, tolerability, and immunogenicity data, the companies said in a statement.

The Phase 2/3 randomized trial included ~4,500 children between the ages of 5 to 11 years (2,268 from the original group and 2,379 from the supplemental safety group). The FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) gave their positive recommendation after carefully reviewing the trial results.

In the trial, the vaccine demonstrated a favorable safety profile, robust immune responses, and a vaccine efficacy rate of 90.7% in participants without prior SARS-CoV-2 infection, measured from 7 days after the second dose. The Data Monitoring Committee for the study has reviewed the data and has not identified any serious safety concerns related to the vaccine.

Future Plans

As a next step, the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) will meet this week to discuss a potential recommendation for the use and rollout of the vaccine to children 5 through 11 years of age. Pediatric vaccinations are anticipated to start, subject to, and after, CDC endorses the ACIP recommendation.

The companies will begin shipping 10-µg pediatric doses immediately, as directed by the US government (ages referred to as 5y to <12y on the vial and 5 to <12 years on the carton).

Pfizer and BioNTech have submitted requests for authorization of their COVID-19 vaccine in this age group to other global regulators, including the European Medicines Agency. Additionally, they expect the results from the two other age cohorts of the Phase 1/2/3 trial—children 2-5 years of age and children 6 months to 2 years of age as soon as the fourth quarter of this year.

Author

Rajaneesh K. Gopinath