Moderna Will Seek FDA Approval for Vaccine Extension to Teens

Moderna will seek FDA approval for an extension of their emergency use authorization in the coming months to provide their vaccine to teens.

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Following Pfizer’s recent announcement that their Pfizer-BioNTech COVID-19 vaccine had been approved by the United States Food and Drug Administration (FDA) for use in 12- to 15-year-olds, Moderna has announced that its COVID-19 vaccine is 100 percent effective in the same age group. Moderna will seek FDA approval as soon as the results of its 3,700-participant study are officially published.

Moderna will seek FDA approval

Moderna’s announcement came at the close of Phases 2 and 3 of its three-phase adolescent study. The study follows over 3,700 adolescents aged 12 to 17 and currently shows that the vaccine has a 100 percent effective rate in preventing COVID-19 in teens. Though the Moderna vaccine is a two-shot process, participants experienced a 93 percent effective rate of protection after just one dose. According to the data, teens show similar immune responses and side effects to adults after receiving the vaccine.

Moderna is expected to request an extension of its existing emergency use authorization from the FDA in early June. Pfizer applied for an extension on April 9 and was approved on May 10, so Moderna may be able to expect approval just in time for July 4, if it releases the data and applies in the predicted timeframe.

Defining COVID-19 in Adolescents

In Phase 1 of the trial, Moderna used the same criteria for a positive COVID-19 case as it did in adult trials late last year. For Phase 2, however, the company used a much stricter definition set by the US Center for Disease Control and Prevention (CDC), since adolescents typically have a lower incidence rate and lesser symptoms than adults when they contract COVID-19. The definition used in Phase 2 classified a positive case as the presence of a single COVID-19 symptom and a positive test.

Reopening Schools for Fall

“Today’s action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic,” Acting FDA Commissioner Janet Woodcock, M.D., explained during the Pfizer-BioNTech press conference in early May. “Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations.”

With both the Moderna and Pfizer vaccines available to teens, more schools will be able to return to in-person classes without fear this fall. All three vaccine producers – Pfizer, Moderna, and Johnson & Johnson – are also beginning trials of their vaccines on children under the age of 12.


We hope this information on how Moderna will seek FDA approval to provide vaccines to teens is helpful to you.

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