June 17, 2022
The US Food and Drug Administration (FDA) today granted emergency use authorization (EUA) to the Moderna and Pfizer COVID-19 vaccines for use in children 6 months of age and older, one of the final steps in a long-awaited authorization process to extend protection to the youngest of Americans.
The agency's move comes after a closely watched FDA advisory group vote earlier this week, which resulted in a unanimous vote in favor of the FDA authorizing both vaccines in this age group.
"The FDA's evaluation and analysis of the safety, effectiveness and manufacturing data of these vaccines was rigorous and comprehensive, supporting the EUAs," the agency said in a news release.
The data shows that the “known and potential benefits” of the vaccines outweigh any potential risks, the agency said.
The Moderna vaccine is authorized as a two-dose primary series in children 6 months to 17 years of age. The Pfizer vaccine is now authorized as a three-dose primary series in children 6 months up to 4 years of age. Pfizer's vaccine was already authorized in children 5 years and older.
Now all eyes are on the Centers for Disease Control and Prevention (CDC), which is expected to decide on the final regulatory hurdle at a meeting Saturday. The CDC's Advisory Committee on Immunization Practices (ACIP) has scheduled a vote on whether to give the vaccines the green light.
If ACIP gives the OK, CDC Director Rochelle Walensky, MD, MPH, is expected to endorse the recommendations for use shortly thereafter.
Following these final regulatory steps, parents could start bringing their children to pediatricians, family physicians or local pharmacy for vaccination as early as Monday.
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Medscape, June 17, 2022.
FDA news release June 17, 2022.