FDA Approves Pfizer Vaccine for Children Ages 12 to 15

The Food and Drug Administration has granted emergency use authorization of the Pfizer-BioNTech COVID-19 vaccine for people in the United States between the ages of 12 and 15 years old.

via: Revolt

This will become the first COVID vaccine in the country that has been authorized to be used on young teens and adolescents, as it was previously only permitted for those who were 16 and older. Moderna and Johnson & Johnson vaccinations are only authorized to be given to those who are 18 and older.

Pfizer said that at the end of March a clinical trial involving over 2,200 12-to-15-year-olds showed the vaccine’s effectiveness was at 100 percent.

According to CNN, the FDA’s Vaccines and Related Biological Products Advisory Committee did not convene to vote on the expansion. However, the U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet on Wednesday (May 12) to advise the CDC on whether or not to use the vaccine on the age group.

The FDA’s Vaccines and Related Biological Products Advisory Committee has a meeting scheduled for June 10 to discuss the potential expansion of the vaccine to children under 12.

“During the meeting, the agency will provide a status update on our approach to emergency use authorization (EUA) for COVID-19 vaccines intended for use in individuals 12 through 17 years of age,” the FDA said in a statement Monday (May 10).

“The committee will also discuss the data needed to support an EUA and a biologics license application (BLA) for a COVID-19 vaccine intended for use in children less than 12 years of age,” it added. “The committee will not discuss any specific products.”

Once they receive the final approval from CDC, the Biden Administration plans on acting quickly on distribution efforts by making the vaccine available through pediatricians, family doctors, and local pharmacies.

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