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FDA grants emergency use authorization for Pfizer COVID-19 vaccine for ages 12-15

 

The US Food and Drug Administration has expanded the emergency use authorization for Pfizer’s COVID-19 vaccine to include people ages 12 to 15.

This is the first COVID-19 vaccine in the United States authorized for use in younger teens and adolescents; the vaccine had previously been authorized for people age 16 and older. COVID-19 vaccines from Moderna and Johnson & Johnson are authorized for use in people age 18 and older.

To support the extended use, the FDA reviewed data submitted by Pfizer. The company said at the end of March that a clinical trial involving 2,260 12-to-15-year-olds showed the vaccine’s efficacy is 100% and it is well tolerated.

The FDA’s independent Vaccines and Related Biological Products Advisory Committee did not meet to vote on whether to recommend the expansion of the EUA to 12-to-15-year-olds. But the US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices is scheduled to meet Wednesday to advise CDC on whether to recommend use of the vaccine in this age group. CDC Director Dr. Rochelle Walensky will then decide whether the agency will recommend the vaccine’s use in the new group.

Vaccinations for 12-to-15-year-olds are not expected to begin until after that recommendation. The Biden administration has said it will quickly mobilize to ready vaccinations for 12-to-15-year-olds through the federal pharmacy program, pediatricians and family doctors.

Expanding authorization to people 12 to 15 opens COVID-19 vaccination to another 5% of the US population, nearly 17 million more people. The expanded authorization means 85% of the US population is eligible to receive a COVID-19 vaccine.

Pfizer said last week it expects to submit for emergency use authorization for its COVID-19 vaccine for children ages 2 to 11 years old in September. Its vaccine safety and efficacy study in children ages 6 months to 11 years old is ongoing.

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