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FDA expanded the emergency use authorization (EUA) for Pfizer's COVID-19 vaccine (Comirnaty) to include 16- and 17-year-olds, .

This comes on the heels of FDA authorizing booster doses for all individuals ages 18 and up less than a month ago. Pfizer's vaccine was approved for ages 16 and up, but a single-dose booster at least 6 months after the two-dose primary series had not been extended to the younger end of the age spectrum until now.

"The Pfizer-BioNTech COVID-19 vaccine has been available to individuals 16 years of age and older for nearly a year, and its benefits have been shown to clearly outweigh potential risks," said Peter Marks, MD, PhD, director of the FDA's Center for Biologics Evaluation and Research, in a statement. "Since we first authorized the vaccine, new evidence indicates that vaccine effectiveness against COVID-19 is waning after the second dose of the vaccine for all adults and for those in the 16- and 17-year-old age group."

Interestingly, the FDA noted that they did not convene the Vaccines and Related Biological Products Advisory Committee (VRBPAC) to support this decision, "as the agency previously convened the committee for extensive discussions regarding the use of booster doses of COVID-19 vaccines" and "concluded that the request does not raise questions that would benefit from additional discussion by committee members."

Evidence for the EUA comes from the same study that supported the booster authorization in adults: immune response data from about 200 adults ages 18-55 that found a booster response when a single dose was administered about 6 months after a two-dose primary series.

FDA used this evidence to extend the EUA, writing, "based on the available data for individuals 18 and older regarding effectiveness, the FDA has concluded that these data support extending the eligible booster age population to 16- and 17-year-olds."

The agency noted additional real-world data about vaccine-associated myocarditis, but concluded that the benefits continue to outweigh the risks of vaccination in this population. The most common systemic side effects of a booster dose are fatigue, headache, muscle or joint pain, and chills, with the agency noting lymphadenopathy was more frequently observed after the booster dose than the primary series.

Without convening its Advisory Committee on Immunization Practices, the CDC swiftly expanded the Pfizer booster recommendations to include this younger age group.

"Although we don't have all the answers on the Omicron variant, initial data suggests that COVID-19 boosters help broaden and strengthen the protection against Omicron and other variants," CDC Director Rochelle Walensky, MD, said .

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