FDA Panel in Favor of COVID-19 Vaccines for Kids as Young as 6 Months

The Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee met this week to discuss amending the Emergency Use Authorizations (EUA) of the Moderna COVID-19 Vaccine to include the administration of the primary series to children 6 months to 17 years of age, and the Pfizer-BioNTech COVID-19 Vaccine to include the administration of the primary series to children 6 months through 4 years of age.

• On the question of whether the benefits of the Moderna COVID-19 Vaccine when administered as a 2-doses series (100mcg each dose) outweigh its risks for use in adolescents 12 through 17 years of age, the panel voted 22 yes, 0 no.

• On the question of whether the benefits of the Moderna COVID-19 Vaccine when administered as a 2-doses series (50mcg each dose) outweigh its risks for use in children 6 through 11 years of age, the panel voted 22 yes, 0 no.

• On the question of whether the benefits of the Moderna COVID-19 Vaccine as a 2-dose series (25mcg each dose) outweigh its risks for use in infants and children 6 months through 5 years of age, the panel voted 21 yes, 0 no.

• On the question of whether the benefits of the Pfizer-BioNTech COVID-19 Vaccine when administered as a 3-dose series (3mcg each dose) outweigh its risk for use in infants and children 6 months through 4 years of age, the panel voted 21 yes, 0 no.

Although not bound to the committee’s recommendations, the FDA does take them into consideration when making decisions on authorization. According to the Centers for Disease Control, as of June 7, 2022, there have been over 13.1 million cases of COVID-19 among children and adolescents 0 to 17 years of age. Taking into consideration the incidence of COVID-19 in this patient population, the risks associated with the disease including hospitalization, multisystem inflammatory syndrome, and death, the panel voted unanimously for the use of these 2 vaccines in younger individuals.

Reference

Vaccines and Related Biological Products Advisory Committee June 14 to 15, 2022 Meeting Announcement. https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-june-14-15-2022-meeting-announcement