FDA Authorizes Pfizer COVID-19 Vaccine for Children 5-11
On Tuesday, the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommended the agency issue an emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine for use in children ages 5 to 11 years old. The panel’s vote in recommending the EUA was 17-0 with one abstention.
The FDA VRBPAC received data from Pfizer-BioNTech indicating the vaccine is safe and 90.7 percent effective in preventing COVID-19 infections in this age group. A dose of the Pfizer-BioNTech vaccine for young children contains one-third the amount of active ingredient compared to the adult dose. Children would receive a second dose 21 days or more after their first dose.
The FDA adopted the recommendation from VRBPAC today, authorizing the vaccine for use among children 5-11. The decision now moves to the U.S. Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) to make its own recommendations and offer guidelines on the vaccine’s use among this age. The CDC ACIP is scheduled to meet on Tuesday and Wednesday of next week.
Following the FDA VRBPAC recommendation on Tuesday, California Health and Human Services (CalHHS) Secretary Dr. Mark Ghaly and California Department of Public Health (CDPH) Director and State Public Health Officer Dr. Tomás Aragón issued a statement indicating the recommendation brings the state closer to protecting more residents and ending the pandemic. The officials noted the evidence shows the vaccine is safe and highly effective in the age group. CDPH will await further federal direction, as well as direction from the Western States Scientific Safety Review Workgroup, before administering vaccines to children ages 5-11.