USA – FDA panel split on approach to COVID-19 vaccines for younger children

Members of the US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) disagreed as to whether the agency should grant emergency use authorizations (EUAs) for COVID-19 vaccines for children at a 10 June meeting.
 
Some said that EUAs were necessary to get the pediatric population vaccinated quickly to achieve herd immunity as the country emerges from the pandemic and that these vaccines should be available soon as the fall and flu season approach and the risk of contracting respiratory infections increases.
 
The meeting, which was not convened to discuss any specific vaccines, followed FDA’s decision last month to authorize the Pfizer-BioNTech vaccine for adolescents 12 to 15 years of age. (RELATED:  FDA authorizes Pfizer-BioNTech vaccine in children 12-15Regulatory Focus 10 May). Pfizer recently announced it will begin a late-stage trial of the vaccine in children under 12 years of age and Moderna has requested an EUA for its vaccine in children 12 and up.
 
Some members of the committee who were wary of EUAs in younger age groups said there was insufficient justification and safety data to support emergency use in this population and were concerned about recent reports from Israel that cited elevated cases of myocarditis, or inflammation of the heart, in males ages 16 to 30 who received both doses of Pfizer-BioNTech’s mRNA-based vaccine Comirnaty…