US FDA Vaccine Advisors Leave Door Open For COVID Emergency Use Authorizations For Young Children
Many members of FDA’s Vaccines Related and Biologic Products Advisory Committee were emphatic about not closing off the EUA pathway for COVID-19 vaccines for younger children – a bit of a contrast to FDA’s unsureness in its briefing documents for the panel. However, the committee also had a solid minority of vocal opponents to speeding up pediatric approval of COVID vaccines given new myocarditis concerns and lower risk of poor COVID outcomes.
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Company says it is pursuing authorization for 2-18 year-olds due to unmet need and lack of an authorized vaccine in the youngest age group; however, the relatively small size of the safety database, the single-arm design of the pediatric immunobridging study conducted solely in India, and lack of authorized use in adults spell trouble for the request.
Briefing documents for the upcoming advisory committee tout potential ‘indirect’ benefits and argue that lower dose should address myocarditis concerns.
Rare Or Common Events? COVID Vaccine Trials In Children Boost Safety Databases, Triggering Fears Of Heart Events
US FDA seems to want Moderna and Pfizer to study their mRNA vaccines in 3,000 people ages five to 11, suggesting the rate of myocarditis in younger children may be higher than in older teens. Such a finding, and even the hunt for it, could push back any COVID-19 vaccine authorization for this population.