US FDA Not Yet Sold On COVID Vaccine Emergency Use Authorization For Children Under 12
Advisory committee will discuss merits of longer-term safety data for COVID-19 vaccines in children under 12, which could leave EUA pathway out of reach for this population. Immunobridging studies may also be more challenging in this population due to potential need for dose reductions.
You may also be interested in...
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.
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.
Concerns about cases of heart muscle inflammation occurring in older male adolescents and young men shortly after the second dose of Pfizer and Moderna mRNA vaccines hung over FDA advisory committee discussions on pediatric safety data requirements for COVID-19 vaccines; CDC’s ACIP will take up the myocarditis issue at an 18 June meeting.