Rare Or Common Events? COVID Vaccine Trials In Children Boost Safety Databases, Triggering Fears Of Heart Events

 
• By Sarah Karlin-Smith
  
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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.

Updated sample size request could indicate concern myocarditis adverse events may be more common in younger children. • Source: Alamy

Moderna, Inc.confirmed on 26 July that it plans to expand the safety database of its COVID-19 vaccine study in children age 5 to 11 following conversations with the US Food and Drug Administration in order to increase the likelihood of detecting rare events, but some experts said the sample size being reported may suggest concern about more common adverse events. 

A company spokesperson indicated the increased sample size could shift timelines for a package that supports authorization and that at...

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