mRNA COVID-19 Vaccines To Add Warning Language On Myocarditis Risk
US FDA will rapidly update fact sheets with information on myocarditis/pericarditis occurring primarily in young men and adolescent males following the second dose, agency's Doran Fink tells the CDC’s Advisory Committee on Immunization Practices, which said benefit-risk of the Pfizer/BioNTech and Moderna vaccines remains favorable.
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For males 16-17 years old, excess cases of myocarditis/pericarditis from Comirnaty would exceed COVID-19 hospitalizations and deaths under ‘worst case’ scenario modeled by US FDA; agency nevertheless deemed approval warranted in this subpopulation, citing prevention of nonhospitalized COVID cases and public health benefits from vaccination.
Recipients of AstraZeneca’s vaccine hospitalized with vaccine-induced immune thrombocytopenia and thrombosis (VITT) had overall mortality of 22%, NEJM study finds. JAMA reports 15 children who had myocarditis following Pfizer/BioNTech vaccine were mildly affected. Efficacy of Moderna vaccine in adolescents and durability of Pfizer vaccine in cancer treatment recipients is also reported.
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.