Pfizer/BioNTech’s COVID-19 Vaccine Moves Into Adolescents; Adcomm To Weigh Broader Pediatric Issues
Emergency use authorization in 12-15 year-olds follows announcement of a June advisory committee meeting on pediatric data requirements, including the FDA’s criteria for younger children. Authorization for US adolescents has raised ethical questions about prioritizing this lower-risk group over hard-hit populations overseas.
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Moderna COVID Vaccine’s Myocarditis Risk Has Improved With Time, US FDA Says
‘Robust results’ from recent US surveillance studies show slight decreases in the myocarditis risk differential between the Moderna and Pfizer/BioNTech vaccines, agency says in briefing documents for panel review of Moderna’s pediatric EUA request.
Moderna’s COVID Vaccine Sheds Negative Comparison On Myocarditis With BLA Approval
Unlike the current EUA fact sheet, Spikevax’s approved labeling does not state that the vaccine may pose an increased risk of myocarditis ‘relative to other authorized or approved mRNA COVID-19 vaccines.’ Approval brings Moderna a priority review voucher, as did Comirnaty’s approval for BLA sponsor BioNTech.
With Many More COVID-19 Vaccine Changes Ahead, ACIP Expecting Fewer Public Meetings
CDC’s Advisory Committee on Immunization Practices wants a more feasible and sustainable meeting schedule in 2022, which would reduce transparency.