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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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.
Coronavirus Notebook: EMA To Decide On Comirnaty In 12-15-Year-Olds, Cuba Presses On With Homegrown Vaccine Rollout
At global level, Médecins Sans Frontières has called for all countries to support a revised version of the IP waiver for COVID-19 vaccines, singling out the recalcitrant European Commission for special attention.
Moderna's mRNA-1273 vaccine prevented significant illness after two doses in all patients in the TeenCOVE trial, ages 12-18. The company will submit the data to global regulators in June. Meanwhile, J&J has applied for the Japanese approval of its vaccine, Moderna progresses plans in Korea, and India plans to ramp up vaccine supplies.