Pandemic Perspectives: US FDA Wastes No Time In COVID-19 Emergency Use Authorization Reviews
Since the WHO’s pandemic declaration, the agency has granted 10 EUAs for therapeutics and three for vaccines, all of which were reviewed in less than 90 days; EUA requests from government entities boast two of the three fastest review times but were revoked or limited in the face of emerging evidence.
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High-profile programs, such as convalescent plasma, also created public confusion about role of preapproval access and highlighted the importance of prospectively planning for reliable data collection, experts said at the DIA global annual meeting.
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.
US FDA not planning an advisory committee for Pfizer/BioNTech’s request for authorization in 12-15-year olds at this time, but CDC’s ACIP is likely to weigh how to balance timing of COVID vaccination with administration of other immunizations generally recommended for adolescents.