US FDA Advisors' Push For BA.4/BA.5 COVID-19 Boosters Sets Up Regulatory, Manufacturing Crunch

 
• By Sarah Karlin-Smith

If FDA wants to follow its external experts' advice on new booster composition, it would likely have to authorize BA.4/BA.5-targeting boosters on preclinical and manufacturing data only, and companies would have to quickly pivot manufacturing.

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FDA was urged to go where the puck is going when picking strains for updated COVID-19 vaccines. • Source: Shutterstock

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