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FDA approves Novavax’s COVID-19 vaccine but with unusual restrictions

Written by | 10 Jun 2025 | COVID-19

The FDA has issued a long-awaited approval of Novavax’s COVID-19 vaccine but with unusual restrictions.

Novavax makes the nation’s only traditional protein-based coronavirus vaccine – and until now it had emergency authorization from FDA for use in anyone 12 and older.

But now the FDA granted the company full approval for its vaccine for use only in adults 65 and older – or those 12 to 64 who have at least one health problem that puts them at increased risk from COVID-19,

Vaccines made by Novavax’s competitors Pfizer and Moderna already are fully licensed for use in anyone 12 and older, and also are authorized for use in children as young as 6 months.

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