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Novavax Readies COVID-19 Vaccine Request For EUA, But How Much Longer Will The Door Be Open?

 
• By Sue Sutter

Availability of emergency authorization route in US depends upon lack of 'adequate, approved and available alternatives,' but as more vaccines make their way through the BLA process sponsors may find the EUA door slowly closing.

Emergency door
The door for emergency use COVID-19 vaccines may start closing with more approvals. • Source: Alamy

Novavax, Inc.’s forthcoming emergency use authorization request for NVX-CoV2373 could lead to the availability of a fourth COVID-19 vaccine in the US, but that alone is unlikely to trigger a rethinking by the Food and Drug Administration as to how much longer to keep the EUA pathway open.

On 31 December, the company said it had completed submission of the chemistry, manufacturing and controls portion of the data package for its recombinant nanoparticle protein-based

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Legal, Process Problems May Plague New US FDA COVID-19 Vaccine Policy

 
• By Sarah Karlin-Smith

The FDA may have violated laws and regulations along with many norms in how it released its planned changes for COVID-19 vaccine approvals.