Novavax Readies COVID-19 Vaccine Request For EUA, But How Much Longer Will The Door Be Open?
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.
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The agency also includes a myocarditis warning in the fact sheet for the first protein-based COVID-19 vaccine to reach the US market.
Now that multiple vaccines using different platforms seem to be associated with heart inflammation, the FDA and others want more data on whether a common characteristic of the virus or vaccine manufacturing is related.
Vaccines and Related Biological Products Advisory Committee members agree another option should be made available, especially if Novavax's protein-based design could encourage those who refused the mRNA vaccines to be inoculated.