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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Novavax EUA Justified By US FDA With Claims Of COVID Vaccine Supply Constraints
The agency also includes a myocarditis warning in the fact sheet for the first protein-based COVID-19 vaccine to reach the US market.
Is A Class-Wide Myocarditis Warning Coming For COVID-19 Vaccines?
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.
Novavax Gains US FDA Advisory Committee Endorsement, But So Does Myocarditis Risk Statement
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.