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.
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The FDA Commissioner suggests the US may need to fix economic incentives that keep industry from completing studies of drugs granted speedier paths to market before opening those pathways to new disease areas, but expressed particular interest in thinking about how EUAs could be used for non-opioid pain treatments.
Agency policy now allows several others, along with the FDA chief scientist, to authorize emergency use of products, including CBER Director Peter Marks, who signed the EUA for the modified dosing of the monkeypox vaccine.
One switch raised questions, but by the time the COVID-19 vaccine reached commercial scale, the changes were considered minor.