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.
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All Myocarditis, Pericarditis Cases With COVID-19 Vaccines Now Must Be Reported To VAERS
The change to three vaccine emergency use authorizations was made quietly, most recently for the Novavax vaccine.
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.
CBER’s Goal To Reach Normal Ops In 2023 Includes Clearing IND, Meeting Backlogs In 2022
CBER director Peter Marks also wants to work on rare disease gene therapy issues and increase hiring before the end of the year.