Invivyd (IVVD) said Wednesday that it has urged the US Food and Drug Administration to focus on monoclonal antibodies for the prevention of COVID-19 to rebuild Americans' trust in scientific data and public health recommendations.
The company said the citizen petition it filed with the FDA requested a re-evaluation of COVID-19 mRNA vaccines as well as new clinical trials to assess vaccine effectiveness.
Invivyd said it has also asked the US health regulator to make clear that biologics license application approval is appropriate based on serum virus neutralizing antibody titers.
The company's shares rose 7% in recent premarket activity on Wednesday.
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