US FDA Vaccines Adcomm May Be Called To Review COVID-19 Vaccine Strain Changes
CBER Director Peter Marks said the VRBPAC may need to opine on the immunogenicity data gathered for vaccine updates.
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US FDA v. COVID Mutants: Multi-Factorial Assessments Will Determine When Product EUAs Need To Change
Acting Commissioner Janet Woodcock offers hints as to the content of upcoming guidance on how emerging virus variants may impact vaccine and therapeutic development. US may need multivalent vaccine and multiple boosters.
While vaccine has efficacy rate of 74% in the US, it completely prevented hospitalizations and deaths, which Fauci says is the most important result from a public health perspective. Vaccine findings cannot be compared given emergence of variants since Moderna and Pfizer conducted their studies, Janssen global head of R&D says.
The drug maker played up the 85% prevention of severe disease and 100% prevention of hospitalization and death despite lower overall efficacy relative to mRNA vaccines.