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President Biden’s informal declaration that the COVID-19 pandemic is ‘over’ likely portends a formal end of the Public Health Emergency. But many of the US FDA’s COVID flexibilities don’t directly depend on that decision.
A new medicine to protect newborns and infants from RSV infection and a new treatment for DLBCL are among a dozen drugs that have been recommended for pan-EU approval.
The change to three vaccine emergency use authorizations was made quietly, most recently for the Novavax vaccine.
But agency assessors also said there did not appear to be a biological reason for the vaccine to cause depression when granting the emergency use authorization for use of the Novavax vaccine in 12- to 17-year-olds.
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