backThe FDA, on February 4, 2021, announced its plan to develop “guidances for diagnostic, therapeutic and vaccine developers to help guide ongoing medical product development.” Specifically, the FDA is working to provide guidance on the types of data vaccine manufacturers would need to support changes in the composition of authorized vaccines. The emergence of new COVID-19 variants has raised questions about whether or not authorized vaccines will work, but the FDA reiterated that “available information suggests that the authorized vaccines remain effective in protecting the American public.”
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(Source: FDA Announcement – February 4, 2021)
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