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Opinion: The FDA is circumventing key roles and procedures for licensure and use of Covid vaccines
The FDA’s recent activities regarding Covid-19 vaccines stray far from the well-established standards of vaccine regulatory processes.
The Food and Drug Administration’s recent activities regarding Covid-19 vaccines stray far from the well-established standards of vaccine regulatory processes.
The first sign of trouble was the failure to rule on the licensure of the Novavax protein-based Covid-19 vaccine by the established deadline of April 1. This should have been a standard review timeline given the extensive efficacy and safety data obtained through large randomized placebo-controlled clinical trials conducted during the pandemic. However, the ruling was delayed until May 19, when the vaccine was approved only for use in “adults 65 years and older and in individuals 12 through 64 years of age with at least one underlying high risk medical condition for severe outcomes from COVID-19.”
