(Sharecast News) - America's top health official warned of the risks of applying political pressure on the Food and Drug Administration to extend emergency use authorisation for its Covid-9 vaccine candidate before the November presidential elections in the US.
In an interview with Reuters, overnight the head of the National Institute of Allergy and Infectious Diseases, Anthony Fauci, emphasised the need to to not extend an EUA before there was a "signal of efficacy".
Among the potential dangers he cited was the possibility that premature approval might make it more difficult for other vaccines to enroll people in their trials.
Fauci also reportedly explained to Reuters that the FDA's guidance for vaccines, whether for full approval or an EUA, explicitly required a demonstration of both efficacy and effectiveness.
Once those are proven, then an EUA might be appropriate, even before the FDA completes a formal review of a company's marketing application.
"To me, it's absolutely paramount that you definitively show that a vaccine is safe and effective, both."
Astrazeneca (AZN)26 Apr 2024 09:33
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