COVID-19 Vaccines Are Coming Soon, But Therapeutics Needed Now
Executives at Pfizer and Moderna expressed confidence in their US government partners for initial COVID-19 vaccine distribution and expect pediatric studies to begin before the end of the year. Regeneron will “do the right thing” in pricing its antibody cocktail.
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Plus: Humainigen announced data from its still-blinded Phase III trial, while Korea's GeneOne advanced a DNA vaccine candidate.
CEO Len Schleifer said he does not know the timeline for when the US FDA could authorize REGN-COV2 but expects to hear from the agency soon.
Guidance on COVID-19 vaccine development and licensure appears to set a precedent in specifying the clinical efficacy rate for a product approval; agency also takes accelerated approval off the table for now and says emergency use authorization may be granted only after safety and efficacy have been demonstrated.