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Coronavirus Update: AstraZeneca’s Vaccine Trials Cleared To Restart In the US, J&J Prepares To Restart Its Vaccine Study
Two potential COVID-19 vaccine trials from AstraZeneca and Johnson & Johnson are set to resume in the US following temporary pauses due to safety concerns. Data from both could come later this year.
But advisory committee members caution against including pediatric population in COVID-19 vaccine trials, and one member expresses concern that Pfizer is testing those as young as 12 years of age. Agency is in discussions with product sponsors about enrollment of adolescents.
Gilead's remdesivir is first drug fully approved by FDA to treat COVID-19. Roche and Atea team up on an investigational direct acting antiviral while Moderna reaches the 30,000-patient enrollment target for its Phase III COVE study of the company's investigational mRNA vaccine.
FDA's recommendation that COVID-19 vaccine sponsors conduct two months of median follow-up to support an emergency use authorization may not be long enough, some experts say in what can be viewed as validation for agency's position in battle with White House.
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