Coronavirus Notebook: Moderna Claims 94.5% Vaccine Efficacy, Janssen Starts Second ENSEMBLE Trial
The European Medicines Agency has begun a rolling review of Moderna’s mRNA vaccine, and its new executive director, Emer Cooke, has taken up her role with a promise to make tackling COVID-19 her “number one priority.”
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J&J executive emphasizes that fast-tracked development of COVID-19 vaccines does not come with any corners cut around safety. Indian partner Biological E also outlines the complexities in manufacturing and believes that the candidates from J&J, AstraZeneca and others will be more suitable in profile and price terms to contain the pandemic globally.
The company is on track to provide hundreds of millions of doses of its COVID-19 vaccine in the first half of 2021, Gorsky reaffirmed during the Milken Institute Future of Health Summit.
US FDA’s biologics center director Peter Marks discusses future COVID-19 vaccine trials, post-market safety monitoring, and how FDA is juggling reviewing two emergency use authorization requests at once in an interview with Pink Sheet.