Operation Warp Speed: Moderna says COVID-19 vaccine could be approved in December

The Week via Yahoo News ^ | 10/20/2020 | Peter Weber

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Stéphane Bancel, chief executive of Moderna Inc., said Monday that the federal government could grant emergency use authorization for its COVID-19 vaccine in December, assuming the company gets promising data from its Phase 3 trial in November. Moderna started its final-phase trial with 30,000 volunteers in July, and in order to apply for emergency authorization, 53 of the subjects have to become infected with the new coronavirus, and the cases have to be significantly higher in the half of the trial that received a placebo.

That first analysis will likely happen in November, Bancel said at a Wall Street Journal conference, but "it's hard to predict exactly which week because it depends on the cases, the number of people getting sick." If the results don't show sufficient efficacy, Moderna will try again when 106 trial participants contract symptomatic COVID-19, likely delaying authorization until early next year. Under Food and Drug Administration guidelines, drugmakers also have to show that their vaccine is safe for at least two months after vaccination, a benchmark Bancel said Moderna should hit in late November.

Moderna is testing one of four viable COVID-19 vaccines, and its timeline is closest to Pfizer, which said last week it expects to seek emergency use authorization of its vaccine in late November. The trials of vaccine candidates from Johnson & Johnson and AstraZeneca are on pause while the companies look into unexplained health issues among participants. Moderna says it plans to produce 20 million does of its vaccine this year and 500 million next year.

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After the election.