Monday, October 25, 2021

Moderna CEO says coronavirus vaccine won’t be ready for FDA till late November: FT


As late-stage trials progress—or not—COVID-19 vaccine timelines have grown clearer. And here’s another data point—Moderna, a leading player, doesn’t expect to be ready to file for an emergency use authorization until late November, its CEO said this week. 

Speaking at a Financial Times event, Moderna CEO Stéphane Bancel said it’ll be November 25 at the earliest before the company can seek an emergency nod. Under guidelines Moderna worked out with the agency, the biotech will compile two-month safety data for at least half of trial participants who have received their second doses. 

In the company’s phase 3 trial, the 15,000th participant received the second dose last Friday, Sept. 25, he said. That means it’ll be Nov. 25 at the earliest before the company can seek an EUA. 

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Bancel’s comments come as President Donald Trump and others in his administration maintain a vaccine is just weeks away. Pfizer has said it expects early efficacy data in late October, but the big pharma’s CEO voiced concerns about politics entering the process in an open letter this week. 

Pfizer’s trial design could give that company a faster timeline to the FDA, Bancel said. Still, experts have urged Pfizer to hold off until it can review two-month safety data.

RELATED: Pfizer urged to hold off on coronavirus vaccine until late November

For a full approval and general distribution, Moderna is aiming for the spring, Bancel told FT.

At Tuesday’s presidential debate, moderator Chris Wallace asked Trump about administration health officials’ statements that it’ll be next summer before a COVID-19 vaccine is “generally available.” The president responded that he’s “spoken to the companies, and we can have it a lot sooner.”  

Aside from Moderna and Pfizer, AstraZeneca, Johnson & Johnson and Novavax are also in late-stage testing. The partnership between Sanofi and GSK recently started a phase 1/2 study with plans to file for approvals during the first half of 2021. 

RELATED: Trump, Biden spar over COVID-19 vaccines at debate. Will it help public trust in the process? 

AstraZeneca’s vaccine has started a “rolling review” in Europe even as its U.S. trial remains halted for an FDA safety investigation. J&J expects early doses of its vaccine to be available in early 2021, while Novavax’s CEO has said the company expects to file for approval in December. 



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