Moderna CEO Says COVID Vaccine Ready to Roll Out Within Day of FDA Approval in December

Moderna CEO Says COVID Vaccine Ready to Roll Out Within Day of FDA Approval in December
The boss of biotech company Moderna has said its COVID vaccine could roll out to Americans within 24 hours of government approval.

Stéphane Bancel, CEO of the Massachusetts-based company, told Fox Business host Maria Bartiromo today the firm applied for Emergency Use Authorization from the Food and Drug Administration (FDA)—and authorization could come next month.

Earlier today, Moderna announced a study of the vaccine candidate involving 30,000 people found the treatment was over 94 percent effective against COVID.

In a press release, Moderna said the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) was expected to review the findings on December 17. While promising, the results of the studies have not been peer reviewed.

“The FDA has indicated to us that it is likely the VRBPAC meeting… should happen on December 17 and hopefully if everything goes well in the next couple of weeks you could expect, between I would say a day to two after the VRBPAC meeting, a potential approval, meaning we’re able to ship the product,” Bancel told Bartiromo.

“Operation Warp Speed led by General [Gustave] Perna has been working on a daily basis very closely with us and the goal is to start vaccinating Americans within 24 hours after the FDA gives an approval,” the Moderna chief executive added.

Operation Warp Speed, established by the White House in May, is a partnership between federal health and defense agencies, academics and businesses that has the aim of making and delivering 300 million vaccine doses, starting January 2021.

Moderna has forecast it should have around 20 million doses of the candidate—which is called mRNA-1273—available in the U.S. by the end of 2020. It claims to be on track to manufacture between 500 million and one billion doses globally in 2021.

The fact that any vaccine won’t be widely available initially was stressed today by the Warp Speed Vaccine Czar Dr. Slaoui, also appearing on Fox Business.

“While we’ve done tremendous work to make these vaccines available, we only have enough vaccines to immunize 20 million people in the month of December, so it’s going to take a while before we have enough vaccines for everybody,” he said.

Bancel, however, pitched the development of vaccines as being “light at the end of the tunnel” and appeared to be optimistic the candidate would get FDA approval.

“Assuming the vaccine gets approved before the end of the year we will be starting to vaccinate health care workers [and] people at very high risk,” he said, adding that in the first half of 2021 he expects to see a wider rollout of treatments to begin.

“I think in the second quarter every American who is older than 18 should be able to get vaccinated,” he said. “[I hope] by the end of the spring we should be in a place where most Americans that want the vaccine will have access to a good vaccine.”

On November 16, Bancel told CNBC his company was making more of the candidate every day and then “stockpiling it” in preparation for the potential FDA approval.

Moderna
This picture taken on November 18, 2020 shows a bottle reading “Vaccine Covid-19” next to the Moderna biotech company logo. Moderna’s CEO said its COVID vaccine candidate could roll out to Americans within 24 of government approval.
JOEL SAGET/AFP/Getty

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