Warp Speed Chief Softens Aggressive COVID Vaccine Targets

Alicia Ault

August 10, 2020

The chief of the federal government's Operation Warp Speed, the COVID-19 vaccines and therapeutics development effort, said the 300 million vaccine doses the program aims to deliver would likely not fully occur until the middle of 2021.

And, said Moncef Slaoui, PhD, the program aims to deliver 300 million courses of therapy, not individual doses, as some vaccines will likely require two doses.

Operation Warp Speed's stated goal is to deliver 300 million doses by January 2021. Those targets have been repeated by government officials in testimony to Congress and in media interviews.

But Slaoui clarified that 300 million courses of therapy will only be possible if six or seven of the vaccine candidates that have been selected for government support were all successful. And that those courses will not be available immediately in January, but over the first 6 months of 2021.

"But that's hypothetical," said Slaoui, who spoke on August 7 to a National Academies of Sciences, Engineering, and Medicine committee that will issue recommendations on COVID-19 vaccine allocation in September. He reiterated that the vaccine effort is dependent "on the actual data."

Full FDA Approval Pledged

The vaccine candidates that have been selected for government backing include those being developed by Moderna and Pfizer (both messenger RNA platforms); AstraZeneca/Oxford University and Janssen (both non-replicating vectors); and Novavax and Sanofi/GlaxoSmithKline (both protein adjuvanted). Operation Warp Speed has not yet announced a partner company for a live attenuated platform technology, said Slaoui.

He said that every candidate would seek full approval from the Food and Drug Administration (FDA), as opposed to an emergency use authorization, which has been used for most of the COVID-19 diagnostics and therapeutics that have been brought to the US market so far.

"Our aim is to develop these vaccines to seek a BLA [biologics licensing application] approval, ie, full approval by the FDA," Slaoui continued.

There has been some concern that the FDA will be pressured to grant emergency use or otherwise quickly approve a vaccine. Slaoui said that Operation Warp Speed had an agreement with the FDA to quickly review data, but that no corners would be cut.

Approval criteria "will be the same as those used for any regular vaccine," he said.

He did, however, say that if those criteria are in the process of being met, "the FDA, on its own, of course, may decide to provide for the emergency use authorization."

All of the vaccine makers have committed to being fully transparent with their data and to granting access to their data, Slaoui added.

National Academies committee member Reed V. Tuckson, MD, asked Slaoui whether the transparency would extend to Operation Warp Speed and the FDA also, and he wanted to know if the vaccine studies would be "linked to rapid publications in peer-reviewed journals so that the public will have a chance to look over the shoulder" of the government.

Said Slaoui: "All of the above and 100% of it."

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