Merck, advancing single-dose and oral coronavirus vaccines, could still make Warp Speed

The U.S. government’s Operation Warp Speed has already inked COVID-19 vaccine research and manufacturing pacts with major vaccine players—excluding Merck & Co., that is. But the group’s description of an as-yet-unnamed participant matches Merck’s early-stage research, Bloomberg reports, indicating the drugmaker could still get in.  

Merck publicly entered COVID-19 vaccine research later than its peers through a buyout of the biotech Themis and a partnership with nonprofit research group IAVI. The company started phase 1/2 testing earlier this month with technology acquired in the Themis buy. The IAVI partnership uses the same platform as Merck's Ebola vaccine, which won FDA approval late last year.

Merck’s vaccines are live attenuated candidates, meaning they use weakened viruses that replicate in the body to generate an immune response. Merck is testing a vaccine that could be given orally, which would “help lower the barrier to vaccination should it be effective,” Merck R&D chief Roger Perlmutter said on a July conference call. 

“In dealing with an aggressive, globally dispersed disease like COVID-19, we believe that it is wise to lower the barrier to vaccination as much as possible, for example, by launching a vaccine that is effective with just a single administration,” Perlmutter said. 

Those details match the description of a vaccine that Moncef Slaoui, head of Operation Warp Speed, highlighted as a potential participant during a Wednesday presentation, according to Bloomberg. Merck and the Department of Health and Human Services declined to comment to the news service. 

Back in June, the New York Times reported that Merck was among a group of companies selected as Warp Speed finalists. The drugmaker has yet to enter a public deal with the group.

To help support early research, Merck struck a $38 million deal with the U.S. government’s Biomedical Advanced Research and Development Authority in May.

Operation Warp Speed agreements have been on a much larger scale than that, though, with each coming in at $1 billion or more. Warp Speed already has deals with Moderna, AstraZeneca, Novavax, Johnson & Johnson, Sanofi/GSK and Pfizer/BioNTech, which are using various vaccine technologies.

Meanwhile, leading companies are already in phase 3 testing and could secure emergency use authorizations in late 2020 or early 2021. Most of the late-stage candidates are two-dose regimens, but Johnson & Johnson just entered phase 3 with a one-dose vaccine. Pfizer has said it expects early efficacy data in late October for its two-dose regimen.

https://www.fiercepharma.com/pharma/merck-advancing-single-dose-and-oral-coronavirus-vaccines-could-still-make-warp-speed