Calling vaccine makers: Moderna, NIH need partner to make coronavirus shot

Moderna and the National Institutes of Health quickly struck up work on a potential vaccine against the deadly new coronavirus. But the team hasn’t found a pharma partner to manufacture the vaccine for real-world use, a top official said Tuesday.

NIH and Moderna could develop a vaccine in a little over a year if all goes well, but they wouldn’t be able to produce the doses needed to deploy the shot against the outbreak, National Institute of Allergy and Infectious Diseases director Anthony Fauci said at an Aspen Institute panel. That’d require a pharma partner, and so far, NIH hasn’t found its manufacturer.

The virus has caused more than 45,000 infections and more than 1,100 deaths. The vast majority of cases have been in China.

If a pharma company were to get involved, it would have to adjust manufacturing facilities and sacrifice the “opportunity cost” of producing the profit-making shots it typically makes, Fauci said at the panel. It’s a dynamic that’s “very difficult and very frustrating,” he added.

Numerous times over the years, emerging disease outbreaks have caught the scientific and medical community off guard. Pharma companies and others have routinely rushed in on R&D work, but outbreaks have tended to fade before the would-be vaccine makers could develop effective countermeasures. Now, companies seem more cautious about jumping right into the next new outbreak.

During the Ebola crisis, a major pharma company “got burned” with its investment and is now backing out of the field, Fauci said at the panel. That’s likely a reference to GlaxoSmithKline, which bought NIH-partnered Okairos back in 2013 and picked up Ebola vaccine candidates and several other pipeline programs. Last year, the company exited Ebola vaccine research by licensing its candidates to the Sabin Vaccine Institute.

Another top vaccine player, Sanofi, got involved during the Zika outbreak, but its partnership with the U.S. government led to a controversy over potential vaccine pricing. Sanofi later exited the collaboration.

Despite the risk, Johnson & Johnson said Tuesday it’s joining up with the U.S. Department of Health and Human Services to accelerate vaccine development against COVID-19. Both partners are chipping in funding to get the vaccine into the clinic, and the government could provide more money for further development.

Alongside the R&D effort, J&J is readying production facilities so that it can “meet global health needs” if the shot is deployed.

On the NIH/Moderna collaboration, Fauci said the team should be able to get into the clinic in about two and a half months from the time it received the initial virus sequence. Then, he expects three months of testing in phase 1. If all goes well, the team could advance to phase 2 testing in China that’d take six to eight months.

After that, the group would be ready to start producing vaccines for use in the field. Production would require an amount of time that’s as “problematic” as developing the shot itself, Fauci said. That’s unless the team produces vaccines “at-risk,” or before getting proof the vaccine will even work.

https://www.fiercepharma.com/pharma/amid-deadly-outbreak-nih-hasn-t-found-its-pharma-partner-to-manufacture-coronavirus-vaccines