US halts funding for new COVID-19 vaccines

The US Department of Health and Human Services (HHS) has issued stop work orders to GeoVax and CastleVax on the companies’ development of new COVID-19 vaccines.

Development of these vaccines was partially funded by the Project NextGen initiative of the US Center for the Biomedical Advanced Research and Development Authority. These are the second and third stop work orders issued to vaccine developers that received funding through Project NextGen; the first order went to Vaxart in February. Project NextGen is also funding the development of several other COVID-19 vaccines and therapeutics.

The three companies issued stop work orders are developing COVID-19 vaccines that use new technology to improve effectiveness and tolerability. Vaxart is developing an oral vaccine pill, CastleVax is working on an intranasal vaccine, and GeoVax is developing a vaccine designed to be effective in immunocompromised people.

In February, Vaxart told C&EN via email that the firm was allowed to continue a 400-person cohort arm of its clinical trials while a 10,000-person cohort trial was paused. The stop work order is valid for 90 days, after which the grant will be extended, canceled, or terminated in its entirety.

Representatives for both GeoVax and CastleVax say their firm expects its grant to be terminated but that it plans to push on without the funding.

A GeoVax press release from earlier this month refers to the stop work order as “the termination of its Project NextGen (PNG) award.” In an email to C&EN, GeoVax CEO David Dodd says that “the financial impact to GeoVax is estimated at less than $750,000 annually, toward reimbursement of existing personnel and overhead costs. GeoVax therefore does not anticipate any significant changes to its ongoing operations resulting from the contract termination.” On April 24, GeoVax presented positive Phase 2b results of its COVID-19 vaccine at the World Vaccine Congress.

CastleVax CEO Michael Egan spoke to Endpoints News about the stop work order, saying that “it looks [to] me like it’s a hard and fast stop-work order leading to termination, unfortunately.” He adds that the company intends to continue developing the vaccine on its own.

In the past HHS secretary Robert F. Kennedy Jr. has criticized vaccines, including repeating misinformation that suggests vaccines cause autism. Under his leadership, other HHS-sponsored vaccine research initiatives have been disrupted, including the cancellation of BioNTech’s malaria vaccine trial and terminating grants related to understanding vaccine hesitancy and uptake.

C&EN reached out to the HHS for comment but did not receive a reply by the time of publication. In February, the HHS issued a statement to C&EN via email in response to an inquiry about the stop work order for Vaxart.

“While it is crucial that the U.S. Department and Health and Human Services support pandemic preparedness, four years of the Biden administration’s failed oversight have made it necessary to review agreements for vaccine production,” the statement reads.