BARDA provides Osivax with $19.5 million for universal flu vaccine

The US Center for the Biomedical Advanced Research and Development Authority (BARDA), an office that falls under the Department of Health and Human Services (HHS) Administration for Strategic Preparedness and Response, has awarded the French vaccine manufacturer Osivax $19.5 million for development of a universal flu vaccine.

The award comes as somewhat of a surprise given that HHS secretary Robert F. Kennedy Jr. has repeatedly made misleading claims about the effectiveness and safety of vaccines. The HHS under Kennedy has canceled grants that funded new COVID-19 vaccines and mRNA vaccines, dismissed all members of the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices, and promised to investigate the previously debunked link between childhood vaccines and autism.

The HHS also recently approved new COVID-19 booster shots for fall 2025—meaning it’s been difficult to get a read on exactly how the Donald J. Trump administration values vaccination.

Osivax’s executive chairman and cofounder, Alexandre Le Vert, says that talks with BARDA have been ongoing since the Joe Biden administration. They were briefly paused when HHS halted all external communications in February but eventually continued without a change in the personnel involved, Le Vert says.

The funding that resulted from those negotiations is meant to aid in the development, manufacturing, and evaluation of OVX836, a recombinant vaccine that contains the nucleoprotein of a strain of influenza A virus. Le Vert says the nucleoprotein is “very well conserved among all strains of influenza A,” which is the group of influenza viruses that includes all bird flu viruses.

Strains of influenza A virus are also responsible for most seasonal flu outbreaks, though some outbreaks are caused by influenza B strains. Le Vert says OVX836 is not designed to be effective against influenza B, but the company does plan to tackle influenza B in the future.

Preclinical work showed OVX836 to be protective against multiple influenza A strains in mice (npj Vaccines 2019, DOI: 10.1038/s41541-019-0098-4), and more recent work has shown promising results in humans (Lancet Infect. Dis. 2023, DOI: 10.1016/S1473-3099(23)00351-1).

Osivax is developing OVX836 with two use cases in mind. The first is to combine it with inactivated influenza vaccines produced by other companies to increase their efficacy. Le Vert says that current flu vaccines are only about 40% effective at preventing symptoms on average and that the addition of OVX836 could increase that rate to 80%.

The second is the reason BARDA is funding Osivax: to develop OVX836 to be a standalone shot “that could be stockpiled and that could be protective on day zero after the emergence of a pandemic,” Le Vert says.

The company says in a press release that $8 million of the award is going toward a large field efficacy study in which the effectiveness of the vaccine candidate at preventing flu symptoms will be evaluated at scale.

Le Vert declines to comment on HHS’s or BARDA’s attitudes and commitment toward vaccination broadly, but he does say that “we really feel we have responsibility to push this program forward, because we think it could be a real option as a medical countermeasure, among others, when a new, novel pandemic comes.”