Moderna received a significant boost from the federal government, snagging a $176 million contract to help advance a bird flu vaccine.
The award, which was granted by the Biomedical Advanced Research and Development Authority (BARDA), aims to support “late-stage development” of a pre-pandemic candidate targeting the H5 avian flu strain, Moderna said Tuesday. The highly infectious subtype has infected cattle across the country with select spillover cases in humans.
Moderna said the agreement also “includes additional options to prepare and accelerate a response to future public health threats.”
Stéphane Bancel“We are pleased to continue our collaboration with BARDA to expedite our development efforts for mRNA-based pandemic influenza vaccines and support the global public health community in preparedness against potential outbreaks,” CEO Stéphane Bancel said in a statement.
One such program, MRNA-1018, is advancing a handful of vaccine candidates through a Phase 1/2 study, including two targeting the H5 and H7 flu virus strains. Later this year, Moderna expects to have safety and immunogenicity data, which “will inform Phase 3 development plans.”
In a recent interview with Endpoints News, BARDA Director Gary Disbrow said the agency receives about $320 million annually for pandemic flu preparedness efforts. He noted that’s not enough for a “robust preparedness posture.”
“Any large-scale response to this current H5N1 situation would require additional supplemental funding from Congress if we needed to scale up manufacturing and manufacture vaccines sufficient for the US population,” he said.
That money has been spread across manufacturing, licensing and cross-agency efforts, Disbrow said, like one with the CDC, which has developed vaccine virus candidates that BARDA has manufactured and filled for testing. In partnership with the Department of Defense, BARDA is also advancing three self-amplifying RNA candidates from AstraZeneca, Arcturus Therapeutics and Access to Advanced Health Institute (AAHI).
Notably, the money awarded to Moderna does not come from BARDA’s $4.7 billion Project NextGen pool. It was funneled through the Rapid Response Partnership Vehicle (RRPV), a new program that aims to more quickly develop countermeasures in health emergencies. It also capitalizes on a wrinkle in federal policy about how agencies spend their money. So, money given through the RRPV is considered an “other transaction agreement” that skirts some of the procedures associated with federal procurement.
BARDA has used RRPV as the mechanism to allocate some NextGen funds. Vaxart, GeoVax, CastleVax and CyanVac — all vaccine developers — were awarded millions of dollars last month to launch Phase 2b studies of their investigational candidates for Covid-19. The first award given through the RRPV was in May, to a decentralized clinical trial company trying to better collect correlates of protection data.
Moderna and BARDA’s new partnership comes as another has stalled. Earlier this year, Moderna said it would need more external funding to advance a BARDA-backed Zika vaccine through Phase 3 development. The federal agency originally awarded Moderna more than $100 million for the candidate, but has since de-obligated more than $36 million and disbursed $23.2 million, according to contract records.
A spokesperson for BARDA’s parent agency, the Administration for Strategic Preparedness and Response, did not immediately respond to a request for comment.