The United States Government will pay Moderna $176 million to develop an mRNA vaccine against pandemic flu, an award given as the highly pathogenic H5N1 avian influenza virus continues to spread widely among U.S. dairy cattle.
The funding is being channeled through BARDA, the Biomedical Advanced Research and Development Authority, as part of a new Rapid Response Partnership Vehicle (RRPV) Consortium. The program aims to establish partnerships with industry to help the country better prepare for pandemic threats and develop medical countermeasures, according to the Department of Health and Human Services. saying in a press release on Tuesday.
In its own announcement On Tuesday, Moderna said it began a Phase 1/2 trial of a pandemic influenza virus vaccine last year, which included versions targeting the H5 and H7 strains of bird flu viruses. The company said it expects to release results from that trial this year and that those results will guide the design of a Phase 3 trial, which is expected to begin in 2025.
The funding agreement will support late-stage development of a “pre-pandemic H5 influenza virus vaccine,” Moderna said. But the agreement also includes options for the development of additional vaccines should other public health threats emerge.
“mRNA vaccine technology offers advantages in efficacy, speed of development, scalability and reliability of production to address infectious disease outbreaks, as demonstrated during the COVID-19 pandemic,” Moderna CEO Stéphane Bancel said in the announcement. “We are pleased to continue collaborating with BARDA to accelerate our mRNA-based pandemic influenza vaccine development efforts and support the global public health community in preparing for potential outbreaks.”
U.S. health officials have said earlier that were in talks with Moderna and Pfizer about developing a pandemic bird flu vaccine. The prospective vaccine will add to the standard protein-based bird flu vaccines already in development. In recent weeks, the health department has said it is working to manufacture 4.8 million vials of H5 flu vaccine in the coming months. The plans come three months after the H5N1 outbreak in dairy products, which is a far cry from initial hopes for containment.
Failed response
The United States is making a very poor response to this unprecedented outbreak, prompting criticism from both American and international experts. Genetic analyses suggest the virus has been spreading among the country’s dairy cattle since late last year. But it was not until Months later, on March 25thThe U.S. Department of Agriculture confirmed the first four infected herds in two states (Texas and Kansas). The outbreak has since spread to about 140 herds in at least 12 states.
Some farms are refusing to test and experts expect there to be a significant number of undocumented infections in livestock, particularly given the widespread screening of inactivated H5N1 in the commercial milk supply. Also, of the 140 herds with documented infections, federal officials do not know how many are still actively infected rather than having recovered. It is unclear whether infected cows can become reinfected and, if so, how quickly after an infection.
While the risk to the general public is currently considered to be low, farm workers are at increased risk of contracting the infection. To date, three infections have been confirmed among dairy farm workers: one in Texas and two in Michiganwhich has had an exceptionally robust response to the outbreak. Still, with hundreds of thousands of farmworkers at risk of contracting the virus, only 53 people in the country have been tested for H5 influenza to date.