HHS awards Moderna $176 million to develop mRNA H5 avian flu vaccine

The U.S. Department of Health and Human Services (HHS) today announced, through the Biomedical Advanced Research and Development Authority (BARDA), that it has awarded $176 million to Moderna, Inc. for the development of a pre-pandemic vaccine against H5 avian influenza.

the announcementHHS said the contract will bolster domestic pandemic influenza vaccine production capacity, which currently relies on older vaccine platforms. Moderna will leverage its large-scale domestic commercial mRNA vaccine manufacturing platform and ongoing development of an mRNA-based seasonal influenza vaccine.

The award comes as authorities identify more cases of H5N1 avian influenza in U.S. cattle and poultry.

Phase 3 trials could begin next year

Dawn O'Connell, assistant secretary for preparedness and response at the Department of Health and Human Services, said the $176 million is a base grant, and the agreement also includes other options that would allow the government to quickly redirect funds to other mRNA vaccines if a new strain of influenza or other disease threat emerges. She said the H5 vaccine is in clinical development, and Phase 3 trials could begin in 2025.

The contract also includes options for large-scale production and pandemic response. At a briefing today, Dr. Robert Johnson, director of medical preparedness for BARDA, said it's too early to predict production capacity. He said the numbers will depend on dosing information that's expected to be released later this year.

Moderna is statement The company announced today that Phase 1/2 clinical trials of its investigational pandemic influenza vaccine in healthy adults, including candidates against H5 and H7 viruses, will begin in 2023, with results expected this year.

Meanwhile, fill-and-finish operations are continuing to produce vaccines from a large stockpile of the candidate cell-based, adjuvanted H5 vaccine made by CSL Securis, and O'Connell said the first of 4.8 million doses would be available in mid-July, with production continuing until August – earlier than the government had expected.

Officials consider early vaccine use in high-risk groups

As vaccine production and planning continues, federal officials continue to debate how to best protect farmworkers and others who come into contact with cattle.

Nirav Shah, M.D., principal deputy director of the Centers for Disease Control and Prevention (CDC), said that if the primary goal is to prevent infection, giving antiviral drugs to patients and their contacts may achieve that goal more quickly than a vaccine. Health officials are considering the risks and benefits and whether people who have been in contact with infected cows would accept the vaccine, he said.

So far, more than 780 people who had contact with the cows have been monitored and at least 53 people with flu-like symptoms have been tested for the H5 virus, he said. So far, there have been three confirmed human cases linked to the dairy cow virus.

Shah said the country is well equipped with H5 tests, with 750,000 available and 1.2 million more to be made available in the coming months.

Further detection in cattle and poultry

According to the US Department of Agriculture (USDA), the number of officially confirmed cases of H5N1 in dairy herds remains at 137 across 12 states. Animal and Plant Quarantine Inspection AgencyHowever, affected states have announced several more detections, including: Minnesota, Another cluster of infected animals was identified in Benton County, in the central part of the state.

With regard to poultry, USDA Aphids Four more cases of the H5N1 virus have been confirmed in two states, Colorado and Minnesota, both of which are battling the virus in dairy cows. The two Colorado outbreaks are in home chicken flocks in Morgan and Larimer counties, and the two Minnesota outbreaks are on commercial turkey farms in Otter Tail and Swift counties.

At a press conference today, federal officials were asked about recent reports that the H5 avian influenza virus had been detected in San Francisco's wastewater. Wastewater Scan Six states have had positive cases consistent with a cattle outbreak, with only some detections in California.

Shah noted that San Francisco is not known for its dairy industry and that there could be links to live bird markets. USDA Aphids Sporadic detections of highly pathogenic avian influenza have been reported in live bird markets in five states, most recently in San Francisco in May of this year.