The US government will pay $176 million to Moderna Inc. for the development of an mRNA vaccine against pandemic influenza, a bounty that comes as the highly pathogenic H5N1 avian influenza virus continues to circulate widely among US dairy cows.
The funding will be provided through the Biomedical Advanced Research and Development Authority (BARDA) as part of the new Rapid Response Partnership Vehicle (RRPV) consortium, a program aimed at building partnerships with industry to help the nation better prepare for and develop medical countermeasures against pandemic threats. The Department of Health and Human Services said in a press release on Tuesday..
in Moderna announced on Tuesday The company said last year that it had begun a Phase 1/2 trial of a pandemic influenza virus vaccine, including one targeting the H5 and H7 strains of the avian influenza virus. The company said it expects to release the results of that trial later this year, which will determine the design of a Phase 3 trial, which is expected to begin in 2025.
Moderna said the funding agreement will support the late-stage development of a “pre-pandemic vaccine against H5 influenza viruses,” but the agreement also includes options for developing additional vaccines in case other public health threats emerge.
“mRNA vaccine technology has advantages in efficacy, speed of development, scalability of production and reliability in addressing infectious disease outbreaks, as demonstrated by the COVID-19 pandemic,” Moderna CEO Stéphane Bancel said in the announcement. “We are pleased to continue our collaboration with BARDA to accelerate the development of an mRNA-based pandemic influenza vaccine and support the global public health community in preparing for a potential outbreak.”
US health officials have previously said they are in talks with Moderna and Pfizer to develop a pandemic avian flu vaccine. This future vaccine would be in addition to the standard protein-based avian flu vaccines already in development. The Ministry of Health has said in recent weeks that it is working to produce 4.8 million bottles of H5 flu vaccines over the next few months. The plans were announced three months into the H5N1 dairy outbreak, far from initial hopes of containment.
Failed response
The United States has botched its response to the unprecedented outbreak, drawing criticism from experts both in the U.S. and abroad. Genetic analysis suggests that the virus has been circulating among dairy cows in the country since late last year. But it wasn’t until several months later, on March 25, that the U.S. Department of Agriculture confirmed the infection in the first four herds in two states (Texas and Kansas). Since then, the outbreak has spread to about 140 herds in at least 12 states.
Some farms refuse to be tested, and experts expect there are significant numbers of undocumented herd infections, especially since inactivated H5N1 has been widely detected in commercial milk supplies. In addition, federal officials do not know how many of the 140 herds with documented infections are still infected rather than recovered. It is unclear whether infected cows can become reinfected, and if so, how quickly they can become reinfected after infection.
While the risk to the general public is currently considered low, farmworkers are at high risk for infection. To date, there have been three confirmed cases among dairy workers, one in Texas and two in Michigan. Michigan has taken its own strong response to the outbreak. Still, only 53 cases of H5 influenza have been tested in the country so far, while hundreds or thousands of farmworkers are at risk of contracting the virus.
“At a presentation in London last month, global health leader Seth Berkley said:It’s shocking to see the incompetence.“Regarding the U.S. response to the H5N1 influenza epidemic,” he said. Like other experts, he questioned whether the U.S. public health community had learned or improved from its failures during the COVID-19 pandemic.
As with any pandemic, a major obstacle in responding to H5N1 has been the reluctance of farmers and farmworkers to cooperate with state and federal health authorities. Federal agencies, which have limited authority within states, have announced a series of assistance programs for dairy farms, including compensation and access to personal protective equipment for farmworkers. They have also issued guidance and restrictions to strengthen biosecurity measures. But there has been little voluntary participation on either front.
For example, officials found from the beginning that the main way H5N1 spread on dairy farms was through the movement of cattle, workers and equipment between farms. In April, the USDA required testing of some cattle before they could be moved across state lines, but intrastate movement is regulated by states. Last month, a study that collected data from 54 percent of farms that were then infected found that: More than 60% of farmers said they continue to remove cattle from infected farms. After animals show clinical signs of infection.
The more the virus spreads across U.S. dairy farms, adapts to new mammalian hosts, and comes into contact with humans, the more opportunities there are for the virus to acquire the ability to infect humans and spread among us.
When the Department of Health and Human Services announced the grant to Moderna on Tuesday, Under Secretary for Preparedness and Response Dawn O’Connell spoke about growing concerns that H5N1 influenza outbreaks could spark a new pandemic. “Today’s grant is part of a long-standing commitment to strengthen pandemic influenza preparedness,” O’Connell said. “Adding this technology to our pandemic influenza preparedness toolkit will increase our ability to respond nimbly and rapidly to circulating strains of the virus and their potential variants.”