The U.S. government will pay Moderna $176 million to develop an mRNA vaccine against pandemic influenza — an award made in light of the widespread spread of the highly pathogenic bird flu virus H5N1 among U.S. dairy cattle.
This funding flows 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. The Department of Health and Human Services said in a press release on Tuesday,
In In its announcement on Tuesday, Moderna said reported that last year it began a Phase 1/2 trial of a pandemic influenza virus vaccine, including versions targeting the H5 and H7 varieties of the bird flu virus. The company said it expects to release results of that trial this year and that those results will guide the design of a Phase 3 trial, which is expected to begin in 2025.
Moderna said the funding deal will support late-stage development of a “pre-pandemic vaccine against the H5 influenza virus.” But the deal also includes options for additional vaccine development in case other public health threats arise.
“mRNA vaccine technology offers advantages in efficacy, speed of development, and production scalability and reliability in addressing infectious disease outbreaks, as demonstrated during the COVID-19 pandemic,” Moderna CEO Stephane Bancel said in the announcement. “We are pleased to continue our collaboration with BARDA to accelerate our development efforts for mRNA-based pandemic influenza vaccines and support the global public health community in preparing against potential outbreaks.”
US health officials previously said they were in talks with Moderna and Pfizer about developing a pandemic bird flu vaccine. The future vaccine would be in addition to the standard protein-based bird flu vaccine already developed. In recent weeks, the health department has said it is working to manufacture 4.8 million vials of the H5 influenza vaccine in the coming months. The plan comes three months after the H5N1 dairy outbreak far surpassed initial hopes of containment.
Poor response
The US has failed miserably in its response to this unprecedented outbreak, which has been criticised by both US-based and international experts. Genetic analyses suggest the virus has been spreading among the country’s dairy cattle since late last year. But, several months later, on March 25, the US Department of Agriculture confirmed the first four infected herds in two states (Texas and Kansas). Since then, the outbreak has spread to nearly 140 herds in at least 12 states.
Some farms are refusing to test, and experts expect there are a much larger number of undetected herd infections, especially given how widely dormant H5N1 is found in the commercial milk supply. Moreover, of the 140 herds with documented infections, federal officials do not know how many are still actively infected, rather than recovered. It is unclear whether infected cows can become reinfected, and if so, how quickly after infection.
While the risk to the general public is currently considered low, farm workers are at high risk of infection. To date, three infections have been confirmed in dairy farm workers — one in Texas and two in Michigan, which has mounted a uniquely robust response to the outbreak. Still, with hundreds to thousands of farm workers at risk of contracting the virus, only 53 people in the country have been tested for H5 influenza so far.
In a presentation in London last month, global health leader Seth Berkley said that “It is shocking to see the incompetenceAsked about the U.S. response to the H5N1 outbreak, he said he, like other experts, questioned whether the U.S. public health community had learned from or improved upon the failures of the COVID-19 pandemic.
Similar to problems faced during pandemics, a major obstacle in the H5N1 response is resistance by farmers and farm workers to partner with state and federal health officials. Federal agencies have limited authority within states, but they have announced a series of assistance programs for dairy farms, including compensatory funds and access to personal protective equipment for farm workers. They have also issued guidelines and restrictions to tighten biosecurity measures. But there has been little voluntary participation on both fronts.
For example, officials discovered early in the outbreak that movement of cattle, workers and equipment between farms was the main way H5N1 spread in dairies. In April, the USDA mandated testing a portion of cows before they moved across state borders. But movement within states is controlled by the states. In a survey last month that collected data from 54 percent of the farms affected at the time, More than 60 percent of farmers said they continue to remove cattle from their infected farms After you see clinical signs of infection in your animals.
The more the virus spreads across American dairy farms, adapts to its new mammalian host, and comes into contact with humans, the greater the chance that it will jump to humans and gain the ability to spread among us.
In HHS’ announcement of the Moderna award on Tuesday, Assistant Secretary for Preparedness and Response Don O’Connell spoke of the growing concern that the H5N1 outbreak could lead to another pandemic. “Today’s award is part of our long-term commitment to strengthen our preparedness for pandemic influenza,” O’Connell said. “Adding this technology to our pandemic flu toolkit increases our ability to be agile and nimble against circulating strains and their potential variants.”
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