As concerns grow about the potential for avian influenza to spread among humans, the federal government is pouring more money into developing new vaccines, including mRNA vaccines.
On Friday, the Department of Health and Human Services announced about $590 million in funding for Moderna Part of the effort is to rapidly develop mRNA vaccines against avian influenza viruses currently circulating in wild birds, poultry and dairy cows.
The funding is in addition to the $176 million the U.S. Department of Health and Human Services (HHS) awarded the drugmaker in July to develop an avian flu vaccine.
The federal government already has two bird flu vaccine candidates in limited quantities in the national stockpile. These vaccines use traditional vaccine technology, but take much longer to produce — a hurdle in emergencies like fast-moving epidemics.
Dawn O'Connell, HHS assistant secretary for preparedness and response, said mRNA-based avian influenza vaccines are important because the technology is faster to develop and easier to update than traditional vaccines.
"When I think about the advantages of this technology, I think about the vulnerability that the country faces in the early stages of any emerging threat," O'Connell said. "Because it can be manufactured quickly, if we start to see something sweep across the country quickly, we can move quickly to provide the first line of protection for the American people."
So far, health officials say this is unnecessary. The Centers for Disease Control and Prevention considers the risk to the public to be low.
Avian influenza viruses do not usually infect humans, except for sporadic cases among people who have been in close contact with infected animals.
However, scientists have become increasingly wary since the virus became prevalent in dairy cows last March. The virus has since spread to at least 928 cattle herds in 16 states, according to the Department of Agriculture. Most of the herds are located in California.
According to the CDC, 67 human cases have been confirmed in the United States. An elderly Louisiana patient has died. Almost everyone has contact with dairy cows or poultry.
The federal government began working with Moderna in 2023 to develop an mRNA flu vaccine.
In addition to the avian flu vaccine currently in the U.S. against the H5N1 strain, the drugmaker will continue to develop a vaccine against the H7N9 strain and conduct Phase 3 clinical trials.
Robert Johnson, director of the HHS Biomedical Advanced Research and Development Authority's Medical Countermeasures Program, said the government has no clear timeline for when an mRNA vaccine will be ready, noting that will depend on science and data.
Johnson added that the investment demonstrates how federal health officials view mRNA technology, including its versatility and ability to be used in different ways.
"It's very important that we study the mRNA platform not only against H5, but also against other influenza strains," Johnson said.
Since bird flu broke out in dairy cows, public health officials have relied primarily not on vaccines but on antiviral drugs like Tamiflu. It is suitable for prevention in patients infected with the virus and in people who come into contact with sick animals.
As the virus continues to spread among wild birds, poultry and dairy cows — giving it more opportunities to mutate and spread more easily among people — federal health officials say the U.S. will need more tools to protect the public , most notably vaccines.
The National Institutes of Health announced earlier this month that it would provide $11 million in funding for further countermeasure research.
"We always want to be prepared for an outbreak or sustained human-to-human transmission," said Dr. Michael Eason, chief of the Respiratory Diseases Branch in the Division of Microbiology and Infectious Diseases at the National Institutes of Health. "Along these lines, the best The solution is to get vaccinated.”
He said two vaccine candidates in the stockpile are regularly tested against currently circulating strains of avian influenza. While this means scientists don't have to start from scratch as with coronavirus, current vaccines may still not offer the best possible protection and are unlikely to offer protection against multiple variants, he said.
"Ideally, we would like the vaccine to not need to be updated and provide cross-protection no matter which virus emerges," Eason said.
Eason said the government is preparing for the possibility that bird flu does become more easily spread to humans.
The NIH funding announced this month will also be used to help develop new drugs, such as antivirals and monoclonal antibodies, Eason said. However, he said most of the money would be used to develop or enhance vaccines.
Matthew Freeman, a professor of viral pathogen research at the University of Maryland School of Medicine, said he is one of the researchers receiving the new NIH grant.
Freeman, along with researchers at the University of Maryland School of Dentistry, is developing an adjuvant — a substance used in some vaccines that can help generate a stronger immune response — that could be added to the H5N1 vaccine.
Freeman said work on developing an avian flu adjuvant has been underway for about three years, and the team is currently testing the adjuvant in mice to see how effective it is and comparing it to other adjuvants currently used in humans. Make a comparison.
He said they hope to move from preclinical stages to early clinical trials in about a year.
"You don't want to wait until it's everywhere before you decide to make a vaccine," Freeman said. "Because we know this virus is already inhabited, primed and able to spread, potentially requiring only a few mutations to jump, there is an urgent need for vaccines to be tested immediately."
Ted Ross, global director of vaccine development at the Cleveland Clinic in Florida, is working on a universal flu vaccine that would protect against all forms of influenza, including seasonal flu and the avian flu virus currently circulating in dairy cows.
A universal flu vaccine has been a long-term goal of scientists. For example, in 2018, the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health (NIH), launched a strategic initiative focused on developing a drug.
Rose's team began receiving funding from the NIH in 2018 and received additional funding through the agency's new announcement.
Ross said that while an avian flu pandemic has not yet occurred, the threat continues to grow and stressed the need for immediate preparation.
"The difference between what we're doing and what some other groups are doing is that our vaccine candidates are not only able to neutralize the virus that's circulating today, but they're also going to be able to transmit and neutralize the virus that's circulating next year and the year after that," he said. ."
The vaccine has been tested against prevalent strains in dairy cows, Ross said it "neutralizes nicely."
Ross said the vaccine is scheduled to enter Phase 1 clinical trials sometime in 2026, but the "urgency" of H5N1 may push the trial date to some time this year.
"What's disturbing is that it now seems to be more efficiently transferred from birds to mammals," he said. "Chickens are a big problem. Turkeys are a big problem. But now, it's getting into cattle, pigs and cats, and it seems to be very deadly."
Dr. Ofer Levy, director of the Precision Vaccine Program at Boston Children's Hospital, is working on another avian flu vaccine adjuvant as well as other viral vaccines, specifically one that would be effective in older adults, who he said often run into trouble. The vaccine produces a strong immune response.
Levy said studies in mice supported by the NIH showed that the adjuvant, called PVP-037, can produce strong immune responses.
He said they were still months away from releasing the data because they wanted to test the adjuvant against the latest bird flu viruses.
"We are currently working to develop a better, broader vaccine for avian influenza," Levy said. "Every life is precious and we want to protect the most vulnerable."
The goal, he said, is that adjuvants can be added to any vaccine to enhance its effectiveness.
"This may not turn into a large-scale epidemic or pandemic, but we cannot sit idly by because the consequences of doing so will be dire," Levy said.