As fears grow over a possible avian flu pandemic in humans, the federal government is investing more money in developing new vaccines, including an mRNA shot.
On Friday, the Department of Health and Human Services announced it would provide approximately $590 million in funding to Moderna. in part to accelerate the development of an mRNA vaccine that targets strains of avian flu currently circulating in wild birds, poultry and dairy cows.
That money is in addition to $176 million HHS awarded the drugmaker in July to develop a bird flu vaccine.
The federal government already has two avian flu vaccine candidates in limited quantities in its national stockpile. These shots use traditional vaccine technology, but take much longer to produce — an obstacle in an emergency like a fast-moving pandemic.
Dawn O’Connell, assistant secretary for preparedness and response at HHS, said an mRNA-based avian flu vaccine is important because the technology is faster to develop and easier to update than more traditional vaccines.
“When I think about the benefits of this technology, I think about the country’s vulnerability in the early stages of any emerging threat,” O’Connell said. “Because it can be manufactured quickly, if we started to see something spread quickly across the country, that would allow us to act quickly, to give the first line of protection to the American people.”
This is something health officials have so far said is unnecessary. The Centers for Disease Control and Prevention maintains that the risk to the general public is low.
Avian flu viruses do not usually infect humans, except for sporadic cases in people in close contact with infected animals.
However, scientists have become increasingly alarmed since the virus spread among dairy cows last March. Since then, the disease has spread to at least 928 herds across 16 states, according to the Department of Agriculture. The majority of herds are in California.
There have been 67 confirmed human cases in the United States, according to the CDC. One patient, an elderly person in Louisiana, died. Almost everyone has had contact with dairy cows or poultry.
An mRNA vaccine against avian flu
The federal government began working with Moderna in 2023 to develop mRNA flu vaccines.
In addition to the avian flu vaccine targeting the strain currently in the United States, called H5N1, the pharmaceutical manufacturer will also continue work on a vaccine targeting the H7N9 strain in a phase 3 clinical trial.
Robert Johnson, director of the medical countermeasures program at HHS’s Biomedical Advanced Research and Development Authority, said the government does not have a definitive timetable for when it expects an mRNA vaccine be prepared, noting that this will depend on science and data. .
Johnson added that the investment shows federal health officials’ views on mRNA technology, including its versatility and ability to be used in different ways.
“It’s really important that we look at the mRNA platform not only against the H5 virus, but also against other influenza strains,” Johnson said.
More countermeasures
Since the outbreak of avian flu in dairy cows, the main tool public health officials have relied on has not been vaccines but antivirals such as Tamiflu. It is administered to patients infected with the virus and as a prophylactic measure to people exposed to sick animals.
As the virus continues to spread among wild birds, poultry and dairy cows — giving it a greater chance of mutating in ways that make it easier to spread among humans — federal health officials say the U.S. The United States will need more tools to protect the public, including vaccines.
The National Institutes of Health announced earlier this month that it was providing $11 million in funding for additional research into countermeasures.
“We always want to be prepared in the event of outbreaks or sustained human-to-human transmission,” said Dr. Michael Ison, chief of the Respiratory Diseases Branch in the NIH Division of Microbiology and Infectious Diseases. “In this sense, the best approach to achieve this is vaccination. »
The two vaccine candidates in stock are regularly tested against strains of avian flu currently circulating, he said. While this means scientists won’t need to start from scratch as with Covid, he said, current vaccines may not offer the best possible protection and are unlikely to offer protection against several variations.
“Ideally, we would like vaccines to not need to be updated and to provide cross-protection regardless of the emerging virus,” Ison said.
Prepare for possible human spread
Ison said the government is preparing for a possible scenario in which bird flu becomes more easily transmissible to humans.
The NIH funding announced this month will also be used to help develop new drugs, such as antivirals and monoclonal antibodies, Ison said. However, he said, the majority of funding will go toward developing or improving vaccines.
Matthew Frieman, a professor of viral pathogen research at the University of Maryland School of Medicine, said he was among the group of researchers receiving new funding from the NIH.
Working with researchers at the University of Maryland School of Dentistry, Frieman is developing an adjuvant – a substance used in some vaccines that can help generate a stronger immune response – that could be added to H5N1 shots .
Work to develop an avian flu adjuvant has been going on for about three years, Frieman said, 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. man.
They hope, he said, to move from preclinical to early clinical trials in about a year.
“You don’t want to wait until it’s everywhere and then decide to make a vaccine,” Frieman said. “Since we know that this virus is sort of perched, ready and able to spread with probably only a handful of mutations before it can jump, there is an urgent need to test vaccines immediately.”
A universal vaccine
Ted Ross, global director of vaccine development at the Cleveland Clinic in Florida, is working on a universal flu vaccine that could protect against all forms of flu, including seasonal flu and the current strain of bird flu that is spreading among dairy cows.
A universal flu vaccine has been a long-standing goal of scientists. In 2018, for example, the National Institute of Allergy and Infectious Diseases, part of the NIH, launched a strategic initiative focused on developing such an initiative.
Ross’ group began receiving money from the NIH in 2018 and received additional funding thanks to the agency’s new announcement.
Although a bird flu pandemic is not occurring at present, Ross said the threat continues to grow, emphasizing the need to prepare now.
“The difference between what we’re doing and what maybe other groups are doing is that our vaccine candidate is able to not only neutralize what’s circulating today, but it can also circulate and neutralize what’s circulating over the year. next and the year after,” he said. .
The vaccine has already been tested against the circulating strain in dairy cows, which Ross said he neutralized “very well.”
Ross said the vaccine is expected to enter phase 1 clinical trials sometime in 2026, but the “emergency” of H5N1 could move the trial date to this year.
“The disconcerting thing is that it now appears to be spreading more effectively to mammals than to birds,” he said. “Chickens are a big problem. Turkey is a big problem. But now it attacks cows, pigs and cats, and appears to be very deadly. »
A better and broader vaccine
Dr. Ofer Levy, director of the precision vaccine program at Boston Children’s Hospital, is working on another adjuvant for avian flu vaccines, as well as other virus vaccines, particularly one that works well in very old people, who, according to him, often have problems. generate a strong immune response thanks to vaccines.
Levy said research in mice, with support from the NIH, showed that the adjuvant, called PVP-037, generates a strong immune response.
It will take them a few more months to release the data, he said, because they want to test the adjuvant against the newer strains of bird flu.
“We are currently working on developing a more effective and broader avian flu vaccine,” Levy said. “Every life is precious and we want to protect the most vulnerable. »
The goal, he said, is that an adjuvant can be added to any vaccine to improve it.
“It might not turn into a huge epidemic or a pandemic, but we cannot sit idly by because the consequences would be very serious,” Levy said.
