Tag: Develop

As fears grow of a possible bird flu pandemic in humans, the federal government is pouring more money into the development of new vaccines, including an mRNA shot.

On Friday, the Department of Health and Human Services announced it’s providing about $590 million in funding to Moderna in part to fast-track the development of an mRNA vaccine that targets the strains of bird flu currently circulating in wild birds, poultry and dairy cows. 

The money is in addition to the $176 million HHS awarded the drugmaker in July to develop a bird flu vaccine.

The federal government already has two bird flu vaccine candidates in limited quantities in the nation’s stockpile. Those shots use traditional vaccine technology, but take far longer to produce — a hindrance during an emergency like a fast-moving pandemic.

Dawn O’Connell, assistant secretary for preparedness and response at HHS, said an mRNA-based bird flu vaccine is important because the technology is faster to develop and easier to update than more traditional vaccines. 

“When I think about the advantages of this technology, I think about the vulnerability that the country has in the early stages of any emerging threat,” O’Connell said. “Because it can be manufactured quickly, if we began to see something sweep across the country quickly, it would allow us to move fast, to give the first line of protection to the American people.”

That’s something that 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. 

Bird flu viruses typically don’t infect humans, aside from sporadic cases in people who have close contact with infected animals. 

Scientists have grown increasingly alarmed, however, since the virus took hold in dairy cows last March. It’s since spread to at least 928 herds across 16 states, according to the Agriculture Department. The majority of the herds are in California.

There have been 67 confirmed cases in humans in the U.S., according to the CDC. One patient, an older person in Louisiana, has died. Nearly all of the people had contact with either dairy cows or poultry.

An mRNA bird flu vaccine

The federal government began working with Moderna in 2023 to develop mRNA influenza vaccines.

In addition to the bird flu vaccine targeting the strain currently in the U.S., called H5N1, the drugmaker will also continue work on a vaccine that targets the strain H7N9 in a phase 3 clinical trial.

Robert Johnson, director of the medical countermeasures program at HHS’ Biomedical Advanced Research and Development Authority, said the government doesn’t have a definitive timeline for when it expects an mRNA vaccine to be ready, noting that it will depend on the science and data.

Johnson added the investment shows federal health officials’ view on mRNA technology, including its versatility and its ability to be used in different ways.

“It’s really important that we look at the mRNA platform not just against H5, but against other strains of influenza, as well,” Johnson said.

More countermeasures

Since the bird flu outbreak began in dairy cows, the primary tool that public health officials have relied on hasn’t been vaccines but antivirals such as Tamiflu. It’s given to patients infected with the virus and prophylactically to people exposed to sick animals. 

As the virus continues to spread among wild birds, poultry and dairy cows — giving it more chances to mutate in ways that could make it easier to spread 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’s providing $11 million in funding for additional research into countermeasures.  

“We always want to be prepared for if there becomes episodes or sustained human-to-human transmission,” said Dr. Michael Ison, chief of the respiratory disease branch within the division of microbiology and infectious disease at the NIH. “Along those lines, the best approach to that is vaccination.” 

The two vaccine candidates in the stockpile are regularly tested against currently circulating strains of bird flu, he said. While that means scientists won’t need to start from scratch like with Covid, he said, the current shots still may not provide the best protection possible and are unlikely to provide protection against multiple variants. 

“Ideally, we would like vaccines that don’t need to be updated and provide cross protection irrespective of which virus emerges,” Ison said.

Preparing for possible human spread

Ison said the government is preparing for a possible scenario that bird flu does become more easily transmissible to humans.

The NIH funding announced this month will also be used to help develop new medications, such as antivirals and monoclonal antibodies, Ison said. However, he said, the majority of the funding will go toward developing or enhancing vaccines.

Matthew Frieman, a professor of viral pathogen research at the University of Maryland School of Medicine, said he is among the group of researchers receiving new funding from the NIH.

Along 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.

The work to develop a bird 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 well it works and comparing it to other adjuvants currently used in humans.

They hope, he said, to move from the preclinical stage to early-stage clinical trials in about a year. 

“You don’t want to wait until it’s everywhere and then you decide to make a vaccine,” Frieman said. “Since we know this virus is kind of perched, ready and able to spread with probably only a handful of mutations before it could jump, there’s a dire need immediately for vaccines to be tested.” 

A universal vaccine

Ted Ross, global director of vaccine development at Cleveland Clinic in Florida, is working on a universal flu vaccine that could protect against all forms of influenza, including seasonal flu and the current bird flu strain spreading in dairy cows.

A universal flu vaccine has been a long-time 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 one.

Ross’ group began getting money from the NIH in 2018 and has received additional funds through the agency’s new announcement.

While a bird flu pandemic isn’t happening right now, Ross said the threat keeps growing, emphasizing the need to prepare now.

“The difference between what we’re doing and what maybe some other groups are doing is that our vaccine candidate is able to not only neutralize what circulates today, but it can circulate and neutralize what circulates next year and the year after,” he said. 

The vaccine has already been tested against the circulating strain in dairy cows, which Ross said it “neutralized very well.”

Ross said the vaccine is scheduled to enter phase 1 clinical trials sometime in 2026, but the “urgency” of H5N1 may move the trial date to sometime this year. 

“What’s disconcerting is that it seems to be now more efficiently moving into mammals, going from birds,” he said. “Chickens are a big problem. Turkey is a big problem. But now, it’s getting into cows and pigs and cats, and seems to be very lethal.” 

A better and broader vaccine

Dr. Ofer Levy, director of the precision vaccines program at Boston Children’s Hospital, is working on another adjuvant for bird flu vaccines, as well as other vaccines for viruses, particularly one that works well in the very old, who he said often have trouble generating a strong immune response from vaccines. 

Levy said research in mice, with support from NIH, has shown that the adjuvant, called PVP-037, generates a strong immune response. 

They’re still a couple of months away from releasing data, he said, as they want to test the adjuvant against the most recent strains of bird flu. 

”We’re currently doing the work to try to build a better and broader bird flu vaccine,” Levy said. “Every life is precious and we want to protect our most vulnerable.”

The goal, he said, is that adjuvant can be added to any vaccine to enhance it.

“It could be that this doesn’t turn into a huge epidemic or pandemic, but we can’t sit on our hands because the consequences of that would be very bad,” Levy said.