The US Department of Health and Human Services (HHS), through its Biomedical Advanced Research and Development Authority (BARDA), today announced that it has awarded Moderna $176 million to develop a prepandemic vaccine against H5 avian influenza.
In its announcement, HHS said the award helps bolster the nation's pandemic flu vaccine capacity, which currently relies on an older traditional vaccine platform. Moderna will leverage its domestic large-scale commercial mRNA vaccine manufacturing platforms and ongoing development of mRNA-based seasonal flu vaccines.
The award comes as officials confirm more H5N1 avian flu in US cattle and poultry.
Dawn O'Connell, JD, assistant secretary for preparedness and response at HHS, said the $176 million represents the base award and the agreement contains other options that allow the government to quickly pivot funding to other mRNA vaccines when new flu strains or other disease threats emerge. She said the H5 vaccine is in clinical development and that phase 3 trials could begin in 2025.
The award also includes an option for large-scale production and pandemic response. At today's briefing, Robert Johnson, PhD, director of medical countermeasures at BARDA, said it's too early to project production capacity. He said the number will depend on dosing information, which should be available later this year.
Moderna said in a statement today that in 2023 it launched a phase 1/2 clinical trial of an investigational pandemic flu vaccine in healthy adults, which included candidates against H5 and H7 viruses, and results are expected this year.
Meanwhile, fill-and-finish activity continues on vaccine from bulk stocks of candidate cell-based adjuvanted H5 vaccine made by CSL Seqirus, and O'Connell said the first of 4.8 million doses will be available in the middle of July, with production continuing through August. This is faster than the government had anticipated.
As vaccine production and planning continues, federal officials are in ongoing discussions about how to best protect farm workers and others exposed to cattle.
Nirav Shah, MD, JD, principal deputy director for the Centers for Disease Control and Prevention (CDC), said if the main goal is to prevent transmission, using antiviral drugs for patients and their contacts may achieve the goal faster than a vaccine. He said health officials are weighing the risks and benefits, as well as whether people exposed to infected cattle will accept the vaccine.
So far, more than 780 people exposed to cattle have been monitored, and at least 53 with flulike illness symptoms have been tested for H5, he said. At this point, the number of confirmed human infections linked to the virus in dairy cows stands at three.
Shah said the nation has an ample supply of H5 tests, with 750,000 available and 1.2 million coming online over the next several months.
The official number of confirmed cases of H5N1 in dairy herds remains at 137 in 12 states, according to the US Department of Agriculture (USDA) Animal and Plant Health Inspection Service. But individual affected states have announced a few more detections, including Minnesota, with another infected herd in Benton County, located in the state's central region.
Regarding poultry, USDA APHIS added confirmations of four more H5N1 outbreaks in flocks in two states, Colorado and Minnesota, both of which are also battling the virus in dairy cattle. Colorado's two outbreaks involve backyard flocks in Morgan and Larimer counties, and Minnesota's two outbreaks involve commercial turkey farms in Otter Tail and Swift counties.
At today's media briefing, federal officials were asked about recent reports of wastewater detections of H5 avian flu virus in San Francisco. Tracking from WastewaterSCAN has detected positive findings that aligned with outbreaks in cattle in six states, except for some detections in California.
Shah said San Franciso isn't known for dairy industries, and one hypothesis is a potential link to live-bird markets. Since 2022, USDA APHIS has reported sporadic highly pathogenic avian flu detections at live-bird markets in five states, with the most recent one reported from San Francisco in May of this year.
Signs of H5N1 bird flu virus have been detected at three wastewater sites in the San Francisco Bay Area, according to sampling data.
Although positive wastewater samples have been found in seven other states, California is the only one that has yet to report a bird flu outbreak in a herd of dairy cows.
Genetic evidence of bird flu was detected in San Francisco wastewater on June 18 and June 26. Additional H5 hits were seen at a site in Palo Alto on June 19, and another on June 10 from the West County Wastewater facility in Richmond.
A statement from the states department of public health noted that its staffers are working with the CDC and local health departments to determine the source of H5 in wastewater. It noted that they are looking at non-human sources, including domestic poultry and wild birds.
As with the previous detections reported from before mid-May 2024, it is unclear what the source of H5N1 is, and an investigation is ongoing, department officials wrote in a statement. It is possible that it originated from bird waste or waste from other animals due to San Franciscos sewer system that collects and treats both wastewater and stormwater in the same network of pipes.
Health officials said the risk remains low for the general public.
The virus has not been identified in California cows, but it has been found in wild birds and domestic poultry in the state.
The finding is concerning because of their urban origin, said Devabhaktuni Srikrishna, an entrepreneur who is developing techniques for disease detection, and the chief executive and founder of PatientKnowHow.com. There are not many dairy or animal farms in San Francisco.
There are also no dairy farms in Palo Alto or Richmond.
Julie Weiss, Palo Altos watershed protection program manager, said her departments role in the wastewater research does not extend beyond providing wastewater samples to the research team. Kate Gibbs, the spokeswoman for Richmonds West County Wastewater facility, referred all questions to the state.
Although the samples from the Bay Area wastewater sites tested positive for H5, the testing was not specific to H5N1.
However, researchers say a positive genetic identification for H5 is suggestive of bird flu whether H5N1, the virus that has been found in U.S. dairy cattle (and which has infected three dairy workers ) or H5N2, the subtype implicated in the death of a man in Mexico City earlier this year.
Most human influenza A viruses are of the H1 and H3 variety.
The virus has been detected in 133 dairy herds across 12 states. It has also been found in wild birds and domestic poultry flocks throughout the United States.
In recent weeks, H5 was also detected in wastewater samples in Idaho, among other states.
Although there is no threat to the general public from the H5 detection in wastewater at this time, said Christine Hahn, Idaho state epidemiologist, we have determined that it is important that we work to understand these recent findings as much as possible.
The state is workingwith the Centers for Disease Control and Prevention to investigate the issue.
WastewaterSCAN, the research organization that detected the virus, is an infectious disease monitoring network run by researchers at Stanford, Emory University and Verily, Alphabet Inc.s life sciences organization.
A review of their data which takes samples from 194 locations across the country suggests H5 has also been detected at sites in Michigan, Texas, Minnesota, South Dakota and Iowa.
California is the only one of these states that has not reported H5N1-infected cattle.
Colorado health officials on Wednesday announced that a dairy worker in northeastern Colorado contracted bird flu after having close contact with sick cattle.
The worker, an adult man, had a mild eye infection. He has since recovered.
The human case is the first to be identified in Colorado related to the ongoing outbreak of avian influenza among dairy cattle. The outbreak among Colorados dairy herds is now the worst in the nation, with 27 cases having been identified in dairy herds, all in northeastern Colorado.
Nationwide, four dairy workers have now tested positive for bird flu after working closely with infected cattle. Eye infections were most common among those workers, possibly due to contact with infected milk during milking operations.
There have been no serious illnesses from the human cases related to dairy cattle, and there has been no evidence of person-to-person transmission of the virus.
The risk to most people remains low, Dr. Rachel Herlihy, the state epidemiologist, said in a statement. Avian flu viruses are currently spreading among animals, but they are not adapted to spread from person to person. Right now, the most important thing to know is that people who have regular exposure to infected animals are at increased risk of infection and should take precautions when they have contact with sick animals.
This is the second human case of bird flu in a person in Colorado in the past two years, after a worker on a poultry farm in Montrose County tested positive for the virus in 2022. That worker likewise experienced mild symptoms and recovered with no known lasting ill effects.
As Colorados outbreak of bird flu among dairy cattle has widened, state and local health officials are currently monitoring more than 500 people who had exposure to sick cattle. More than 100 additional people have previously completed monitoring.
Following federal guidance, the state is conducting tests only on those who show possible symptoms of infection. The state has tested eight people so far for bird flu. All tests except for the most recent came back negative.
Health officials released few details about the infected worker to preserve his privacy. They said the worker reported his symptoms to the Colorado Department of Public Health and Environment, which tested him for influenza at the state health lab. Samples were sent to the federal Centers for Disease Control and Prevention for additional testing, which confirmed an infection of H5N1 avian influenza.
Our partnership with the Colorado Department of Agriculture has been crucial in disseminating information to dairy farmers across the state, Jill Hunsaker Ryan, the executive director of CDPHE, said in a statement. Coloradans should feel confident that the state is doing everything possible to mitigate the virus.
To quell the outbreak among cattle, Colorado is focusing its efforts on improving farms biosecurity the systems and protections they use to prevent the spread of disease. The state has a program that will provide personal protective equipment such as gloves, masks and goggles, to farms.
But implementing such systems can be difficult, especially in the heat of summer. Dairy barns and milking parlors can be hot places, making it uncomfortable for workers to wear goggles or face coverings for long periods of time. But removing the equipment potentially exposes workers to bits of flu virus contained in aerosolized particles of milk or other possible routes of infection.
Dr. Maggie Baldwin, the state veterinarian, said last week that agriculture officials are working with dairies to come up with individual plans for reducing the risk of flu transmission.
One of our really big focuses in the last week or so has been working directly with the farms on coming up with an actionable biosecurity plan that makes sense for that facility, Baldwin said in an interview.
Despite the new human case of bird flu, infectious disease experts have repeatedly said that the risk to the general public currently is low. Milk products are safe to consume so long as they are pasteurized; beef is safe to eat so long its cooked. There is no evidence that flu is spreading undetected among the general public.
Where we need to ramp up the level of concern in the population, Elizabeth Carlton, a professor of epidemiology at the Colorado School of Public Health, said last week, is when we see those dairy farm workers get infected and spread it to their families.
Based on facts, either observed and verified directly by the reporter, or reported and verified from knowledgeable sources.
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Health officials announced a farmworker in Colorado is the fourth person in the U.S. infected with bird flu.
In a statement from the Colorado Department of Public Health and Environment (CDPHE), health officials said the male worker had direct contact with infected dairy cows on a northeast Colorado farm and developed bird flu.
The man developed mild symptoms and reported to health officials that he had pink eye.
In accordance with the U.S. Centers for Disease Control and Prevention, the man was given antiviral treatment and recovered.
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Cows graze in an oil production field. A dairy farmworker in Colorado was infected with bird flu. (Reuters/Nick Oxford/File Photo)
Dr. Rachel Herlihy, state epidemiologist with CDPHE, said the risk of bird flu remains low for the public but may be heightened for those who are regularly exposed to infected animals.
"The risk to most people remains low. Avian flu viruses are currently spreading among animals, but they are not adapted to spread from person to person," Herlihy said.
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"Right now, the most important thing to know is that people who have regular exposure to infected animals are at increased risk of infection and should take precautions when they have contact with sick animals," she said.
Dr. Rachel Herlihy said the risk to the public of developing bird flu is low. (Reuters/Jim Vondruska/File Photo)
Three previous cases of human infection linked to cows were reported in dairy workers in Texas and Michigan since March.
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Two of those workers also developed pink eye, while one had mild respiratory symptoms.
In 2022, the first U.S. case of bird flu was detected in a Colorado farmworker exposed to infected poultry.
Sarah Rumpf-Whitten is a breaking news writer for Fox News Digital and Fox Business.
She is a native of Massachusetts and is based in Orlando, Florida.
Story tips and ideas can be sent to sarah.rumpf@fox.com and on X: @s_rumpfwhitten.
The U.S. government will pay the vaccine maker Moderna $176 million to accelerate development of a pandemic influenza vaccine
July 2, 2024, 10:34 AM ET
2 min read
The U.S. government will pay the vaccine maker Moderna $176 million to accelerate development of a pandemic influenza vaccine that could be used to treat bird flu in people, as concern grows about cases in dairy cows across the country, federal officials announced Tuesday.
Moderna already has a bird flu vaccine in very early-stage testing that uses the same mRNA technology that allowed rapid development and rollout of vaccines to protect against COVID-19. The new funds from the U.S. Department of Health and Human Services include continued development of the vaccine, including a late-stage trial next year if those early study results are positive.
But the project can be quicky redirected to target another form of influenza if a different threat than the H5N1 form of bird flu emerges, HHS officials stressed.
The award was made through the Biomedical Advanced Research and Development Authority, or BARDA, a program that focuses on medical treatments for potential pandemics.
The H5N1 virus was detected earlier this year in dairy cows and has spread to more than 135 herds in 12 states and infected three people to date, all with mild cases. Federal health officials stress that the risk to the wider population remains low.
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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institutes Science and Educational Media Group. The AP is solely responsible for all content.
A new human bird flu case in the U.S. has been found further west than in the past, this time in a dairy worker in Colorado. Its the fourth human case of highly pathogenic avian influenza thats been detected related to an outbreak among U.S. dairy cows.
Previous cases were reported in Texas and Michigan, according to the Centers for Disease Control and Prevention, which announced detection of the new case Wednesday. The dairy worker was treated for symptoms and has since recovered from the infection, which occurred in April.
While the strain of avian influenza designated H1N5 has proven deadly for some people worldwide, cases so far related to this outbreak have shown up as pink eye among people who work closely with infected dairy herds.
The Department of Agriculture reported that, as of Wednesday, there were 139 dairy herds that had tested positive for bird flu, located in a total of 12 states: Colorado, Idaho, Iowa, Kansas, Michigan, Minnesota, New Mexico, North Carolina, Ohio, South Dakota, Texas and Wyoming.
CDC has been watching influenza surveillance systems closely, particularly in affected states, and there has been no sign of unusual influenza activity in people, including in syndromic surveillance, the public health agencys notice reported. Risk to humans from the outbreak is considered low, the CDC said.
Among monitoring efforts, the CDC maintains a wastewater map of the country that shows levels of influenza A detection in the past two weeks. That includes bird flu, but doesnt separate it out from other influenza A strains. Nor does it say whether the virus samples came from animals or humans. It could come from a human or from an animal like a bird or an animal product, like milk from an infected cow, according to the explanation of the map.
As NBC reported, The CDC recommends that anyone in contact with dairy cattle wear protective equipment, including safety glasses, waterproof aprons and boots that can be sanitized.
USDA, Food and Drug Administration and CDC officials have said that while avian flu remnants were found in milk samples from infected dairy cows, milk that has been pasteurized was tested and proved safe for people to consume. Testing of dairy, beef and poultry products similarly showed they are safe to eat as long as they are handled properly and cooked adequately, as Deseret News previously reported.
While bird flu has been found most often in birds, it has also been found in a variety of animals, from sea lions to bears. It was detected in Idaho alpacas, North American river otters, Virginia possums, a couple of Utah mountain lions and a red fox.
As Deseret News reported, Avian influenza in the United States has been detected in big cats, mountain lions, bobcats, brown bears, black bears and polar bears, bottlenose dolphins, grey seals, harbor seals, red foxes, coyotes, fishers, American martens, North American river otters, raccoons, skunks, Virginia possums and Aberts squirrels. There have been outbreaks in cattle and in mink. But most of the wild mammal infections are considered dead end, meaning a mammal ate an infected bird, got infected and died without contributing to spread of the virus.
But theres no indication that the virus has mutated in ways that facilitate easy spread to or among humans, although health officials are watching closely. To become a pandemic, the CDC said that sustained person-to-person spread is needed.
BALTIMORE Concern for cat owners as their furry friends might be at risk of getting avian influenza, better known as the bird flu. Researchers at University of Maryland's School of Public Health say the bird flu infecting cats could also put humans at risk. So, how are cats getting the virus? "Small animals like rodents and birds, they may prey upon them. Also on farms, cats may consume unpasteurized milk byproducts," said Ian Bemis, UMD School of Public Health, PHD candidate. The researchers found this out while scouring over 20 years of data. "This is preliminary research for the stuff we'll be doing in the future. Looking at avian influenza and animal shelters," said Bemis. Bird flu isn't currently contagious between humans. But, the research showed an increase in domestic cat infections starting in 2023. Something researchers theorize could allow the virus to mutate and become infectious to people. "There is a risk and there has been documented cases of that. However, for all the cats and people in the world it's a very rare event," said Bemis. So, what should cat owners do with a sharp increase in bird flu infections impacting cats? "The best thing that can be done is keeping your cat indoors or avoid your cats being unsupervised outdoors," said Bemis. The signs of bird flu in cats are neurological issues, difficulty walking or breathing. If you notice them in your cat the best plan of action is to take it to the vet.
Two of those cases, in Texas and Michigan, reported eye irritation as their only symptom, while one farm worker in Michigan also suffered from a mild respiratory illness.
In a statement released on Wednesday, the US Centre for Disease Control (CDC) said it still considers the health risk of H5N1 to the wider public to be low. Still, it encouraged anyone who works closely with livestock to report signs of illness to the relevant health authorities.
Although the virus has shown it can easily spill over to humans, there is no evidence yet of human-human transmission.
Many have criticised the CDCs response to the latest case, as well as its overall monitoring and surveillance of H5N1 this year, however.
Notice no mention of when the case occurred, how long the CDC has been aware of the case, and the withholding of information, said Dr Rick Bright, an immunologist and influenza expert, on X (formerly Twitter).
This is a ticking time bomb. The H5N1 virus is an unpredictable, rapidly evolving, easily transmissible virus that can cause severe illness and death. The more its allowed to spread among mammals, unchecked and unmitigated, the greater the risk it becomes to humans, he added.
Experts expect the human case number to rise significantly in the coming weeks, as state health authorities up their surveillance efforts to try and curb the spread.
After a slow start, the US authorities recently instigated a program of financial incentives designed to get farmers to cooperate with testing.
As part of the plan, the US government will pay up to $28,000 per farm over the next four months in an attempt to prevent the spread of bird flu in dairy cattle.
The funds are expected to go towards the use of personal protective equipment (PPE), decontamination of farming equipment, and testing capacity - both for animals and humans.
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The U.S. government will pay the vaccine maker Moderna $176 million to develop a pandemic vaccine that could be used to treat bird flu, caused by the H5N1 virus, in humans as cases in dairy cows continue to mount across the country, federal officials announced Tuesday.
Moderna will launch trials to test the safety and effectiveness of a vaccine that could be used to scale up a response to a bird flu pandemic if needed.
The H5N1 bird flu virus was detected earlier this year in dairy cows and has spread to more than 132 herds in 12 states. It's the first time the bird flu virus has impacted dairy cows, but it is commonly found in other mammals each year.
According to the Centers for Disease Control and Prevention's latest data, the bird flu virus has only infected three people to date, all of whom had interacted with infected cows or poultry. The human cases were mild.
Federal health officials stress that the risk to the wider population remains low.
The CDC said it is assisting the Michigan Department of Health and Human Services with a bird flu seroprevalence study of individuals exposed to sick cows to determine if there has been asymptomatic infection with the H5N1 bird flu virus among people, if certain jobs might increase risk of exposure and how personal protective equipment can protect against infection.
Related Story: FDA shares research plans as it continues to monitor bird flu outbreak
The funds for the potential pandemic vaccine are targeted for release through the U.S. Department of Health and Human Services and will pay for continued development of a vaccine that uses the same mRNA technology that allowed rapid development and rollout of vaccines to protect against COVID-19.
The award was made through the Biomedical Advanced Research and Development Authority, or BARDA, a program that focuses on medical treatments for potential pandemics.
DENVER (KDVR) Colorado officials say a man who was only reporting symptoms of conjunctivitis recently tested positive for avian flu but has recovered.
This would be the fourth human case of bird flu associated with U.S. dairy cows this year, according to health officials. The first was identified in March in Texas, and two more were identified in Michigan.
This case was regarding an employee at a dairy farm in northeast Colorado with direct exposure to dairy cattle that were infected with avian flu. Northeast Colorado is also where the first case of highly pathogenic avian influenza was detected on April 25.
According to the Colorado Department of Public Health and Environment, the worker reported his symptoms to state health officials and specimens were forwarded to the Centers for Disease Control and Prevention for additional testing, which were positive for avian flu. The worker was given antiviral treatment with oseltamivir, which follows the CDCs recommendations, and has since recovered.
CDPHE said the states last case of H5N1 in humans was in 2022 after someone was exposed to infected poultry. The virus in humans often presents with flu-like symptoms, such as a cough, congestion, sore throat and watery eyes. Eye symptoms were the only symptoms reported by the first two infected individuals who tested positive.
The risk to most people remains low. Avian flu viruses are currently spreading among animals, but they are not adapted to spread from person to person, said Dr. Rachel Herlihy, state epidemiologist with CDPHE, in a release. Right now, the most important thing to know is that people who have regular exposure to infected animals are at increased risk of infection and should take precautions when they have contact with sick animals.
H5N1s spread has since led to 10 dairy facilities being placed under quarantine. The bird-borne virus causes cattle to exhibit signs like low appetite, decreased milk production and abnormal colostrum-like milk.
According to CDPHE, it is safe to drink pasteurized milk and eat properly handled and cooked dairy, beef, and poultry products, because the process kills bacteria and viruses, including avian flu.
Our partnership with the Colorado Department of Agriculture has been crucial in disseminating information to dairy farmers across the state, said Jill Hunsaker Ryan, executive director, CDPHE, in a release. Coloradans should feel confident that the state is doing everything possible to mitigate the virus.
The state health agency told Coloradans not to touch dead or sick animals, but if its unavoidable:
If you work with dairy cows that may have avian flu and start to feel ill, CDPHE encourages you to call 303-692-2700 during regular business hours, or 303-370-9395 outside of those hours. H5N1 must be reported to the Colorado Veterinarians Office. There is also an emergency rule enacted for mandatory testing of lactating dairy cattle moving interstate.
