Moderna received federal funding to accelerate development of a new bird flu vaccine using the same mRNA technology as their COVID-19 vaccine. (AP Photo/Mark J. Terrill, File)
Moderna will receive $176 million to develop a pandemic flu vaccine for humans following a concerning outbreak of bird flu in dairy cows across the country, federal officials announced Tuesday.
We have successfully taken lessons learned during the COVID-19 pandemic and used them to better prepare for future public health crises, said Health and Human Services Secretary Xavier Becerra said in an announcement Tuesday. As part of that, we continue to develop new vaccines and other tools to help address influenza and bolster our pandemic response capabilities.
The federal money will go to the late-stage development of an mRNA-based vaccine for influenza using similar technology as the COVID-19 vaccine and to accelerate responses to similar future public health threats, Moderna said Tuesday. The company already has development of the vaccine in the works, and development could move to a late-stage trial next year if early results are positive.
The bird flu, a H5N1 variant of influenza, is a highly infectious form of the viral infection. A multistate outbreak of the virus was first reported in late March, the CDC stated, the first time bird flu viruses have been found in cows.
According to the latest CDC data, 12 states have now had outbreaks of bird flu in 136 total herds of cattle. There have been three reported cases of bird flu spreading to humans since the outbreak.
The CDC has maintained the position that the current risk to the general public from bird flu viruses is low, though the geographic spread of the dairy cow infection could create additional opportunities for people to be exposed to these viruses. Mammal to mammal spread of the virus is thought to be rare.
Mammals can contract the illness if they eat infected birds, poultry, or other animals and/or if they are exposed to environments contaminated with virus, the CDC states.
The federal vaccine funding is coming through HHSs Biomedical Advanced Research and Development Authority, or BARDA, a program focused on developing countermeasures for public health threats. The HHS release stated the funding will also help support a fair pricing agreement which will continue ensuring enduring equitable access to vaccines.
The mRNA technology used to develop the COVID-19 vaccine offers advantages in efficacy, speed of development, and production scalability and reliability, Moderna Chief Executive Officer Stphane Bancel said Tuesday.
The company began collecting safety and other data on the vaccine in healthy adults 18 years of age and older in 2023, the company said. Results are expected in 2024 and will inform Phase 3 development plans, Moderna added.
Federal officials stressed the development of the vaccine technology allows for a more rapid response to potential new threats.
Adding this technology to our pandemic flu toolkit enhances our ability to be nimble and quick against the circulating strains and their potential variants, said Assistant Secretary for Preparedness and Response Dawn OConnell.
Moderna will employ the same mRNA vaccine technology that was pioneered to develop COVID-19 vaccines.
In the ongoing waves of bird flu outbreaks, with the virus spreading to more than 141 herds in 12 states, the risk of another full-blown pandemic like COVID-19 is becoming a distinct possibility. In preparation for just such a disaster, the U.S. government will pay pharmaceutical company Moderna $176 million to develop a vaccine that protects against the H5N1 virus. Moderna will employ the same mRNA vaccine technology that was pioneered to develop COVID-19 vaccines in 2020, as well as the booster shots that have followed.
Moderna is already in the early stages of testing its new mRNA vaccine, meaning that it will be receiving supplementary funds for that research from the U.S. Department of Health and Human Services (HHS). The award was made through an agency organization called the Biomedical Advanced Research and Development Authority, or BARDA.
We have successfully taken lessons learned during the COVID-19 pandemic and used them to better prepare for future public health crises. As part of that, we continue to develop new vaccines and other tools to help address influenza and bolster our pandemic response capabilities, HHS Secretary Xavier Becerra said in a statement. Importantly, we are doing this work in partnership with some of the nations leading scientists and clinicians. The Biden-Harris Administration wont stop until we have everything we need to prepare for pandemics and other public health emergencies that impact the American public.
Because influenza strains are closely related to each other, the scientists can pivot from the avian flu to a different type of flu if a separate and more serious outbreak emerges. The current concern, however, is about the H5N1 virus. The strain has been virulent across U.S. dairy farms in 2024, even infecting three people, although they all had relatively mild cases. From a medical perspective, the biggest concern about the current bird flu strain is that it can spread from birds to mammals. This suggests that it can not only be transmitted to humans, but is capable of evolving to be particularly infectious.
The bovine situation is a step up from this, just due to how widespread the virus is, and how many people have exposure to cattle (compared to small mink farms or remote sea lion colonies), Dr. Tom Peacock, a virologist at Imperial College London and the Pirbright Institute, told Salon in June. This clearly represents a much larger human-animal interface than the other examples.
The disease risks to humans from industrialized intensive animal farming are enormous, the study says.
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The agreement will ensure fair pricing for American consumers, one federal official told Bloomberg on Tuesday. Modernas stock price climbed just shy of 1 percent on the news Tuesday.
Moderna is Massachusetts largest homegrown drug maker, with more than 4,400 employees in the state as of late 2023.
The vaccine relies on messenger RNA, or mRNA, to stimulate immunity, in a fashion similar to the COVID-19 vaccines produced by Moderna and Pfizer-BioNTech. Moderna recently obtained US regulatory approval of its vaccine for respiratory syncytial virus, or RSV, in older adults the companys first mRNA vaccine cleared for a disease other than COVID.
Moderna president Stephen Hoge told Bloomberg in March that the company sees bird flu as a clear threat.
The current strain of bird flu, or H5N1, surged in the United States earlier this year. Though the viruss effect on wild bird populations is well documented and was seen in New England as early as 2022 researchers are concerned about transmission to mammals and, potentially, to humans.
Last year, the highly-pathogenic virus was responsible for the deaths of tens of thousands of seals and sea lions off the coast of South America. In March, it was reported that American livestock were contracting the disease, worsening fears of interspecies transmission.
So far, though, only three people are known to have been infected with the virus in the United States, all of them dairy workers who likely caught it from diseased cows. There have been no reports of human-to-human transmission, and the risk to the general population is considered low, according to the Centers for Disease Control and Prevention.
Scientists have also voiced concern over another strain of the virus, H5N2, which led to the death of a 59-year-old man in Mexico in early June. That was the first recorded H5N2 case in humans, according to the World Health Organization. Although the source of transmission is currently unknown, the new strain is not yet considered a serious threat to humans by WHO.
The vaccine deal is welcome news for Moderna, which has seen a steep decline in sales of its COVID-19 vaccine, Spikevax. That vaccine made Moderna a household name, but investors have grown anxious over the prospects of the company, particularly after a dismal first-quarter earnings report.
Since then, the company has secured regulatory approval for its vaccine for RSV, a common and potentially deadly seasonal virus. In addition, Moderna recently announced that its combination flu and COVID shot met the goals of a pivotal late-stage trial, bringing the company one step closer to a more convenient jab that could help combat vaccine fatigue.
The federal government is also pursuing the development of other influenza vaccine candidates, including two traditional vaccines that are tailored to H5N1. Bloomberg reported that the United States is likely eyeing another contract, potentially with Pfizer, to develop an mRNA-based flu vaccine.
Material from Globe wires and previous Globe coverage was used in this report.
Camilo Fonseca can be reached at camilo.fonseca@globe.com. Follow him on Twitter @fonseca_esq and Instagram @camilo_fonseca.reports.
(Precision Vaccinations News)
In the past two years, H5 influenza virus subtypes have caused severe disease in birds and mammals in the United States. Because of various media reports, there is concern about the risk of theseviruses spreading to humans, which could generate another pandemic.
On June 27, 2024, the U.S. Centers for Disease Control and Prevention (CDC) confirmed that the risk to people is very low. However, the U.S. government continues its multi-year effort to prepare for this risk.
Moderna, Inc.today announced a project award of $176 million to accelerate the development of mRNA-based pandemic influenza vaccines. The award program is within the U.S. Department of Health and Human Services (HHS).
The project award will support the late-stage development of an mRNA-based vaccine to enable the licensure of a pre-pandemic vaccine against the H5 influenza virus.
This new HHS agreement also includes additional options to prepare and accelerate responses to future public health threats.
"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," said Stphane Bancel, Chief Executive Officer of Moderna, in a press release on July 2, 2024.
In July 2023, Moderna initiated aPhase 1/2 studyto generate safety and immunogenicity data for the investigational pandemic influenza vaccine (mRNA-1018) in healthy adults. The study includes vaccine candidates against H5 and H7 avian influenza viruses.
Results from the study are expected in 2024 and will inform Phase 3 development plans.
Currently, there are U.S. FDA-approved pandemic vaccines(Audenz) and various development initiatives underway, funded by the U.S. government.
Furthermore, the CDC has confirmed annual flu shots may not be effective against these influenza subtypes.
As authorities work to restrict the spread of the deadly H7 strain of bird flu affecting chickens and eggs across Australia, ecologists and advocates warn a different strain of the virus could lead to an environmental disaster in some wild birds.
The H5N1 avian influenza has caused mass mortality events in wildlife on every other continent on Earth, particularly among birds and animals that eat infected birds.
As the yearly migration of birds to Australia in spring approaches, experts say more communication and planning is needed, with unique species most at risk.
Federation University ecologist Meagan Dewar has tracked the spread of H5N1 throughout Antarctica since February and witnessed mass casualties among many species including Adlie penguins and southern elephant seals.
"Unfortunately our wildlife is integrated and interconnected so [remote ecosystems] aren't as safe as we think," she said.
But Dr Dewar said it would be migrating birds from Asia that would "most likely" bring H5N1 to Australia in spring.
"The virus is coming closer, and it is on our doorstep," she said.
More than 650,000 seabirds are known to have died from H5N1 in South America since 2022, Dr Dewar said.
Animals that prey on dead infected birds also contract the virus. It killed 95 per cent of southern elephant seal pups in Argentina in 2023.
It has killed more than 30,000 South American sea lions. Australia's population is only 12,000.
Dr Dewar said Australia's unique ecosystems with small animal populations were most at risk of collateral damage.
"If it gets into our highly endangered or critically endangered bird species that could have very severe consequences for them and their survival," she said.
"We can get alterations in our ecosystems because we are losing large proportions of animals and birds."
Dr Dewar said her greatest concern was animals like threatened sea lions or vulnerable little penguin colonies with "small population numbers that really can't afford to be hit by a large-scale virus".
On the NSW south coast, Barunguba Montague Island (Barunguba) is culturally significant for the Yuin people and an ecological epicentre for almost 100 bird species.
It is the northernmost breeding colony for Australian fur seals, long nose fur seals and sea lions and is home to NSW's largest little penguin colony during breeding season.
According to a study published in the journalGenome Biology, the H5N1 virus could make the black swan, a culturally significant species to the Yuin people, locally extinct.
However, Dr Dewar said species such as seals, sea lions, seabirds and little penguins could also be at threat if susceptible to the virus.
Narooma-based seal-diving and tourism operator Francois Van Zyl said the effects of the virus on the island would be horrific.
"The seals play a big part in our small-town community," Mr Van Zyl said.
"Yes it will have catastrophic financial issues on small coastal towns, however I think the larger concern is: 'What's going to happen to the wildlife?'"
While there are reports of mammal-to-mammal transmission in North American cattle and South American sea mammals, virus ecologist Michelle Wille said those were two context-specific cases and those strains were unlikely to threaten Australia.
This is still very much an avian virus, she said.
But like any virus, Dr Wille said managing the spread would reduce the risk of mammal-to-mammal variations occurring because there would be less chance of mutations developing.
Its important we focus on whats happening in birds because thats where everything jumps out of, she said.
The more dead birds there are in the landscape, the higher the likelihood that some mammal is going to be infected over and over until you get that right combination of the exactly right genetic make up and exactly the right mammal that allows for [mammal to mammal transmission].
In the Netherlands and Belgium, collecting dead birds before predators can feed on them reduced mammal fatalities by 80 per cent.
It is one strategy in Phillip Island Nature Parks' site-specific contingency plan for the virus. However not all similar ecosystems across the country have such a plan.
Invasive Species Council advocacy director Jack Gough wants the federal government to establish a national task force and help develop similar, localised strategies for ecosystems right across Australia.
"Right now, Australia is not prepared in terms of our wildlife if the deadly H5 strain turns up," he said.
"If it turns up here, it will cause damage and that there are opportunities with isolated populations to make sure that we can respond quickly."
Biosecurity PhD candidate at UNSW Hayley Stone said the virus arriving in Australia was inevitable and early detection was critical to managing its spread.
"You want to catch it as quickly as possible," she said.
"It needs to be on a federal level. There needs to be federal policy that everyone can follow.
"America didn't realise they were having an outbreak until it had already hit poultry."
She said there could be more testing under the National Avian Influenza Wild Bird surveillance program, which tests sick wild birds for diseases.
The Department of Agriculture, Fisheries and Forestry (DAFF) declined an interview, but in a statement, said the department would coordinate a national approach in the event of a large outbreak.
In April 2024, DAFF and Wildlife Health Australia published guidelines helping wildlife managers to deal with high-risk bird flu virus, such as the H5N1 strain.
It includes prevention measures, and tips for creating a site-specific plan, which it says is the responsibility of individual jurisdictions.
The guidelines recommend dead birds be reported to the Emergency Animal Disease Hotline (1800 675 888).
"There is no way to prevent new strains of avian influenza viruses including this H5 strain entering Australia through migratory birds," a department spokesperson said in a statement.
Mr Gough said part of the solution was improving local awareness that dead birds washing up on a beach in Tasmania or Far North Queensland, for example, was a sign the virus had arrived.
He said the federal government had more to do in bringing people together and creating localised plans to manage the virus.
"That involves tourism operators, local fishers people who are out seeing these environments that they know what bird flu is, that they're checking for it and that if they see any signs of it, they're able to really quickly notify the authorities and get on top of it," he said.
"Bring wildlife carers, zoos, veterinarians, tourism operators, fishers everyone together. Make sure that everyone is aware, knows what to look for if this turns up and that we can respond quickly."
July 3, 2024 A human case of highly pathogenic avian influenza(HPAI) A(H5) (H5 bird flu) virus infection in the United States has been identified in the state of Colorado. This is the fourth case associated with an ongoing multistate outbreak of A(H5N1) in dairy cows and the first in Colorado. Previous cases were reported in Texas(1) and Michigan(2). As with previous cases, the person is a worker on a dairy farm where cows tested positive for A(H5N1) virus. The person reported eye symptoms only, received oseltamivir treatment, and has recovered. CDC has been watching influenza surveillance systemsclosely, particularly in affected states, and there has been no sign of unusual influenza activity in people, including in syndromic surveillance.
Based on the information available at this time, this infection does not change CDCs current H5N1 bird flu human health risk assessment for the U.S. general public, which the agency considers to be low. However, this development underscores the importance ofrecommended precautionsin people with exposure to infected animals. People with close or prolonged, unprotected exposures to infected birds or other animals (including livestock), or to environments contaminated by infected birds or other animals, are at greater risk of infection.
Case Background
A dairy worker who was being monitored because of their work exposure to H5N1 virus-infected cattle reported symptoms to state health officials. Testing results were inconclusive at the state. Specimens forwarded to CDC for additional testing were positive for influenza A(H5). The state was then notified of the results. The designation of the influenza virus neuraminidase (the N in the subtype) is pending genetic sequencing at CDC. Attempts to sequence the virus in the clinical specimen are underway and will be made available within 1-2 days if successful. Additional genetic analysis will look for any changes to the virus that could alter the agencys risk assessment.
CDC Activities
This case was detected through the states implementation of CDCs recommended monitoring and testing strategies in exposed persons. In addition to enhanced and targeted surveillance, CDC also has:
CDC Recommendations
More information about A(H5N1) is available on the CDC website at https://www.cdc.gov/flu/avianflu/avian-flu-summary.htm.
A fourth dairy worker in the U.S. has tested positive for bird flu following exposure to infected cows, the Centers for Disease Control and Prevention (CDC) reported Wednesday (July 3).
The case is the first human illness detected in Colorado in connection with an ongoing outbreak in cattle. It follows one human case in Texas and two in Michigan. The second case in Michigan caused mild respiratory symptoms, such as coughing, but the other three cases including the most recent in Colorado have only included eye symptoms, such as redness.
The culprit behind these infections is a bird flu virus called influenza A(H5N1). This subtype of flu was first spotted among U.S. dairy cows in March. Since then, dozens of herds across the country have tested positive for the virus.
Recent research suggests that, when it infects cows, the virus can end up in the animals' milk and remain infectious in unpasteurized milk for at least an hour after harvest. This poses a significant risk to dairy workers, who may come into contact with contaminated milk through contact with cows or with milking equipment. The pasteurized milk supply, on the other hand, is safe because the pasteurization process inactivates any viruses in the milk.
Related: 'Playing Russian roulette with your health': Officials warn that social media trend of consuming raw milk will not protect you from bird flu
Because of the risk posed by raw milk, the CDC recommends that dairy workers wear personal protective equipment.
In the recent Colorado case, the individual was being monitored because they'd been exposed to H5N1-infected cattle at work. Clinical samples from the person were sent to the CDC, who confirmed an infection with an influenza A(H5) virus. The agency is continuing to analyze the sample to confirm that the virus is in fact H5N1.
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The infected person was treated with a common drug for seasonal flu, called oseltamivir; Tamiflu is a well-known, brand-name version of the drug. The person recovered following this treatment.
All three people previously infected in the outbreak also recovered from their mild infections. In the past, though, H5N1 has been known to sometimes kill people.
Overall, the Colorado case doesn't change the CDC's overall assessment of the unfolding outbreak.
"CDC has been watching influenza surveillance systems closely, particularly in affected states, and there has been no sign of unusual influenza activity in people," the agency reported. "Based on the information available at this time, this infection does not change CDC's current H5N1 bird flu human health risk assessment for the U.S. general public, which the agency considers to be low."
Nonetheless, the CDC will continue to monitor for unusual flu activity. There's a possibility that, in time, H5N1 could pick up mutations that enable the virus to spread easily from person to person something it hasn't yet been able to do. Such a change in the virus' genetics would be concerning because the pathogen could then potentially spark a widespread outbreak, or even a pandemic.
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Over one-half of Americans are not sure if pasteurised milk is safer than raw milk. In the time of avian flu epidemics in US cattle, this could even prove dangerous.
As the fourth human case of H5N1 avian flu in a US farmworker in Colorado was confirmed Wednesday by the US Centers for Disease Control and Prevention (CDC), so far, only farm workers, and not consumers, have reported avian flu infections.
This is likely due, at least in part, to the successful inactivation of the virus during the milk pasteurization process, experts say. And yet one-half or more Americans seem to have little idea about the dangers of drinking raw milk, according to a recent poll conducted by the University of Pennsylvania researchers.
The survey, which included a demographically representative sample of the US adult population, found that less than half (47% percent) of the U.S. adults surveyed understood that drinking raw milk not as safe as drinking pasteurized milk. Conversely, 53% of respondents dont actually believe that pasteurized milk is safer. And 9% of respondents actually believed raw milk is safer, while 15% said it was just as safe and 30% were unsure.
Nearly a quarter (24%) of Americans either do not believe that pasteurization is effective at killing bacteria and viruses in milk products (4%) or are not sure whether this is true (20%), according to the survey of over 1000 US adults, conducted by the Annenberg Public Policy Center (APPC). The survey has a 3-3.5% statistical error rate.
That, despite the fact that studies report that pasteurized milk limits hospitalizations for related illnesses by an order of 45, according to the APPC report.
The French Scientist Louis Pasteur invented the pasteurization process 160 years ago, after recognizing that it killed off otherwise dangerous bacteria present in unheated wine. The process, which soon became a milk industry standard in the United States, successfully inactivates the modern-day avian flu virus, significantly limiting the risk of infection for the general public.
In fact, only about 2% of Americans report drinking raw milk at least once a month, according to a Food and Drug Administration (FDA) study based on 2019 data.
Paradoxically, however, raw milk sales in the US have increased in recent months, according to some US media reports, despite the recent risks posed by a widening circle of avian influenza among dairy cattle.
Debate has been spurred by the increased anti-science bent of some US political leaders.Presidential candidate Robert F. Kennedy Jr., for instance, who also has been a staunch opponent of COVID vaccination, has been quoted saying that he drinks raw milk exclusively.
The APPC survey also found that Republicans are more likely than Democrats to believe that drinking raw milk is as safe as pasteurized milk (57% vs. 37%). People living in an urban environment also are more likely to believe that pastuerized milk is safer than raw milk as compared to people in a rural environment (49% vs. 32%).
The difference in views of raw milk that we see between Democrats and Republicans is difficult to disentangle from the difference between rural and urban dwellers, said Kathleen Hall Jamieson, director of the Annenberg Public Policy Center. Those in rural areas are both more likely to identify as Republicans and to consume raw milk.
Some 55 more cattle herds in seven states have been infected with the virus over the past 30 days, according to CDC tracking. Infections in the past 30 days represent 40% of the total of 138 cattle herds infected in 12 states since the outbreak in dairy cattle was first reported on 25 March, the CDC reported.
The real number of infections of both humans and cattle is very likely underestimated, insofar as farmers have been reluctant to have their staff or herds tested, experts warn.
Even so, the CDC maintained that infection risks for the general public remain low.
Based on the information available at this time, this infection does not change CDCs current H5N1 bird flu human health risk assessment for the U.S. general public, which the agency considers to be low, the CDC said in a statement.
Image Credits: Cotonbro studio, APCC, CDC.
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The Centers for Disease Control and Prevention (CDC) just announced another human case of bird flu. It is the fourth human infection so far to be linked to an ongoing multistate outbreak of H5N1 avian influenza in US dairy cattle.
Read more: US To Test Ice Cream And Butter For H5N1 Bird Flu Virus
As with the previous three, this fourth case is a dairy worker who came into contact with infected cows while carrying out their job. The worker was initially monitored due to their exposure and later reported symptoms to state officials.
The Colorado worker received antiviral medication and has since recovered, while the CDC is currently analyzing a sample of the virus to see if it has developed any new mutations.
As the virus spreads among mammals, it could mutate to make human-to-human infection more likely. However, the CDCs overall health risk assessment of the bird flu outbreak remains low, despite its continued spread and the additional risk of mutation that each new human spillover case brings.
This latest is the first case in Colorado, preceded by one in Michigan and two in Texas. According to the USDA, Colorado has the highest total number of infected cattle herds. The mountain state was also home to a separate human case of H5N1 back in 2022.
Read more: More US Bird Flu Cases Likely After Second Human Infected By Cows
Last month, former CDC director Robert Redfield who headed the agency during the COVID-19 pandemic warned that bird flu is very likely to be the next human pandemic. Speaking to News Nation, he said Its not a question of if, its more of a question of when.
In April, the first-ever human case of H5N2, a separate strain of bird flu, killed a man in Mexico. As with H5N1, its likely he caught the virus from an infected animal. Other strains of bird flu have previously killed humans, including 18 deaths from H5N6 in China in 2021.
While the US government maintains that the current risk to humans from H5N1 bird flu remains low, officials say they are taking the possibility of further transmission seriously. Two potential vaccines in millions of doses are ready for immediate rollout, if necessary.
Read more: Bird Flu In Dairy Cows: How Worried Should We Be?
