virus

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US prepares for bird flu pandemic with $176M Moderna vaccine deal

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Pandemic fears —

Phase 3 trial is expected to begin next year.

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US prepares for bird flu pandemic with $176M Moderna vaccine deal

The US government will pay Moderna $176 million to develop an mRNA vaccine against a pandemic influenza—an award given as the highly pathogenic bird flu virus H5N1 continues to spread widely among US dairy cattle.

The funding flows through BARDA, the Biomedical Advanced Research and Development Authority, as part of a new Rapid Response Partnership Vehicle (RRPV) Consortium. The program is intended to set up partnerships with industry to help the country better prepare for pandemic threats and develop medical countermeasures, the Department of Health and Human Services said in a press announcement Tuesday.

In an announcement of its own Tuesday, Moderna noted that it began a Phase 1/2 trial of a pandemic influenza virus vaccine last year, which included versions targeting H5 and H7 varieties of bird flu viruses. The company said it expects to release the results of that trial this year and that those results will direct the design of a Phase 3 trial, anticipated to begin in 2025.

The funding deal will support late-stage development of a “pre-pandemic vaccine against H5 influenza virus,” Moderna said. But, the deal also includes options for additional vaccine development in case other public health threats arise.

“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,” Moderna CEO Stéphane Bancel said in the announcement. “We are pleased to continue our collaboration with BARDA to expedite our development efforts for mRNA-based pandemic influenza vaccines and support the global public health community in preparedness against potential outbreaks.”

US health officials have said previously that they were in talks with Moderna and Pfizer about the development of a pandemic bird flu vaccine. The future vaccine will be in addition to standard protein-based bird flu vaccines that are already developed. In recent weeks, the health department has said it is working to manufacture 4.8 million vials of H5 influenza vaccine in the coming months. The plans come three months into the H5N1 dairy outbreak, which is very far from the initial hopes of containment.

Botched response

The US is badly fumbling its response to the unprecedented outbreak, drawing criticism from US-based and international experts alike. Genetic analyses suggest that the virus has been spreading among the country’s dairy cattle since late last year. But, it wasn’t until months later, on March 25, that the US Department of Agriculture confirmed the first four infected herds in two states (Texas and Kansas). Since then, the outbreak has spread to around 140 herds in 12 states—at least.

Some farms are refusing to test, and experts expect that there is a significant number of undocumented herd infections, particularly given the widespread detection of inactivated H5N1 in the commercial milk supply. Further, of the 140 herds with documented infections, federal officials do not know how many are still actively infected rather than recovered. It is unclear if infected cows can become reinfected, and if so, how quickly after an infection.

While the risk to the general public is considered to be low currently, farm workers are at higher risk of contracting the infection. To date, there have been three confirmed infections among dairy farm workers—one in Texas and two in Michigan, which has had a uniquely robust response to the outbreak. Still, with hundreds to thousands of farm workers at risk of contracting the virus, only 53 people in the country to date have been tested for H5 influenza.

In a presentation in London last month, global health leader Seth Berkley said it was “shocking to watch the ineptitude” of the US response to the H5N1 outbreak. He, like other experts, questioned whether the US public health community has learned or improved from the failures of the COVID-19 pandemic.

Similar to problems during the pandemic, a key barrier to the H5N1 response is resistance from farmers and farm workers to partner with state and federal health officials. Federal agencies have limited authority within states, but they have announced an array of assistance programs for dairy farms, including compensatory funding and access to personal protective equipment for farm workers. They have also issued guidance and restrictions to tighten biosecurity measures. But there has been little voluntary participation on both fronts.

For instance, officials figured out early in the outbreak that movement of cattle, workers, and equipment between farms is the main way H5N1 is spreading among dairies. In April, the USDA required testing of a portion of cows prior to their movement across state lines. But movement within states is governed by states. In a survey last month, which captured data from 54 percent of affected farms at the time, more than 60 percent of farmers said they continued to move cattle off their infected farms after the onset of clinical signs of infection in their animals.

The more the virus expands its footprint across US dairy farms, adapts to its newfound mammalian host, and comes in contact with humans, the more and more chances it has to leap to humans and gain the ability to spread among us.

In HHS’s Tuesday announcement of the Moderna award, Dawn O’Connell, assistant secretary for Preparedness and Response, spoke to the growing concern that the H5N1 outbreak could spark another pandemic. “The award made today is part of our longstanding commitment to strengthen our preparedness for pandemic influenza,” O’Connell said. “Adding this technology to our pandemic flu toolkit enhances our ability to be nimble and quick against the circulating strains and their potential variants.”

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After mice drink raw H5N1 milk, bird flu virus riddles their organs

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Deadly dairy —

No, really, drinking raw milk during the H5N1 outbreak is a bad idea.

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Fresh raw milk being poured into a container on a dairy farm on July 29, 2023, in De Lutte, Netherlands.

Enlarge / Fresh raw milk being poured into a container on a dairy farm on July 29, 2023, in De Lutte, Netherlands.

Despite the delusions of the raw milk crowd, drinking unpasteurized milk brimming with infectious avian H5N1 influenza virus is a very bad idea, according to freshly squeezed data published Friday in the New England Journal of Medicine.

Researchers at the University of Wisconsin-Madison squirted raw H5N1-containing milk from infected cows into the throats of anesthetized laboratory mice, finding that the virus caused systemic infections after the mice were observed swallowing the dose. The illnesses began quickly, with symptoms of lethargy and ruffled fur starting on day 1. On day 4, the animals were euthanized to prevent extended suffering. Subsequent analysis found that the mice had high levels of H5N1 bird flu virus in their respiratory tracts, as well their hearts, kidneys, spleens, livers, mammary glands, and brains.

“Collectively, our data indicate that HPAI [Highly Pathogenic Avian Influenza] A(H5N1) virus in untreated milk can infect susceptible animals that consume it,” the researchers concluded. The researchers also found that raw milk containing H5N1 can remain infectious for weeks when stored at refrigerator temperatures.

Bird flu has not historically been considered a foodborne pathogen, but prior to the unexpected outbreak of H5N1 in US dairy cows discovered in March, it had never been found at high levels in a food product like milk before. While experts have stepped up warnings against drinking raw milk amid the outbreak, the mouse experiment offers some of the first data on the risks of H5N1 from drinking unpasteurized dairy.

Before the mouse data, numerous reports have noted carnivores falling ill with H5N1 after eating infected wild birds. And a study from March in the journal Emerging Infectious Diseases reported that over half of the 24 or so cats on an H5N1-infected dairy farm in Texas died after drinking raw milk from the sick cows. Before their deaths, the cats displayed distressing neurological symptoms, and studies found the virus had invaded their lungs, brains, hearts, and eyes.

While the data cannot definitely determine if humans who drink H5N1-contaminated raw milk will suffer the same fate as the mice and cats, it highlights the very real risk. Still, raw milk enthusiasts have disregarded the concerns. PBS NewsHour reported last week that since March 25, when the H5N1 outbreak in US dairy cows was announced, weekly sales of raw cow’s milk have ticked up 21 percent, to as much as 65 percent compared with the same periods a year ago, according to data shared by market research firm NielsenIQ. Moreover, the founder of California-based Raw Milk Institute, Mark McAfee, told the Los Angeles Times this month that his customers baselessly believe drinking H5N1 will give them immunity to the deadly pathogen.

In normal times, the Centers for Disease Control and Prevention and the Food and Drug Administration strongly discourage drinking raw milk. Without pasteurization, it can easily be contaminated with a wide variety of pathogens, including Campylobacter, Cryptosporidium, E. coli, Listeria, Brucella, and Salmonella.

Fortunately, for the bulk of Americans who heed germ theory, pasteurization appears completely effective at deactivating the virus in milk, according to thorough testing by the FDA. Pasteurized milk is considered safe during the outbreak. The US Department of Agriculture, meanwhile, reports finding no H5N1 in retail beef so far and, in laboratory experiments, beef patties purposefully inoculated with H5N1 had no viable virus in them after the patties were cooked to 145°F (medium) or 160°F (well done).

To date, the USDA has reported that H5N1 has infected at least 58 dairy herds in nine states.

After mice drink raw H5N1 milk, bird flu virus riddles their organs Read More »

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20% of grocery store milk has traces of bird flu, suggesting wider outbreak

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widespread —

The milk is still considered safe, but disease experts are alarmed by the prevalence.

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20% of grocery store milk has traces of bird flu, suggesting wider outbreak

The Food and Drug Administration reported late Thursday that about 20 percent of retail milk samples from around the country tested positive for genetic fragments of the bird flu, aka highly pathogenic avian influenza (HPAI) virus H5N1. While retail milk is still considered to be safe, the finding suggests that the spread of the virus in cows is more extensive than is currently known.

The FDA used a test called quantitative polymerase chain reaction (qPCR), which can only detect the presence of genetic fragments. In pasteurized retail milk, it is highly likely that those genetic snippets are merely remnants of virus particles destroyed during pasteurization. The FDA is currently conducting additional testing using egg inoculation tests, a gold standard for detecting a live virus, to confirm the effectiveness of pasteurization. Meanwhile, the director of the National Institute of Allergy and Infectious Diseases, Jeanne Marrazzo, told reporters Wednesday that tests at the agency’s federal labs so far did not identify live virus from any of its sampling. Additionally, several previous studies have found that pasteurization of eggs—which is done at a lower temperature than it is for milk—was effective at destroying H5N1.

While experts are largely unconcerned with the safety of commercial milk, the potential for wide, unrecognized spread of bird flu in dairy herds is alarming. To date, the US Department of Agriculture has only confirmed infections in 33 herds in eight states. The FDA acknowledged that of its positive samples, “a greater proportion of positive results [are] coming from milk in areas with infected herds.” But with tens of thousands of dairy herds in the US, the finding suggests that infections are being missed. It does not necessarily suggest that 20 percent of all cows are affected, since milk is pooled for commercial distribution. But 33 herds alone are unlikely to explain the high prevalence.

Last week, The New York Times reported that the one dairy herd that tested positive for bird flu in North Carolina did not show any symptoms of the infection. The possibility of asymptomatic spread of the virus among cows will make containment and monitoring far more difficult—and could explain why infections may be easily missed. On Wednesday, the USDA issued a federal order requiring dairy cattle to have a negative H5N1 test before being moved across state lines.

For now, the risk to the public is still considered low by the Centers for Disease Control and Prevention. But the more the bird flu virus spreads among mammals—and mammals with close contact with humans—the more opportunities it has to evolve to jump to and among people, experts warn.

20% of grocery store milk has traces of bird flu, suggesting wider outbreak Read More »

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Concern grows as bird flu spreads further in US cows: 32 herds in 8 states

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Rapidly evolving —

Experts say the US is not sharing as much data on the outbreak as it should.

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Greylag geese sit on a field and rest while a cow passes by in the background.

Enlarge / Greylag geese sit on a field and rest while a cow passes by in the background.

Researchers around the world are growing more uneasy with the spread of highly pathogenic avian influenza (H5N1) in US dairy cows as the virus continues to make its way into new herds and states. Several experts say the US is not sharing enough information from the federal investigation into the unexpected and growing outbreak, including genetic information from isolated viruses.

To date, the US Department of Agriculture has tallied 32 affected herds in eight states: Idaho, Kansas, Michigan, New Mexico, North Carolina, Ohio, South Dakota, and Texas. In some cases, the movement of cattle between herds can explain the spread of the virus. But the USDA has not publicly clarified if all the herds are linked in a single outbreak chain or if there is evidence that the virus has spilled over to cows multiple times. Early infections in Texas were linked to dead wild birds (pigeons, blackbirds, and grackles) found on dairy farms. But the USDA reportedly indicated to Stat News that the infections do not appear to be all linked to the Texas cases.

Spread of the virus via cattle movements indicates that there is cow-to-cow transmission occurring, the USDA said. But it’s unclear how the virus is spreading between cows. Given that even the most symptomatic cows show few respiratory symptoms, the USDA speculates that the most likely way it is spreading is via contaminated milking equipment.

Adding to the uncertainty of the virus’s spread, The New York Times on Friday reported that the one herd found infected with H5N1 in North Carolina showed no symptoms of the virus. This raises the possibility that the virus could be silently spreading in unknown numbers of other asymptomatic herds and states. In its most recent FAQ document, the USDA encouraged testing for H5N1 if herds show clinical symptoms, such as lethargy, fever, low milk production, and loose stools. But the Times noted that the agency has begun reimbursing farms for testing asymptomatic cows.

Meanwhile, the USDA also reported that it has evidence that H5N1 from dairy farms has spread back into birds in nearby poultry farms, but how this is happening is also unknown.

Data gaps

All the uncertainty and widespread transmission raises concern about how the virus is evolving to infect mammals and whether it is heading for humans. Last week, the chief scientist for the World Health Organization, Jeremy Farrar, told reporters in Geneva that the spread of the virus in US dairy cows is an “enormous concern,” according to CNN.  “The great concern, of course, is that in doing so and infecting ducks and chickens—but now increasingly mammals—that that virus now evolves and develops the ability to infect humans. And then critically, the ability to go from human-to-human transmission.”

In particular, experts are wary that the dairy cow outbreaks could spill over to nearby pig farms as it’s doing with nearby poultry farms. Pigs can be infected with both bird flu viruses and human flu viruses, making them potential melting pots for new recombinant flu strains.

So far, the USDA says that genetic sequences of H5N1 viruses infecting cows has not revealed any mutations that “would make it more transmissible to humans and between people.” But last Thursday, Stat reported that international experts have faulted the USDA for not sharing more genetic data from its investigation, among other information. Until this weekend, the agency had only shared a few genetic sequences in an international database of viral genome sequences (GISAID).

“A country with capacity like the United States should be able to generate this information within days,” Marion Koopmans, head of the department of viroscience at Erasmus Medical Center in the Dutch city of Rotterdam told Stat last week. “I would expect very fast, very transparent updates, and it’s somewhat amazing not to see that happening.”

On Sunday, facing mounting criticism, the USDA announced the release of 239 genetic sequences to GISAID. It noted it is also adding raw data to a US federal database “in the interest of public transparency and ensuring the scientific community has access to this information as quickly as possible.” The agency said it will continue to make such data available on a rolling basis.

Dr. Rosemary Sifford, the USDA’s chief veterinarian, told the Times, “Please recall that we’ve been engaged in this for less than a month. We are working very hard to generate more information,” she said.

Overall, the USDA and the US Centers for Disease Control and Prevention continue to consider the risk to the public to be low. Farmworkers and others who have direct contact with infected animals are encouraged to take precautions, however.

While deadly to birds, H5N1 in cows is relatively mild, rarely if ever causing deaths. Milk from sick animals contains high levels of virus, but it is being destroyed. Even if some infected milk makes its way into the milk supply, the Food and Drug Administration is confident that the virus would be killed in the pasteurization process. “Pasteurization has continually proven to inactivate bacteria and viruses, like influenza, in milk,” the agency said in an FAQ Friday. Some experts have called for data confirming this, though.

Concern grows as bird flu spreads further in US cows: 32 herds in 8 states Read More »

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Measles erupts in Florida school where 11% of kids are unvaccinated

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outbreak potential —

Over 100 children at the school are susceptible to virus.

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A child with measles.

Enlarge / A child with measles.

Florida health officials on Sunday announced an investigation into a cluster of measles cases at an elementary school in the Fort Lauderdale area with a low vaccination rate, a scenario health experts fear will become more and more common amid slipping vaccination rates nationwide.

On Friday, Broward County Public School reported a confirmed case of measles in a student at Manatee Bay Elementary School in the city of Weston. A local CBS affiliate reported that the case was in a third-grade student who had not recently traveled. On Saturday, the school system announced that three additional cases at the same school had been reported, bringing the current reported total to four cases.

On Sunday, the Florida Department of Health in Broward County (DOH-Broward) released a health advisory about the cases and announced it was opening an investigation to track contacts at risk of infection.

At Manatee Bay Elementary School, the number of children at risk could be over 100 students. According to a Broward County vaccine study reported by the local CBS outlet, only 89.31 percent of students at Manatee Bay Elementary School were fully immunized in the 2023/2024 school year, which is significantly lower than the target vaccination coverage of 95 percent. The school currently has 1,067 students enrolled, suggesting that up to 114 students are vulnerable to the infection based on their vaccination status.

Measles is one of the most contagious viruses known. It spreads via respiratory and airborne transmission. The virus can linger in air space for up to two hours after an infected person has been in an area. People who are not vaccinated or have compromised immune systems are susceptible, and up to 90 percent of susceptible people exposed to the virus will become infected. Measles symptoms typically begin around eight to 14 days after exposure, but the disease can incubate for up to 21 days. The symptoms begin as a high fever, runny nose, red and watery eyes, and a cough before the telltale rash develops. Infected people can be contagious from four days before the rash develops through four days after the rash appears, according to the Centers for Disease Control and Prevention. About 1 in 5 unvaccinated people with measles is hospitalized, the CDC adds, while 1 in 20 infected children develop pneumonia and up to 3 in 1,000 children die of the infection.

Those who are not immunocompromised and are fully vaccinated against measles (who have received two doses of the Measles, Mumps, and Rubella (MMR) vaccine) are generally not considered at risk. The two doses are about 97 percent effective at preventing measles and protection is considered to be life-long.

The DOH-Broward said it is now “identifying susceptible contacts that may be candidates for post-exposure prophylaxis through MMR or immunoglobulin.”

While the risk of measles is generally low in the US—the country declared it eliminated in 2000—the threat of large outbreaks is growing as vaccination rates slip. Many cases in the US are linked to travel from countries where the virus still circulates. But, if a travel-related case lands in a pocket with low vaccination coverage, the virus can take off. Such was the case in 2019, when the country tallied 1,274 measles cases and nearly lost its elimination status.

Health officials typically consider vaccination coverage of 95 percent or greater to protect from ongoing transmission. In the years since the COVID-19 pandemic began, vaccination rates among US kindergartners have slipped to 93 percent, and vaccination exemptions reached an all-time high in the latest data from the 2022-2023 school year. There are now at least 10 states that have vaccination exemption rates above 5 percent, meaning that even if every non-exempt child is vaccinated, those states will not have enough coverage to reach the 95 percent target.

The CDC has tallied 20 measles cases in the US so far this year. But that is the tally as of February 15; it does not include any of the Florida cases reported since Friday. In 2023, there were 58 measles cases reported to the CDC.

This story was updated to include additional information about measles infection outcomes.

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