Lack of Testing Raises Risk of Bird Flu Pandemic

By Amy Maxmen and Arthur Allen, KFF Health News

Stanford University infectious disease doctor Abraar Karan has seen a lot of patients with runny noses, fevers, and irritated eyes lately. Such symptoms could signal allergies, covid, or a cold. This year, there’s another suspect, bird flu — but there’s no way for most doctors to know.

If the government doesn’t prepare to ramp up H5N1 bird flu testing, he and other researchers warn, the United States could be caught off guard again by a pandemic.

“We’re making the same mistakes today that we made with covid,” Deborah Birx, who served as former President Donald Trump’s coronavirus response coordinator, said June 4 on CNN.

To become a pandemic, the H5N1 bird flu virus would need to spread from person to person. The best way to keep tabs on that possibility is by testing people.

Scientifically speaking, many diagnostic laboratories could detect the virus. However, red tape, billing issues, and minimal investment are barriers to quickly ramping up widespread availability of testing. At the moment, the Food and Drug Administration has authorized only the Centers for Disease Control and Prevention’s bird flu test, which is used only for people who work closely with livestock.

State and federal authorities have detected bird flu in dairy cattle in 12 states. Three people who work on separate dairy farms tested positive, and it is presumed they caught the virus from cows. Yet researchers agree that number is an undercount given the CDC has tested only about 40 people for the disease.

“It’s important to know if this is contained on farms, but we have no information because we aren’t looking,” said Helen Chu, an infectious disease specialist at the University of Washington in Seattle who alerted the country to covid’s spread in 2020 by testing people more broadly.

Reports of untested sick farmworkers — as well as a maternity worker who had flu symptoms — in the areas with H5N1 outbreaks among cattle in Texas suggest the numbers are higher. And the mild symptoms of those who tested positive — a cough and eye inflammation, without a fever — are such that infected people might not bother seeking medical care and, therefore, wouldn’t be tested.

The CDC has asked farmworkers with flu symptoms to get tested, but researchers are concerned about a lack of outreach and incentives to encourage testing among people with limited job security and access to health care. Further, by testing only on dairy farms, the agency likely would miss evidence of wider spread.

“It’s hard to not compare this to covid, where early on we only tested people who had traveled,” said Benjamin Pinsky, medical director of the clinical virology laboratory at Stanford University. “That left us open to not immediately recognizing that it was transmitting among the community.”

In the early months of covid, the rollout of testing in the United States was catastrophically slow. Although the World Health Organization had validated a test and other groups had developed their own using basic molecular biology techniques, the CDC at first insisted on creating and relying on its own test. Adding to delays, the first version it shipped to state health labs didn’t work.

The FDA lagged, too. It didn’t authorize tests from diagnostic laboratories outside of the CDC until late February 2020.

On Feb. 27, 2020, Chu’s research lab detected covid in a teenager who didn’t meet the CDC’s narrow testing criteria. This case sounded an alarm that covid had spread below the radar. Scaling up to meet demand took time: Months passed before anyone who needed a covid test could get one.

Chu notes this isn’t 2020 — not by a long shot. Hospitals aren’t overflowing with bird flu patients. Also, the country has the tools to do much better this time around, she said, if there’s political will.

‘We Should Absolutely Get Prepared’

For starters, tests that detect the broad category of influenzas that H5N1 belongs to, called influenza A, are FDA-approved and ubiquitous. These are routinely run in the “flu season,” from November to February. An unusual number of positives from these garden-variety flu tests this spring and summer could alert researchers that something is awry.

Doctors, however, are unlikely to request influenza A tests for patients with respiratory symptoms outside of flu season, in part because health insurers may not cover them except in limited circumstances, said Alex Greninger, assistant director of the clinical virology laboratory at the University of Washington.

That’s a solvable problem, he added. At the peak of the covid pandemic, the government overcame billing issues by mandating that insurance companies cover tests, and set a lucrative price to make it worthwhile for manufacturers. “You ran into a testing booth on every other block in Manhattan because companies got $100 every time they stuck a swab in someone’s nose,” Greninger said.

Another obstacle is that the FDA has yet to allow companies to run their influenza A tests using eye swabs, although the CDC and public health labs are permitted to do so. Notably, the bird flu virus was detected only in an eye swab from one farmworker infected this year — and not in samples drawn from the nose or throat.

Overcoming such barriers is essential, Chu said, to ramp up influenza A testing in regions with livestock. “The biggest bang for the buck is making sure that these tests are routine at clinics that serve farmworker communities,” she said, and suggested pop-up testing at state fairs, too.

In the meantime, novel tests that detect the H5N1 virus, specifically, could be brought up to speed. The CDC’s current test isn’t very sensitive or simple to use, researchers said.

Stanford, the University of Washington, the Mayo Clinic, and other diagnostic laboratories that serve hospital systems have developed alternatives to detecting the virus circulating now. However, their reach is limited, and researchers stress a need to jump-start additional capacity for testing before a crisis is underway.

“How can we make sure that if this becomes a public health emergency we aren’t stuck in the early days of covid, where things couldn’t move quickly?” Pinsky said.

A recent rule that gives the FDA more oversight of lab-developed tests may bog down authorization. In a statement to KFF Health News, the FDA said that, for now, it may allow tests to proceed without a full approval process. The CDC did not respond to requests for comment.

But the American Clinical Laboratory Association has asked the FDA and the CDC for clarity on the new rule. “It’s slowing things down because it’s adding to the confusion about what is allowable,” said Susan Van Meter, president of the diagnostic laboratory trade group.

Labcorp, Quest Diagnostics, and other major testing companies are in the best position to manage a surge in testing demand because they can process hundreds per day, rather than dozens. But that would require adapting testing processes for their specialized equipment, a process that consumes time and money, said Matthew Binnicker, director of clinical virology at the Mayo Clinic.

“There’s only been a handful of H5N1 cases in humans the last few years,” he said, “so it’s hard for them to invest millions when we don’t know the future.”

The government could provide funding to underwrite its research, or commit to buying tests in bulk, much as Operation Warp Speed did to advance covid vaccine development.

“If we need to move to scale this, there would need to be an infusion of money,” said Kelly Wroblewski, director of infectious disease programs at the Association of Public Health Laboratories. Like an insurance policy, the upfront expense would be slight compared with the economic blow of another pandemic.

Other means of tracking the H5N1 virus are critical, too. Detecting antibodies against the bird flu in farmworkers would help reveal whether more people have been infected and recovered. And analyzing wastewater for the virus could indicate an uptick in infections in people, birds, or cattle.

As with all pandemic preparedness efforts, the difficulty lies in stressing the need to act before a crisis strikes, Greninger said.

“We should absolutely get prepared,” he said, “but until the government insures some of the risk here, it’s hard to make a move in that direction.”

KFF Health News is a national newsroom that produces in-depth journalism about health issues. 

Will Bird Flu Be the Next Pandemic?

By Amy Maxmen, KFF Health News

Headlines are flying after the Department of Agriculture confirmed that the H5N1 bird flu virus has infected dairy cows around the country. Tests have detected the virus among cattle in nine states, mainly in Texas and New Mexico, and most recently in Colorado, said Nirav Shah, principal deputy director at the Centers for Disease Control and Prevention, at a May 1 event held by the Council on Foreign Relations.

A menagerie of other animals have been infected by H5N1, and at least one person in Texas. But what scientists fear most is if the virus were to spread efficiently from person to person. That hasn’t happened and might not. Shah said the CDC considers the H5N1 outbreak “a low risk to the general public at this time.”

Viruses evolve and outbreaks can shift quickly. “As with any major outbreak, this is moving at the speed of a bullet train,” Shah said. “What we’ll be talking about is a snapshot of that fast-moving train.” What he means is that what’s known about the H5N1 bird flu today will undoubtedly change.

With that in mind, KFF Health News explains what you need to know now.

Q: Who gets the bird flu?

Mainly birds. Over the past few years, however, the H5N1 bird flu virus has increasingly jumped from birds into mammals around the world. The growing list of more than 50 species includes seals, goats, skunks, cats, and wild bush dogs at a zoo in the United Kingdom. At least 24,000 sea lions died in outbreaks of H5N1 bird flu in South America last year.

What makes the current outbreak in cattle unusual is that it’s spreading rapidly from cow to cow, whereas the other cases — except for the sea lion infections — appear limited. Researchers know this because genetic sequences of the H5N1 viruses drawn from cattle this year were nearly identical to one another.

The cattle outbreak is also concerning because the country has been caught off guard. Researchers examining the virus’s genomes suggest it originally spilled over from birds into cows late last year in Texas, and has since spread among many more cows than have been tested. “Our analyses show this has been circulating in cows for four months or so, under our noses,” said Michael Worobey, an evolutionary biologist at the University of Arizona in Tucson.

Q: Is this the start of the next pandemic?

Not yet. But it’s a thought worth considering because a bird flu pandemic would be a nightmare. More than half of people infected by older strains of H5N1 bird flu viruses from 2003 to 2016 died. Even if death rates turn out to be less severe for the H5N1 strain currently circulating in cattle, repercussions could involve loads of sick people and hospitals too overwhelmed to handle other medical emergencies.

Although at least one person has been infected with H5N1 this year, the virus can’t lead to a pandemic in its current state. To achieve that horrible status, a pathogen needs to sicken many people on multiple continents. And to do that, the H5N1 virus would need to infect a ton of people. That won’t happen through occasional spillovers of the virus from farm animals into people. Rather, the virus must acquire mutations for it to spread from person to person, like the seasonal flu, as a respiratory infection transmitted largely through the air as people cough, sneeze, and breathe. As we learned in the depths of covid-19, airborne viruses are hard to stop.

That hasn’t happened yet. However, H5N1 viruses now have plenty of chances to evolve as they replicate within thousands of cows. Like all viruses, they mutate as they replicate, and mutations that improve the virus’s survival are passed to the next generation. And because cows are mammals, the viruses could be getting better at thriving within cells that are closer to ours than birds’.

The evolution of a pandemic-ready bird flu virus could be aided by a sort of superpower possessed by many viruses. Namely, they sometimes swap their genes with other strains in a process called reassortment. In a study published in 2009, Worobey and other researchers traced the origin of the H1N1 “swine flu” pandemic to events in which different viruses causing the swine flu, bird flu, and human flu mixed and matched their genes within pigs that they were simultaneously infecting. Pigs need not be involved this time around, Worobey warned.

Q: Can I get sick from contaminated milk?

Cow’s milk, as well as powdered milk and infant formula, sold in stores is considered safe because the law requires all milk sold commercially to be pasteurized. That process of heating milk at high temperatures kills bacteria, viruses, and other teeny organisms. Tests have identified fragments of H5N1 viruses in milk from grocery stores but confirm that the virus bits are dead and, therefore, harmless.

Unpasteurized “raw” milk, however, has been shown to contain living H5N1 viruses, which is why the FDA and other health authorities strongly advise people not to drink it. Doing so could cause a person to become seriously ill or worse. But even then, a pandemic is unlikely to be sparked because the virus — in its current form — does not spread efficiently from person to person, as the seasonal flu does.

Q: What should be done?

A lot! Because of a lack of surveillance, the U.S. Department of Agriculture and other agencies have allowed the H5N1 bird flu to spread under the radar in cattle. To get a handle on the situation, the USDA recently ordered all lactating dairy cattle to be tested before farmers move them to other states, and the outcomes of the tests to be reported.

But just as restricting covid tests to international travelers in early 2020 allowed the coronavirus to spread undetected, testing only cows that move across state lines would miss plenty of cases.

Such limited testing won’t reveal how the virus is spreading among cattle — information desperately needed so farmers can stop it. A leading hypothesis is that viruses are being transferred from one cow to the next through the machines used to milk them.

To boost testing, Fred Gingrich, executive director of a nonprofit organization for farm veterinarians, the American Association of Bovine Practitioners, said the government should offer funds to cattle farmers who report cases so that they have an incentive to test. Barring that, he said, reporting just adds reputational damage atop financial loss.

“These outbreaks have a significant economic impact,” Gingrich said. “Farmers lose about 20% of their milk production in an outbreak because animals quit eating, produce less milk, and some of that milk is abnormal and then can’t be sold.”

The government has made the H5N1 tests free for farmers, Gingrich added, but they haven’t budgeted money for veterinarians who must sample the cows, transport samples, and file paperwork. “Tests are the least expensive part,” he said.

If testing on farms remains elusive, evolutionary virologists can still learn a lot by analyzing genomic sequences from H5N1 viruses sampled from cattle. The differences between sequences tell a story about where and when the current outbreak began, the path it travels, and whether the viruses are acquiring mutations that pose a threat to people. Yet this vital research has been hampered by the USDA’s slow and incomplete posting of genetic data, Worobey said.

The government should also help poultry farmers prevent H5N1 outbreaks since those kill many birds and pose a constant threat of spillover, said Maurice Pitesky, an avian disease specialist at the University of California-Davis.

Waterfowl like ducks and geese are the usual sources of outbreaks on poultry farms, and researchers can detect their proximity using remote sensing and other technologies. By zeroing in on zones of potential spillover, farmers can target their attention. That can mean routine surveillance to detect early signs of infections in poultry, using water cannons to shoo away migrating flocks, relocating farm animals, or temporarily ushering them into barns. “We should be spending on prevention,” Pitesky said.

Q: What could happen to people who get the H5N1 bird flu?

No one really knows. Only one person in Texas has been diagnosed with the disease this year, in April. This person worked closely with dairy cows, and had a mild case with an eye infection. The CDC found out about them because of its surveillance process. Clinics are supposed to alert state health departments when they diagnose farmworkers with the flu, using tests that detect influenza viruses, broadly. State health departments then confirm the test, and if it’s positive, they send a person’s sample to a CDC laboratory, where it is checked for the H5N1 virus, specifically. “Thus far we have received 23,” Shah said. “All but one of those was negative.”

State health department officials are also monitoring around 150 people, he said, who have spent time around cattle. They’re checking in with these farmworkers via phone calls, text messages, or in-person visits to see if they develop symptoms. And if that happens, they’ll be tested.

Another way to assess farmworkers would be to check their blood for antibodies against the H5N1 bird flu virus; a positive result would indicate they might have been unknowingly infected. But Shah said health officials are not yet doing this work.

“The fact that we’re four months in and haven’t done this isn’t a good sign,” Worobey said. “I’m not super worried about a pandemic at the moment, but we should start acting like we don’t want it to happen.”

KFF Health News is a national newsroom that produces in-depth journalism about health issues.