The state of Kansas has filed a lawsuit against the pharmaceutical giant Pfizer, alleging the company made misleading claims about its COVID-19 vaccine.
The lawsuit was filed by Kansas Attorney General Kris Kobach (R), and in it, he says that Pfizer made false claims about the effectiveness and the risks associated with the vaccine.
Kobach filed the lawsuit in the District Court of Thomas County. He claims in the filing that the drug company misled the states residents when it said the vaccine was safe and allegedly hid evidence of the shots link to myocarditis and pregnancy issues.
It also says that Pfizer boasted about the vaccine being effective but at the same time knew the shot would wane over time and not be effective against variants of the virus.
Pfizer made multiple misleading statements to deceive the public about its vaccine at a time when Americans needed the truth, Kobach said in a statement.
The suit says that Pfizer not only misled but worked with social media employees to censor speech critical of the vaccines and attempted to avoid oversight from the government.
Kobach is arguing that the language Pfizer used in its statements was in violation of the Kansas Consumer Protection Act and is seeking monetary damages for the companys actions. The amount Kobach is seeking has not been shared.
The Food and Drug Administration added a warning about the rare heart inflammation conditions myocarditis and pericarditis that were found to be connected to Pfizer and Modernas vaccines in June 2021.
However, it was discovered in a review by the National Institute of Health last year that the COVID-19 vaccine was not linked to an increased risk of miscarriage.
Pfizer has responded to the suit, telling The Hill that the case has no merit and is planning on responding in due course.
We are proud to have developed the COVID-19 vaccine in record time in the midst of a global pandemic and saved countless lives. The representations made by Pfizer about its COVID-19 vaccine have been accurate and science-based, the company said, adding later, Patient safety is our number one priority, which is why we follow diligent safety and monitoring protocols.
One in five adults infected with COVID-19 may still be suffering its effects months after their diagnosis, according to new research out of the United States.
An investigation by more than two dozen researchers found while the average time of recovery was 20 days, an estimated 22.5 per cent failed to recover 90 days after infection.
The report, based out of the United States and published in the Journal of the American Medical Association, mirrored recent reporting by Australian researchers.
The peer-reviewed study used data from the Collaborative Cohort of Cohorts for COVID-19 Research (C4R), a long-term collaboration of 14 different studies across the US.
Some of the studies have been following its own participants for up to 50 years, meaning they can now compare their health pre- and post-COVID-19 diagnosis.
A total of 4,708 participants were asked whether they were "completely recovered from COVID-19".
Once they confirmed their recovery, they were asked how long it had taken.
"[We] found that one in five adults infected with SARS-CoV-2 did not fully recover by three months post-infection in a racially and ethnically diverse US population-based sample," the report said.
"Recovery by 90 days was less likely in women and participants with pre-pandemic clinical cardiovascular disease.
"Vaccination prior to infection and infection during the Omicron variant wave were associated with greater recovery results were similar for reinfections."
The research team noted the results may have been limited by the self-reported recovery time and the "potential for measurement error, uncontrolled confounding and selection bias".
Dr Mulu Abraha Woldegiorgis, a researcher at the Australian National University (ANU), told the ABC it was "interesting" to see the findings classified by "before and after Omicron".
"The prevalence [of long COVID] during Omicron was the same as ours," she said.
"They use slightly different definitions and methodology, but even with that the prevalence was high. It shows us that long COVID is still a public health concern globally."
Four years after the beginning of the pandemic, much about "long COVID" remains a mystery for health officials.
According to the World Health Organization, long COVID "occurs in individuals with a history of probable or confirmed SARS-CoV-2 infection, usually 3 months from the onset of COVID-19 with symptoms that last for at least 2 months and cannot be explained by an alternative diagnosis."
Earlier this year Queensland's chief health officer called for the term "long COVID" to be scrapped despite stating the symptoms were "real".
"Using this term long COVID implies this virus has some unique, exceptional and sinister property that differentiates it form other viruses," Dr John Gerrard said.
"I want to make it clear that the symptoms that some patients describe after having COVID-19 are real. We believe they are real."
A study of more than 11,000 Australians who had tested positive for COVID-19 has had similar results almost one in five were still experiencing symptoms three months after a 2022 diagnosis.
The joint ANU and Western Australia Department of Health study, released in March, found 90 per cent of participants with long COVID were suffering multiple symptoms.
Tiredness, fatigue, "brain fog", sleep problems, coughing, and changes in their menstrual cycle were frequently reported.
"Among respondents with long COVID who had worked or studied prior to their infection, 15.2 per cent had reduced their number of hours, and 2.7 per cent had not returned to work at all," the report said.
The researchers also noted long COVID was more prevalent in its sample than the levels reported by other studies in the United Kingdom and Canada.
Dr Woldegiorgis was the lead researcher on the ANU report. She said Australia presented a "unique" cohort of highly vaccinated people.
"You have multiple symptoms, it's not just cough, or tiredness, they have multiple symptoms and that affects them," she said.
"A longer term assessment is important. What we saw was by 90 days, so a long term follow-up may provide additional information on how people are going in a year or two.
"What's the recovery period? Are they recovering soon or is the term longer?"
The report also found those who had been vaccinated were less at risk of developing long COVID.
"I want to stress the importance of vaccination," Dr Woldegiorgis said.
"In Australia the vast majority were vaccinated ... at least one dose prevents long COVID compared to no vaccination."
The call from President Donald Trump arrived at 9:30 Sunday morning, Nov. 1, 2020 two days before Election Day, when voters would decide whether Trump or challenger Joe Biden would occupy the White House.
Tony, I really like you but what the f--- are you doing? Trump told Anthony S. Fauci, according to the physicians new memoir, On Call: A Doctors Journey in Public Service.
For the next 15 minutes, the president aboard Air Force One mused about why Americans hated Fauci, mocked Bidens campaign as lackluster and vowed he would win reelection in a landslide. You really need to be positive you constantly drop bombs on me, Trump told Fauci.
The presidents anger had been stirred by Faucis interview with The Washington Post, in which the governments leading infectious-disease expert warned that coronavirus cases were surging again and called for the nation to abruptly change its response to save lives.
But the president ignored the most pointed criticism Fauci leveled in his interview with The Post, which was that the Biden campaign was taking covid-19 seriously from a public health perspective. Meanwhile, Trumps packed, maskless rallies were probably sources of viral spread, public health experts warned.
The call became the final conversation between the two native New Yorkers, Fauci writes a relationship that spanned the first year of the pandemic and became a source of national fascination.
It is just one of the revelations in Faucis 455-page memoir, which was published Tuesday.
On Call joins at least 16 other memoirs from former Trump and Biden officials that have attempted to explain the governments response to a pandemic that has killed more than 1 million Americans. Among them: books from former White House coronavirus coordinator Deborah Birx, former U.S. surgeon general Jerome Adams, former coronavirus testing coordinator Brett Giroir, and former White House adviser Scott Atlas. (Some of those memoirs have not sold well.)
None of those officials was Fauci the de facto face of the nations coronavirus response, as he acknowledges in his book.
This was good, in that I could both calm the countrys anxieties and provide factual information, Fauci writes. But it also led to the gross misperception, which only grew exponentially over time, that I was in charge of most or even all the federal governments response to the coronavirus.
Democrats ended up cheering Fauci for fact-checking the presidents claims sometimes in real time in White House meetings or briefings, where Trump repeatedly proclaimed that the anti-malarial drug hydroxychloroquine could fight covid-19, despite Fauci and other scientists saying there was no evidence to support that. In his memoir, Fauci details other private clashes, such as an Oval Office briefing in August 2020 when he told Trump that the president was wrong to dismiss the value of coronavirus testing. Trump ignored Fauci and simply moved onto the next topic.
The episodes soured Republicans on Fauci, and conservative media increasingly portrayed him as Trumps antagonist and blamed him for the most stringent coronavirus responses, such as social distancing. The scrutiny continues today: A Senate hearing scheduled for Tuesday, co-led by Sen. Rand Paul (R-Ky.), one of Faucis fiercest critics, is expected to examine whether Faucis former agency played a role in funding risky virus research that contributed to the start of the pandemic a claim Fauci says is baseless.
Most of Faucis memoir is devoted to earlier episodes in his career, such as his work combating HIV/AIDS across four decades or the anthrax scares following the Sept. 11, 2001, terrorist attacks.
He also recounts his interactions with previous presidents, such as an Oval Office meeting on Oct. 30, 1989, when he turned down then-President George H.W. Bushs offer to lead the National Institutes of Health, the United States premier scientific agency. Fauci said he preferred to remain director of the National Institute of Allergy and Infectious Diseases, a more hands-on role than leading the entire NIH. Fauci wound up holding that role until retiring from government in December 2022.
You son of a bitch, then-White House Chief of Staff John H. Sununu told Fauci after the meeting. Nobody says no to the president.
Those brushes with past leaders and experience saying no informed his interactions with the 45th president. Fauci writes that he first met Trump in September 2019 as the president signed an executive order to boost flu vaccine manufacturing an effort somewhat at odds with Trumps own beliefs. Trump told Fauci he had never received a flu vaccine until becoming president, because he never needed one.
Fauci was summoned to the White House to help lead the nations early coronavirus response in January 2020 partly because conservative political commentator Lou Dobbs, who had interviewed Fauci over the years, personally praised him to Trump.
Initially, the relationship between the president and the doctor was warm, in part because the two New Yorkers were able to relate to each other, Fauci writes. Even as anger grew over social distancing and other aspects of the governments response and conservative media lampooned Fauci Trump was the one person at the White House [who] continued to remain friendly to me, Fauci writes.
As the pandemic dragged on, Trump increasingly turned on his scientific adviser, saying he was too pessimistic, failing to inspire Americans.
In a June 2020 phone call, Trump screamed at Fauci for saying in a JAMA interview that the durability of coronavirus vaccines was uncertain and shots might be needed annually. The pronouncement coming on the heels of positive news about vaccine trials depressed the stock market, Trump asserted, costing the nation one trillion f---ing dollars.
President Trumps tendency to announce that he loved me and then scream at me on the phone well, lets just say that I found this to be out of the ordinary, Fauci writes in a chapter titled He loves me, he loves me not.
Masking was a repeated flash point. Fauci writes that Trump snapped at him before a May 2020 Rose Garden event when Fauci chose to wear a mask, with the president saying it would send the wrong signal to Americans watching at home. After Fauci insisted that he would stay masked, Trump ordered other officials such as Health and Human Services Secretary Alex Azar to remove their face coverings.
Fauci also describes strange and confusing conversations with the president, who sometimes had a distorted view of the doctors government role. After Trump tested positive for the coronavirus in October 2020 and received an experimental antibody treatment, he insisted that Fauci should approve the treatment for all Americans. Fauci responded that it was a Food and Drug Administration regulatory issue, and he had no sway.
Faucis memoir includes criticism of Trumps deputies: that Vice President Mike Pence sometimes overdid his subservience to Trump; that White House economic adviser Peter Navarro could not accept reality about hydroxychloroquine; and that Atlas delivered exactly what the president wanted to hear rather than public health advice. He also details episodes when the Trump White House sought to muzzle or attack him by circulating opposition research, although he shares some praise for Jared Kushner, the presidents son-in law and White House senior adviser, writing that Kushner had good common sense and certainly was not a villain despite his frequent portrayal in the media.
Fauci is much warmer about Trumps Democratic opponents, writing that former president Barack Obama called to personally reassure him as Fauci faced scrutiny over his agencys funding of experiments involving dogs, and that Biden and his deputies embraced and empowered him. No opposition research directed at me with this group, he writes.
The book does not dwell on congressional investigations that continue to ensnare Fauci or address Faucis conversations with scientists early in the pandemic as they debated the possible lab origins of the virus. David Morens, a former NIH official being probed by Congress for deleting emails related to the coronavirus, is not mentioned in the book, although Fauci includes him among the dozens of officials he thanks in the acknowledgments. Fauci told Congress earlier this month that he did not have a close working relationship with Morens and criticized his decision to delete emails.
Fauci details threats on his life, such as when he opened a letter in August 2021 containing white powder and a dire message: MANDATORY LOCKDOWNS REAP WHAT YOU SOW. ENJOY YOUR GIFT. Testing confirmed that the powder was not hazardous, but Fauci and his family spent hours worried he had been exposed to a deadly toxin.
I do not fear death, Fauci writes. But I was not ready to leave this earth yet. Not by a long shot.
At long last, New Yorkers have some more concrete insight into how the state conducted its COVID-19 emergency response in the crucial first two pandemic years in the form of a 262-page report from the firm Olson Group Ltd., commissioned in late 2022 by Gov. Hochul.
The study acknowledges much of what we already knew: preparations could be laid for a situation a bit like COVID, but no one could have predicted the scale and horrific contours of the emergency it created. Playbooks existed for the ramp-up of the disease up to a point, but beyond that it was uncharted territory.
Olson says that those best positioned to navigate these treacherous waters would have been a variety of bureaucrats and subject matter experts who had spent careers developing just such plans and emergency responses. Per the report, this is where things started really going off the rails, as former Gov. Andrew Cuomo decided to centralize decision-making, relying on executive orders to run the pandemic response out of his office.
Cuomos spokesman issued a statement on Twitter calling it ironic that the review found that in a time of unprecedented crisis, state government should vacate responsibility and delegate leadership. But the alternative wasnt to hand off COVID to some unknown; it was still part of Cuomos administration, so why not let it administer?
While Cuomos clear voice was welcome in a time of chaos, lower levels of his government still had a role. How is delegating tasks to his own agencies some kind of weak-willed abdication?
These lessons and others including the directive to improve access to health for marginalized populations overall, which were often left behind during the early pandemic in particular should be absorbed by decision-makers ahead of the unfortunately likely scenario of more highly infections and novel diseases.
And the report also hardly reckons with the thinking behind the biggest Cuomo-era COVID-related controversy the decision to make nursing homes accept COVID-19 patients discharged from hospitals in the early days of the pandemic. Yes, those were the peoples homes, but as we would learn, the nursing homes werent equipped to handle the infection. And then theres the matter of how to properly account for the deaths and where the deceased caught COVID. That also tripped up Cuomo and his aides.
Olson does delve into the nursing home matter, but does not answer crucial questions about who made that call or what went into it. Those are queries that still require more concrete answers.
Those answers about nursing homes and an understanding of why did the public health departments on the city and state level have their syndromic surveillance fail to flag COVID earlier, should come from a government review of the government response, by passing a state law to set up a formal commission, with subpoena power, a legal authority that Olson lacked.
The Olson report cost New York $4.3 million, or $16,500 in taxpayer money per page, including title and table of contents. Its real money, but COVID has killed more than 83,000 New Yorkers. Getting all the answers from a commission will be well worth whatever the price tag comes to be.
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In the US, a dairy-farm worker develops itching, blood-shot eyes. In Australia, a young girl falls ill after a foreign holiday and is rushed to hospital. In Mexico, another man, already ill and bed-bound, becomes seriously unwell and dies.
Each of these recent cases was caused by a different strain of influenza virus. In each case, it was an animal virus, which should not normally have turned up in humans at all. Should stories like this worry us?
When stories like this hit the news (and for influenza viruses, this happens quite often), journalists write to virologists and ask: how worried are you about this one?
The honest answer is that how any virologist really feels about a story depends on a lot of things, including our personalities: some of us are natural optimists, while others tend to catastrophise.
But our professional background does give us an idea of what to look for in a news story about a novel virus. When you next read about a novel virus in the news yourself, these are the questions that can help you decide how much of a worry it might be.
This is usually the first question. It's actually really hard for a virus to adapt to growing well in a new host species. Even influenza viruses basically bird viruses, but notorious for causing repeated human pandemics only manage it every few decades.
For a virus, crossing into people from a different animal host is a staged process. (I'm writing "people", but it's the same logic if you're worried about a virus crossing between any two host species, say, bird flu adapting to spread in cattle.)
Have people been exposed to the new virus and developed immune responses, but with no signs of infection? If there has been a "spillover" infection of a human (whether or not this caused serious illness), is there any sign that the virus has adapted enough to spread onwards to other people? And if the virus is now spreading among people, is that spread still at a point where it can be contained?
Surveillance is hard work that requires resources and cooperation, but it is hugely important in understanding and controlling outbreaks. So what do we look for?
Testing people for immune responses to a virus (serology) tells us who has previously been exposed. Sequencing viral genomes (from infected people or from the environment) tells us where the virus is now, but it also lets us work out how it is spreading and how it is changing.
We can do this because viruses mutate quickly. Lining up the differences in their genetic sequences lets us build family trees ("phylogenetic trees"), which we can use to reconstruct how the virus got to particular places at particular times.
Are we looking at one big outbreak or lots of separate outbreaks? Family trees can show us this. Looking at the changes in the virus' genome also lets us look for any telltale signs that it is adapting to a new species assuming we understand the virus well enough to work that out.
The better we understand a virus, the more we can anticipate what it might do next. For some very well-studied viruses, like the influenza viruses, we know some of the genetic changes that are warning signs of adaptation to a new host species.
What else can we look for? We worry more about viruses jumping between similar host species, because this is easier for the virus to do. Influenza that's already in a mammal is closer to being able to infect us than influenza from a bird.
We can look at likely routes of transmission a respiratory virus is likely to spread more quickly than a virus spread through sexual contact. We can also try to guess at the outcomes of infection viruses that cause serious disease are concerning, but in terms of spread, we also worry about less serious cases, which could lead to people spreading the virus without realising it.
However, viruses are tricky things, and in practice, it's really hard to predict what they will do.
The current outbreak of H5N1 influenza A viruses in cattle is a good example of this. An influenza A virus infecting cattle and then spreading through milk were both huge surprises. And while H5N1 is known to be capable of causing very severe disease, it seems that some cattle are carrying the virus without serious illness.
Experimental virology, in which animals and cell cultures are infected and studied under controlled conditions in secure laboratories, can be essential for understanding what a virus is really capable of.
Adapting to humans is hard for a virus, so anything that gives a virus more chances to pull this off is a concern. Sustained outbreaks are more of a risk than one-off cases.
We worry more about viruses in animals with close contact with humans. H5N1 spreading in North American cattle is more worrying than H5N1 spreading in South American elephant seals.
We worry about viruses taking shortcuts to adapting. For influenza viruses, this can happen in hosts like pigs that can pick up more than one virus at the same time and allow them to swap bits of their genome with each other.
And we worry about people doing anything that gives a virus more chances to get used to them. Things like drinking unpasteurised milk in areas where it could carry H5N1 influenza viruses, for example.
What would happen if things did get worse? Do we already have vaccines to this virus or to one very like it? Is there the capacity for making large numbers of those vaccines and distributing them to large numbers of people? Do we already have antiviral drugs? Do we know what's needed to manage the symptoms caused by the virus effectively?
Here, at least, it helps to face a virus like influenza that we've already been trying to fight for a long time.
The spread of a new strain of influenza virus around the world is just one of many viral threats, but the H5N1 strain of the virus has been doing a lot of things recently that cause us, as virologists, to watch it with concern.
While isolated cases can be devastating for the people involved, the bigger risk to society comes from viruses that spread and H5N1 influenza is now spreading, in US cattle as well as in birds around the world.
Importantly though, what it is not doing at the moment is anything that we would associate with it spreading among humans.
The current mood among virologists is definitely not what it was in, for example, February 2020, when it became clear that SARS-CoV-2 was spreading uncontrollably among humans.
But bird flu is doing enough concerning things at the moment to make us pay close attention to it. Hopefully, if we do that, we can all prevent things becoming a lot more worrying than they are now.
Ed Hutchinson, Senior Lecturer, Centre for Virus Research, University of Glasgow
This article is republished from The Conversation under a Creative Commons license. Read the original article.
The American population has little to no pre-existing immunity to the H5N1 avian flu virus circulating on dairy and poultry farms, according to preliminary findings from ongoing testing by the Centers for Disease Control and Prevention (CDC).
In other developments, outbreaks in dairy herds continue to be reported at a steady pace, along with sporadic detections in poultry flocks.
The CDC based its serology findings on blood collected from people in all 10 US regions during two earlier flu seasons2021-22 and 2022-23.
Scientists challenged the blood samples with the H5N1 virus to gauge if there was an antibody reaction. They found that antibody levels were low in people who were or weren't vaccinated against seasonal flu, hinting at little to no pre-existing immunity and that most of the population would be susceptible if the virus changed to a form that more easily spreads among people.
"This finding is not unexpected because A(H5N1) viruses have not spread widely in people and are very different from current and recently circulating human seasonal influenza A viruses," the CDC said regarding the study findings, which it included in aregular update on its response activities.
The risk to the general public remains low, and so far only three human infections have been reported in connection to the dairy farm outbreaks. All involved people who worked closely with cows.
In late May, federal health officials contracted withCSL Seqirus to fill and finish bulk supplies of one of two candidate H5 virus, enough for 4.8 million doses. The CDC has said the vaccine is a good match to the circulating H5N1 strain.
Globally, the main threat from the 2.3.4.4b clade viruses seems to be to people who have been exposed to infected animals. In a related development, Finland's health ministry last weekannounced that it will offer avian flu vaccine to people who may be exposed to the virus, such as poultry and fur-farm workers and veterinarians.
The ministry said it will receive a supply of the vaccine as part of a joint procurement among 15 European Union countries and that vaccination will begin as soon as possible. The vaccine was developed by Seqirus UK, Ltd.
The US Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) hasconfirmed 6 more H5N1 outbreaks in dairy herds, lifting the US total to 102. The latest confirmations involved 5 farms in Colorado and 1 in Iowa.
Also, the Iowa Department of Agriculture and Land Stewardship, in two separate statements, has reported three more outbreaks in dairy herds, two more inSioux County and one inPlymouth County, both in the northwestern part of the state.
Meanwhile, Minnesota reported another outbreak in commercial poultry, which involves a turkey farm that houses 33,100 birds in Stearns County in the central part of the state, according toAPHIS.
Blood tests show there is extremely low to no population immunity among Americans to the H5N1 avian flu virus, said theCenters for Disease Control. Most of the population would be vulnerable if the virus mutated to become more readily contagious, said the CDC, but it has identified two candidate vaccines that would offer good cross-protection against it.
Meanwhile, theAgriculture Departmentsaid H5N1 bird flu was confirmed in 102 dairy herds, up from 94 herds at the end of last week. Outbreaks have been identified in 12 states, from Idaho to North Carolina. Michigan has the most, with 25.
In an update posted on its website, the CDC said its ongoing tests of blood samples collected in two recent flu seasons suggest that there is extremely low to no population immunity to the H5N1 virus, regardless of whether people had received a vaccination against the seasonal flu.
This means that there is little to no pre-existing immunity to this virus and most of the population would be susceptible to infection from this virus if it were to start infecting people easily and spreading from person-to-person. This finding is not unexpected because A[H5N1] viruses have not spread widely in people and are very different from current and recently circulating human seasonal influenza A viruses, said the CDC.
However, earlier analyses found the virus is susceptible to antiviral medications used against the flu, and two candidate vaccines have been identified that would offer good production. The Department of Health and Human Services has ordered 4.8 million doses of vaccine as a precaution and says it has no plans at present to use them.
Federal officials said the bird flu risk to the general population is low. Three farmworkers contracted mild cases of bird flu since April 1. To date, more than 550 people have been monitored for bird flu as a result of exposure to infected or potentially infected animals, and at least 45 people have been tested for the H5N1 virus after developing flu-like symptoms, said the CDC.
Over the past few months, a bird flu outbreak has spread swiftly through dairy cows in the United States, infecting more than 90 herds in 12 states. Along the way, the virus has caused collateral damage in several other species, spreading from dairies to poultry farms and from cows into at least three farm workers, who developed symptoms of mild illness.
It has also caused mounting casualties in cats. On some dairy farms, sick or dead cats have provided an early signal that something was amiss. Theyre a bit of a canary in a coal mine, Dr. Kammy Johnson, a veterinary epidemiologist for the Agriculture Department, said at a news briefing on Thursday.
Since the dairy outbreak was first detected in late March, at least 21 cats in nine states have caught the virus, according to the department, which recently began tracking the feline cases.
Scientists have long known that cats are vulnerable to being infected by avian influenza, a group of flu viruses typically found in birds. In 2020, a new version of a bird flu virus, known as H5N1, emerged. It has spread rapidly around the world, infecting many wild birds and repeatedly spilling over into mammals, including cats.
Domestic cats are actually highly susceptible to avian influenza, and especially H5N1, said Kristen Coleman, an infectious disease researcher at the University of Maryland. But there has been a recent uptick in domestic cat infections, a drastic uptick.
There have been sporadic reports of infected dogs, too.
While bird flu infections of pets remain rare overall, they can be severe, especially in cats. It results in very severe illness and oftentimes death, Dr. Coleman said. So its very serious, and it should be taken seriously.
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A "small but detectable quantity" of infectious H5N1 bird flu virus was able to survive a common approach to pasteurizing milk, according to new research co-authored by scientists at the National Institutes of Health.
The findings, published Friday in The New England Journal of Medicine, were based on experiments run at the agency's lab. The researchers note this is not the same as finding infectious H5N1 virus in milk from grocery stores.
So far, officials have not detected infectious virus in any supermarket milk samples.
click to expand
The finding comes as authorities are still identifying new infected herds in this year's unprecedented outbreak of H5N1 bird flu in dairy cattle.
Infections have been detected in cows across farms in at least a dozen states, with most of the positive tests coming from raw milk samples that were teeming with the virus. Authorities have called on states to curb raw milk sales that could spread the virus, and have warned consumers against drinking raw milk.
"The study reflected experimental conditions, and should not be used to draw any conclusions about the safety of the U.S. milk supply," a Food and Drug Administration spokesperson said in a statement.
In the real world of commercial dairy processing, milk from infectious cows is likely being mixed with milk from healthy cows, diluting the virus and making it less likely there would be enough of it to survive. Technical details of how the milk is pasteurized, as well as additional steps to treat the milk, also cut the risk. Pasteurization involves treating the milk at high temperatures for a period of time to kill contamination.
Results from previous FDA studies of 297 samples of retail dairy products like milk and yogurt did not turn up any infectious virus. Earlier tests found only some harmless fragments of the virus leftoverfrom pasteurization.
"These are more or less experimental laboratory conditions. And we think that mechanical pasteurization in dairy farming will probably be more effective than what we do," said Vincent Munster, chief of the virus ecology unit at the National Institute of Allergy and Infectious Diseases.
Munster's lab in Montana has done work for years studying the ability of viruses to stay infectious in various conditions, including previous work pasteurizing pathogens in milk, like from an outbreak of coronaviruses in camels from Jordan.
In this study, they looked at two approaches of pasteurization, tested on milk with concentrations of H5N1 they added at levels similar to what has been seen from some highly infectious cows.
One pasteurization method they looked at heated milk to 72 degrees Celsius (about 161 degrees Fahrenheit) for 15 seconds, similar to the "high temperature short time" method that is used widely across the dairy industry. That yielded milk with what Munster said still had "minute amounts of infectious virus."
"You're really talking about like 10 virus particles, whereas the initial starting dose would be something like 10 million or 100 million virus particles," said Munster.
He also pointed to differences between the lab study and real-world industry practices which give commercial milk pasteurization a step up against the virus.
"There is an initial period in the dairy milk pasteurization that the milk needs to get from let's say 4 degrees to 72 degrees [Celsius]. And obviously once it starts hitting around 56 degrees, it already starts inactivating the virus," he said.
The second pasteurization approach a half hour at 63 degrees Celsius was more effective. Infectious virus was undetectable within minutes, long before pasteurization was over.
"Pasteurization methods were developed to actually reduce the amount of viable bacteria in milk to prolong fridge life, so to speak. And they're not necessarily initially designed to inactivate viruses," said Munster.
Munster thinks that even adding 5 to 10 more seconds of pasteurization could offer the dairy industry a "safety buffer," ensuring that there's no active virus leftover in milk even if their raw milk supply turns out to have greater concentrations of infectious virus than the lab's .
"If you really want to make 100% sure there's no active virus, increasing the duration even by like 5 to 10 seconds of pasteurization would allow you to actually increase that safety margin," Munster said.
But an FDA spokesperson said that their testing data so far shows the pasteurization processes used by U.S. dairy companies are effective at killing H5N1. Many companies "use temperatures that are greater, often much greater than the minimum standards," the spokesperson said, and equipment that more consistently heats milk.
"[T]he United States would hesitate to change pasteurization parameters without data to demonstrate a public health need," the spokesperson said, warning that changing the standards would affect the flavor of dairy products.
The agency has so far not released results from its own study to validate the pasteurization of raw milk for H5N1, first announced earlier this year. Last month, it cited "the totality of the evidence" in reiterating that "the commercial milk supply is safe."
The spokesperson said the FDA's study "is a top priority for the agency" and that they were working to share the results in the near future. The agency is looking to validate "real-world processing conditions" with equipment used in commercial facilities.
"Sound science is critical to informing public health decisions like those made by the FDA related to food safety and we take this current situation and the safety of the milk supply very seriously," the spokesperson said.
Munster said the FDA and the U.S. Department of Agriculture also have studies looking at pasteurization, among a number of groups that have confirmed heating up milk is often able to fully inactivate the threat from H5N1 virus.
"Fortunately, they do actually inactivate viruses very well. But I think the focus point should be two fold: making sure that pasteurization is up to the task we're asking from it, and the data suggests that it is, but also that we should minimize any H5N1 positive milk actually coming into these dairy pasteurization," he said.
Alexander Tin is a digital reporter for CBS News based in the Washington, D.C. bureau. He covers the Biden administration's public health agencies, including the federal response to infectious disease outbreaks like COVID-19.
