Major hospital system's vaccine mandate may have violated religious rights, court says
by JACKSON WALKER | The National Desk
File photo of protesters rallying against required COVID-19 vaccinations (Photo by RINGO CHIU/AFP via Getty Images).
ROCHESTER, Minn. (TND)
The top-ranked Mayo Clinic, headquartered in Minnesota, may have violated the religious rights of five of its employees who were dismissed for failing to comply with its COVID-19 vaccine mandate, an appeals court ruled last week.
A district court in 2023 ruled the workers had failed to ground their complaint against the mandate in sincere Christian beliefs and ordered the suit be tossed out. However, a panel of judges with the 8th U.S. Circuit Court of Appeals in St. Louis now says the case warrants further review.
Contributing to the decision was Judge Duane Benton, an appointee of former President George W. Bush, and Judges Ralph Erickson and Jonathan Kobes, who were appointed by former President Donald Trump.
Mayo Clinic said it will vigorously defend its actions in a statement to The National Desk (TND).
Mayo Clinic established its vaccination program to protect the health and safety of our staff, patients and communities, it wrote. The program included an exemption to accommodate sincerely held religious beliefs, and Mayo granted the majority of requests for religious exemptions. In its decision, the Court of Appeals did not criticize Mayos vaccination program or its employment actions; rather, the court merely ruled that the plaintiffs may resume their legal claims.
Other major health providers have come under fire for similar vaccine requirements. Catholic healthcare system Providence Health & Services in 2023 asked its employees to receive a COVID vaccine to protect its "vulnerable patient population" and community.
Follow Jackson Walker on X at @_jlwalker_ for the latest trending national news. Have a news tip? Send it to jacwalker@sbgtv.com.
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Some 4.8 million doses of flu vaccine are now being prepared for use in response to the growing U.S. outbreak of highly pathogenic avian influenza, or H5N1, officials say.
The order for the doses to be filled into vials comes as the Centers for Disease Control and Prevention is investigating a growing number of human cases linked to the unprecedented outbreak of the virus in dairy cattle this year.
The supplies will be pulled from a "pre-pandemic" stockpile funded by the federal Administration for Strategic Preparedness and Response. Vaccinemaker CSL Seqirus has been tasked with manufacturing the doses at its North Carolina plant.
"It utilizes a highly scalable method of production and is currently positioned to deliver up to 150 million influenza vaccine doses to support an influenza pandemic response within six months of a pandemic declaration," CSL Seqirus said in a release.
The doses combine bulk stockpilesof two key ingredients: an "antigen" targeted at the H5 portion of the H5N1 virus with an "adjuvant" designed to boost the immune response triggered by the vaccine.
While manufacturing of these new bird flu doses is set to be completed by "later this summer," the vaccines still may not be immediately ready for use.
"I do want to decouple availability and manufacturing completion, because there is of course that regulatory component that would be needed to either approve or authorize actual use of the doses," ASPR's David Boucher told reporters Thursday.
The FDA has previously approved other vaccines to prepare for potential H5N1 pandemics, including a vaccine by Seqirus. It is unclear how soon the FDA could grant authorization to clear use of the new shots.
"While CDC's current risk assessment to the general public is low, if it is determined that the U.S. population needs to be vaccinated to prevent H5N1 influenza, then the FDA will use its regulatory pathways to take the appropriate steps to ensure vaccines are available in the timeliest manner possible," an FDA spokesperson said in a statement.
Boucher also said that authorities have so far not decided whether to recommend use of the vaccines. It is unclear who would be prioritized for the first shots if they are eventually deemed to be needed and rolled out for the public.
"If that changes in the future, we would be looking at the population for whom vaccination would be recommended and then making any decisions on prioritization at that time," said Boucher.
A panel of the CDC's outside vaccine advisers, which has discussed previous pandemic vaccines, is scheduled to meet in June to discuss H5N1 alongside its routine votes on recommendations for seasonal flu vaccines.
While the CDC says the risk to the general public from H5N1 remains low for now, the agency has warned that workers in places like dairy farms and production facilities are now at higher risk of infection and it has urged the industry to take precautions.
At least three workers at U.S. dairy farms have tested positive this year after working directly with infected cows.
The latest case in Michigan developed respiratory symptoms, officials announced Thursday, which could make it easier for the virus to spread from person to person.
"Simply put, someone who's coughing may be more likely to transmit the virus than someone who has an eye infection like conjunctivitis," the CDC's Nirav Shah said Thursday.
However, Shah said there is no evidence that person-to-person spread has happened so far. Contacts of the patient have so far not tested positive. Previous H5N1 spillovers around the world from different strains have also fizzled out after limited spread between people.
The CDC is now looking to see if the strain that infected the latest Michigan patient might have developed key mutations that could raise its risk of spread.
"The mere fact that this individual displayed some respiratory symptoms, again we should be alert, but in and of itself is not a cause to change course or suggest that we're at an inflection point," Shah 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.
The United States Department of Health and Human Services has expanded its avian flu pandemic preparedness partnership with CSL Seqirus, lining up the vaccine specialist to complete the fill-finish process for the shots.
Execution of this stage will increase the arsenal of vaccines acquired by the Biomedical Advanced Research and Development Authority (BARDA) under its National Pre-Pandemic Influenza Vaccine Stockpile (NPIVS) program.
It is the fourth award from BARDA to CSL Seqirus related to preparations for a potential outbreak of avian influenza (HPAI) virus, which has been detected in wild birds and livestock throughout the U.S.
With this agreement, CSL Seqirus will deliver 4.8 million vaccine doses that are matched to the current H5N1 strain of the virus.
On Thursday, the CDC reported on the spread of H5N1 in dairy cattle and two cases of humans contracting the virus.
The CDC maintains the risk to public health as low. We are closely monitoring the situation because we are acutely aware of the threat that influenza virus strains like H5N1 can pose and take seriously our role in preparedness efforts alongside our government and public health partners, Marc Lacey, CSL Seqirus, Global Executive Director for Pandemic, said in a release.
CSL will provide the vaccines from its massive manufacturing site in Holly Springs, N.C. which was built through a public-private partnership between the company and BARDA 15 years ago.
The facility can deliver up to 150 million doses within six months of the declaration of a pandemic, CSL Seqirus said, with a second phase of manufacturing enabling more vaccines as needed.
Two years ago, CSL Seqirus gained a ready to respond designation, meaning that in the case of a pandemic, it would immediately shift from its usual production of seasonal flu shots to the manufacture of those for the emergency.
Of the potential $2 billion award amount from the government to CSL Seqirus, BARDA has obligated $1.1 billion to the company, with $139 million of that paid for, according to USASpending.com.
In October 2022, CSL Seqirus scored a $30 million contract from BARDA to conduct a phase 2 trial of its avian flu candidate. In August of last year, BARDA awarded a $46.3 million contract to the company for one bulk lot of HPAI vaccines.
By Arthur Allen May 31, 2024
Even a peep of news about a new flu pandemic is enough to set scientists clucking about eggs.
They worried about them in 2005, and in 2009, and theyre worrying now. Thats because millions of fertilized hen eggs are still the main ingredient in making vaccines that, hopefully, will protect people against the outbreak of a new flu strain.
Its almost comical to be using a 1940s technology for a 21st-century pandemic, said Rick Bright, who led the Health and Human Services Departments Biomedical Advanced Research and Development Authority (BARDA) during the Trump administration.
Its not so funny, he said, when the currently stockpiled formulation against the H5N1 bird flu virus requires two shots and a whopping 90 micrograms of antigen, yet provides just middling immunity. For the U.S. alone, it would take hens laying 900,000 eggs every single day for nine months, Bright said.
And thats only if the chickens dont get infected.
The spread of an avian flu virus has decimated flocks of birds (and killed barn cats and other mammals). Cattle in at least nine states and at least three people in the U.S. have been infected, enough to bring public health attention once again to the potential for a global pandemic.
As of May 30, the only confirmed human cases of infection were dairy workers in Texas and Michigan, who experienced eye irritation. Two quickly recovered, while the third developed respiratory symptoms and was being treated with an antiviral drug at home. The viruss spread into multiple species over a vast geographic area, however, raises the threat that further mutations could create a virus that spreads from human to human through airborne transmission.
If they do, prevention starts with the egg.
To make raw material for an influenza vaccine, virus is grown in millions of fertilized eggs. Sometimes it doesnt grow well, or it mutates to a degree that the vaccine product stimulates antibodies that dont neutralize the virus or the wild virus mutates to an extent that the vaccine doesnt work against it. And theres always the frightening prospect that wild birds could carry the virus into the henhouses needed in vaccine production.
Once those roosters and hens go down, you have no vaccine, Bright said.
Since 2009, when an H1N1 swine flu pandemic swept around the world before vaccine production could get off the ground, researchers and governments have been looking for alternatives. Billions of dollars have been invested into vaccines produced in mammalian and insect cell lines that dont pose the same risks as egg-based shots.
Everyone knows the cell-based vaccines are better, more immunogenic, and offer better production, said Amesh Adalja, an infectious disease specialist at Johns Hopkins Universitys Center for Health Security. But they are handicapped because of the clout of egg-based manufacturing.
The companies that make the cell-based influenza vaccines, CSL Seqirus and Sanofi, also have billions invested in egg-based production lines that they arent eager to replace. And its hard to blame them, said Nicole Lurie, HHS assistant secretary for preparedness and response under President Barack Obama who is now an executive director of CEPI, the global epidemic-fighting nonprofit.
Most vaccine companies that responded to an epidemic Ebola, Zika, covid ended up losing a lot of money on it, Lurie said.
Exceptions were the mRNA vaccines created for covid, although even Pfizer and Moderna have had to destroy hundreds of millions of doses of unwanted vaccine as public interest waned.
Pfizer and Moderna are testing seasonal influenza vaccines made with mRNA, and the government is soliciting bids for mRNA pandemic flu vaccines, said David Boucher, director of infectious disease preparedness at HHS Administration for Strategic Preparedness and Response.
Bright, whose agency invested a billion dollars in a cell-based flu vaccine factory in Holly Springs, North Carolina, said theres no way in hell we can fight an H5N1 pandemic with an egg-based vaccine. But for now, theres little choice.
BARDA has stockpiled hundreds of thousands of doses of an H5N1-strain vaccine that stimulates the creation of antibodies that appear to neutralize the virus now circulating. It could produce millions more doses of the vaccine within weeks and up to 100 million doses in five months, Boucher told KFF Health News.
But the vaccines currently in the national stockpile are not a perfect match for the strain in question. Even with two shots containing six times as much vaccine substance as typical flu shots, the stockpiled vaccines were only partly effective against strains of the virus that circulated when those vaccines were made, Adalja said.
However, BARDA is currently supporting two clinical trials with a candidate vaccine virus that is a good match for what weve found in cows, Boucher said.
Flu vaccine makers are just starting to prepare this falls shots but, eventually, the federal government could request production be switched to a pandemic-targeted strain.
We dont have the capacity to do both, Adalja said.
For now, ASPR has a stockpile of bulk pandemic vaccine and has identified manufacturing sites where 4.8 million doses could be bottled and finished without stopping production of seasonal flu vaccine, ASPR chief Dawn OConnell said on May 22. U.S. officials began trying to diversify away from egg-based vaccines in 2005, when avian flu first gripped the world, and with added vigor after the 2009 fiasco. But with the resources we have available, we get the best bang for our buck and best value to U.S. taxpayers when we leverage the seasonal infrastructure, and thats still mostly egg-based, Boucher said.
Flu vaccine companies have a system that works well right now to accomplish their objectives in manufacturing the seasonal vaccine, he said. And without a financial incentive, we are going to be here with eggs for a while, I think.
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Eggs are a major tool in making vaccines that could potentially protect people from a bird flu outbreak -- but with the virus leading to the culling of birds, some scientists are worried. CBS News medical contributor Dr. Cline Gounder has more.
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The bird flu outbreak in U.S. dairy cows is prompting development of new, next-generation mRNA vaccinesakin to COVID-19 shotsthat are being tested in both animals and people.
Next month, the U.S. Agriculture Department is to begin testing a vaccine developed by University of Pennsylvania researchers by giving it to calves. The idea: If vaccinating cows protects dairy workers, that could mean fewer chances for the virus to jump into people and mutate in ways that could spur human-to-human spread.
Meanwhile. the U.S. Department of Health and Human Services has been talking to manufacturers about possible mRNA flu vaccines for people that, if needed, could supplement millions of bird flu vaccine doses already in government hands.
"If there's a pandemic, there's going to be a huge demand for vaccine," said Richard Webby, a flu researcher at St. Jude Children's Research Hospital in Memphis. "The more different (vaccine manufacturing) platforms that can respond to that, the better."
The bird flu virus has been spreading among more animal species in scores of countries since 2020. It was detected in U.S. dairy herds in March, although investigators think it may have been in cows since December. This week, the USDA announced it had been found in alpacas for the first time.
At least three peopleall workers at farms with infected cowshave been diagnosed with bird flu, although the illnesses were considered mild.
But earlier versions of the same H5N1 flu virus have been highly lethal to humans in other parts of the world. Officials are taking steps to be prepared if the virus mutates in a way to make it more deadly or enables it to spread more easily from person to person.
Traditionally, most flu vaccines are made via an egg-based manufacturing process that's been used for more than 70 years. It involves injecting a candidate virus into fertilized chicken eggs, which are incubated for several days to allow the viruses to grow. Fluid is harvested from the eggs and is used as the basis for vaccines, with killed or weakened virus priming the body's immune system.
Rather than eggsalso vulnerable to bird flu-caused supply constraintssome flu vaccine is made in giant vats of cells.
Officials say they already have two candidate vaccines for people that appear to be well-matched to the bird flu virus in U.S. dairy herds. The Centers for Disease Control and Prevention used the circulating bird flu virus as the seed strain for them.
The government has hundreds of thousands of vaccine doses in pre-filled syringes and vials that likely could go out in a matter of weeks, if needed, federal health officials say.
They also say they have bulk antigen that could generate nearly 10 million more doses that could be filled, finished and distributed in a matter of a few months. CSL Seqirus, which manufactures cell-based flu vaccine, this week announced that the government hired it to fill and finish about 4.8 million of those doses. The work could be done by late summer, U.S. health officials said this week.
But the production lines for flu vaccines are already working on this fall's seasonal shotswork that would have to be interrupted to produce millions more doses of bird flu vaccine. So the government has been pursuing another, quicker approach: the mRNA technology used to produce the primary vaccines deployed against COVID-19.
These messenger RNA vaccines are made using a small section of genetic material from the virus. The genetic blueprint is designed to teach the body how to make a protein used to build immunity.
The pharmaceutical company Moderna already has a bird flu mRNA vaccine in very early-stage human testing. In a statement, Moderna confirmed that "we are in discussions with the U.S. government on advancing our pandemic flu candidate."
Similar work has been going on at Pfizer. Company researchers in December gave human volunteers an mRNA vaccine against a bird flu strain that's similar tobut not exactly the same asthe one in cows. Since then, researchers have performed a lab experiment exposing blood samples from those volunteers to the strain seen in dairy farms, and saw a "notable increases in antibody responses," Pfizer said in a statement.
As for the vaccine for cows, Penn immunologist Scott Hensley worked with mRNA pioneer and Nobel laureate Drew Weissman to produce the experimental doses. Hensley said that the vaccine is similar to the Moderna one for people.
In first-step testing, mice and ferrets produced high levels of bird flu virus-fighting antibodies after vaccination.
In another experiment, researchers vaccinated one group of ferrets and deliberately infected them, and then compared what happened to ferrets that hadn't been vaccinated. All the vaccinated animals survived and the unvaccinated did not, Hensley said.
"The vaccine was really successful," said Webby, whose lab did that work last year in collaboration with Hensley.
The cow study will be akin to the first-step testing initially done in smaller animals. The plan is initially for about 10 calves to be vaccinated, half with one dose and half with another. Then their blood will be drawn and examined to look for how much bird flu-fighting antibodies were produced.
The USDA study first will have to determine the right dose for such a large animal, Hensley said, before testing if it protects them like it did smaller animals.
What "scares me the most is the amount of interaction between cattle and humans," Hensley said.
"We're not talking about an animal that lives on a mountain top," he said. "If this was a bobcat outbreak I'd feel bad for the bobcats, but that's not a big human risk."
If a vaccine reduces the amount of virus in the cow, "then ultimately we reduce the chance that a mutant virus that spreads in humans is going to emerge," he said.
2024 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed without permission.
Another human case of bird flu linked to sick dairy cows has been detected in Michigan, marking the third farmworker diagnosed with the illness in the United States since March, the Centers for Disease Control and Prevention reported Thursday. None of the cases are connected.
This is the second farmworker in Michigan in a week to be diagnosed with the illness. And a dairy worker in Texas was diagnosed in March. In those cases, the patients' only sign of illness was pinkeye, or conjunctivitis.
This latest case is different, however, because the patient also had upper respiratory symptoms, including sore throat, cough and congestion.
During a media briefing Thursday, Dr. Nirav Shah, the CDC's principal deputy director, said there's no indication yet that the virus, an A strain of influenza called H5N1, is spreading from person to person, although the risk does increase with respiratory symptoms.
"Simply put, someone who's coughing may be more likely to transmit the virus than someone who has an eye infection like conjunctivitis," he said.
The CDC is performing genetic testing on samples of the virus taken from the patient to look for changes that would indicate whether its mutating in ways that would allow it to be more transmissible. Those results could be available within days.
The latest patient also had eye discomfort and watery eyes, but it was unclear whether the person had been diagnosed with pinkeye. Like in the previous cases, the patient was given Tamiflu and was reportedly recovering.
Dr. Natasha Bagdasarian, chief medical executive for the Michigan Department of Health and Human Services said that neither of the sickened Michigan workers had been wearing full personal protective equipment, or PPE, when they became infected.
With the first case in Michigan, eye symptoms occurred after a direct splash of infected milk to the eye. With this case, respiratory symptoms occurred after direct exposure to an infected cow," Bagdasarian wrote in a press announcement. "PPE is an important tool in preventing spread."
All of the farmworkers at this latest Michigan dairy are being monitored for symptoms. The CDC recommended that anyone who comes into contact with a sick cow watch for symptoms for 10 days.
As many as 67 herds in nine states have been affected, according to the U.S. Agriculture Department. In addition to herds in Michigan, dairy cattle in Colorado, Kansas, Idaho, New Mexico, North Carolina, Ohio, South Dakota and Texas have also tested positive for bird flu.
Given the extent of the spread of this virus in dairy cows, additional human cases in people with higher risk exposures would not be surprising, the CDC said in a press release.
Federal health officials said that the risk of bird flu to the general public remains low, and that their focus continues to be on the potential risks among dairy workers.
"We should remain alert, not be alarmed," Shah said. The CDC said that its influenza surveillance systemshave not picked up any unusual flu activity.
The Department of Health and Human Services previously said that the government had started the "fill and finish" process of about 4.8 million doses of a bird flu vaccine. That process is likely to last until later this summer, said David Boucher, director of infectious diseases preparedness at HHS Administration for Strategic Preparedness and Response
At that point, the Food and Drug Administration would have to consider whether it is necessary to authorize such a vaccine.
Boucher said it would premature to speculate on who might be first in line for the shots.
This is the fourth case of H5N1 overall in the U.S. An inmate in Coloradowho had been working on a farm culling birds suspected to be infected with bird flu was diagnosed in 2022. His only symptom was fatigue.
Globally, less than 1,000 cases of H5N1 in humans have been identified. CDC data shows that more than half of those patients died, but that death rate may be an overestimate as mild cases may go undetected.
TheCDC recommendsthat anyone in contact with dairy cattle including bedding and animal feces wear protective equipment, including safety glasses, waterproof aprons and boots that can be sanitized.
The agency also said that people should not drink unpasteurized raw milk.
Erika Edwards is a health and medical news writer and reporter for NBC News and "TODAY."
Rise and shine, everyone, another busy day is on the way. We can tell because countless birds are chirping outside our window, the pace of motor vehicles passing by is picking up, and the official mascots are busy foraging for snacks on the campus. As for us, we are engaged in the usual ritual of brewing cups of stimulation. Our choice today is orange cream. As always, you are invited to join us. Meanwhile, here is the latest menu of tidbits for you to digest as you embark on your journey, which we hope is satisfying and rewarding. On that note, time to get cracking. Best of luck, and do keep in touch.
The U.S. government is nearing an agreement to bankroll a late-stage trial of Modernas mRNA pandemic bird flu vaccine, hoping to bolster its pandemic jab stockpile as an H5N1 outbreak spreads through egg farms and among cattle herds, The Financial Times reports. The federal funding from the governments Biomedical Advanced Research and Development Authority, known as BARDA, could come as early as next month. The agreement is expected to total several tens of millions of dollars, and could be accompanied by a commitment to procure doses if the Phase 3 trials are successful. Bird flu has been detected on poultry farms in 48 states and in dairy cow herds across nine states.
Clinical trials that are funded by the U.S. National Institutes of Health often enroll fewer Black patients and other underrepresented racial groups than planned, STAT writes, according to a study of 30 such trials sampled by the Office of the Inspector General of the Department of Health and Human Services. Most NIH-funded clinical trials that were reviewed missed planned enrollment targets by varying degrees. Clinical trials most commonly recruited fewer Black, Native American and Alaska Native, and Asian participants than originally planned. Clinical trials missed targets for female participants more often than they did for male participants.
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Moderna is nearing a deal with the US government to fund a late-stage trial of its bird flu vaccine, the Financial Times reported Thursday.
Millions of dollars of federal funding from the Biomedical Advanced Research and Development Authority could come as soon as next month, according to the report.
The Cambridge-based biotechnology company declined to share specifics but confirmed to the Globe that Moderna is in talks with the government and has finished testing a vaccine candidate on volunteers in a trial, with data expected soon. The vaccine appears to protect people from the bird flu variant that is circulating in the United States right now, according to Moderna.
We remain committed to using our mRNA platform to respond to public health concerns, the company said Thursday.
Moderna is the largest homegrown drug maker in Massachusetts by head count, with more than 4,400 employees in the state of as late 2023, the company has said.
The bird flu, which can be deadly, is an influenza virus that was initially discovered in the mid-1990s and became especially prominent in 2003, following a significant outbreak in poultry in China, according to previous Globe coverage. Human cases are not common and the public health risk is low, according to the US Centers for Disease Control and Prevention.
The CDC reports that 48 states have bird flu outbreaks in their poultry farms, which amounts to more than 92 million birds impacted by the virus.
Modernas potential agreement with the federal government comes as it faced a decline in COVID-19 vaccine sales and won a key battle in a vaccine patent dispute with Pfizer and BioNTech. The biotech giant faced loses of about $1.2 billion during the first quarter, according to its earnings report. It is now working on therapeutic vaccines to treat cancer, the Globe previously reported.
A timeline of the agreement has not yet been announced.
As of Thursday, Modernas share price had risen nearly 40 percent since the start of April.
Material from previous Globe coverage was used in this report. Staff writer Jonathan Saltzman contributed reporting.
Esha Walia can be reached at esha.walia@globe.com.
The US government is negotiating a deal to fund a late-stage trial of Modernas mRNA pandemic bird flu vaccine, the Financial Times reported on Thursday.
The news comes amid one of the worst H5N1 outbreaks in the recent years, with bird flu detected in poultry farms in 48 states and dairy herds in nine states.
Federal funding from the Biomedical Advanced Research and Development Authority (BARDA) could come as soon as next month, and would also include a promise to procure doses if the phase-three trials turn out to be successful, the report said.
It is expected to total several tens of millions of dollars, and could be accompanied by a commitment to procure doses if the phase-three trials are successful, it said.
Moderna and the US Department of Health and Human Services (HHS) did not immediately respond to Reuters requests for a comment.
The United States, Canada and Europe have been in active talks with firms such as CSL Seqirus and GSK to acquire or manufacture H5N1 bird flu vaccines, which could be used to protect at-risk poultry and dairy workers, veterinarians and lab technicians.
Last week, a second human case of bird flu was confirmed in the United States since the virus was first detected in dairy cattle in late March.
Bird flu has fuelled concerns as the disease is increasingly spreading to mammals, with the first-ever outbreaks detected in dairy cows in the United States, raising concerns about it spreading to humans through the nations milk supply.
Since 2022, bird flu has infected more than 90 million chickens, 9,000 wild birds, 52 dairy herds and three people in the country.
Jim Pollard is an Australian journalist based in Thailand since 1999. He worked for News Ltd papers in Sydney, Perth, London and Melbourne before travelling through SE Asia in the late 90s. He was a senior editor at The Nation for 17+ years.
