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EPISODE 156 OSTERHOLM UPDATE
Episode 156: H5N1: An Impending Crisis?
Dr. Osterholm
WHERE TO LISTEN

May 2, 2024
In "H5N1: An Impending Crisis," Dr. Osterholm and Chris Dall discuss the spread of H5N1 avian influenza in US
dairy cows, cover the latest COVID-19 trends, review two articles on long COVID, and answers a listener question about the safety of raw milk and other dairy products. Dr. Osterholm also shares a timely "This Week in Public Health History" segment and interviews the final two members of the podcast team.

Early tests of H5N1 prevalence in milk suggest U.S. bird flu outbreak in cows is widespread (STAT, subscription may be required)
Massive amounts of H5N1 vaccine would be needed if there's a bird flu pandemic. Can we make enough? (STAT, subscription may be required)
Long-COVID patients more likely to report psychiatric symptoms, cost barriers to therapy (CIDRAP News)
The persistence of SARS-CoV-2 in tissues and its association with long COVID symptoms: a cross-sectional cohort study in China (Lancet Infectious Diseases)

EPISODE
156
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Episode 156: H5N1: An Impending Crisis?
01:01:19

https://www.statnews.com/2024/...

Bird flu virus circulated in cows for four months before outbreak confirmed by USDA, analysis shows
Megan Molteni
By Megan Molteni May 2, 2024

Colorized microscopic image of H5N1 bird flu virus particles (in yellow).
NIAID
As agricultural authorities and epidemiologists try to get their arms around the scope of the latest confounding chapter in the decades-long story of the H5N1 avian influenza virus — its jump into U.S. herds of dairy cattle — they're turning to the genetic breadcrumbs the virus leaves behind in the animals' nose, lungs, and, primarily, milk.

On Wednesday, U.S. Department of Agriculture scientists released a preprint — a study that has not yet been peer-reviewed — describing for the first time what their investigations of 220 viral genomes from infected cows have so far turned up. The study's authors suggest that the spread in cattle started from a single spillover event from birds in the Texas panhandle that may have happened in early December. The USDA didn't confirm the presence of H5N1 in a Texas herd until March 25.

"These data support a single introduction event from wild bird origin virus into cattle, likely followed by limited local circulation for approximately 4 months prior to confirmation by USDA," the authors wrote.

The findings add more precision to what had previously been reported by academic scientists. Reading viral genomes can provide clues to the origins of the outbreak and allows researchers to monitor how the virus, which primarily infects wild and farmed birds, is changing as it finds a foothold in bovine hosts.

In an initial analysis of USDA genome sequence data released last week, academic DNA sleuths had revealed that the outbreak in dairy cows has likely been going on for months longer than previously realized, and has probably spread more widely than official numbers would suggest. So far, the USDA has reported 36 herds in nine states have tested positive for the virus.

The new analysis also offers a window into how the bird flu is changing as it spends time in the bodies of cattle.

In the last few years, H5N1 has spread from wild birds to a variety of carnivorous mammals, including foxes, bears, and seals, but in each of those instances, the virus has hit a dead end. The outbreak in dairy cows represents one of the first times that this bird flu virus has demonstrated the ability to efficiently transmit between mammals, said Thomas Mettenleiter, a virologist who served as the director of the Friedrich Loeffler Institut — Germany's leading animal disease research center — from 1996 until he stepped down last year. The other instance was a number of outbreaks at mink farms in Spain and Finland in 2022 and 2023, respectively.

"These spillover events don't usually lead to transmission chains," he said. "This situation is definitely an eye-opener for me."

Related: Tracking bird flu virus changes in cows is stymied by missing data, scientists say
The USDA's analysis found about two dozen mutations that have arisen in the H5N1 virus as it has circulated in dairy cattle that are known to make influenza viruses more deadly or more likely to be able to infect humans.

"It's still really difficult to draw a risk map out of that, but there seems to be ongoing evolution," Mettenleiter said. "This is not surprising but it's good to know. All these mammal-to-mammal passages, as we would do experimentally, put an evolutionary pressure on the virus to mutate and this is what we see with the increase of these known mammalian adaptation markers."

Vivien Dugan, director of the influenza division at the Centers for Disease Control and Prevention, told STAT Thursday that the mutations found so far did not raise any immediate red flags for increased risk to human health.

"I think based on our analysis of the consensus and some of that raw [sequence] data — because we have a good data-sharing relationship with USDA — we've not seen anything that would be concerning to us for mammalian adaptation, at this point," Dugan said.

The CDC has been testing existing H5 vaccines in ferrets, and found that vaccination appears to offer cross-protection against the virus from the man who was infected in Texas.

Scientists who have been frustrated by the slow drip of data from the USDA's investigations hailed the preprint on social media as progress. "Really grateful to this research team for sharing this, though I hope they weren't holding on to the data solely to ensure they published first," Angela Rasmussen, a virologist who studies pathogens that jump from animals to people at the Vaccine and Infectious Disease Organization at the University of Saskatchewan, in Saskatoon, Canada, posted on X on Thursday.

For weeks, the agency has been facing criticism from scientists and pandemic experts for a lack of transparency and timely sharing of data about the outbreak that has slowed down efforts to track its progress. When the USDA finally uploaded a large tranche of genetic sequences of the pathogen to a public database, researchers eager to analyze the sequences to determine if the H5N1 virus has been changing as it is transmitted from cow to cow quickly discovered that the sequences didn't include necessary information about when and where the samples were collected. All are simply labeled with "USA" and "2024."

The USDA has denied taking that basic information — called metadata — off the sequence files. The agency's Animal and Plant Health Inspection Service has said it is sharing raw sequence data as quickly as it is available and plans to upload "consensus sequences," which are more thoroughly edited and contain the metadata scientists are seeking, when they are ready.

https://www.statnews.com/2024/...

Massive amounts of H5N1 vaccine would be needed if there's a bird flu pandemic. Can we make enough?
Helen Branswell
By Helen Branswell April 24, 2024

The unsettling reality of H5N1 bird flu circulating in dairy cow herds in multiple parts of the United States is raising anxiety levels about whether this dangerous virus, which has haunted the sleep of people who worry about influenza pandemics for more than 20 years, could be on a path to acquiring the ability to easily infect people.

To be clear, there is no evidence that this is currently the case — the sole confirmed human case reported in Texas three weeks ago was in a farm worker who had contact with cattle. There is no way to predict if the virus will acquire the capacity to spread between people, or when and under what conditions it would make that fateful leap if it does.

But the first signs that H5N1 — or any new flu virus — was starting to spread from person to person would trigger a race to produce massive amounts of vaccine to try to mitigate the damage a flu pandemic might be expected to cause. While the 2009 H1N1 pandemic is estimated to have killed about a quarter-million people worldwide — severe flu seasons sometimes kill more — the 1918 Spanish flu pandemic is believed to have killed between 50 million and 100 million people, many times more than Covid-19.

The good news: The world makes a lot of flu vaccine and has been doing it for decades. Regulatory agencies have well-oiled systems to allow manufacturers to update the viruses the vaccines target without having to seek new licenses. The United States even has some H5 vaccine in a stockpile that it believes would offer protection against the version of the H5N1 virus infecting dairy cattle, though there would not be nearly enough doses for the entire country.

Related: H5N1 bird flu virus particles found in pasteurized milk but FDA says commercial milk supply appears safe
The bad news: The current global production capacity isn't close to adequate to vaccinate a large portion of the world's population in the first year of a pandemic. And batches of flu vaccine, often (though not always) produced in hen's eggs, take months to produce.


The Covid pandemic saw vaccine manufacturers around the world pump out unprecedented amounts of vaccine in an extraordinarily short period of time. By February 2022, 14 months after vaccination efforts began, it was estimated that 11 billion doses of vaccine had been produced and delivered. Could that record be matched — broken? — if H5N1 starts a pandemic? Would the profound inequity of the Covid vaccine distribution, which had affluent countries awash with doses while low-income countries waited for supplies, be remedied or repeated?

Experts STAT interviewed suggested that in some respects, the world is better positioned to produce pandemic flu vaccines, if the need arises. But a number warned that assuming the successes of Covid vaccine production would automatically influence the speed and scale of pandemic flu vaccine production would be unwise.

"You just have a different [production] system for flu vaccines than we developed on the fly for Covid," said Richard Hatchett, CEO of the Coalition for Epidemic Preparedness Innovations, better known as CEPI, an international organization tasked with spurring development of medical countermeasures for diseases that can cause epidemics and pandemics. "And the … system that we developed for Covid can't just be repurposed for flu."

Let's explore some of the ways the world is perhaps better prepared than it was in the past, and some of the snarls that could slow efforts to protect against a dangerous pandemic.

What the need would be
To gain protection against seasonal flu, most people get vaccinated with one dose of vaccine. Young children who've never been vaccinated against flu are an exception; kids ages 6 months to 8 years must get two doses of vaccine, at least four weeks apart, the first time they are vaccinated.

Why? Because they are considered to be "naive" to influenza, and their immune systems need to be primed (introduced to flu viruses) and then boosted. Anyone over age 8 is likely to have encountered flu before; they've already been primed. One dose is sufficient to acquaint immune systems to the evolved versions of previously encountered seasonal flu viruses.

But with a brand-new flu virus — and H5N1 definitely falls into that category for humans — everyone will be naive. So the assumption of pandemic planners is that everyone would need two doses of vaccine in the first season of vaccinating against H5N1. (During the 2009 H1N1 pandemic, the new virus was distantly related to one that had circulated for much of the previous century, and one dose was adequate for protection. There's no expectation that would be true with an H5 pandemic.)

That math is daunting: The 8.1 billion people worldwide times two is 16.2 billion doses. Babies under the age of 6 months aren't vaccinated against flu — their immune systems aren't yet sufficiently developed for it to be effective — so that number would be a bit lower. But there's always waste in vaccine delivery, so the 16 billion probably isn't far off.

Who's most at risk?
Speaking of kids, there's a dynamic at play with H5N1 that wasn't seen in the Covid pandemic, one that adds to the complexity of vaccinating the planet in a flu pandemic.

The vast majority of Covid deaths were in older adults; there were relatively few deaths in children. But flu infections are hardest on older adults and little kids. In the 2009 H1N1 pandemic, it is estimated that nearly 1,300 children under the age of 17 died in the United States, a high toll when compared to a typical flu season. And 2009 was mild, in pandemic terms.

Furthermore, kids amplify the transmission of flu in communities, Hatchett said, noting the fall wave of the 2009 pandemic in the U.S. started in late summer, when southern states went back to school. A really bad pandemic could change public opinion rapidly, but at present it seems unlikely there would be much appetite for closing schools to slow spread of a new flu virus. School closures are one of the most reviled of the containment measures that were used in the Covid pandemic.

"The disease is different. It behaves differently. It has different mortality patterns and different transmission patterns. And we would be in a setup because we'd be coming out of Covid with a Covid mindset and Covid biases that would jeopardize our ability to do the right thing if there were a flu pandemic," Hatchett said.

So while the United States waited into 2022 before starting to vaccinate children against Covid — and some countries didn't vaccinate children at all — kids will be in the pool of people who need to be vaccinated when the next flu pandemic hits.

What the current production capacity is
An assessment of market capacity published by the World Health Organization in January estimated that the combined global supply was 1.2 billion trivalent doses of flu vaccine, which target three flu virus strains at a time. During a pandemic, the vaccine made would target a single virus, the new one.

So, in theory, 1.2 billion vaccine doses could become 3.6 billion vaccine doses. More than 85% of those doses are made by seven producers, the WHO analysis said, and over 95% of seasonal vaccine doses are used in high- and upper-middle income countries, which will almost certainly have first dibs on pandemic vaccines. More on this later. Back to the math.

How much vaccine would each person need?
The 3.6 billion doses would be enough for 1.8 billion people. But that's only if the same amount of vaccine used to protect against seasonal flu viruses would protect against H5N1. And there we run into another problem.

Research done in the mid-2000s found that H5N1 is poorly immunogenic in people; it doesn't trigger a strong immune response unless it's administered in large amounts, or is given with a boosting compound known as an adjuvant that broadly stimulates the immune system.

In a seasonal flu shot, each component contains 15 micrograms of antigen or vaccine. In that study, which was published in the New England Journal of Medicine, it took two doses of 90 micrograms — 12 times the amount used to protect against a strain in the seasonal vaccine — to induce what's thought to be a protective response in just over half of the volunteers. In a world where need will outstrip supply, that's a wholly unworkable dosage.

In the years since, multiple studies have been conducted to see whether adjuvants could lower the amount of antigen needed and stretch supplies. They do. Some studies have even suggested fractional doses, with an adjuvant, could be effective. For example, CSL Seqirus, which supplies flu vaccine to the U.S. market and has a licensed pandemic H5N1 vaccine in the National Pre-Pandemic Influenza Vaccine Stockpile (NPIVS), showed that 7.5 micrograms, with an adjuvant, would generate what's thought to be a protective response in a portion of adults. The studies were small, so the range of the estimates is broad, but between 28% and 64% of volunteers ages 18 through 64 and 17% to 57% of volunteers ages 65 and older developed what is thought to be a protective level of antibodies from the 7.5 microgram shot.

Related: Why a leading bird flu expert isn't convinced that the risk H5N1 poses to people has declined
But not all flu vaccine manufacturers use or have proprietary adjuvants. CSL Seqirus and GSK do; Sanofi, a major producer of flu vaccines, currently does not. And the global supply of adjuvants could be a bottleneck in any effort to vaccinate the world against H5N1, experts say.

"I would be very curious to know what the global production capacity for the relevant adjuvants that we have data for would be. And I suspect it would be vastly insufficient to what is needed," Hatchett said.

The U.S. has stores of adjuvants in the NPIVS, said David Boucher, director of infectious diseases preparedness and response for the Administration for Strategic Preparedness and Response (ASPR), a division of the Department of Health and Human Services.

How quickly could the U.S. respond?
The United States has been doing active pandemic preparedness work for at least the past two decades. It understood that domestic production of flu vaccine would be critical in a pandemic, when borders might close to exports if a situation became dire. (Witness India's refusal to export Covid vaccines in spring 2021 when it was hit with a huge wave of cases.) The government incentivized development of flu vaccine manufacturing and fill-and-finish operations in the U.S.

The country, through ASPR, has worked with flu vaccine manufacturers to develop and test batches of H5N1 vaccines targeting different versions of the virus. H5N1 vaccine has already been tested in children, which will help speed availability for a group that is typically at the end of the testing list. (Manufacturers are reluctant to test vaccines in children until they have lots of adult safety data.)

There are currently four types of H5N1 vaccine in the NPIVS, said Boucher. Analysis of the viruses they are based on and the viruses from the cattle outbreaks suggests that two of the stockpiled vaccines are sufficiently close, genetically, to be useful, should this version of the virus take off, the WHO and the CDC have stated.

"We have right now two candidate vaccine viruses that are very well matched to the current virus from those we have," Boucher said. About 10 million doses are being stored in bulk, and "hundreds of thousands" of doses have already been placed in vials.

That's a start. But with two doses needed per person, it would not go very far. Boucher said decisions on who the first doses would go to have yet to be made.

Those vaccines haven't been approved by the Food and Drug Administration, but the agency has a fast-track process for updating flu vaccines, and a lot of recent experience with emergency authorization of pandemic vaccines. It can make this happen fast.

"Some fraction" of the doses in the filled vials could be available within weeks, Boucher said, depending on how quickly the regulatory process went. And while the bulk antigen was being put into vials, large-scale manufacturing would kick into gear. He estimated that tens of millions of doses could be manufactured over a four- or five-month period. An ASPR spokesperson later put the figure at about 125 million doses. (Remember, 125 million doses would be enough to vaccinate 62.5 million people, about a fifth of the U.S. population.)

Kathleen Neuzil, a longtime influenza vaccine researcher at the University of Maryland who takes over as director of the Fogarty International Center at the National Institutes of Health in early May, studied one of the two stockpiled vaccines that Boucher mentioned. It is based on an H5N8 virus and has the same key component as H5N1. (The major target of a flu vaccine is the hemagglutinin protein on the viruses' surface, the H in a strain's name.) Her group tested blood from people vaccinated with it against a virus related to the ones that have been seen in cows, which come from a subgroup of H5N1 known as 2.3.4.4b. Although the vaccine targets a 2.3.4.4c virus — a slightly different clade — the researchers saw good antibody responses in people who had received two 15-microgram doses of the vaccine, with adjuvant.

"We had tested this H5N8 vaccine that's in the stockpile to that strain, and it had pretty good cross reactivity — if you use an adjuvant," Neuzil told STAT.

Would the stockpiled vaccine protect us, if H5 triggers a pandemic?
Two vaccine and pandemic preparedness experts who used to work for the FDA recently questioned how useful the stockpiled vaccine would be, in an opinion piece in STAT. "Let's say that by a miracle that it really is a good match, that it's protective and all that. It's available in such limited numbers it's just not meaningful for the response," Luciana Borio, a former acting chief scientist at FDA and former member of the National Security Council, said in an interview.

Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, said it would be prudent to remember the vaccine experience of the 2009 pandemic when making projections about how effective the stockpiled vaccine might be against a virus that evolves to be able to spread from person to person. A study of how well the vaccine worked then showed good protection for young people but no discernible protection for older adults. "You had the strain in the vaccine. And you still saw a relative lack of protection that you would expect to have with a closely matched virus," he said.

Then there's the issue of how long it takes to produce additional doses, if they are needed. Making a new type of flu vaccine requires manufacturers to learn how to grow large volumes of the viruses. Some viruses grow better than others; sometimes it takes time to learn how to optimize growth. In 2009, manufacturers initially struggled to produce adequate supply of viruses, delaying rollout of the vaccines.

In fact, though tens of millions of Americans were vaccinated against H1N1 in 2009, the fall wave of that pandemic — when the vast majority of U.S. cases occurred — had already largely subsided by the time vaccine doses were available in substantial numbers.

(Source: The Center for Infectious Disease Research and Policy, the University of Minnesota)

Could mRNA vaccines be a wild card?
During the Covid pandemic, messenger RNA vaccines — which are quicker to make because they don't require growing supplies of virus — hit the market with incredible speed. But it's not clear what role mRNA vaccines would play in a flu pandemic, if one were to occur soon.

Both Pfizer and Moderna, the major mRNA players, are developing flu vaccines they hope to combine with Covid shots in a bid to boost flagging sales of the latter and grab a share of the pretty saturated seasonal flu vaccine market. Both have reported that for influenza A — H5N1 belongs to that large flu family — their vaccines appeared to induce immune responses similar to those seen generated by traditional flu vaccines.

Moderna is currently testing an H5N1 vaccine, from the 2.3.4.4b subset of viruses, in people. That trial began last summer.

But the trial's listing in the Clinicaltrials.gov database is cagey about the dosages Moderna is testing, calling them simply dose number 1, 2 and 3. Christopher Ridley, Moderna's vice president of communications, said the detail was obscured for "competitive reasons." Given how likely it is for mRNA vaccines to induce unpleasant side effects, especially at higher doses, and given how poorly immunogenic H5N1 viruses are, finding a sweet spot — an mRNA H5 vaccine that would be both effective and tolerable to take — could take some work.

Hatchett thinks that regulators will want more data before they embrace mRNA vaccines as a solution in a flu pandemic — though he and others have noted that in a true crisis, "all bets are off."

"My intuition would be that we are still in a vulnerable period when it's not just an instant solution," he said of the mRNA option. "I think if we make the proper investments, we could very soon get to the point where we know what the dose needs to be and have mRNA vaccines against avian strains as part of our arsenal and scale it quickly. I just don't think we've worked that through yet."

Boucher said ASPR is looking to add mRNA H5N1 vaccine to the stockpile, having recently issued a request for proposals from manufacturers. It is still assessing the submissions it generated, he said.

Seth Berkley, who stepped down last summer after 12 years as CEO of Gavi, the Vaccine Alliance, raised other questions about mRNA as an option for a pandemic flu response, noting that with the Covid mRNA vaccines, the protection against any infection waned quickly and the vaccines needed to be stored at ultra-cold temperatures, which made them impractical for parts of the world.

"But if you were to say, we want to make flu vaccines for the world, would that be mRNA technology? Or … wouldn't you want a vaccine, probably adjuvanted, that would take a little longer to make, but might be inexpensive and easy to produce and give longer immunity?" Berkeley mused. "We don't know, but those are the questions that will have to get asked, and they didn't get asked in Covid because of the emergency we were in."

Will lower-income countries have to wait yet again?
In 2009, the Obama administration announced it would donate 10% of the U.S. stocks of vaccine, as they rolled off the manufacturing line, starting after high-risk people in the country were vaccinated. Hatchett was one of the people tasked with running that program.

Other countries were persuaded to join, and the WHO led an effort to redistribute vaccine to countries that could not buy their way into the vaccine purchasing lines. Eventually, Hatchett said, about 200 million doses were donated, but by the time they were available, the pandemic had subsided. When the program was wound down in October of 2010, about 80 million doses had been distributed.

Fast forward to the Covid pandemic. Nearly 2 billion doses of Covid vaccine were distributed through COVAX, an entity set up by the WHO, Gavi, CEPI, and UNICEF (the United Nation's Children's Fund) to try to secure vaccine for countries boxed out of the market. And still, vaccine distribution was hugely inequitable. That fact was part of the inspiration for the ongoing efforts to come up with an international pandemic accord that would try to ensure vaccines, drugs, and other medical essentials are more fairly distributed in the next pandemic. Those efforts have struggled to reach a consensus acceptable to all parties.

People who know the flu vaccine market think the dynamics may not be vastly different in the next pandemic than they were in the last two.

"I would say even today, it's true that the countries with the manufacturing capacity will be the countries with the early access to these vaccines," Neuzil cautioned.

An in-depth analysis of global seasonal and pandemic flu vaccine production capacity, led by the WHO and based on 2019 data, showed that low- and middle-income countries made up 38% of the world's population, but produced 2% of seasonal influenza vaccine. There was no flu vaccine production in Africa, and a Moderna plan to build an mRNA vaccine production facility there was recently shelved, a move the company ascribed to the sharp drop in sales of its Covid vaccine.

Hatchett said a problem that existed in 2009 was the fact that high-income countries that bought seasonal flu vaccine had provisions in their contracts that gave them first or early access to pandemic vaccine, if the need arose. When H1N1 emerged, "all of the vaccine that could be produced in Europe was absorbed," he said. "And I suspect those contingent purchase contracts are probably still in place, and probably you would have the exact same phenomenon again."

https://www.cidrap.umn.edu/avi...

USDA genome study sheds light on H5N1 avian flu spillover to cows, but data gaps remain
Lisa Schnirring Today at 3:19 p.m.
Avian Influenza (Bird Flu)

The H5N1 virus infecting dairy cattle in multiple states was probably circulating in the animals for 4 months before scientists confirmed it in late March, and missing data and surveillance gaps raise the possibility of undetected transmission chains, a research team led by the US Department of Agriculture (USDA) National Veterinary Services Laboratory (NVSL) reported in a new preprint study.

In the first published report that interlaces genetic sequencing findings with what's known from the epidemiological investigation, the group said asymptomatic cattle movement to other states is likely driving transmission and that they are already seeing a few variants with mutations that could lead to interspecies transmission. The group published their findings yesterday on the preprint server bioRxiv.

In other H5N1 developments, the USDA last night announced that its tests on retail ground beef from affected states were negative, and two affected states—Michigan and Colorado—announced new emergency measures.

Data gaps and timeline questions
Phylogenetic analysis using genome sequencing suggests that there was a reassortment event in late 2023 between the current highly pathogenic 2.3.4.4b clade in wild birds and a low-pathogenic wild bird strain, which produced the B3.13 genotype now circulating in dairy cows.

The NP gene acquired during reassortment may have played a role in the emergence in cattle, they wrote, noting that the NP gene seems to allow influenza viruses to spread more easily in pigs.

Their analysis suggests there were as many as five B3.13 introductions from cattle to poultry, one to a raccoon, two to domestic cats, and three to wild birds. Though the findings track with epidemiological findings of spread through movement of herds to other states, they emphasized that there are still gaps. "We cannot exclude the possibility that this genotype is circulating in unsampled locations and hosts as the existing analysis suggests that data are missing and under surveillance may obscure transmission inferred using phylogenetic methods," they wrote.

For example, they said the B3.13 virus from the human infection doesn't nest within cattle sequences, which could suggest that viruses from unsampled cows were the source of the infection or that evolution within the host was enough to result in a different phylogenetic grouping. "It is most likely, however, that asymptomatic transmission and undersurveillance in epidemiologically important populations drove this pattern."

They conclude that the potential for B3.13 to become endemic in cattle will influence the zoonotic risk from the virus and warned that if the low level of mammalian adaptations they're seeing become dominant, the risk of interspecies transmission will be higher.

Scientists welcome new data
After the group published its report, Angela Rasmussen, PhD, a virologist with the University of Saskatchewan's Vaccine and Infectious Disease Organization, on X (formerly known as Twitter), praised the group for sharing the critical data.

However, she said more information is needed, such as the tissue and or sample type each genome came from, which is essential for understanding how cows are transmitting the virus and planning experiments to test transmission hypotheses. "This is an all-hands situation and transparency & data access are required for an effective response," Rasmussen wrote.

Michael Osterholm, PhD, MPH, who directs the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota, publisher of CIDRAP News, also credited the USDA group for sharing their findings and said the science community has been anxiously waiting for the critical information.

"This will help people better understand how the spillover unfolded," he said.

Ground beef tests negative for H5N1 traces
In its update, the USDA said it tested 30 samples of retail ground beef from states where dairy herds tested positive for H5N1. The samples underwent polymerase chain reaction (PCR) testing, which can identify traces of the virus but not live virus, at the NVSL. All were negative.

"These results reaffirm that the meat supply is safe," the agency said.

The USDA added that PCR testing is under way on muscle samples from culled dairy cows at selected USDA Food Safety and Inspection Service (FSIS) slaughter facilities and that its Agricultural Research Service is conducting a cooking study using a virus surrogate in ground beef to examine the impact of different cooking temperatures on virus levels.

Michigan and Colorado announce emergency measures
Two states affected by H5N1 outbreaks in dairy herds yesterday announced emergency measures aimed at controlling the spread of the virus.

In Michigan, where recent outbreaks in dairy cows and massive outbreaks in poultry were reported across seven counties, the Department of Agriculture and Rural Development (MDARD) announced an extraordinary emergency measure that requires dairy farms and commercial poultry farms to implement biosecurity steps such as designating a biosecurity manager, establish cleaning procedures, and keeping a log book of vehicles and people who have crossed farm-access points.

The order also bars all lactating cattle from being displayed until the state has passed 60 days with no new dairy farm detections. Officials also announced a similar restriction for poultry, but for 30 days with no new detections.

Elsewhere, Colorado's agricultural commission approved, and the state's agriculture commissioner yesterday adopted, an emergency rule designed to limit the spread of H5N1. Colorado is the most recently affected state in the outbreak involving dairy cattle, and so far, it's not clear how the cows were exposed to the virus.

In its announcement, the Colorado Department of Agriculture said the emergency rule requires mandatory testing of lactating cattle moving interstate, which they said allows implementation of the recent federal order, which took effect on April 29.

https://www.cidrap.umn.edu/cov...

High-risk patients with COVID symptoms should use PCR rather than rapid tests, study suggests
Mary Van Beusekom, MS Today at 12:07 p.m.
COVID-19

Study findings that reveal a sensitivity of 47% for COVID-19 rapid antigen tests (RATs) compared with reverse-transcription polymerase chain reaction (RT-PCR) tests during Omicron variant predominance should prompt clinicians to consider using the latter test in high-risk patients eligible for antiviral drugs, the authors say.

The study, published in Morbidity and Mortality Weekly Report, also showed a RAT sensitivity of 80% compared with viral culture.

93% reported symptoms
From November 2022 to May 2023, a team led by researchers from the US Centers for Disease Control and Prevention (CDC) and Vanderbilt University compared the results of SARS-CoV-2 RATs and same-day RT-PCR and viral culture among participants in a household virus-transmission study enrolled within 7 days of symptom onset. Participants completed daily symptom diaries and collected two nasal swabs for 10 days and reported RAT results.

Among 354 participants with 2,244 RAT results in 129 households, 67% tested positive for COVID-19 and were included in the study. For infected participants, the researchers calculated the proportions of positive RAT, RT-PCR, and culture tests daily after symptom onset or, for symptom-free participants, from the date of positive result. Only one commercially available RAT was used.

Participants were aged 2 months to 83 years (median, 36 years), 56% were White, and 59% were female. Forty percent of participants had received a COVID-19 vaccine dose within the last year, and 35% had received at least two doses, with the most recent dose received more than a year before.

In total, 24% were unvaccinated or had received only one dose, and 43% had self-reported or serologic evidence of previous COVID-19 infection. At least one symptom was noted by 93% of participants, including 77% and 66% who reported cough and fever, respectively.

Culture is only method to detect live virus
RATs were initially rolled out in the United States to aid in the diagnosis and treatment of COVID-positive people and help prevent onward transmission when SARS-CoV-2 immunity was low and rates of poor outcomes were high, the authors said.

Also, demands for testing exceeded supply, and long turnaround times for RT-PCR results contributed to ongoing COVID-19 spread, they added.

Studies performed during the pre-Delta and Delta variant surges showed that RATs have high specificity but lower sensitivity than RT-PCR, leading to a high number of missed infections but approximating viral culture, the researchers noted. Culture isn't often used in routine patient care, but it can detect live virus, while RT-PCR can't discern between live virus and viral fragments.

Use rapid tests only after symptom onset
A total of 61% of participants received at least one positive viral culture result, and 69% had one or more positive RATs. The sensitivity of RATs was 47% (95% confidence interval [CI], 44% to 50%) compared with RT-PCR and 80% (95% CI, 76% to 85%) versus viral culture. The proportion of positive RAT (59.0%) and RT-PCR (83.0%) results peaked 3 days after symptom onset, compared with 2 days after onset for viral culture (52%).

The low sensitivity of antigen testing among persons with asymptomatic infections illustrates that these tests should only be used once symptoms are present.
"Although viral culture is not an absolute marker of transmissibility, this pattern suggests that positive antigen test results could indicate transmissible virus; thus, antigen tests might aid persons with COVID-19 in determining when they are no longer infectious once symptoms begin to resolve," the researchers wrote.

Of the 219 participants with symptoms, the highest proportion of COVID-positive RATs was 65% 3 days after onset among those who had any symptom and 80% at 2 days among those who reported fever.

"The low sensitivity of antigen testing among persons with asymptomatic infections illustrates that these tests should only be used once symptoms are present," the researchers wrote. "Conversely, the higher sensitivity when symptoms are present (especially cough or fever) supports the need to stay at home when symptomatic, irrespective of test result."

When stratified by symptoms, RAT sensitivity rose with occurrence of any COVID-19 symptom (56% and 85% vs RT-PCR and culture, respectively) and peaked on days that fever was reported (77% and 94% compared with RT-PCR and culture, respectively). Compared with RT-PCR and culture, RAT sensitivity was low on symptom-free days (18% and 45%, respectively).

"Clinicians should be aware of the lower sensitivity of antigen testing compared with RT-PCR, which might lead to false-negative results," the authors wrote. "This finding has implications for timely initiation of SARS-CoV-2 antiviral treatment, when early diagnosis is essential; clinicians should consider RT-PCR for persons for whom antiviral treatment is recommended.

"Alternatively, if RT-PCR tests are not available or accessible, clinicians and patients should follow FDA's [Food and Drug Administration's] serial antigen testing recommendations to help optimize diagnostic test performance," they added.

https://www.cidrap.umn.edu/cov...

Caregiver stress lessened after pandemic lockdowns lifted, study finds
News brief 58 minutes ago.
Stephanie Soucheray, MA
Topics COVID-19

A study based on a national survey in Australia shows caregiver and parental stress during the pandemic lessened in 2022 and 2023 after lockdowns were lifted, but female caregivers reported more stress throughout the 3-year study.

The study was published today in Pediatrics and is based on responses to Australia's National Child Health Poll, which was conducted across six waves from June 2020 to April 2023. A total of 12,408 caregivers and 20,339 children aged 0 to 17 years participated in the poll.

Caregivers were asked to report mental health for themselves and each child, as well as perceived impacts of the pandemic on their own and their children's mental health (negative versus none/positive).

Peak of distress was summer 2021
Three surveys were conducted during Australia's lockdowns, which occurred until October 2021. Those surveys were followed by three surveys given in the post-lockdown period, beginning in April 2022.

The peak of negative mental health reporting for both children and caregivers was July 2021. Seventeen percent to 20% of caregivers reported poor mental health in the lockdown periods of 2020-2021, compared to 12% to 14% in 2022-2023. From June 2020 to July 2021, caregivers reported that 6% to 13% of children had poor or fair mental health, with that percentage reducing to 6% in April 2023.

"Perceived negative mental health impacts were more commonly reported by female than male caregivers," the authors said.

Perceived negative mental health impacts were more commonly reported by female than male caregivers.
Sole caregivers reported double the levels of poor mental health self-ratings compared with multicaregiver households. Speaking a language other than English in the home and having lower education status were also linked to worse mental health during the lockdown periods.

"This study is 1 of the first to investigate mental health during the postlockdown period, and shows significant recovery for Australian families," the authors concluded. "Despite this level of resilience, there remain inequities, not unlike the prepandemic distribution of mental health disorders."

https://www.cidrap.umn.edu/cov...

Dip in alcohol consumption in early pandemic linked to less social drinking
News brief Today at 3:24 p.m.
Stephanie Soucheray, MA
Topics COVID-19

Katarzyna Bialasiewicz / iStock
With the closures of indoor dining, bars, theaters, and concert venues in the early months of the COVID-19 pandemic, heavy drinking young adults found themselves consuming 13 less drinks per month compared to pre-pandemic months, according to a new study in the journal Nature Mental Health.

Moreover, this decline in consumption was still evident in 2022 after the initial pandemic restrictions had ended.

"These results highlight the social nature of drinking and speak to the importance of the social context in driving drinking behavior," said Aidan Wright, PhD, of the University of Michigan in a press release from Carnegie Mellon.

These results highlight the social nature of drinking and speak to the importance of the social context in driving drinking behavior.
The protective study followed study prospectively examined the drinking patterns of 234 heavy-drinking young adults ages 21 to 29 years. Participants were asked about their drinking habits every six months from February 2018 to March 2022.

Heavy drinkers were those who said they consumed four (women) or five (men) drinks in one sitting at least 4 times per month.

Slight increase in solitary drinking
The authors said the drop in number of drinks consumed each month was largely driven by significant decreases in weekend (versus weekday) drinking quantity and frequency and drinks per drinking day.

Solitary drinking did increase by 4% during the first year of the pandemic. But the study authors suggested this finding was reflective of the limitations on social drinking.

"Drinking to cope is the main reason young people engage in solitary drinking," said Kasey. "But in this study, we actually saw a decrease in drinking to cope motives along with decreases in negative affectivity, so we think this increase in solitary drinking is less of a signal of something problematic happening and more a result of pandemic-related restrictions on social drinking settings."

Oh oh, I'm signed up for a 5 session cooking class, and the teacher just mentioned that she's really into raw milk. She buys it at a local farm, and makes her own yogurt and other things from it as well as drinking it. If it shows up in our cooking class, I'm going to say I have problems with dairy.

Think I would pass also, and not just because of H5N1.

Me too, not every local farm is as clean (sterile) as it should be. Scary.

I expect no one will protest you NOT eating any of those raw milk items. And you don't even have to 'explain' - there are so many folks with special diets.

I went to a 'party' once selling Pampered Chef. The seller demonstrated putting mayo on raw chicken to bake it. Yup, stuck the rubber spatula back in the mayo jar , to get more, after using it to spread some on raw chicken. at least she said 'oh, I guess I shouldn't do that..'

Yuck, can you just imagine what she feeds her family????

https://static.nytimes.com/ema...


All vaccines have at least occasional side effects. But people who say they were injured by Covid vaccines believe their cases have been ignored.

By Apoorva Mandavilli
Apoorva Mandavilli spent more than a year talking to dozens of experts in vaccine science, policymakers and people who said they had experienced serious side effects after receiving a Covid-19 vaccine.

May 3, 2024
Within minutes of getting the Johnson & Johnson Covid-19 vaccine, Michelle Zimmerman felt pain racing from her left arm up to her ear and down to her fingertips. Within days, she was unbearably sensitive to light and struggled to remember simple facts.

She was 37, with a Ph.D. in neuroscience, and until then could ride her bicycle 20 miles, teach a dance class and give a lecture on artificial intelligence, all in the same day. Now, more than three years later, she lives with her parents. Eventually diagnosed with brain damage, she cannot work, drive or even stand for long periods of time.

"When I let myself think about the devastation of what this has done to my life, and how much I've lost, sometimes it feels even too hard to comprehend," said Dr. Zimmerman, who believes her injury is due to a contaminated vaccine batch.

The Covid vaccines, a triumph of science and public health, are estimated to have prevented millions of hospitalizations and deaths. Yet even the best vaccines produce rare but serious side effects. And the Covid vaccines have been given to more than 270 million people in the United States, in nearly 677 million doses.

Dr. Zimmerman's account is among the more harrowing, but thousands of Americans believe they suffered serious side effects following Covid vaccination. As of April, just over 13,000 vaccine-injury compensation claims have been filed with the federal government — but to little avail. Only 19 percent have been reviewed. Only 47 of those were deemed eligible for compensation, and only 12 have been paid out, at an average of about $3,600.

Some scientists fear that patients with real injuries are being denied help and believe that more needs to be done to clarify the possible risks.

"At least long Covid has been somewhat recognized," said Akiko Iwasaki, an immunologist and vaccine expert at Yale University. But people who say they have post-vaccination injuries are "just completely ignored and dismissed and gaslighted," she added.

In interviews and email exchanges conducted over several months, federal health officials insisted that serious side effects were extremely rare and that their surveillance efforts were more than sufficient to detect patterns of adverse events.

"Hundreds of millions of people in the United States have safely received Covid vaccines under the most intense safety monitoring in U.S. history," Jeff Nesbit, a spokesman for the Department of Health and Human Services, said in an emailed statement.

But in a recent interview, Dr. Janet Woodcock, a longtime leader of the Food and Drug Administration, who retired in February, said she believed that some recipients had experienced uncommon but "serious" and "life-changing" reactions beyond those described by federal agencies.

"I feel bad for those people," said Dr. Woodcock, who became the F.D.A.'s acting commissioner in January 2021 as the vaccines were rolling out. "I believe their suffering should be acknowledged, that they have real problems, and they should be taken seriously."

"I'm disappointed in myself," she added. "I did a lot of things I feel very good about, but this is one of the few things I feel I just didn't bring it home."

Federal officials and independent scientists face a number of challenges in identifying potential vaccine side effects.

The nation's fragmented health care system complicates detection of very rare side effects, a process that depends on an analysis of huge amounts of data. That's a difficult task when a patient may be tested for Covid at Walgreens, get vaccinated at CVS, go to a local clinic for minor ailments and seek care at a hospital for serious conditions. Each place may rely on different health record systems.

There is no central repository of vaccine recipients, nor of medical records, and no easy to way to pool these data. Reports to the largest federal database of so-called adverse events can be made by anyone, about anything. It's not even clear what officials should be looking for.

"I mean, you're not going to find 'brain fog' in the medical record or claims data, and so then you're not going to find" a signal that it may be linked to vaccination, Dr. Woodcock said. If such a side effect is not acknowledged by federal officials, "it's because it doesn't have a good research definition," she added. "It isn't, like, malevolence on their part."

The government's understaffed compensation fund has paid so little because it officially recognizes few side effects for Covid vaccines. And vaccine supporters, including federal officials, worry that even a whisper of possible side effects feeds into misinformation spread by a vitriolic anti-vaccine movement.

'I'm Not Real'
Patients who believe they experienced serious side effects say they have received little support or acknowledgment.

Shaun Barcavage, 54, a nurse practitioner in New York City who has worked on clinical trials for H.I.V. and Covid, said that ever since his first Covid shot, merely standing up sent his heart racing — a symptom suggestive of postural orthostatic tachycardia syndrome, a neurological disorder that some studies have linked to both Covid and, much less often, vaccination.

He also experienced stinging pain in his eyes, mouth and genitals, which has abated, and tinnitus, which has not.

"I can't get the government to help me," Mr. Barcavage said of his fruitless pleas to federal agencies and elected representatives. "I am told I'm not real. I'm told I'm rare. I'm told I'm coincidence."

Renee France, 49, a physical therapist in Seattle, developed Bell's palsy — a form of facial paralysis, usually temporary — and a dramatic rash that neatly bisected her face. Bell's palsy is a known side effect of other vaccines, and it has been linked to Covid vaccination in some studies.

But Ms. France said doctors were dismissive of any connection to the Covid vaccines. The rash, a bout of shingles, debilitated her for three weeks, so Ms. France reported it to federal databases twice.

"I thought for sure someone would reach out, but no one ever did," she said.

Similar sentiments were echoed in interviews, conducted over more than a year, with 30 people who said they had been harmed by Covid shots. They described a variety of symptoms following vaccination, some neurological, some autoimmune, some cardiovascular.

All said they had been turned away by physicians, told their symptoms were psychosomatic, or labeled anti-vaccine by family and friends — despite the fact that they supported vaccines.

Dr. Buddy Creech, 50, who led several Covid vaccine trials at Vanderbilt University, said his tinnitus and racing heart lasted about a week after each shot.

Renee France, 48, a physical therapist in Seattle, developed Bell's palsy — a form of facial paralysis, usually temporary — and a dramatic rash.Credit...Jovelle Tamayo for The New York Times
Even leading experts in vaccine science have run up against disbelief and ambivalence.

Dr. Gregory Poland, 68, editor in chief of the journal Vaccine, said that a loud whooshing sound in his ears had accompanied every moment since his first shot, but that his entreaties to colleagues at the Centers for Disease Control and Prevention to explore the phenomenon, tinnitus, had led nowhere.

He received polite responses to his many emails, but "I just don't get any sense of movement," he said.

"If they have done studies, those studies should be published," Dr. Poland added. In despair that he might "never hear silence again," he has sought solace in meditation and his religious faith.

Dr. Buddy Creech, 50, who led several Covid vaccine trials at Vanderbilt University, said his tinnitus and racing heart lasted about a week after each shot. "It's very similar to what I experienced during acute Covid, back in March of 2020," Dr. Creech said.

Research may ultimately find that most reported side effects are unrelated to the vaccine, he acknowledged. Many can be caused by Covid itself.

"Regardless, when our patients experience a side effect that may or may not be related to the vaccine, we owe it to them to investigate that as completely as we can," Dr. Creech said.

Federal health officials say they do not believe that the Covid vaccines caused the illnesses described by patients like Mr. Barcavage, Dr. Zimmerman and Ms. France. The vaccines may cause transient reactions, such as swelling, fatigue and fever, according to the C.D.C., but the agency has documented only four serious but rare side effects.

Two are associated with the Johnson & Johnson vaccine, which is no longer available in the United States: Guillain-Barré syndrome, a known side effect of other vaccines, including the flu shot; and a blood-clotting disorder.

The C.D.C. also links mRNA vaccines made by Pfizer-BioNTech and Moderna to heart inflammation, or myocarditis, especially in boys and young men. And the agency warns of anaphylaxis, or severe allergic reaction, which can occur after any vaccination.

Listening for Signals
Agency scientists are monitoring large databases containing medical information on millions of Americans for patterns that might suggest a hitherto unknown side effect of vaccination, said Dr. Demetre Daskalakis, director of the C.D.C.'s National Center for Immunization and Respiratory Diseases.

"We toe the line by reporting the signals that we think are real signals and reporting them as soon as we identify them as signals," he said. The agency's systems for monitoring vaccine safety are "pretty close" to ideal, he said.

Dr. Zimmerman now lives with her parents, and said she could not work, drive or even stand for long periods of time.
Those national surveillance efforts include the Vaccine Adverse Event Reporting System (VAERS). It is the largest database, but also the least reliable: Reports of side effects can be submitted by anyone and are not vetted, so they may be subject to bias or manipulation.

The system contains roughly one million reports regarding Covid vaccination, the vast majority for mild events, according to the C.D.C.

Federal researchers also comb through databases that combine electronic health records and insurance claims on tens of millions of Americans. The scientists monitor the data for 23 conditions that may occur following Covid vaccination. Officials remain alert to others that may pop up, Dr. Daskalakis said.

But there are gaps, some experts noted. The Covid shots administered at mass vaccination sites were not recorded in insurance claims databases, for example, and medical records in the United States are not centralized.

"It's harder to see signals when you have so many people, and things are happening in different parts of the country, and they're not all collected in the same system," said Rebecca Chandler, a vaccine safety expert at the Coalition for Epidemic Preparedness Innovations.

An expert panel convened by the National Academies concluded in April that for the vast majority of side effects, there was not enough data to accept or reject a link.

Asked at a recent congressional hearing whether the nation's vaccine-safety surveillance was sufficient, Dr. Peter Marks, director of the F.D.A.'s Center for Biologics Evaluation and Research, said, "I do believe we could do better."

A close-up view of Mr. Barcavage's EKG levels on his smartphone.
Mr. Barcavage's EKG readings on his phone at home. He was among the first to receive the Pfizer vaccine in 2020, and his symptoms included stinging pain in his eyes, mouth and genitals, which has abated, and tinnitus, which has not.Credit...Hannah Yoon for The New York Times
Image
A portrait of Mr. Barcavage, whose eyes appear to be welling with tears.
"I am told I'm not real. I'm told I'm rare. I'm told I'm coincidence," Mr. Barcavage said.Credit...Hannah Yoon for The New York Times
A Red Flag
In some countries with centralized health care systems, officials have actively sought out reports of serious side effects of Covid vaccines and reached conclusions that U.S. health authorities have not.

More on Covid-19
Airborne Diseases, Redefined: After a drawn-out global controversy over the coronavirus, the W.H.O. has updated its classification of how pathogens spread through the air.
Four Years Later: Covid was declared a national emergency on March 13, 2020, a moment that changed the world. But even as the threat has faded, the pandemic has reshaped life for many Americans.
What's Next?: Scientists are studying the virus's continuing evolution and the body's immune responses, hoping to head off a resurgence and to better understand long Covid.
Covid Mysteries: In the four years since the W.H.O. declared a global pandemic, scientists have begun answering some of the biggest questions about Covid. Here is what we have learned.
In Hong Kong, the government analyzed centralized medical records of patients after vaccination and paid people to come forward with problems. The strategy identified "a lot of mild cases that other countries would not otherwise pick up," said Ian Wong, a researcher at the University of Hong Kong who led the nation's vaccine safety efforts.

That included the finding that in rare instances — about seven per million doses — the Pfizer-BioNTech vaccine triggered a bout of shingles serious enough to require hospitalization.

The European Medicines Agency has linked the Pfizer and Moderna vaccines to facial paralysis, tingling sensations and numbness. The E.M.A. also counts tinnitus as a side effect of the Johnson & Johnson vaccine, although the American health agencies do not. There are more than 17,000 reports of tinnitus following Covid vaccination in VAERS.

Are the two linked? It's not clear. As many as one in four adults has some form of tinnitus. Stress, anxiety, grief and aging can lead to the condition, as can infections like Covid itself and the flu.

There is no test or scan for tinnitus, and scientists cannot easily study it because the inner ear is tiny, delicate and encased in bone, said Dr. Konstantina Stankovic, an otolaryngologist at Stanford University.

Still, an analysis of health records from nearly 2.6 million people in the United States found that about 0.04 percent, or about 1,000, were diagnosed with tinnitus within three weeks of their first mRNA shot. In March, researchers in Australia published a study linking tinnitus and vertigo to the vaccines.

The F.D.A. is monitoring reports of tinnitus, but "at this time, the available evidence does not suggest a causal association with the Covid-19 vaccines," the agency said in a statement.

Despite surveillance efforts, U.S. officials were not the first to identify a significant Covid vaccine side effect: myocarditis in young people receiving mRNA vaccines. It was Israeli authorities who first raised the alarm in April 2021. Officials in the United States said at the time that they had not seen a link.

On May 22, 2021, news broke that the C.D.C. was investigating a "relatively few" cases of myocarditis. By June 23, the number of myocarditis reports in VAERS had risen to more than 1,200 — a hint that it is important to tell doctors and patients what to look for.

Later analyses showed that the risk for myocarditis and pericarditis, a related condition, is highest after a second dose of an mRNA Covid vaccine in adolescent males aged 12 to 17 years.

In many people, vaccine-related myocarditis is transient. But some patients continue to experience pain, breathlessness and depression, and some show persistent changes on heart scans. The C.D.C. has said there were no confirmed deaths related to myocarditis, but in fact there have been several accounts of deaths reported post-vaccination.

Pervasive Misinformation
Image
A close-up view of a sticker that reads "I got the Covid-19 vaccine."
Credit...Maddie McGarvey for The New York Times
The rise of the anti-vaccine movement has made it difficult for scientists, in and out of government, to candidly address potential side effects, some experts said. Much of the narrative on the purported dangers of Covid vaccines is patently false, or at least exaggerated, cooked up by savvy anti-vaccine campaigns.

Questions about Covid vaccine safety are core to Robert F. Kennedy Jr.'s presidential campaign. Citing debunked theories about altered DNA, Florida's surgeon general has called for a halt to Covid vaccination in the state.

"The sheer nature of misinformation, the scale of misinformation, is staggering, and anything will be twisted to make it seem like it's not just a devastating side effect but proof of a massive cover-up," said Dr. Joshua Sharfstein, a vice dean at Johns Hopkins University.

Among the hundreds of millions of Americans who were immunized for Covid, some number would have had heart attacks or strokes anyway. Some women would have miscarried. How to distinguish those caused by the vaccine from those that are coincidences? The only way to resolve the question is intense research.
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But the National Institutes of Health is conducting virtually no studies on Covid vaccine safety, several experts noted. William Murphy, a cancer researcher who worked at the N.I.H. for 12 years, has been prodding federal health officials to initiate these studies since 2021.

The officials each responded with "that very tired mantra: 'But the virus is worse,'" Dr. Murphy recalled. "Yes, the virus is worse, but that doesn't obviate doing research to make sure that there may be other options."

A deeper understanding of possible side effects, and who is at risk for them, could have implications for the design of future vaccines, or may indicate that for some young and healthy people, the benefit of Covid shots may no longer outweigh the risks — as some European countries have determined.

Thorough research might also speed assistance to thousands of Americans who say they were injured.
Image
A portrait of Ilka Warshawsky, who wears a red blazer and black slacks and sits on a small chair with a piece of art behind her, which has the words "Blessings and Curses" readable in its middle.
Ilka Warshawsky, a 58-year-old pathologist, lost all hearing in her right ear after a Covid booster shot, and had vertigo and mild tinnitus.Credit...Daniel Lozada for The New York Times
The federal government has long run the National Vaccine Injury Compensation Program, designed to compensate people who suffer injuries after vaccination. Established more than three decades ago, the program sets no limit on the amounts awarded to people found to have been harmed.

But Covid vaccines are not covered by that fund because Congress has not made them subject to the excise tax that pays for it. Some lawmakers have introduced bills to make the change.

Instead, claims regarding Covid vaccines go to the Countermeasures Injury Compensation Program. Intended for public health emergencies, this program has narrow criteria to pay out and sets a limit of $50,000, with stringent standards of proof.

It requires applicants to prove within a year of the injury that it was "the direct result" of getting the Covid vaccine, based on "compelling, reliable, valid, medical, and scientific evidence."

The program had only four staff members at the beginning of the pandemic, and now has 35 people evaluating claims. Still, it has reviewed only a fraction of the 13,000 claims filed, and has paid out only a dozen.

Ilka Warshawsky, a 58-year-old pathologist, said she lost all hearing in her right ear after a Covid booster shot. But hearing loss is not a recognized side effect of Covid vaccination.

The compensation program for Covid vaccines sets a high bar for proof, she said, yet offers little information on how to meet it: "These adverse events can be debilitating and life-altering, and so it's very upsetting that they're not acknowledged or addressed."

Dr. Zimmerman, the neuroscientist, submitted her application in October 2021 and provided dozens of supporting medical documents. She received a claim number only in January 2023.

In adjudicating her claim for workers' compensation, Washington State officials accepted that Covid vaccination caused her injury, but she has yet to get a decision from the federal program.

One of her therapists recently told her she might never be able to live independently again.

"That felt like a devastating blow," Dr. Zimmerman said. "But I'm trying not to lose hope there will someday be a treatment and a way to cover it."

sallyg said: I expect no one will protest you NOT eating any of those raw milk items. And you don't even have to 'explain' - there are so many folks with special diets.

I went to a 'party' once selling Pampered Chef. The seller demonstrated putting mayo on raw chicken to bake it. Yup, stuck the rubber spatula back in the mayo jar , to get more, after using it to spread some on raw chicken. at least she said 'oh, I guess I shouldn't do that..'

I am aghast!

I think that some physicians are dismissive of reactions to drugs they prescribe and that's not limited to COVID vaccines.

I have a friend who was diagnosed with Parkinson's. She was put on 1/2 strength medication which worked beautifully for a few weeks. The plan was to increase it to full strength after a period of time, which they did. Overnight her cognitive functions were compromised, but the neurologist who prescribed the drugs was dismissive that the increased dosage had any part of causing that. Wouldn't even consider it as a possibility. In time after wires were implanted, the medications were reduced in strength and the cognitive issues improved. Unfortunately, they haven't improved back to where they were. At this time, it doesn't appear they will recover fully. The onset was so abrupt and corresponded so precisely with the meds as was the improvement after reducing the strength, it's hard to accept they had no part in it. Combine that with my personal experience of giving a physician the list of meds you take (always requested) and then being prescribed a med that's incompatible with them. Twice relatively recently. If I hadn't read about it myself and just trusted the doctor, I would have taken it without question. Instead, I contacted the other physician who prescribed the original med and was taken off the med until the newer prescription was finished. That has happened to me more than once. I wonder why they even ask to know what meds you are on. It appears they don't look at it. At least they haven't addressed it with me. They just give a new prescription. The new med is probably justified for the purpose it's prescribed, but the effect of taking it with an already prescribed med seems to be up to the patient.

Donald, you are not alone in this. An old friend lost his wife to over prescribing of blood thinners. I've personally experienced the same as you, where a doctor prescribed a medication that contained a substance I'm allergic to, and that was shortly after confirming the allergy with her! During the pandemic, my PCP was handing out antidepressants like candy. When I told her I wasn't interested, she became defensive. I pointed out that one of the biggest dangers for older people is over prescribing, and that the best thing we can do is to seek to solve problems without the use of drugs if possible. How could any doctor become defensive over that? Well, they do.

Think its like everything else, buyer beware.

crawgarden said: Think its like everything else, buyer beware.

To an extent, yes, but it's also the Hippocratic Oath which should supersede buyer beware. Especially in cases where a patient cannot fend for his or herself. We who can are very lucky, but even we have a hard time navigating all the spin and marketing. Often, $hit happens.

Yep, have a good friend with Parkinson's who was given a medication (not Levodopa), he started gradually declining, serious sore on his ankle, got to the point where he was barelyable to move, kept trying to get an appointment, the earliest was 3 months down the line. Finally got to the facility, 3 months later and was told the dr was sick, earliest appointment was 1 month. Not until his wife threw a crying shit fit in the building and said they were not leaving did a dr come out, the medication that he had been on, was only supposed to be used for a few weeks...put him on Levodopa and the recovery was swift.

That is such a terrible story.