Category: Vaccine

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Tips for perfecting your downward-facing dog, aligning your chakras, and the dangers of life-saving vaccinations. These are the conversations Naomi Klein claims are taking places at classes in yoga studios on both sides of the Atlantic, which have turned into hotbeds for conspiracy theories.

The Canadian author and commentator, famed for her best-selling 1999 book No Logo, has turned her attention to the latest threat to public health: Fitness and wellbeing gurus.

Vaccination hesitation has seen a surge in recent years in the wake of the Covid-19 pandemic, but it has posed an issue for decades.

Cases of measles in the UK shot up from 735 cases in 2022 to 1,603 in 2023, with the NHS urging parents to vaccinate their children from the deadly disease. The escalation comes as the number of young school children who have had both doses ofthe MMR vaccinelies about ten per cent below WHO targets.

Klein has warned it is no longer the fringes of society that succumb to the dangerous, outlandish speculation spreading fear in developed Western economies.

Far from the dark corners of the internet, she claims it is now the affluent, educated and seemingly normal members of society that subscribe to these ideas.

Klein writesin her book latest bookDoppelganger that this is where the white, wealthy, libertarian streak in the wellness industry can become lethal.

She goes on the say that it is gym and yoga classes that are primarily playing into conspiracy theories - bolstered by fitness influencers glamorous social media platforms preaching to millions of ordinary people vying to lead a healthier life.

So many of those fit and beautiful influencers stopped merely offering encouraging words to motivate our workouts and green juicing, she writes, and started whispering to us alarmingly about dark forces coming to poison us, and eventually to gag, jab and dominate us.

She was also unsurprised by figures showing the uptake in the measles vaccine were lowest in wealthier, more affluent postcodes where boutique gyms and yoga studios are more common

In March the House of Commons library revealed that the local authorities with the lowest rates of MMR vaccines were the London boroughs of Westminster and Kensington of Chelsea.

Klein herself turned to yoga several years ago and grew obsessive with the practice as she was treated for thyroid cancer.

She told The Times how her own experience spoke to how the community can fall victim to unfounded teachings from teachers with unchallenged authority.

Yoga became a carrier, she told the paper. Not all yoga, but I think theres a reason why yoga studios were very much a hotbed for conspiracy culture.

These figures positioned themselves as having access to a higher form of knowledge because they had taken a six-week yoga teacher training class, or maybe even been to India once, she added. That got us into a world of trouble.

Online, these messages translate as truth to audiences wanted to level-up their lives with beautiful fitness and wellbeing gurus.

She told the paper that the phenomenon of the masses turning away from top-down narratives and towards social media sources has spread misinformation like wildfire - with theories around the Covid vaccine pulling people further away from trusting vaccines.

We need major public education about childhood vaccinations, I think we are almost back to zero, after so many years of so much misinformation, she said. Even someone like Robert Kennedy Jr, now running for president, this is his main issue. We need to take it extremely seriously.

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Naomi Klein says yoga teachers and white wealthy fitness gurus are fuelling vaccine scepticism - The Independent

A group of Dutch medical researchers has ignited a firestorm by calling for an investigation of the deaths caused by vaccine mandates and lockdowns imposedon the public during the COVID-19 pandemic.

Whats wrong with that?

Everything, if youre part of the global public health mafia and want to avoid questions about the mistakes you made and the lies you told.

We all saw Anthony Fauci squirming last week when he was forced to admit to the House Oversight and Accountability Committee that social-distancing rules like the six-foot rule on which the lockdowns were based were pulled out of thin air.

The Dutch researchers want answers.

They insist every death needs to be acknowledged and accounted for, including deaths caused by policy mistakes the collateral damage from heavy-handed public health policies.

One conclusion is already crystal clear: Dont entrust your life or health to the government.

The Dutch researchers examined data from 47 western countries, including the United States, and found that many months after the lockdowns began and vaccines were rolled out, death rates stayed higher than in pre-pandemic years.

The lockdowns and vaccines werent stopping the virus, it turns out, but were apparently causing other deaths a classic case of the cure being worse than the disease.

Zeroing in on the United States, they cited double-digit increases in alcohol-caused fatalities and drug-overdose fatalities.

A separate pair of researchers, Rob Arnott and University of Chicago economics professor Casey Mulligan, reported the same.

During the pandemic, they found,US deaths from alcoholism, drug addiction, car accidents, hypertension, heart disease and diabetes soared, exceeding by 100,000 a year what would ordinarily occur.

They pinned those excess deaths on government COVID-19 policies that drove people to addiction, overeating and other acts of despair.

Even more tragically, those deaths of despair affected younger people, so each death meant many more years of life lost than when an elderly person died of COVID-19.

Young and middle-aged adults succumbed to alcoholism or drug addiction as they were laid off or watched their businesses and savings disappear because of the lockdowns.

Whats worse, even when it became obvious lockdowns were failing, government health officials stayed their deadly course.

They put their egos over the publics welfare.

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The Dutch researchers stunning data showed that for children the virus posed a minuscule 0.0003% risk of death, probably less risk than crossing the street to get to the playground.

Doctors like the Hoover Institutions Scott Atlas urged policymakers to target the high-risk elderly, rather than to lock down the low-risk young only to be demonized for questioning the Centers for Disease Control orthodoxy.

Had the public-health-industrial complex listened, children would have been in school learning, instead of home suffering learning losses.

Even now, as Dr. Joel Zinberg points out, children age 5 to 17 account for less than one-tenth of 1% of COVID deaths, but officials are still recommending vaccines for all schoolchildren.

Crazy.

The Dutch researchers touched off furious pushback with their suggestion that more investigation is needed into whether the vaccines themselves caused some pandemic-era and post-pandemic deaths.

In all likelihood, the vaccine is helpful for most adults, especially the elderly. But there are exceptions.

Research in the journal Human Vaccines and Immunotherapeutics showed that men can incur a higher risk of cardiac-related deaths after taking the mRNA vaccines.

In hospital settings, common fatal conditions such as ischemic stroke and acute coronary syndrome might not be readily identified and reported as possibly vaccine-caused.

The Dutch researchers didnt analyze any causal connection between vaccines and higher deaths.

But just suggesting further research into that issue provoked a nasty backlash.

Thats the public-health-industrial complex closing ranks.

No surprise. In August 2023, the prestigious Journal of the American Medical Association published an attack smearing 52 physicians for disseminating misinformation: The offending scientists disagreed with the CDC, which now has been proven wrong on almost every pandemic issue.

The global public-health establishment, including many journal editors and government advisers the Anthony Faucis and Deborah Birxes of the world dont want us to look back.

Kudos to the Dutch researchers for raising questions and challenging public health orthodoxy. That is what scientists are supposed to do, the status quo be damned.

With bird flu and other threats looming, we need to demand the truth about what saved lives and what killed.

Betsy McCaughey is a former lieutenant governor of New York.

Twitter: @Betsy_McCaughey

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Excess post-COVID deaths the collateral damage of lockdown - New York Post

SARS-CoV-2 keeps evolving, and its time for COVID-19 vaccines to again follow suit, advisers to the U.S. Food and Drug Administration (FDA) agreed early last week. The panel voted unanimously in favour of updating the shots to more closely match virus strains now circulating. http://www.science.org/content/article/covid-19-vaccines-should-get-fall-update-panel-concludes?utm_source=sfmc&utm_medium=email&utm_content=alert&utm_campaign=WeeklyLatestNews&et_rid=785235729&et_cid=5240384

Although the FDA still needs to greenlight the change, the next iteration of vaccine is likely to match one of two versions of the virus, either JN.1, which emerged in September 2023, or one of its descendants, such as KP.2 (colloquially known as a FLiRT variant). Although such offshoots are now circulating more widely than JN.1, advisers urged FDA to at a minimum permit JN.1 vaccines, because the company Novavax is already working on one and says it cant quickly pivot to something different.

A retooled vaccine, its hoped, will be more likely to blunt COVID-19 symptoms and the risk of hospitalization, and somewhat dent transmission of the virus compared with the current version, which is tailored to XBB.1. That strain has now vanished, and 94% of infections are attributed to the JN.1 family. In late April, the World Health Organization (WHO) asked vaccine companies to supply JN.1 vaccines globally later this year.

The advisory committee considered whether the FDA should follow WHOs lead, embracing JN.1, or request a vaccine containing one of its progeny, some of which are now circulating much more widely than their parent. All three companies supplying COVID-19 vaccines to the United StatesModerna, Pfizer, and Novavaxsaid at the meeting they can have ample supply of a JN.1 vaccine available by late summer. But Novavax followed the WHO recommendation and has already settled on a JN.1 vaccine because its protein-based product requires roughly 6 months to produce, longer than messenger RNA (mRNA)-based vaccines from Moderna and Pfizer. Novavax Chief Medical Officer Robert Walker says the company could not offer a fall vaccine in the U.S. if FDA requested a different strain, such as KP.2.

Although the advisory committees 16-0 vote to update the vaccine was no surpriseresearchers are now attuned to SARS-CoV-2s shape shiftingunanswered questions kept bubbling up. Its still unclear whether and to what degree young, healthy people benefit from annual COVID-19 vaccinations, whether regular boosting cuts the risk of Long Covid, and how long protection from severe disease after vaccination lasts.

Data presented at last weeks meeting by Ruth Link-Gelles, an epidemiologist at the U.S. Centers for Disease Control and Prevention (CDC) indicated protection from symptoms and hospitalization took a nosedive within 6 months of an updated XBB shotsometimes to near zero. Earlier publications have reported a similar waning of COVID-19 vaccines. But protection against death and intensive care unit admission was much more durable.

The endless permutations in the number of vaccine doses and the number and timing of infections in the U.S. population are making it harder to resolve some questions about the shots. Still, many are answerable, but I dont know if people are interested in answering them by collecting the data, says David Ho, a virologist at Columbia University who posted a preprint last month analyzing recent SARS-CoV-2 evolution and how different variants might respond to vaccination. The pandemic is gone in most peoples minds. That was reflected by last years vaccine uptake: Just 22% of adults in the U.S. got a COVID-19 vaccine, compared with 48% who rolled up their sleeves for a flu shot.

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In a first-of-its-kind operation, a 71-year-old man with a liver tumour had the malignant lobe of the organ removed and replaced with a pig liver genetically engineered to resist rejection, his surgeons in China reported. Following the 17 May operation, he was in good health this week with no signs of infection or rejection, and the liver was producing healthy quantities of bile, says Sun Beicheng of the First Affiliated Hospital of Anhui Medical University, who led the operation. http://www.science.org/content/article/news-glance-tracking-clouds-reducing-fake-news-posts-and-counting-ties-big-tobacco?

A team at Yunnan Agricultural University developed the genetically modified pig. Another team in China previously reported transplanting such a liver into a patient who had been declared brain-dead. The latest procedure adds to a growing list of transplants of genetically modified pig organs, including kidneys and hearts. But a setback came last week when surgeons at NYU Langone Health had to remove an engineered pig kidney from a woman 47 days after the transplant surgery because it stopped working.

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A little-known pathogen named the Oropouche virus is on the move in South America, alarming scientists and public health experts. Brazil has reported 5530 cases so far this year, compared with 836 in all of 2023. Bolivia, Colombia, and Peru have seen upticks as well. Although the virus has traditionally been endemic in the Amazon Basin, it is now sickening people far from the rainforest. In May, Cuba reported its first cases. http://www.science.org/content/article/little-known-virus-rise-south-america-could-overwhelm-health-systems

The surge has scientists concerned that the virus, transmitted primarily by biting midges, could be the next one to cause a big outbreak in Latin America, which battled major epidemics of Zika and chikungunya in the past decade and is now in the middle of one of the worst dengue epidemics ever. Most cases of Oropouche fever are mild, with symptoms such as headache, body pains, nausea, and rashbut the virus can also cause brain inflammation and neurological problems, including vertigo and lethargy. And even a mild epidemic could overwhelm the continents health systems.

What worries us most is the expansion of a disease that was practically restricted to the Amazon, which has a very low-density population, to areas with greater population density, says Marcus Lacerda, an infectious disease researcher at the Oswaldo Cruz Foundation (Fiocruz).

The strain driving the outbreak originated with a genetic change a decade ago, but the Oropouche virus was first identified in 1955 in the village of Oropouche, in Trinidad and Tobago. In 1960, it turned up in a blood sample from a sick sloth during the construction of the Belm-Braslia highway. A year later, many people in Belm fell ill with what was believed to be Oropouche fever. Most of the roughly 30 outbreaks in Latin America since then have occurred in the Amazon Basin as well. In the forest, the virus circulates among primates, sloths, and birds; its unclear which insect spreads it there. In urban settings, the pinhead-size midge Culicoides paraensis transmits the disease between humans.

The first cases in the current outbreak were detected in Roraima, a state in northern Brazil, at the end of 2022. Since then, the disease has emerged along Brazils populous East Coast, including the states of Rio de Janeiro, Santa Catarina, Bahia, and Minas Gerais. Some patients had traveled in the Amazonian region, but others had not, meaning the virus is now circulating locally. The numbers are likely to be underestimates: Oropouches symptoms resemble those of dengue, Zika, and several other diseases, and an infection can only be confirmed using polymerase chain reaction or antibody tests.

For the few scientists who study Oropouche fever, none of this was a big surprise. Since 2000, the virus has increasingly ventured outside its endemic region, says virologist Socorro Azevedo at the Evandro Chagas Institute, a research center for tropical diseases in the Brazilian Amazon. What we are seeing is a chronicle of a tragedy foretold, she says.

Oropouche fever is not known to have killed anyone, but a few suspected fatalities are under investigation, says Fiocruz virologist Felipe Naveca. As the number of infected people increases, so does the chance that we will discover unexpected impacts, says Naveca, who notes that Zika, a disease that seemed relatively innocuous at first, led to a wave of babies born with an underdeveloped brain from women infected with the virus. The Oropouche virus can also infect the brain, he points out.

Controlling Oropouche is a challenge. C. paraensis is a neglected vector for a neglected disease, says Joaquim Pinto Nunes Neto, an entomologist at Evandro Chagas. No one has cared about studying how to control it. The tiny midges easily pass through the mesh of mosquito nets, and common insect repellents may not work, Nunes Neto says. What may help is eliminating food waste and dead leaves that attract the insects and draining water reservoirs where females lay their eggs.

How much farther the disease could spread is unclear. C. paraensis has been found all the way from the United States to northern Argentina, but not every place has the right conditions for Oropouches spread. A model published in 2023 by Romero-lvarez that took into consideration current climate and vegetation loss suggested up 5 million people across the Americas are at risk. But the number is likely an underestimate, as the model did not predict the current disease expansion to big cities such as Rio de Janeiro and didnt factor in future deforestation and climate change. It also didnt account for the possibility that the common house mosquito (Culex quinquefasciatus)and perhaps other insectscan transmit Oropouche, as some studies suggest.

Scientists worry that as the virus spreads, it could undergo genetic changes that make it more dangerous. The genomes of most insect-borne viruses consist of just one RNA segment, but the Oropouche virus has three. When two different strains infect the same cell, they can swap segments, resulting in a new and different combination of genes. Naveca, who leads a group that tracks Oropouche mutations, has traced the current outbreak to a variant that arose in Brazil in 2015 from reassortment between virus lineages from Peru and Colombia. Whether this exchange made the virus more transmissible isnt clear, Naveca says.

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Meanwhile in the battle against various types of cancer:

A drug that engages the immune system completely eliminated advanced colorectal cancers in six out of ten people. Thirty two people with a particular kind of advanced colorectal cancer were given the immunotherapy pembrolizumab (Keytruda). Tumours disappeared in 59% of participants and the remaining 41% underwent surgery to remove their tumours. All participants were cancer-free after treatment, compared with around 5% of people given standard treatment with chemotherapy and surgery. If you melt the cancer away before surgery you normally triple survival chances, says lead investigator and oncologist Kai-Keen Shiu. Patients also dont need any chemotherapy after, so they avoid all those side effects.

The Guardian | 3 min read Reference: American Society of Clinical Oncology (ASCO) annual meeting abstract

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A lung-cancer drug has achieved stunning success in a landmark clinical trial. The study included 296 people with advanced non-small cell lung cancer. Participants were randomised to receive either lorlatinib (Lorbrena) or standard treatment with crizotinib. After five years, 60% of the group treated with lorlatinib were alive without cancer progression, compared with 8% of people treated with the standard drug. You dont need a magnifying glass to see the difference, says Julie Gralow, the chief medical officer at the American Society of Clinical Oncology. These long-term data results are off the chart, says David Spigel, the chief scientific officer at the Sarah Cannon Research Institute.

The Guardian | 3 min read Reference: ASCO annual meeting abstract

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Lalita Panicker is Consulting Editor, Views and Editor, Insight, Hindustan Times, New Delhi

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COVID-19 continues to evolve, vaccines must keep up the pace; The latest health stories from around the world - Hyderus Cyf

The Food and Drug Administration has approved giving GSK's vaccine for respiratory syncytial virus down to age 50 years old, to those who are at higher risk of severe RSV, the company said Friday, making it the first shot greenlit for use in this age group to guard against RSV.

Global vaccine and drugmaker GSK asked the FDA in February to expand approval beyond adults 60 and older, citing data showing the immune response in adults vaccinated from this younger age group looked similar. Further trials are planned looking at adults between 18 and 49 years old, GSK said, with results expected in the second half of this year.

Two other companies Pfizer and Moderna also manufacture RSV vaccines approved for adults 60 and older, and are testing their shots in younger adults. Pfizer told investors last month it was getting ready to submit "positive" data from studies of its own shot down to age 18.

GSK's vaccine will next need to be recommended for adults between 50 and 59 years old by the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices. Their backing, at upcoming meetings in June or October, would tee up insurance coverage.

Vaccinating adults in their 50s for RSV likely has a public health benefit, a work group within the CDC's committee concluded last year ahead of the approval, though it is narrower than for older adults who are at higher risk from their age alone.

Under 60 years old, pre-existing medical issues play larger roles in the risk of RSV infections taking a dangerous turn.

"A lot of disease comes because the virus is triggering your underlying medical conditions, whether it's COPD, heart failure, etc. So the virus is more of a trigger for exacerbation," said Dr. Phil Dormitzer, senior vice president and global head of vaccines research and development at GSK.

Dormitzer said GSK had seen "relatively comparable" safety results from its vaccine in this group, compared to when it was given to those 60 and over. Some of the vaccine's side effects did look to be a little stronger, likely as a result of better immune responses in this age group.

The CDC panel has also previously wrestled with rare but serious cases of a neurological disorder called Guillain-Barr syndrome seen after the use of the RSV shots.

Around 1.5 cases of the syndrome per million doses given of GSK's vaccine have been reported, the CDC said last week. The agency's survey data has found that close to a quarter of adults ages 60 and older had received an RSV shot since they were approved last year.

GSK's trials did not turn up any "concerning" trends of GBS cases in the 50 to 59 age group, Dormitzer said.

"The risk of GBS tends to go up, it's another one of those risks that tends to go up, with age. But there's nothing to indicate that there's any particular risk of GBS," he said.

The CDC panel is also expected to weigh the possibility of whether and when adults will need to start getting booster shots for RSV. Dormitzer said GSK is planning on presenting more trial results to the CDC committee in June, looking at boosters spaced out as much as three years after an initial shot.

"This is a really key question. People originally anticipated it might have to be an every year immunization. But then we found the duration of protection actually lasts for more than one season, clearly," he said.

Alexander Tin is a digital reporter for CBS News based in the Washington, D.C. bureau. He covers the Biden administration's public health agencies, including the federal response to infectious disease outbreaks like COVID-19.

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FDA approves first RSV vaccine for at-risk adults in their 50s - CBS News

Good morning, and happy Monday! Special shout-out to my colleague Fenit Nirappil for his help with todays newsletter top. Send tips to McKenzie.Beard@washpost.com.

Todays edition: A growing trend of at-home medical testing is booming, but medical providers worry about the tests accuracy and reliability. Federal health officials released data showing gains in health-care coverage among minority communities. But first

How the CDC is taking on mpox this summer

With summer travel picking up and Pride festivities underway, public health experts are bracing for a return of mpox, the infectious disease formerly known as monkeypox.

The virus fueled a peak of up to 3,000 weekly cases in the United States between mid-July and late August 2022, predominantly spreading among men who have sex with men and killing at least 58 people. Vaccination efforts and behavioral changes quelled the outbreak, but the virus has continued to circulate at low levels throughout the country ever since.

On the ground, providers like Joseph Cherabie, medical director of the St. Louis STI/ HIV Prevention Training Center, says the mpox cases he has treated recently are largely in younger Black people and patients with uncontrolled HIV who are unvaccinated. He told my colleague Fenit Nirappil in a recent interview that more cases may be going undetected as mpox falls off the radar of patients and health providers, and noted that shots have become a harder sell as people have developed vaccine fatigue.

This comes as the Centers for Disease Control and Prevention is paying close attention to a version of the virus in the Democratic Republic of Congo linked to more fatalities.

I recently caught up with Christina L. Hutson, chief of the CDCs Poxvirus and Rabies Branch, about how the agency is working to raise awareness about mpox in hope of averting a summer surge. This conversation has been edited for clarity and brevity.

Health Brief: How are you approaching your outreach efforts this year?

Hutson: Our goal right now is creating awareness about the continued circulation of the virus in the U.S. and encouraging those who are unvaccinated or received only one dose to complete the two-dose vaccination series.

For the second year, were again working closely with the HHS Office of the Assistant Secretary of Health on a summer Pride initiative. This effort is really focusing on improving vaccine equity by partnering with health departments and community-based organizations to provide comprehensive sexual health services, including mpox vaccines, at local pride and LGBTQIA+ events.

Were also leaning on some of our existing partnerships with LGBTQIA+ organizations, and we have social media influencers we work with to make sure were getting that communication out there.

Finally, weve been funding the creation of materials that help address questions that men who have sex with men have raised about mpox and its vaccine. We now have social media tool kits, an mpox vaccine locator, and digital and print materials that have all been developed to help both clinicians and those at risk.

Health Brief: A recent report from the CDC indicates that there is long-term protection from the mpox vaccine, but Ive heard questions swirling about whether those at risk need a third dose. Can you explain why that isnt necessary?

Hutson: The paper looked at a total of 32,819 probable or confirmed mpox cases from the start of the outbreak up until May 2024, and we saw that less than 1 percent occurred in people who were fully vaccinated. This really illustrates that the vaccine is effective, and when we do see breakthrough infections, they are generally more mild.

The data set doesnt indicate that a booster is necessary, but it does illustrate that only 1 in 4 people who are eligible are fully vaccinated.

More patients are turning to a shadow system of DIY medical tests

A growing trend of at-home medical testing enabled by Silicon Valley start-ups and independent labs has boomed in recent years, The Posts Elizabeth Dwoskin, Daniel Gilbert and Tatum Hunter report. But medical providers worry this convenience comes with a slew of concerns, including the accuracy and reliability of these tests.

Venture capitalists and entrepreneurs told The Post they envision a world where frequent at-home testing is a routine part of life, enabling everyone to become the CEO of their own health, said Luca Springer, who co-founded a Silicon Valley start-up that aims to make cancer testing as simple as a home-pregnancy test.

But the boom angers some doctors, who argue that circumventing their offices can lead to questionable remedies, misdiagnosis or delayed medical care.

While the FDA generally reviews all but the lowest-risk medical tests, it doesnt supervise wellness tests marketed directly to consumers. Other start-ups avoid stringent FDA review by having physicians oversee some part of the testing process creating what experts call a two-track system of standards.

Its likely that some companies break the rules entirely, evading the agency and betting it wont police a fast-growing market, said Alberto Gutierrez, a former senior FDA official.

The FDA is starting to pay attention: Regulators finalized a contentious rule in April to begin holding lab-made tests to the same standards as conventional ones, phasing out a historically hands-off position in response to the ballooning industry. Still, businesses are charging ahead.

In other industry news, GlaxoSmithKline announced Friday that the FDA has approved its vaccine Arexvy for preventing respiratory syncytial virus (RSV) in adults ages 50 to 59 at increased risk.

The move to include those younger than 60 is aimed at addressing hospitalization rates among adults ages 50 to 64 with conditions such as COPD, asthma, heart failure and diabetes. The company said more than 13 million people have medical conditions that increase their risk of developing severe RSV outcomes.

Democrats ramp up patent battle with drug industry

Our colleague Dan Diamond sends us this dispatch.

Sen. Elizabeth Warren (D-Mass.) and Rep. Pramila Jayapal (D-Wash.) last week sent letters to eight pharmaceutical company CEOs, urging them to take down 130 patents listed in an FDA registry, I scooped on Friday.

Its the latest skirmish in a bigger fight over whether pharma companies are taking advantage of the FDAs Orange Book to box out generic competitors by making tiny tweaks to their products, like changing the design of an inhaler cap. If a patent is listed in the registry, it can effectively delay generic competition for another 2.5 years.

The Federal Trade Commission has twice warned pharmaceutical companies that hundreds of their patents are improperly listed in the Orange Book and must be taken down. The pharma industry has complied in some cases, but industry officials and some companies have pushed back, saying the Orange Book rules are unclear, and insisting theyre not trying to game patent rules.

The latest flash point: The FTC in April flagged more than 300 patents, including the 130 that Warren and Jayapal are focusing on.

Today is the deadline for pharma companies to either take down that batch of patents or reaffirm that they belong in the registry, a source familiar told me. Democrats say theyll continue to target more patents and push the industry, too.

Theyre making too damn much money off these inaccurate listings, Warren told me. And theyre not about to delist, unless they get a good hard shove from someone.

HHS sees improvements in health-care coverage for minorities

The Department of Health and Human Services released data Friday showing gains in health-care coverage among minority communities. The administration said the five reports highlight the progress made to increase affordable and quality health care.

From 2010 to 2020, there were significant declines in the percentages of uninsured people, with the highest decrease among Latinos. Black Americans saw their rate drop from 20.9 to 10.8 percent, Latinos from 32.7 to 18 percent, Asian American and Native Hawaiian/Pacific Islander from 16.6 to 6.2 percent and American Indians and Alaska Natives from 32.4 to 19.9 percent.

Today, external FDA advisers are set to convene to discuss the safety and efficacy of Eli Lillys experimental Alzheimers drug donanemab.

On Tuesday: A House appropriations subcommittee meets at 6 p.m. to discuss appropriations for fiscal 2025, including for the FDA.

On Wednesday: The Senate Finance Committee has scheduled a 10 a.m. hearing on youth residential treatment facilities.

From Wednesday to Friday, the Childrens Hospital Association will host its family advocacy days in D.C. Pediatric patients and their families will visit Capitol Hill to share their stories and advocate for policies that ensure childrens access to high-quality medical care.

Email fenit.nirappil@washpost.com and lena.sun@washpost.com with your questions or any suggestions for what youd like to see in future coverage of an outbreak of a highly virulent bird flu in dairy cattle that also infected at least three dairy workers.

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Analysis | Federal officials urge mpox vaccinations to blunt a summer surge - The Washington Post

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A new combined flu and Covid vaccine could be approved for NHS use this year or next following clinical trials.

New data from clinical trials held by Covid vaccine creator Moderna suggests combined jabs provoke a higher immune response than separate single jabs.

The results raise hopes the new vaccine could be approved by regulators by 2025, with the possibility of it being rolled out on the NHS. Most recent data showed more than 1,300 people were hospitalised with Covid.

A spokesman for Moderna said they hoped the jab would be available for the 2025 or 2026 flu season.

At the moment, Modernas Spikevax vaccine for Covid is used in the NHS booster programmes, alongside Pfizer-BioNTechs Comirnaty.

A newer version of Spikevax has been created and tested by Moderna which includes a dose of flu vaccine.

The combination means people would only need one jab rather than two, as at the moment, to give them full protection against Covid and flu.

This is the first time final phase three data for a combined vaccine has been published by any firm.

The news comes after high street pharmacies this year began providing the Pfizer-BioNTech Covid vaccine over the counter.

The most recent data published by NHS England on Covid hospital admissions showed as of 31 March 2024, 1,384 hospital beds were filled with suspected Covid patients compared to 2,780 confirmed patients in March 2023.

In the week up to 29 May, 1,604 community cases of Covid were reported by the UK Health Security Agency.

Any new vaccine would first have to be approved for use by the Medicines and Healthcare Products Regulatory Agency.

The findings from Moderna showed that the mRNA-1083 vaccine led to higher immune responses against flu and Covid than two other single vaccines currently in use, including the current Spikevax.

Stephane Bancel, chief executive of Moderna, said: Combination vaccines have the potential to reduce the burden of respiratory viruses on health systems and pharmacies, as well as offer people more convenient vaccination options that could improve compliance and provide stronger protection from seasonal illnesses.

The randomised controlled trial involved two groups of about 4,000 people each, with the first group aged 65 and over testing the new jab compared with a flu vaccine, Fluzone, and the current Spikevax jab.

The second group included adults aged 50 to 64.

The mRNA-1083 jab matched or bettered current flu jabs and was better than the existing Spikevax at making the body produce antibodies probably because it had been designed to fight more recent variants circulating around the world, Mr Bancel told the BBC.

Professor John Tregoning, Professor in Vaccine Immunology, Imperial College London, said: Moderna have undertaken a phase III clinical trial of their new RNA vaccine that targets both influenza and Covid-19.

He said the results of the study looked: the level of antibody against the viruses in the vaccine in the blood of volunteers. The press release does not include a large amount of data it is quite a high level summary. What they state is that if you compare the antibody response between the new Moderna RNA vaccine and the existing licensed vaccines, there is not a significant difference.

Professor Tregoning said the main conclusion which can be drawn from the Moderna release is that their vaccine produces anti-influenza and anti-Covid antibodies in those who volunteered for the study.

This story was updated at 16:25 on 10 June following new comments from Moderna on when the vaccine could be available for NHS use and a comment from ProfessorJohn Tregoning.

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Combined Covid and flu vaccine could be approved for use on NHS by next year - The Independent

The devastated family of a fit and healthy young actor who died a fortnight after taking a Covid vaccine have called out the callous 'indifference' of society and government to her death.

Katie Lees, 34, took the first dose of the AstraZeneca vaccine in July 2021, driven by her desire to 'do her bit' to help bring lockdown to an end.

But just 13 days later her family were forced to make the harrowing decision to turn off her life support.

Ms Lees, an actor and comedian who lived in Sydney's inner-west, had suffered a severe vaccine-induced blood clot in her brain.

'The last time I ever spoke to her on the morning of July 22 (and) she said, "Im getting my AstraZeneca this afternoon." She said to me how proud she was for doing it,' Katie's father, Ian, told news.com.au.

'It turned out that was the last time I would ever speak to her. She was actually following the governments advice, trying to do the right thing for the sake of the community.'

Mr Lees, 66, said the hardest part about his daughter's death was that people didn't believe the vaccine had killed her and met the news with 'silence, mockery, discrediting and disbelief'.

'Wed say to people our daughter died from the AstraZeneca vaccine and theyd say, "Oh really? How do you know?",' he said.

In a public submission to the federal governments Covid Response Inquiry, Ms Lee's parents said they were galled by the 'indifference of our society to her death'.

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'Every morning, our first thought is how Katie died and the sinking feeling that we were used and discarded by our government, by AstraZeneca and by our society,' they wrote.

They added: 'Katie did not need the vaccine she wouldnt have died if she got Covid.

'Katie took this action, not because she was worried about getting Covid, but because she was deeply concerned about the impact of lockdowns on the life of communities and the mental health of individuals.'

The AstraZeneca vaccine was estimated to have saved millions of lives during the pandemic but it also caused rare, and sometimes fatal, blood clots.

In April, AstraZeneca admitted in a UK court that its vaccine could, in very rare instances, could lead to Thrombosis with Thrombocytopenia Syndrome, which causes people to have blood clots and a low blood platelet count.

The vaccine, which was discontinued in Australia in March 2023, was withdrawn globally last month with the manufacturer citing commercial reasons for the decision.

Of the 14 Australians acknowledged by the Therapeutic Goods Administration (TGA) to have died from Covid vaccines, 13 were from AstraZeneca and one from Moderna.

Just under 14 million AstraZeneca jabs were successfully administered across Australia, meaning that

Over 71 million jabs were successfully administered across Australia, meaning that vaccine deaths account for a miniscule fraction of the total.

Daily Mail Australia contacted AstraZeneca for comment.

Ms Lees developed headaches and a rash immediately after her vaccination but doctors did not think anything of it.

Just over a week later on AUgust 1 she woke up with a severe headache and started vomiting.

A CT scan showed a severe clot in her brain.

'Katie slipped into deep unconsciousness around 3pm and never regained consciousness,' her parents wrote in their submission to the inquiry.

'Despite this catastrophic brain injury, undergoing subsequent neurosurgery and being on life support, due to Covid restrictions, we were not permitted to visit Katie until two days after she was admitted.'

The devastated family said that they had been left 'emotionally, mentally and physically traumatised by the way Katie died, the lack of support from government and the pharmaceutical industry and the alienation we feel from the mainstream narrative in our society'.

They have called for an apology from the federal government and more clarity in public health communication about the safety of vaccines.

In addition, they want to see 'substantial increases in the amounts paid to the loved ones of someone who dies from a government-mandated vaccination program'.

The family who received $70,000 in compensation for Katies death, said they hated being branded 'anti-vaxxers'.

They set up the Katie Lees Foundation in March 2023 to support female artists an performers.

Buta funding body asked her parents to remove a statement saying that Katie died from the AstraZeneca vaccine because 'they were a "pro-vaccination" organisation', they claimed.

The Covid Response Inquiry is expected to publish its report in Spring.

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Katie told her father she was going to get the Covid vaccine. He had no idea it would be their last conversati - Daily Mail

Geneva, 7 June 2024 The Board of Gavi, the Vaccine Alliance today announced a series of decisions that provide a framework for an acceleration of global immunisation including approval of "Gavi 6.0", the Alliance's 2026-2030 strategy, expansion of Gavi's vaccine portfolio, and plans to support global health security and regional manufacturing through the African Vaccine Manufacturing Accelerator and a First Response Fund for use in future pandemics. The decisions were taken during a two-day meeting convened in Geneva from 6-7 June.

"Vaccines are one of the most impactful and cost-effective health and development interventions available today," said Professor Jos Manuel Barroso, Chair of the Gavi Board. "As we look to 2030 and progress against the Sustainable Development Goals amidst climate change and other challenges, the message is clear: the world must continue to invest in the transformative impact of vaccines and their ability to save lives and ensure our collective security."

To set the scene for two days of discussions on Gavi's future direction, the Board first reviewed progress for the current strategic period, noting that the Alliance is largely on track across mission indicators despite the disruptions caused by the COVID-19 pandemic. Progress includes critical advances in the push to reach 86 million girls with vaccines against human papillomavirus (HPV), with five new country launches since September 2023, and the new malaria vaccination programme, where 22 country applications have been approved and deeper collaboration with the broader set of malaria stakeholders, including the Global Fund, is underway. While there has been a 12% reduction in the number of outbreaks requiring a response between 2022 and 2023, it continues to be an area of concern that this remains far above pre-pandemic averages, primarily driven by surges in cholera and measles outbreaks.

PRIORITIES FOR GLOBAL IMMUNISATION THROUGH 2030

The Board approved the Vaccine Alliance's strategy for the period 2026-2030, known as "Gavi 6.0". The 6.0 strategy will be the most ambitious in Gavi's history: seeking to protect more people, against more diseases, faster than ever before. This means a continued focus on Gavi's core mission:

The new strategy will also make the Gavi model increasingly responsive to the evolving global context from climate change to the increasing threat of outbreaks, antimicrobial resistance, and fragility and conflict to continue meeting countries' and communities' needs. Key elements to this approach include proposed adjustments to Gavi's co-financing, eligibility and transition approach to ensure the continued sustainability of immunisation programmes; deeper partnerships with global and regional organisations, civil society and communities; differentiated, flexible and tailored support for fragile and humanitarian contexts; streamlining Gavi's operating model; and enhanced support for climate-sensitive and outbreak, epidemic and pandemic-prone diseases. The Alliance begin work on operational details, in preparation for implementation of the strategy beginning in 2026.

The projected impact of the next five years of work, as well as the total funding needs for the strategic period, will be announced on 20 June at the Protecting Our Future: Global Forum for Vaccine Sovereignty and Innovation, co-hosted by the African Union (AU), Africa Centres for Disease Control and Prevention (Africa CDC), Government of France and Gavi. The event will see the launch of both Gavi's Investment Opportunity for 2026-2030 as well as the African Vaccine Manufacturing Accelerator (AVMA), a first-of-its-kind US$ 1 billion financial instrument in support of sustainable vaccine manufacturing on the African Continent. Securing funding for the 2026-2030 period will be vital to ensuring the success of Gavi's strategy.

A critical part of each five-year period is the approval of a new Vaccine Investment Strategy (VIS), which looks at the pipeline of promising vaccines and vaccine candidates and evaluates how best to expand the portfolio of vaccines Gavi offers. The Board approved the 2024 VIS, which will include future vaccination programmes and learning agendas for tuberculosis (adolescent vaccines), group B streptococcus, and dengue fever (the latter investment conditional on availability of relevant data on the burden in Gavi-supported countries), as well as global stockpiles and learning agendas for vaccines against mpox and hepatitis E. In-principle approvals via the Vaccine Investment Strategy allow Gavi to begin market signaling and preparedness activities in advance, which is a critical part of Gavi's model to accelerate access to lower-income countries so new vaccines can be deployed as soon as they become available.

The Board also approved a learning agenda on vaccination against shigella, and, given the levels of coverage achieved, current epidemiology and country demand, recommended sunsetting of the routine COVID-19 vaccination programme at the end of 2025. Potential COVID-19 needs for a "worst-case scenario" after 2025 will be addressed through Gavi's emergency response mechanisms.

For mpox, the Board additionally approved that in the current strategic period, the Alliance would support the response to the on-going outbreak in the Democratic Republic of the Congo (DRC) and further potential outbreaks in surrounding countries including leveraging COVID-19 experiences to coordinate dose donations.

Following Board approval in 2023, decisions were made on the operational parameters for innovative vaccine sovereignty and health security mechanisms set up by Gavi in response to learnings from the COVID-19 pandemic.

The Board approved the final structure of the African Vaccine Manufacturing Accelerator, which will be launched on 20 June. In particular this includes the eligibility criteria designed to focus support on sustainable end-to-end vaccine manufacturing on the Continent. The Board also endorsed AVMA's governance mechanisms, which will involve the Gavi Board as well as partners including the AU, Africa CDC, UNICEF, WHO, manufacturers, and donors. The finalisation of AVMA sends an immediate signal to investors regarding Gavi's long-term commitment to support a sustainable African vaccine manufacturing base, and to improving African pandemic and outbreak vaccine supply resilience.

Another mechanism discussed was the Day Zero Financing Facility for Pandemics, a suite of instruments that will seek to make financing accessible in the first 100 days of a major public health emergency. The Board approved the parameters for the DZF's new First Response Fund, which sets aside US$500 million for rapid response to emergencies. Following the Board's decision, the scope of the First Response Fund was confirmed as core Gavi-eligible countries, with potential for exceptions if needed, and targeted mainly to WHO Public Health Emergencies of International Concern without existing vaccine programmes. The Board also agreed that the funds could be used to procure, alongside vaccines, syringes and ancillaries, personal protective equipment, cold chain, surge capacity, health system and community preparedness and response activities.

"The decisions taken today reflect our full Alliance of stakeholders aligning around a clear goal: ensuring Gavi's model continues to best support the countries and communities who are our partners," said Dr Sania Nishtar, CEO of Gavi. "In a complex and changing world, today's decisions will help Gavi deliver systematic impact faster than ever before."

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Gavi board approves 2030 strategy; new vaccines; key decisions on vaccine sovereignty and health security initiatives - Gavi, the Vaccine Alliance

By Kate Pickles Health Editor For The Daily Mail 17:24 10 Jun 2024, updated 17:50 10 Jun 2024

Patients could soon be given two-in-one flu and Covid jabs after trials found it was just as effective as single shots.

The combined vaccine from Moderna was found to provoke a higher immune response than separate single jabs, according to new data from the firm.

The NHS currently uses Moderna's Spikevax vaccine alongside Pfizer/BioNTech's Comirnaty for Covid-19 for its booster programmes.

But a newer version of Spikevax has been created and tested by Moderna, which includes a dose of flu vaccine.

Experts predict these combination jabs could see patients only needing one jab for protection against both illnesses as soon as 2025, with equivalents being developed by competitors Pfizer and BioNTech.

The findings from Moderna showed that the mRNA-1083 vaccine met its goals and led to higher immune responses against flu and Covid than other single vaccines currently in use, including the current Spikevax.

It is the first time final phase 3 data for a combined vaccine has been published by any firm.

The mRNA-1083 jab matched or bettered current flu jabs and was better than the existing Spikevax at making the body produce antibodies.

Scientists believe this is likely because it had been designed to fight more recent variants circulating around the world.

The randomised controlled trial involved two groups of about 4,000 people each, with the first group aged 65 and over testing the new jab compared with a flu vaccine, Fluzone, and the current Spikevax jab.

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The second group included adults aged 50 to 64 and included use of the flu jab Fluarix.

Stephane Bancel, chief executive of Moderna, told the BBC he hoped the vaccine could be made widely available in 2026 - or perhaps, 2025.

He said: Combination vaccines have the potential to reduce the burden of respiratory viruses on health systems and pharmacies, as well as offer people more convenient vaccination options that could improve compliance and provide stronger protection from seasonal illnesses.

Moderna is the only company with a positive phase 3 flu and Covid combination vaccine.

Building on the momentum of positive phase 3 data across our respiratory portfolio, we continue to address significant unmet medical needs and advance public health.

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Get ready for 2-in-1 Covid and flu jabs after new combined Moderna vaccine trial shows its better than single - Daily Mail

German researchers have pointed out that the onset of excess mortality in early 2021 in the country coincided with the rollout of vaccines, which the team said warranted further investigation.

However, more recent data regarding side-effects has not been made available to the public, with countries keeping their own individual databases of harms, which rely on self-reporting by the public and doctors, the experts warned.

Researchers said that it was likely that the impact of containment measures, restricted healthcare and socioeconomic upheaval during the pandemic had contributed to deaths, although accepted that was difficult to prove.

Gordon Wishart, chief medical officer at Check4Cancer, and visiting professor of cancer surgery at Anglia Ruskin University, warned repeatedly that delaying cancer diagnosis would lead to deaths.

It was predicted early in the lockdown period that limited access to healthcare for non-Covid conditions would lead to delays in the diagnosis and treatment of time-critical conditions such as cancer, cardiac disease, diabetes and dementia and that this would lead to excess deaths from these conditions, he said.

NHS England data shows that per 100,000 people the cancer incidence was 521 in the pre-lockdown year, then fell to 456 in 2020-2021, suggesting around 45,000 cancers were missed in the first pandemic year.

The incidence rate rose to 540 per 100,000 the following year suggesting many cancers were diagnosed late, when treatment would be less effective.

Speaking about the potential for vaccine harm, Mr Wishart added: The authors are correct to point out that many vaccine-related serious adverse events may have been unreported, and point to the fact that the simultaneous onset of excess mortality and Covid vaccination in Germany is worthy of further investigation on its own.

The paper provides more questions than answers but, it is hard to disagree with their conclusion that further analysis is required to understand the underlying causes of excess mortality to better prepare for the future management of pandemic crises

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Covid vaccines may have helped fuel rise in excess deaths - The Telegraph