crkx3egk3ygo (GIF Image, 1 × 1 pixels)
The top US health department plans to require placebo testing for all vaccines in an effort to offer "straightforward" public health information, but experts say such testing could limit availability and raise ethical concerns.
In a statement first given to the Washington Post, the Department of Health and Human Services (HHS) said this week, "All new vaccines will undergo safety testing in placebo-controlled trials prior to licensure — a radical departure from past practices".
The agency did not provide details on which "new vaccines" would be included.
But officials have suggested that updated Covid-19 shots may be included, which vaccine experts say could slow down vaccine access.
Peter Lurie, a former official with the Food and Drug Administration (FDA), said "it's hard to tell exactly what is being proposed."
"But, broadly, if they mean that every modification to an existing vaccine would require a new placebo-controlled trial, they are treading in ethically dubious territory and likely to deny Americans life-saving vaccines at some point."
HHS has not offered details on the timing of the placebo plan or specify the vaccines involved.
An HHS spokesperson told the BBC in a statement that health secretary Robert F Kennedy Jr's goal of "radical transparency" means being "honest and straightforward about what we know — and what we don't know — about medical products, including vaccines".
The statement said none of the childhood vaccines recommended in the US - except the Covid shot - had undergone "inert placebo" testing, meaning "we know very little about the actual risk profiles of these products".
But public health experts say the statement is misleading, as childhood vaccinations, including ones for Hepatitis A and B, rotavirus, polio and the mumps, were all initially tested against a placebo. In fact, all new immunizations already go through the trials - a type of random testing where one test group receives the immunization, and the other gets a placebo, like a saline shot.
But newer versions of the shots may not go through the same process, because it is considered unethical to withhold a shot known to be safe from a particular group, and because the shot is only being tweaked in a minor way, vaccine experts said.
The coronavirus shot, for example, already has gone through rigorous safety testing, said Paul Offit, director of the Vaccine Education Center at Children's Hospital of Philadelphia.
"We have a lot of information about the safety of the vaccine," he said. "All we're doing this year is using a different Omicron variant that we used last year and the year before that."
Still, FDA Commissioner Marty Makary said this week that the agency was "taking a look" at updated coronavirus shots, telling the BBC's US partner CBS News that there is a "void of data".
An HHS spokesperson told the BBC that "significant updates to existing vaccines" may be considered "new products" requiring additional clinical evaluation.
"A four-year-old trial is also not a blank check for new vaccines each year without clinical trial data, unlike the flu shot which has been tried and tested for more than 80 years," the spokesperson said.
Requiring companies to conduct placebo tests for simple upgrades of established vaccines would be costly - and the drug makers could ultimately decide to forgo making the newer, more effective versions of the vaccine altogether, said Dr Lurie.
Before taking office - and since assuming the role as secretary - Kennedy has spread false claims about vaccine safety. His tenure has coincided with one of the worst measles outbreaks in a decade; two children have died and 660 people have been infected in Texas.
This week, he encouraged parents to "do their own research" about the measles vaccine - which has been considered safe and 97% effective for decades - and raised questions about whether the shot could cause seizures or neurological issues.
For months, he has at times endorsed the MMR shot, and at other times, called it a "personal" decision. Kennedy also promoted alternative treatments, which doctors say patients should not use without medical supervision.
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
The Guardian
8 minutes ago
- The Guardian
NIH scientists go public to denounce Trump's deep cuts in health research
In his confirmation hearings to lead the National Institutes of Health, Jay Bhattacharya pledged his openness to views that might conflict with his own. 'Dissent,' he said, 'is the very essence of science.' That commitment is being put to the test. On Monday, scores of scientists at the agency sent their Trump-appointed leader a letter titled the Bethesda Declaration, a frontal challenge to 'policies that undermine the NIH mission, waste public resources, and harm the health of Americans and people across the globe'. It says: 'We dissent.' In a capital where insiders often insist on anonymity to say such things publicly, more than 90 NIH researchers, program directors, branch chiefs and scientific review officers put their signatures on the letter – and their careers on the line. They went public in the face of a 'culture of fear and suppression' they say Donald Trump's administration has spread through the federal civil service. 'We are compelled to speak up when our leadership prioritizes political momentum over human safety and faithful stewardship of public resources,' the declaration says. Named for the agency's headquarters location in Maryland, the Bethesda Declaration details upheaval in the world's premier public health research institution over the course of mere months. It addresses the abrupt termination of 2,100 research grants valued at more than $12bn and some of the human costs that have resulted, such as cutting off medication regimens to participants in clinical trials or leaving them with unmonitored device implants. In one case, an NIH-supported study of multi-drug-resistant tuberculosis in Haiti had to be stopped, ceasing antibiotic treatment mid-course for patients. In a number of cases, trials that were mostly completed were rendered useless without the money to finish and analyze the work, the letter says. 'Ending a $5 million research study when it is 80% complete does not save $1 million,' it says, 'it wastes $4 million.' The four-page letter, addressed to Bhattacharya but also sent to the health secretary, Robert F Kennedy Jr and members of Congress who oversee the NIH, was endorsed by 250 anonymous employees of the agency besides the 92 who signed. Jenna Norton, who oversees health disparity research at the agency's National Institute of Diabetes and Digestive and Kidney Diseases, recently appeared at a forum by Senator Angela Alsobrooks to talk about what is happening at the NIH. At the event, she masked to conceal her identity. Now the mask is off. She was a lead organizer of the declaration. 'I want people to know how bad things are at NIH,' Norton told the Associated Press. The signers said they modeled their indictment after Bhattacharya's own Great Barrington Declaration of October 2020, when he was a professor at Stanford University Medical School. His declaration drew together like-minded infectious disease epidemiologists and public health scientists who dissented from what they saw as excessive Covid-19 lockdown policies and felt ostracized by the larger public health community that pushed those policies, including the NIH. 'He is proud of his statement, and we are proud of ours,' said Sarah Kobrin, a branch chief at the NIH's National Cancer Institute who signed the Bethesda Declaration. As chief of the health systems and interventions research branch, Kobrin provides scientific oversight of researchers across the country who have been funded by the cancer institute or want to be. But sudden cuts in personnel and money have shifted her work from improving cancer care research to what she sees as minimizing its destruction. 'So much of it is gone – my work,' she said. The 21-year NIH veteran said she signed because 'I don't want to be a collaborator' in the political manipulation of biomedical science. Ian Morgan, a postdoctoral fellow with the National Institute of General Medical Sciences, also signed the declaration. 'We have a saying in basic science,' he said. 'You go and become a physician if you want to treat thousands of patients. You go and become a researcher if you want to save billions of patients. 'We are doing the research that is going to go and create the cures of the future,' he added. But that will not happen, he said, if Trump's Republican administration prevails with its searing cuts to grants. The NIH employees interviewed by the AP emphasized they were speaking for themselves and not for their institutes or the NIH. Employees from all 27 NIH institutes and centers gave their support to the declaration. Most who signed are intimately involved with evaluating and overseeing extramural research grants. The letter asserts that 'NIH trials are being halted without regard to participant safety' and that the agency is shirking commitments to trial participants who 'braved personal risk to give the incredible gift of biological samples, understanding that their generosity would fuel scientific discovery and improve health'. The Trump administration has gone at public health research on several fronts, both directly, as part of its broad effort to root out diversity, equity and inclusion values throughout the bureaucracy, and as part of its drive to starve some universities of federal money. This has forced 'indiscriminate grant terminations, payment freezes for ongoing research, and blanket holds on awards regardless of the quality, progress, or impact of the science', the declaration says. Some NIH employees have previously come forward in televised protests to air grievances, and many walked out of Bhattacharya's town hall with staff. The declaration is the first cohesive effort to register agency-wide dismay with the NIH's direction. A Signal group became the place for participants to sort through NIH chatter on Reddit, discern rumor from reality and offer mutual support. The declaration took shape in that group and as word spread neighbor to neighbor in NIH offices. The dissenters remind Bhattacharya in their letter of his oft-stated ethic that academic freedom must be a linchpin in science. With that in place, he said in a statement in April, 'NIH scientists can be certain they are afforded the ability to engage in open, academic discourse as part of their official duties and in their personal capacities without risk of official interference, professional disadvantage or workplace retaliation.' Now it will be seen whether that is enough to protect those NIH employees challenging the Trump administration and him. 'There's a book I read to my kids, and it talks about how you can't be brave if you're not scared,' said Norton, who has three young children. 'I am so scared about doing this, but I am trying to be brave for my kids because it's only going to get harder to speak up. 'Maybe I'm putting my kids at risk by doing this,' she added. 'And I'm doing it anyway because I couldn't live with myself otherwise.'
Daily Mail
18 minutes ago
- Daily Mail
Urgent nationwide recall issued for millions of eggs that could KILL if eaten
Nearly 2million eggs are being recalled over fears they could be contaminated with a potentially deadly pathogen. The FDA revealed the recall of 1.7m brown cage-free and certified organic eggs this week that have already sickened 79 people and hospitalized 21. Sold by California-based August Egg Company, the eggs are reported to be contaminated with salmonella — a bacteria that kills about 420 Americans every year. The eggs were sold between February 29 and May 17 across seven states — California, Washington, Nevada, Arizona, Nebraska, Kentucky and New Jersey. But officials fear that some of the affected cartons could still be lurking in refrigerators, putting others at risk. No deaths have been reported to date. Customers are advised to throw out the recalled eggs or to return them to sellers for a full refund. A total of 29 branded egg packages were included in the recall, including brands like Raleys, Simple Truth and Sun Harvest. The packages have a Julian Date — time stamp indicating when they were packaged — between 32 and 126. The Julian Date can be found on the short side of the carton. Salmonella is killed by cooking eggs because the bacteria cannot survive temperatures above 140F (60C). But officials warn that cooking eggs sunnyside up is risky, saying this may lead to the top of the egg not being hot enough to kill the bacteria. An investigation linked the outbreak to the eggs after 27 out of 30 patients interviewed reported consuming them before falling ill. An inspection at the company's egg processing facility also detected salmonella at the factory — which was linked back to the outbreak. Salmonella can contaminate eggs in two ways: It can enter an egg while it is forming inside a hen, or after an egg has been laid when the bacteria gets onto the shell after contact with feces and penetrates the shell. If salmonella gets onto factor equipment, this can then spread it to multiple other eggs. Experts say that cooking eggs thoroughly — such as via boiling or frying — will kill salmonella, which cannot survive temperatures above 140F (60C). About 1.35million people are infected with salmonella in the US every year, estimates suggest, via consuming contaminated food or water. Symptoms begin six hours to six days after infection, and include diarrhea, stomach pain or cramps and nausea and vomiting. For many patients, the illness goes away on its own within a few days. But in severe cases, it can lead to persistent diarrhea, high fevers, aches, headaches and lethargy. In rare instances, the bacteria can also spread to other organs in the body — which can prove fatal. An infected patient may spread the bacteria to others via touching contaminated surfaces, officials warn.
Daily Mirror
18 minutes ago
- Daily Mirror
Seven symptoms you need to look out for as doctors issue Covid warning
A new variant now spreading across Europe and multiple other continents could leave people with a host of unpleasant symptoms - that don't feel like classic Covid Health officials have warned that people could experience a host of nasty and unusual symptoms if they contract the latest Coronavirus strain. The new variant, named NB.1.8.1, was designated a "SARS-CoV-2 variant under monitoring (VUM)" on May 23, one of six emerging variants currently under WHO monitoring. As of this month, it has crossed multiple continents, with cases flagged in the UK and Ireland in Europe, and further afield in the US and Australia. People have been urged to stay at home for days on end if they find they have symptoms of the new Covid variant, which are a far cry from the classic flu-like signs of their predecessors. While early signs of Covid once included symptoms like a severe cough, sore throat and high fever, NB.1.8.1 is felt most acutely in the gastrointestinal tract. Symptoms of the variant include: Nausea Vomiting Diarrhoea Heartburn Bloating Constipation Abdominal pain Dr Lara Herrero, associate professor and virology research leader at Griffith University in Australia, explained in an article posted on The Conversation that the variant appears to be spreading faster than its predecessors. Of those, Dr Herrero said, it is most similar to subvariants of the Omicron lineage. She said: 'The evidence so far suggests NB.1.8.1 may spread more easily and may partially sidestep immunity from prior infections or vaccination. 'Reports suggest symptoms of NB.1.8.1 should align closely with other Omicron subvariants." The WHO has said the same, stating in its report that the variant has obtained a series of mutations that allow it both to spread easier and potentially evade antibody protections afforded to people by previous infections. The organisation explained: "Spike mutations at position 445 have been shown to enhance binding affinity to hACE2, which could increase the variant's transmissibility." It adds: "Mutations at position 435 shown to reduce the neutralisation potency of class 1 andclass 1/4 antibodies, and mutations at position 478 shown to enhance the evasion of Class 1/2 antibodies." People who exhibit any symptoms have been told to stay indoors by the UK Health Security Agency (UKHSA) which advises people to "avoid contact with vulnerable people and stay at home if possible" for 48 hours.
