US ends use of flu shots with thimerosal in latest move by health secretary Kennedy
Last month, a vaccine panel with members handpicked by Kennedy voted in favor of Americans receiving seasonal flu shots that are free from thimerosal, despite decades of studies showing no related safety issues.
About 5% of flu shots given in the U.S. in the last flu season were multi-dose vials that contained the preservative, which was largely phased out decades ago.
Anti-vaccine groups have for decades linked thimerosal to autism and other neurodevelopmental disorders, and Kennedy wrote a book in 2014 in which he advocated for "the immediate removal of mercury" from vaccines.
The FDA on its website says "there was no evidence that thimerosal in vaccines was dangerous," and that the decision to remove it previously was a precautionary measure to decrease overall exposure to mercury among young infants.
One of the panelists, who voted against the recommendation, had pointed out that the risk of not receiving the influenza vaccine because it contains thimerosal is greater than any known risks of the preservative.
CSL's (CSL.AX), opens new tab Afluria, and Flucelvax and Sanofi's (SASY.PA), opens new tab Fluzone include thimerosal in multi-dose versions, according to the FDA's website.
Kennedy accepted the panel's recommendation, the Department of Health and Human Services said on Wednesday, in the absence of the CDC director, who typically signs off on them before they are implemented.
President Donald Trump's nominee for the CDC director, Susan Monarez, is yet to be confirmed by the U.S. Senate.
Other recommendations made by the panel, known as the Advisory Committee for Immunization Practices, at a meeting in June are still under review, the HHS said.
Vaccine manufacturers have confirmed that they have the capacity to replace multi-dose vials containing the preservative, ensuring that supplies will not be interrupted, HHS said.
Sanofi said it acknowledges the new policy and will have sufficient supply of the flu vaccine this season. CSL did not immediately respond to a Reuters request for comment.
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Reuters
2 hours ago
- Reuters
US FDA's chief medical and science officer Prasad departs agency
July 29 (Reuters) - Vinay Prasad, the U.S. Food and Drug Administration's chief medical and science officer, has left the health regulator, the U.S. Department of Health and Human Services, which oversees the FDA, said on Tuesday, confirming an earlier news report. "Dr. Prasad did not want to be a distraction to the great work of the FDA in the Trump administration and has decided to return to California and spend more time with his family," an HHS spokesperson said in an emailed statement to Reuters. "We thank him for his service and the many important reforms he was able to achieve in his time at FDA.' STAT News first reported about Prasad's departure, saying it came after a number of controversial decisions by the FDA regarding a gene therapy drug for the treatment of Duchenne muscular dystrophy manufactured by Sarepta Therapeutics (SRPT.O), opens new tab. The agency first halted shipments of the drug, called Elevidys, after the deaths of some recipients but rescinded the suspension on Monday. In June, STAT News reported that Prasad was named as the health regulator's chief medical and science officer, citing an internal memo. In May, the FDA named Prasad, an oncologist who previously criticized FDA leadership and COVID-19 mandates, as the director of its Center for Biologics Evaluation and Research.
Daily Mail
9 hours ago
- Daily Mail
Inside the wildly popular gas station drug RFK Jr. wants to ban to prevent the next opioid crisis
Robert F. Kennedy Jr. is cracking down on an opioid-like substance that has gone wildly viral for its addictive properties, misleading marketing and its wide availability. The Department of Health and Human Services recommended on Tuesday that the Drug Enforcement Agency schedule 7-hydroxymitragynine (7-OH) - a compound that appears in kratom leafs - as a class one illicit substance. Kennedy says the hope is that scheduling it as a controlled substance will help 'prevent the fourth wave of addiction' in the U.S. and Food and Drug Commissioner Marty Makary says it's 13 times more potent than morphine. Currently, drinks, gummies and supplements with trace amounts of 7-OH from the kratom plant are widely available for purchase at smoke shops and convenience stores. Some kratom plant products – like Feel Free botanical tonics – have recently gone viral with consumers claiming they quickly became addicted and dependent on the substance available at their local gas stations. HHS recognizes the increase in reports of overdoses and emergency room visits linked to products containing 7-OH, many times from young people, veterans and people suffering from chronic pain. Many who consume 7-OH claim they were not aware they were taking an addictive product. Others who bought it thought they were purchasing a product with the potency of an energy drink. RFK Jr. and Makary warn that if 7-OH is allowed to remain on shelves, it will result in another opioid-crisis like in the 1990s and 2010s. During a Tuesday press conference, the two officials announced they are initiating the process to have the DEA classify 7-OH as an illegal controlled substance. They cited its opioid-like effects on the brain as justification for the scheduling. It can take months and even years for drugs to get official scheduling by the DEA, but leadership at HHS and FDA make clear that this is a priority and suggest the process will be expedited. The DEA must review the recommendation, which can take between two and six months. Then the rule must be opened for a public comment period, which is between 30 and 60 days. During this time, advocates for the use of kratom leaf are likely to come out in opposition of the drug classification. There are many kratom leaf products, like teas and other drinks, that do not fall in the same category as products that have trace amounts of 7-OH. Makary made very clear that the FDA was not focusing on kratom leaf and only the 7-OH compound. Companies that use kratom leaf with trace amounts of 7-OH in their products claim they help with relaxation and pain, as well as assist with productivity and focus. Makary said: '7-OH is not just like an opioid, it does not just have opioid binding properties. 7-OH binds to the mu receptor, which means, scientifically by definition, it is an opioid.' Products with 7-OH claim to help people with relaxation, pain management, productivity and focus. FDA Commissioner Marty Makary said at a press conference on Tuesday: '7-OH binds to the mu receptor, which means, scientifically by definition, it is an opioid' 'And yet it is sold in vape stores, in smoke shops and convenience stores and gas stations that are popping up all over the United States, and nobody knows what it is,' Markay lamented during a press conference at the HHS building on Tuesday. 'It is a synthetic concentrated by-product of kratom. Our focus is not on kratom. Our focus is on 7-OH,' he added. Deputy HHS Secretary Jim O'Neill warned: '7-OH carries a high risk of addiction, on purpose. It is a powerful opioid agonist, many times more potent than morphine,' sold online and in stores with no quality or dosage constraints. 'Young people, veterans and people who suffer from chronic pain or addiction are being misled into thinking that these are safe alternatives. They are not,' he concluded. RFK Jr. opened up about his years-long struggle with heroin addiction and said part of the HHS effort to schedule 7-OH is also to educate the American public about the threat it poses. 'When there is availability that can become a crisis,' Secretary Kennedy said. 'And my addiction started because of, let me say this, it was precipitated by availability.' Kennedy said that he met with Attorney General Pam Bondi this week regarding the action and that she showed the correlation between a high concentration of vape and smoke shops to areas where addiction-related deaths are happening in higher volumes. 'Vape stores are popping up in every neighborhood in America, and many are selling addictive products like concentrated 7-OH,' Makary said. 'After the last wave of the opioid epidemic, we cannot get caught flat-footed again.'
Reuters
11 hours ago
- Reuters
VIVAZEN Applauds Federal Action to Ban Dangerous Synthetic 7-OH and Reaffirms Support for Science-Driven Kratom Reform
PHOENIX, AZ, July 29, 2025 (EZ Newswire) -- VIVAZEN, opens new tab, a leading natural wellness company, issued the following statement today commending the U.S. Department of Health and Human Services (HHS), the Food and Drug Administration (FDA), and the Drug Enforcement Administration (DEA) for taking decisive action this week to protect consumers from the dangerous synthetic 7-hydroxymitragynine (7-OH) and to establish a clear regulatory distinction between adulterated products and natural kratom. 'As someone who has experienced the benefits of kratom firsthand, I've long been an advocate for ensuring that this important botanical is safely and responsibly available to customers. This is a milestone for consumer safety, scientific integrity, and public health,' said Steve Curtis, CEO of VIVAZEN. 'We fully support the FDA and HHS in taking this courageous action in drawing a clear line between the naturally occurring alkaloids in kratom and the synthetic opioid-like compound 7-hydroxymitragynine. These are not the same substance, and conflating them has harmed consumers and held back meaningful botanical research. We further urge the agency to use the full extent of its power to immediately remove 7-OH products from store shelves.' 7-hydroxymitragynine, often produced by chemically oxidizing kratom's primary alkaloid, mitragynine using industrial oxidants like bleach and pool shock, can be present at potent and dangerous concentrations in adulterated products that falsely claim to be 'kratom.' In contrast, natural kratom leaves contain only trace amounts of 7-OH, if any, and have been safely used by millions of Americans. VIVAZEN has long been at the forefront of science-first kratom formulation, ensuring all of its products are rigorously tested, contain no synthetic alkaloids, and comply with evolving state and federal safety standards. 'What's happening now is the beginning of regulatory maturity,' said Curtis. 'FDA's own data now confirms the safety and tolerability of mitragynine at levels up to 140 mg. NIH-funded studies also show kratom enhances, rather than suppresses, respiratory activity, exactly the opposite of synthetic 7-OH. This bifurcation is necessary and overdue.' VIVAZEN encourages the following actions by HHS and FDA: 'Consumers deserve clean, transparent, and trustworthy products,' Curtis added. 'At VIVAZEN, we've built our brand on safety and integrity, and we welcome this renewed focus on scientific truth. We look forward to working with policymakers and regulators to protect the future of kratom and the millions who rely on it.' About VIVAZEN For over a decade, VIVAZEN has delivered trusted, high-quality botanical supplements that provide people with functional wellness without compromise. Rooted in centuries of herbal wisdom and backed by modern innovation, VIVAZEN is a functional, feel-good alternative for those who want to live—and feel—on their own terms. Join the millions who trust VIVAZEN to Feel Great™ naturally, and visit opens new tab. Media Contact Paloma Lehfeldtpress@ ### SOURCE: VIVAZEN Copyright 2025 EZ Newswire See release on EZ Newswire
