Latest news with #AdvisoryCommittee
Libya Observer
a day ago
- Politics
- Libya Observer
UNSMIL invites youth in Ajdabiya, Al-Bayda, Derna, and Shahhat to discuss Advisory Committee options
The United Nations Support Mission in Libya (UNSMIL) has called on young people from the cities of Ajdabiya, Al-Bayda, Derna, Shahhat, and surrounding areas to take part in discussion sessions on the options and recommendations proposed by the Advisory Committee, and to share their concerns and suggestions. In a statement issued Thursday, the UNSMIL stated that the sessions are open to youth aged between 18 and 35. The consultations will be held at municipal headquarters as part of UNSMIL's 'Youth Participate' program, with sessions scheduled to take place in Ajdabiya on Monday, Al-Bayda on Tuesday, Derna on Wednesday, and Shahhat on Thursday. News Tagged: UNSMIL libyan youth
ABC News
a day ago
- Health
- ABC News
Australia's TGA issues interim report to remove supplements high in B6 from shelves as toxicity cases rise
Major changes have been proposed to restrict access to a common over-the-counter vitamin, linked to a growing number of poisoning cases. Vitamin B6 — often listed as pyridoxine, pyridoxal, pyridoxamine — is present in thousands of products in Australia as an additive, including medicines, multivitamin and mineral supplements, energy drinks and weight loss shakes. 174 reports of peripheral neuropathy, peripheral sensory neuropathy, small fibre neuropathy or chronic polyneuropathy for products containing B6 have been reported to the medicines' regulator, the Therapeutic Goods Administration (TGA), though medical practitioners predict the true number is significantly higher. "While most of them have no side effects, if you are taking large doses of B6 your risk of peripheral neuropathy goes up." "We know that reported cases of peripheral neuropathy are a massive underestimate of the problem in the community, because so many people are unaware that that vitamins can cause these symptoms." In a new development to improve public safety, several recommendations have been handed down in a report penned by a senior TGA medical officer known as 'the delegate'. Called the 'Interim Decision', the report acts on the advice of the government's Advisory Committee on Medicines Scheduling. Most notably, it calls for the TGA to reclassify supplements containing more than 50mg of B6 as Schedule 3 (Pharmacist Only), by February 2027. The move would affect around 100 products, requiring pharmacists to first speak with consumers before approving a purchase. "Currently, preparations providing up to 200 mg of [B6] ... are available for self-selection without any professional guidance or oversight," the report states, adding "almost 80 per cent of these products provide a dose of more than 2 mg/day, which is above the RDI for pyridoxine, pyridoxal or pyridoxamine. "The daily requirement of vitamin B6 can be easily obtained from the usual Australian diet, and the use of supplemental vitamin B6 provides limited benefit except in people who have a clinically diagnosed vitamin B6 deficiency. A TGA spokesperson told 7.30 the decision, if implemented, "will reduce the maximum amount of vitamin B6 allowed in oral products than currently available for general sale". "The interim decision balances the risks and benefits of using vitamin B6 including the risk of peripheral neuropathy, acknowledging its potential for irreversible harm at higher doses and variability in individual metabolism," the spokesperson said. But, as detailed in the report, the proposed changes only account for around seven per cent of supplements containing B6 — there are more than 1,500 vitamins listed on the Australian Register of Therapeutic Goods, the majority of which are unscheduled and available over the counter. The report also recommended supplements exceeding 200mg should be reclassified as prescription medicines or 'schedule 4'. "It's a good thing that pharmacists will be able to have a really good counselling session with a patient, to make sure the item they're taking doesn't interact with other medications," said Caroline Diamantis, vice-president of the Pharmaceutical Society of Australia. "People used to think that complimentary medicines were completely safe but the more we delve into it the more we understand they do have unwanted side-effects or interference with other medications," she told 7.30. The interim decision also recommends tightening labelling rules, calling for clearer identification of vitamin B6 on packaging and stronger warnings to help consumers avoid accidental overexposure. "Use of ingredient names in labelling is inconsistent and confusing for consumers … and not always described as vitamin B6," the report said. "Of concern is that there are several products on the market where the front of the label provides no indication that vitamin B6 is an ingredient." It suggested changing the language on warning labels to be more direct. "Excess consumption of vitamin B6 can cause nerve damage. Stop use and see a doctor if you experience tingling, burning or numbness," was a suggestion. The report also calls on the multi-billion-dollar complementary medicines sector to take greater responsibility for educating consumers and reducing the risk of vitamin B6 overexposure, noting current labelling places too much burden on consumers to calculate total B6 intake. "Estimating the total daily vitamin B6 intake … is likely to be beyond the health literacy capability of the typical consumer," it said. The CEO of Complementary Medicines Australia John O'Doherty told 7.30: "we'll be carefully reviewing the interim decision and the recommendations of the Advisory Committee on Medicines Scheduling." Mr O'Doherty argued adverse events relating to the use of vitamin B6 are "extremely rare". "Based on a comparison of sales data with the TGA's public Database of Adverse Events, the chance of a reaction is less than one in half a million — this is extremely rare," he said. However, previous 7.30 investigations have found dozens of Australians have had issues from B6 toxicity, with many only becoming aware of their illness after seeing our reports. The TGA delegate also warns the prevalence could be much higher. "The true rate of occurrence of an adverse event cannot be determined from spontaneous adverse event reporting systems due to both general under-reporting and a lack of usage data," its report read. "A low number of spontaneous adverse event reports cannot be considered evidence of the absence a safety issue." Mr O'Doherty however agreed with some of the labelling recommendations, telling 7.30 his organisation has "been calling on the TGA to implement changes that allow labels and advertising to use terminology and ingredient names that consumers better understand." "At CMA's request, this is now under internal review at the TGA", he said. Medical negligence lawyer Nick Mann said the interim decision is a "small step in the right direction" but argued the TGA "can and should" go further. Mr Mann told 7.30 his legal firm, Polaris, is pursuing a class action lawsuit against one of the largest companies in the complementary medicines industry, Blackmores, "as a matter of public interest and safety". "We continue to investigate the potential class action, and given the response, the support and the evidence that's been pouring in ... with over 140 people contacting us to date," Mr Mann said. "Each of them had heartbreaking stories about how their lives have been affected by B6 toxicity, and sadly, many of them continue to be affected long after ceasing supplements containing Vitamin B6. "We've also had at least 10 doctors contact us to tell us about their own experiences with B6, and to let us know that they have discovered B6 toxicity in several of their patients, after taking supplements containing higher than the RDI of the vitamin over weeks and months," he said. The interim decision recommends the changes be made by 1 February 2027 — offering an 18-month implementation period. Watch 7.30, Mondays to Thursdays 7:30pm on ABC iview and ABC TV Do you know more about this story? Get in touch with 7.30 here.
CNN
3 days ago
- Health
- CNN
New CDC vaccine advisers endorse thimerosal-free flu vaccines, despite no evidence of harm from the preservative
A new slate of vaccine advisers to the US Centers for Disease Control and Prevention voted Thursday to recommend that Americans receive influenza vaccines that are free of thimerosal even though there is no evidence of harm from the preservative. The closely watched vote was among the first for the newly assembled group, which was appointed by US Health and Human Services Secretary Robert F. Kennedy Jr. this month after he dismissed the previous panel of 17 experts, claiming that they had conflicts of interest. However, some of the new members of the committee raised serious concerns from the public health community for their approach to vaccines and scientific evidence. The last-minute addition of thimerosal to the Advisory Committee on Immunization Practices' meeting agenda was a signal to vaccine experts that Kennedy – who led an anti-vaccine group called Children's Health Defense – was seeking to sow doubt about vaccine safety. Thimerosal was largely removed from most vaccines about 25 years ago. The US Food and Drug Administration asked manufacturers to remove it out of an abundance of caution, not because of evidence of harm, according to the CDC. All vaccines routinely recommended for young children now are available in doses that don't have the preservative, which contains a form of mercury. Flu vaccines drawn from multidose vials still contain thimerosal in order to prevent bacterial contamination. Only about 4% of flu vaccines given in the United States last year contained thimerosal as a preservative. Still, on Thursday, the committee heard an unusual presentation by Lyn Redwood, a nurse practitioner and former leader of Children's Health Defense, which has advocated against the use of mercury in vaccines. Unlike most other presentations given at the meeting, Redwood's was not vetted or read by a working group or outside experts in vaccine science before it was voted on, according to Dr. Sean O'Leary, a pediatrician at Children's Hospital of Colorado who has been a liaison member of the Advisory Committee on Immunization Practices, or ACIP. 'This selective use of data and omission of established science undermines public trust and fuels misinformation,' O'Leary said in a statement made on behalf of the American Academy of Pediatrics, which recently announced that it would no longer participate in ACIP meetings because of the changes to committee membership and what's being discussed. In a series of three votes Thursday, the ACIP members voted 5-1, with one member abstaining, to recommend that only single-dose flu vaccines be given to children, adults and pregnant women in the United States. Single-dose shots are free of thimerosal. Drs. Robert Malone, Joseph Hibbeln, Martin Kulldorff, Retsef Levi and Joseph Pagano voted yes on the thimerosal recommendations. Dr. Cody Meissner voted no. Dr. Vicky Pebsworth, volunteer director of research and patient safety at the National Vaccine Information Center, a group that emphasizes risks around vaccines while downplaying their benefit, abstained from the vote because she objected to its wording. In justifying his vote, Meissner, a professor of pediatrics at the Dartmouth Geisel School of Medicine, said he was worried that expressing a preference for single-dose vials might keep people from getting doses from multidose formulations in situations in which those shots may be the only option. 'That might limit the availability of the influenza vaccine for some people,' he said. 'My point is, the risk from influenza is so much greater than the nonexistent — as far as we know — risk from thimerosal, so I would hate for a person not to receive the influenza vaccine,' Meissner said. 'I find that very hard to justify.' Six members of the committee voted to continue to recommend that everyone 6 months and older receive an annual flu vaccine. Pebsworth abstained. Vaccines with thimerosal are still approved by the FDA. The ACIP recommendation now goes to the CDC director or potentially to Kennedy, as CDC nominee Dr. Susan Monarez is still awaiting Senate confirmation. However, ACIP recommendations are tremendously influential in how vaccines are used in the US, with implications for insurance coverage and state policies. The advisers also voted 5-2 on Thursday to recommend the use of a new shot that can protect babies from respiratory syncytial virus, adding an additional tool against the most common cause of hospitalization in infants. The shot, called clesrovimab and given the brand name Enflonsia, is made by Merck and joins two other interventions already on the market to protect babies against severe disease from RSV, a common virus that can be especially dangerous for infants. One, like clesrovimab, is an antibody shot, and the other is a vaccine given during pregnancy. Data presented at the meeting showed that the approved interventions were safe and dramatically reduced hospitalizations among babies from RSV in the last respiratory virus season. 'As a pediatrician, I mean, people need to understand what a spectacular accomplishment these results are,' Meissner said at Wednesday's ACIP meeting. They 'will have an enormous influence on public health.' The new drug was approved this month by the FDA, and the CDC committee's recommendation was the next step in making it widely available for the coming RSV season, which typically begins in the fall. The vote came after Levi, a professor of operations management at the Massachusetts Institute of Technology Sloan School of Management, raised questions Thursday morning about whether there were safety signals that arose in clinical trials of the antibody shots that deserve further scrutiny. Representatives from both the FDA and Merck emphasized the safety of the product and the rigor of the clinical trials. Meissner also expressed how thoroughly the CDC panel's work group on RSV examined the data. 'We went through the details very, very carefully, and I appreciate Dr. [Levi's] careful review of the records, but the work group is comfortable with the results from the different clesrovimab trials,' he said. Levi voted against recommending the Merck shot, joined by Pebsworth. However, the group voted unanimously Thursday that the Merck shot should be included in the Vaccines for Children program, which provides free vaccines to children whose families may not be able to afford them. HHS spokesperson Andrew Nixon said in a statement Thursday, 'The members of this committee are respected experts who take their responsibility to public health seriously. What they did today, just as Secretary Kennedy appointed them to do was review the evidence, debate it with scientific rigor and deliver recommendations rooted in data and medical integrity. The public deserves nothing but this.'
CNN
3 days ago
- Health
- CNN
New CDC vaccine advisers endorse thimerosal-free flu vaccines, despite no evidence of harm from the preservative
A new slate of vaccine advisers to the US Centers for Disease Control and Prevention voted Thursday to recommend that Americans receive influenza vaccines that are free of thimerosal even though there is no evidence of harm from the preservative. The closely watched vote was among the first for the newly assembled group, which was appointed by US Health and Human Services Secretary Robert F. Kennedy Jr. this month after he dismissed the previous panel of 17 experts, claiming that they had conflicts of interest. However, some of the new members of the committee raised serious concerns from the public health community for their approach to vaccines and scientific evidence. The last-minute addition of thimerosal to the Advisory Committee on Immunization Practices' meeting agenda was a signal to vaccine experts that Kennedy – who led an anti-vaccine group called Children's Health Defense – was seeking to sow doubt about vaccine safety. Thimerosal was largely removed from most vaccines about 25 years ago. The US Food and Drug Administration asked manufacturers to remove it out of an abundance of caution, not because of evidence of harm, according to the CDC. All vaccines routinely recommended for young children now are available in doses that don't have the preservative, which contains a form of mercury. Flu vaccines drawn from multidose vials still contain thimerosal in order to prevent bacterial contamination. Only about 4% of flu vaccines given in the United States last year contained thimerosal as a preservative. Still, on Thursday, the committee heard an unusual presentation by Lyn Redwood, a nurse practitioner and former leader of Children's Health Defense, which has advocated against the use of mercury in vaccines. Unlike most other presentations given at the meeting, Redwood's was not vetted or read by a working group or outside experts in vaccine science before it was voted on, according to Dr. Sean O'Leary, a pediatrician at Children's Hospital of Colorado who has been a liaison member of the Advisory Committee on Immunization Practices, or ACIP. 'This selective use of data and omission of established science undermines public trust and fuels misinformation,' O'Leary said in a statement made on behalf of the American Academy of Pediatrics, which recently announced that it would no longer participate in ACIP meetings because of the changes to committee membership and what's being discussed. In a series of three votes Thursday, the ACIP members voted 5-1, with one member abstaining, to recommend that only single-dose flu vaccines be given to children, adults and pregnant women in the United States. Single-dose shots are free of thimerosal. Drs. Robert Malone, Joseph Hibbeln, Martin Kulldorff, Retsef Levi and Joseph Pagano voted yes on the thimerosal recommendations. Dr. Cody Meissner voted no. Dr. Vicky Pebsworth, volunteer director of research and patient safety at the National Vaccine Information Center, a group that emphasizes risks around vaccines while downplaying their benefit, abstained from the vote because she objected to its wording. In justifying his vote, Meissner, a professor of pediatrics at the Dartmouth Geisel School of Medicine, said he was worried that expressing a preference for single-dose vials might keep people from getting doses from multidose formulations in situations in which those shots may be the only option. 'That might limit the availability of the influenza vaccine for some people,' he said. 'My point is, the risk from influenza is so much greater than the nonexistent — as far as we know — risk from thimerosal, so I would hate for a person not to receive the influenza vaccine,' Meissner said. 'I find that very hard to justify.' Six members of the committee voted to continue to recommend that everyone 6 months and older receive an annual flu vaccine. Pebsworth abstained. Vaccines with thimerosal are still approved by the FDA. The ACIP recommendation now goes to the CDC director or potentially to Kennedy, as CDC nominee Dr. Susan Monarez is still awaiting Senate confirmation. However, ACIP recommendations are tremendously influential in how vaccines are used in the US, with implications for insurance coverage and state policies. The advisers also voted 5-2 on Thursday to recommend the use of a new shot that can protect babies from respiratory syncytial virus, adding an additional tool against the most common cause of hospitalization in infants. The shot, called clesrovimab and given the brand name Enflonsia, is made by Merck and joins two other interventions already on the market to protect babies against severe disease from RSV, a common virus that can be especially dangerous for infants. One, like clesrovimab, is an antibody shot, and the other is a vaccine given during pregnancy. Data presented at the meeting showed that the approved interventions were safe and dramatically reduced hospitalizations among babies from RSV in the last respiratory virus season. 'As a pediatrician, I mean, people need to understand what a spectacular accomplishment these results are,' Meissner said at Wednesday's ACIP meeting. They 'will have an enormous influence on public health.' The new drug was approved this month by the FDA, and the CDC committee's recommendation was the next step in making it widely available for the coming RSV season, which typically begins in the fall. The vote came after Levi, a professor of operations management at the Massachusetts Institute of Technology Sloan School of Management, raised questions Thursday morning about whether there were safety signals that arose in clinical trials of the antibody shots that deserve further scrutiny. Representatives from both the FDA and Merck emphasized the safety of the product and the rigor of the clinical trials. Meissner also expressed how thoroughly the CDC panel's work group on RSV examined the data. 'We went through the details very, very carefully, and I appreciate Dr. [Levi's] careful review of the records, but the work group is comfortable with the results from the different clesrovimab trials,' he said. Levi voted against recommending the Merck shot, joined by Pebsworth. However, the group voted unanimously Thursday that the Merck shot should be included in the Vaccines for Children program, which provides free vaccines to children whose families may not be able to afford them. HHS spokesperson Andrew Nixon said in a statement Thursday, 'The members of this committee are respected experts who take their responsibility to public health seriously. What they did today, just as Secretary Kennedy appointed them to do was review the evidence, debate it with scientific rigor and deliver recommendations rooted in data and medical integrity. The public deserves nothing but this.'
CTV News
3 days ago
- Health
- CTV News
Kennedy's vaccine committee endorses preservative-free fall flu shots
U.S. Secretary of Health and Human Services Robert F. Kennedy Jr., testifies during a House Energy and Commerce Committee, Tuesday, June 24, 2025, in Washington. (AP Photo/Mariam Zuhaib) ATLANTA -- The Trump administration's new vaccine advisers on Thursday endorsed this fall's flu vaccinations for just about every American but threw in a twist: Only use certain shots free of an ingredient antivaccine groups have falsely tied to autism. What is normally a routine step in preparing for the upcoming flu season drew intense scrutiny after U.S. Health Secretary Robert F. Kennedy Jr. abruptly fired the influential 17-member Advisory Committee on Immunization Practices and handpicked replacements that include several vaccine skeptics. That seven-member panel bucked another norm Thursday: It deliberated the safety of a preservative used in less than five per cent of U.S. flu vaccinations based on a presentation from an antivaccine group's former leader -- without allowing the usual public presentation of scientific data from the Centers for Disease Control and Prevention. The preservative, thimerosal, has long been used in certain vaccines that come in multi-dose vials, to prevent contamination as each dose is withdrawn. But it has been controversial because it contains a small amount of a particular form of mercury. Study after study has found no evidence that it causes autism or other harm. Yet since 2001, vaccines used for U.S. children age six years or younger have come in thimerosal-free formulas -- including single-dose flu shots that account for the vast majority of influenza vaccinations. The panel voted 5-1, with one abstention, that people ages six months and older get a flu vaccination this fall only using single-dose formulas that are thimerosal-free. 'There is still no demonstrable evidence of harm,' one adviser, Dr. Joseph Hibbeln, a psychiatrist formerly with the National Institutes of Health, said in acknowledging the panel wasn't following its usual practice of acting on evidence. But he added that 'whether the actual molecule is a risk or not, we have to respect the fear of mercury' that might dissuade some people from getting vaccinated. The ACIP, created more than 60 years ago, helps the CDC determine who should be vaccinated against a long list of diseases, and when. Those recommendations have a big impact on whether insurance covers vaccinations and where they're available. Kennedy has long held there was a tie between thimerosal and autism, and also accused the government of hiding the danger. Thimerosal was placed on the meeting agenda shortly after Kennedy's new vaccine advisory was named last week. Some public health experts contend the thimerosal discussion unnecessarily raised doubt in vaccines while possibly also making them more expensive and harder to get this fall. At the panel's meeting Wednesday, Chrissie Juliano, executive director of the Big Cities Health Coalition, lamented the ouster of the former ACIP panel and the agenda of the new one. Her organization, which represents large city health departments, 'is deeply concerned that many routine vaccines may soon become inaccessible or unaffordable for millions of Americans if ACIP makes changes based on ideology rather than science,' she said. 'The stakes are simply too high to let that happen.' ------ By Mike Stobbe And Lauran Neergaard Neergaard reported from Washington. The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
