FDA Approves Merck's RSV Drug for Infants
The Food and Drug Administration (FDA) has approved Merck's drug for respiratory syncytial virus (RSV) in infants.
Regulators cleared Enflonsia, the monoclonal antibody, for newborns and infants 'born during or entering their first RSV season,' the FDA
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Axios
36 minutes ago
- Axios
RFK Jr. names 8 new members of vax advisory panel
HHS Secretary Robert F. Kennedy on Tuesday named eight new members to serve on an influential federal vaccine advisory panel after firing all 17 of the committee's members. Why it matters: While Kennedy posted on X that the new appointees are committed to evidence-based medicine, several have a history of expressing anti-vaccine sentiment or voicing concerns about COVID-19 or mRNA vaccines. Some were also signers of the Great Barrington Declaration, a petition authored by a group of scientists including current NIH Director Jay Bhattacharya that advocated for allowing COVID to spread among young, healthy people to reach herd immunity faster. The approach drew fierce criticism from many experts. The Advisory Committee on Immunization Practices serves as an outside expert source to make recommendations to the Centers for Disease Control. Its recommendations can influence whether insurers cover vaccines. The new members are: Martin Kulldorf, a biostatistician who previously served on the Vaccine Safety Subgroup of ACIP and who was a co-author of the Great Barrington Declaration. He was fired from Harvard University for refusing COVID vaccination. He later claimed it was because he was " too pro-vaccine." Robert Malone, a physician-scientist and biochemist who made early contributions to mRNA vaccine technology. He was dubbed a "misinformation star" by the New York Times for spreading false information about COVID and mRNA shots, including claiming he was an inventor of the technology.. Cody Meissner, a professor of pediatrics at the Geisel School of Medicine at Dartmouth, who has previously held advisory roles for both CDC and FDA. He is also a signer of the Great Barrington Declaration and co-wrote an editorial with FDA Commissioner Marty Makary during the COVID pandemic arguing against masking for children. Retsef Levi, a professor of operations research at MIT. Levi has been a critic of mRNA vaccines, posting on social media in 2023 that "we have to stop giving them immediately." Vicky Pebsworth, a long-time nurse with a Ph.D. in public health. She previously served on the FDA's Vaccine and Related Biological Products Advisory Committee and on the National Vaccine Advisory Committee's vaccine safety working group for the H1N1 vaccine. As of 2022, Pebsworth served on the board of the National Vaccine Information Center, an anti-vaccine group. She's spoken publicly about her son experiencing long-term health issues following vaccines at 15 months old. Joseph Hibbeln, a psychiatrist and neuroscientist who previously worked at the NIH for many years. He primarily studies nutrition and brain health. Michael Ross, a clinical professor of obstetrics and gynecology at George Washington University and Virginia Commonwealth University. James Pagano, an emergency medicine physician licensed in Florida and California. The other side: The announcement immediately stoked fears from some public health experts that the committee selections are overly skeptical of vaccines. "It's entirely possible that some of these people may be completely non-problematic," Angela Rasmussen, a virologist at the Vaccine and Infectious Disease Organization at the University of Saskatchewan. However, others are "unbelievably anti-vax people. They are 100% not going to approach this in good faith."
Yahoo
an hour ago
- Yahoo
Breyers Ice Cream Is Being Recalled Nationwide—Here's What to Know
Breyers recalls mislabeled Rocky Road Ice Cream sold in Chocolate Truffle tubs. Affected cartons were sold nationwide, and they pose an almond allergen risk. Undeclared almonds can cause severe allergic reactions; seek help if symptoms U.S. Food & Drug Administration (FDA) announced a recall on a Breyers ice cream flavor sold nationwide, according to a recent report. This is due to mislabeling causing an undeclared allergen. The ice cream product being recalled is a 1.5-quart carton of Breyers Rocky Road Ice Cream packaged in a Breyers Chocolate Truffle Tub. While the tub bears the label of the chocolate truffle flavor, the lid is accurately labeled as the rocky road flavor. The impacted cartons have a printed best-by date of July 10, 2026, and UPC '077567457288.' Check your ice cream immediately, and if it matches the recall information, dispose of it or return to your place of purchase for a possible refund. This recall was recently classified as a Class II recall, meaning that the product "may cause temporary or medically reversible adverse health consequences." Those that have bought this mislabeled ice cream may unknowingly eat almonds, an undeclared allergen on the product. This can cause an allergic reaction as severe as anaphylaxis for people allergic to nuts. If you are showing signs of anaphylactic shock like nausea, vomiting, abdominal pain, hives or trouble breathing after eating this ice cream, call 911 immediately. Contact the FDA at 1-888-INFO-FDA (1-888-463-6332) for questions or to ask for additional information about this recall. Read the original article on EATINGWELL
Yahoo
an hour ago
- Yahoo
Montana Supreme Court strikes down trio of abortion bills as unconstitutional
In this photo illustration, packages of Mifepristone tablets are displayed at a family planning clinic on April 13, 2023 in Rockville, Maryland. A Massachusetts appeals court temporarily blocked a Texas-based federal judge's ruling that suspended the FDA's approval of the abortion drug Mifepristone, which is part of a two-drug regimen to induce an abortion in the first trimester of pregnancy in combination with the drug Misoprostol. (Photo illustration by) A trio of abortion-related bills, passed in 2021, were declared unconstitutional by a nearly unanimous Montana Supreme Court on Monday. Nearly, because Justice Jim Rice wrote both a concurring and dissenting opinion affirming again Montana's constitutionally protected right-to-privacy, which includes medical procedures and abortion. The laws were halted before they could even be practically enacted, so the hurdles to the procedure, including waiting periods, mandatory ultrasound, a pile of documentation and banning abortion after 20 weeks, even before the point of fetal viability, never rippled throughout the state. Justice Beth Baker wrote the opinion on behalf of the court, which not only reaffirmed the state Constitution's right-to-privacy as unique and separate from federal cases on abortion, but also took the state to task for failing to support its claim that the State of Montana had a compelling interest in abortion, while not proving that any of the legislative hurdles were scientifically supported. The lawsuit was brought by Planned Parenthood of Montana, and had a handful of other entities that wrote friends-of-the-court briefs, including a group of delegates to the 1972 Montana Constitutional Convention. The three laws that were challenged were House Bill 136, House Bill 140 and House Bill 171: HB 136 would have banned abortion at 20 weeks, even though expert opinion agreed that fetal viability is not possible until at least 22 weeks. HB 171 would have put paperwork and more requirements for healthcare providers who provide abortion via medication or telehealth, subjecting them to both civil and criminal penalties. HB 180 would have required healthcare professionals to provide both ultrasound and fetal heartbeat tones to those considering abortion, and requiring a patient to sign a form created by the state, demonstrating that the patient had been offered the choice, and yet declined. Because fetal viability — or the concept a child can survive outside the womb — is dictated by a host of factors, including medical science and approximate age of the fetus, the court rejected the state's attempts to prescribe a fixed number of weeks for viability. 'A fixed gestational age that does not allow a provider's case-specific determination fails to ensure that the government does not interfere with an individual's private medical decision,' the ruling said. 'Until a fetus is viable and able to survive outside the womb, the right of personal autonomy belongs to the person on whose body the fetus depends. 'We find no legal authority for the idea that the state's interest in preserving fetal life or the fetus' right to life takes precedence over all constitutional protections and dignities of the mother.' Attorneys for the state had argued that physical safety risks of abortion increase as the pregnancy progresses, and that abortions lead to worse mental health outcomes, an argument that the Supreme Court dismissed and debunked. 'The record shows that abortion is safe,' the decision said. 'As the district court noted, there were zero deaths cause by abortion in Montana between 2010 and 2020 and only 25 of 8,402 (0.3%) reported abortions in Montana from 2016 to 2021 resulted in complications. This court cannot find a bona fide health risk simply based on a detailed step-by-step description of what the state defines as 'barbaric' and 'gruesome' procedure when the overwhelming evidence shows that procedural abortions are safe.' The ruling also said if the state wanted to address health outcomes or mental health issues, banning abortion was not the least restrictive way to do it. The court also pointed out waiting-periods and requiring multiple in-person visits, as outlined by HB 171, actually increased the odds of harm or complications, instead of avoiding them. 'The record demonstrates that compliance with the 24-hour wait period, the multiple in-person visits, and the telehealth ban serve only to delay access to abortion care — thus increasing the odds that the patient will not be able to obtain an abortion or increasing the odds of the very complications this state asserts it wishes to protect against,' the opinion said. The ruling also said in addition to violating the state's constitutional provisions for privacy, it also impacted physician's free-speech rights by requiring them to provide forms and documents, for example, information about a disputed abortion reversal procedure, that have not been medically verified or supported. They said HB 171 compelled healthcare professionals to give advice contrary to their training and conscience. Physicians and experts also raised concerns about the state's assertion abortion led to other health care concerns, for example, an increase in breast cancer, which has never been scientifically established. 'Forcing medical providers to give medical advice that they disagree with — like the safety and efficacy of abortion reversal — is a form of compelled-speech triggering protections,' the ruling said. '(Planned Parenthood) asserts that patients may mistakenly understand the consent form to indicate DPHHS's and their provider's approval of abortion reversal.' The ruling calls such compelled speech egregious because it 'favors one viewpoint over another — namely, the viewpoint that abortion reversal is safe and possible over the judgements and viewpoints of providers that it is unsafe, ineffective and undermines informed consent.' The court noted the state does not mandate documentation or consent that requires medical providers to discuss the risk of carrying a pregnancy to term. Finally, the court also called into question the real purpose of HB 140, which mandates ultrasounds and fetal heart tones before an abortion, something that providers said either happens during the course of pregnancy, but may not be medically necessary. 'The court stated it was 'left with the strong impression that the law aims to advance the ulterior motive of discouraging abortion,' which is unacceptable under the law,' the ruling said. Montana's highest court found that in the case of HB 140, it was exactly substituting the judgment of the state, and the lawmakers who supported it, with the views of the doctor. 'The court's decision further protects what Montanans need and deserve: Legal access to compassionate, timely abortion care, free from government interference. At the same moment as this win for Montanans, anti-abortion politicians continue to threaten to decimate access to care by 'defunding' Planned Parenthood via the reconciliation bill before Congress, in an effort to shut down health centers who provide abortion and other reproductive care. Montanans agree that abortion should remain legal and accessible, and Planned Parenthood of Montana will always do whatever we can to ensure that patients in Montana have access to abortion care,' said Martha Fuller, president and CEO of Montana Planned Parenthood, after the ruling in a statement. The case was active for several years of litigation, and had district court Judge Amy Eddy sitting in place of former Chief Justice Mike McGrath, who retired at the end of 2024, as well as Judge Shane Vannatta, who was sitting in for Dirk Sandefur, who also retired. McGrath has since been replaced by Chief Justice Cory Swanson, and Sandefur was succeeded by Justice Katherine Bidegaray.
