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FDA Approves First Vaccine for RSV, a Moment Six Decades in the Making
After a 60-year scientific quest, the world has its first vaccine to protect against the respiratory syncytial virus, or RSV — and more are on the way. On Wednesday, the U.S. Food and Drug Administration approved Arexvy, made by GSK, which is designed to be given as a single shot to adults 60 and older.
It could be available for seniors as soon as this fall, pending a recommendation for its use from the U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices, which next meets in June.
GSK’s RSV vaccine works by using a small piece of the virus: a protein that sticks out on its surface called the fusion, or F, protein, which helps the virus glom onto and infect cells in the body’s upper airways. The protein pieces in the vaccine are made in a lab, using cells specially programmed to manufacture them.
The vaccine builds on a pivotal discovery made a decade ago by researchers at the National Institutes of Health, including some of the same scientists who helped make the COVID-19 vaccines.
Older Adults Voice Safety, Efficacy Concerns With COVID Boosters as Fewer Than Half Take Up the Shots
Older adults are expressing concerns about the bivalent COVID booster shots, according to a recent Health Canal survey.
Despite the recommendation by the Centers for Disease Control and Prevention (CDC) for older adults to have new bivalent mRNA COVID-19 vaccines from Moderna and Pfizer, which were launched last year, so far only 42.4% of that age group has received the booster.
Why? Patients are citing personal health and safety concerns (40.7%) as the top reasons for not getting the booster, according to the survey.
They are also deterred by risks they see as associated with the vaccine and potential side effects (31.1%), while another reason listed for not getting the booster was skepticism about the new formula’s effectiveness, with 27.8% reporting that concern.
Walmart Beats Suit for Vaccinating Teen Without Parental Consent
The federal Public Readiness and Emergency Preparedness Act gives Walmart Stores Inc. immunity for administering a COVID-19 vaccination to a teenager without her mother’s consent, a state court in Kansas said.
The law unambiguously and broadly grants covered entities immunity from suit and liability for all claims related to or arising out of the administration or use of a covered countermeasure, including vaccines, the Kansas Court of Appeals said. That includes immunity for a claim related to a lack of parental consent, it said.
Gardasil Gastroparesis Lawsuit Filed Over Side Effects of HPV Vaccine Injection
A former college hockey player has filed a product liability lawsuit against Merck, alleging that his future was derailed by side effects of an HPV vaccine, indicating that he developed gastroparesis from a Gardasil injection received when he was 22 years old.
The complaint was filed by Austin DeGrange in the U.S. District Court for the Western District of North Carolina on April 26, indicating that the drug maker failed to disclose known risks associated with its widely used Gardasil HPV vaccine injection.
Although families and medical providers were led to believe Gardasil was safe, a number of problems have been reported in recent years, including issues where Gardasil caused autoimmune problems, including gastroparesis, postural orthostatic tachycardia syndrome (POTS) and other severe conditions, which have emerged shortly after receiving the injection.
Merck now faces nearly 100 Gardasil lawsuits brought by individuals nationwide, each involving similar allegations that severe and disabling injuries could have been avoided if Merck had adequately researched the HPV vaccine injection and disclosed the potential risks.
MRNA Was a COVID Miracle. Could It Be the Same for the Flu?
The first mRNA flu shots — designed to be better than the existing vaccines that can be as little as 10% effective — were supposed to be rolled out as soon as this year. But data released in February from a shot Moderna is testing proved underwhelming, and in April the company said it needs to keep studying the vaccine before it can declare victory, casting doubt on its timeline to reach the market. Rival Pfizer is still on track to release data later this year.
To revive declining sales, companies have been planning to create mRNA flu shots and combine those with mRNA COVID boosters into a single yearly shot. In the U.S., the flu shot has an uptake rate of about 50%, compared to 17% for the latest COVID vaccine. By pairing them, more people are likely to get both shots, and companies can charge more.
The global market for combined mRNA flu shots and COVID boosters is probably about $50 billion a year, according to Jefferies analyst Michael Yee. They could easily go for $100 a dose, he said. Individual flu shots now typically cost about $30 a shot.
Vaccine makers know for the plan to work things need to start going better, soon. Beyond Pfizer and Moderna, the other flu shot giants — GSK, CSL Seqirus and Sanofi — have their own mRNA flu vaccine efforts underway. Moderna is testing a total of five flu shots, expecting that eventually, one will be a winner.
A Vaccine for Birth Control?
For half a century, Gursaran Pran Talwar has been developing what he hopes will be the next big thing in birth control. A nonagenarian who was once the director of India’s National Institute of Immunology, Talwar envisions bringing to market a new form of contraception that could block pregnancy without the usual trade-offs — an intervention that’s long-acting but reversible; cheap, discreet, and easy to administer; less invasive than an intrauterine device and more convenient than a daily pill.
It would skip messy, sometimes dangerous side effects, such as weight gain, mood swings, and rare but risky blood clots and strokes. It would embody the sort of “set it and forget it” model that’s become a gold standard for health—and, in his words, be “accepted by the world over.”
Talwar’s invention is now in early-stage clinical trials. If all goes well, it could become humanity’s first contraceptive vaccine — one that would prevent pregnancies in a way distinct from any birth control ever cleared for human use.
Whether they’re packaged as pills, patches, implants, or shots, the most common medical contraceptives work by flooding the body with hormones to put a pause on ovulation. Talwar’s vaccine would do something different: It leaves the menstrual cycle unaltered, instead leveraging the powers of the immune system to keep unwanted pregnancies at bay.
Case Builds Against Beta-Blockers Beyond First Year After Heart Attack — Do They Still Have a Role for People Without Heart Failure or LV Systolic Dysfunction?
The conventional wisdom of giving long-term beta-blockers for secondary prevention after myocardial infarction (MI), in the absence of another clinical indication, was questioned by a large cohort study from Sweden.
For survivors who were still on beta-blocker therapy 1 year after heart attack hospitalization and had a normal left ventricular (LV) ejection fraction, the next few years did not bring a significantly lower risk of combined all-cause mortality, MI, unscheduled revascularization and hospitalization for heart failure following inverse propensity score weighting and multivariable adjustment (18.9% vs 21.7% for peers without beta-blockers; adjusted HR 0.99, 95% CI 0.93-1.04).
For many years, American and European guidelines alike have given blanket endorsements to beta-blockers after ST-elevation MI (STEMI) and non-ST elevation MI (NSTEMI), regardless of left ventricular function, and without specifying the duration of therapy.
Any perceived benefits of beta-blockers are also to be weighed against the risk of side effects such as depression and fatigue.
Dog Flu Adapts in the Direction of Being Able to Infect Humans, Chinese Study Says
Dog flu has shown adaptations that allow the virus to recognize a human-like receptor, according to a Chinese study, possibly indicating it may be closer to infecting humans. A receptor is a molecule inside or on the surface of a cell that binds to a specific substance and causes an effect in the cell.
By studying the biological characteristics of H3N2 canine influenza viruses isolated worldwide over the period of a decade, researchers at China Agricultural University and other institutions found that the viruses became able to recognize the human-like SAα2,6-Gal receptor.
In addition, the viruses showed gradually increased hemagglutination — a reaction that causes clumping of red blood cells in the presence of some enveloped viruses — acid stability and replication ability in human airway epithelial cells and acquired a 100% transmission rate via respiratory droplets in testing using ferrets.
“Our results showed that canines may serve as intermediates for the adaptation of avian influenza viruses to humans,” the study said. “Continuous surveillance coordinated with risk assessment for [the viruses] is necessary.”
Federal Rules Don’t Require Period Product Ingredients on Packaging Labels. States Are Stepping In.
Tens of millions of Americans use menstrual products, and while manufacturers contend they are safe, most disclose little about the chemicals they contain. Now, amid calls for more disclosure and research into the health effects of these products, some states require more transparency.
The manufacture and sale of period and related products is a big business, with revenue expected to top $4.5 billion in the United States this year. On average, a person uses up to 17,000 tampons or pads in their lifetime, and they might also use rubber or silicone cups, or absorbent period underwear.
The FDA regulates and classifies menstrual products as medical devices, meaning they are not subject to the same labeling laws as other consumer items. But companies can voluntarily disclose what’s in their products.
Now, some states are stepping into the breach. In 2021, New York became the first state to enact a menstrual product disclosure law requiring companies to list all intentionally added ingredients on the packaging.
Advocacy groups studying the effects of the New York law say the new labels have revealed commonly found ingredients in menstrual products that may contain carcinogens, reproductive toxicants, endocrine disruptors and allergens.
