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COVID Vaccine Injury Suit May Fuel Federal Overhaul, Litigation
A lawsuit by COVID-19 vaccine recipients claiming they were injured by their shots may usher in long-awaited changes to how the federal government handles immunization injuries.
Individuals frustrated by the HHS program designed to compensate them for their injuries are taking their grievances to court. In a lawsuit lodged with the U.S. District Court for the Western District of Louisiana, they say the program is unconstitutional, depriving them of their rights to due process and a jury trial.
Lawyers say the move could spur Congress and the Department of Health and Human Services to reform how they handle vaccine injuries, as well as push more of the individuals alleging injuries to not just sue the government, but the drugmakers that the program is meant to shield from litigation.
For years, attorneys and activists representing Americans injured by routine vaccinations have been pushing lawmakers to reform how the HHS reviews requests for compensation. They say that the process, dubbed the Vaccine Injury Compensation Program, is in desperate need of more special masters to review the backlog of nearly 4,000 injury claims.
Vaccine law experts say the path forward is reforming the VICP and bringing COVID-19 immunization injuries under its umbrella. But doing so takes both the HHS and Congress, and attorneys say efforts from both appear lagging.
5-Year-Old Accidentally Got Double Dose of COVID Vaccine, Morrisville Mom Says
A Morrisville mother told WRAL News her 5-year-old received an accidental double dose of Moderna‘s new COVID-19 vaccine. This comes as the Food and Drug Administration alerted parents and health providers that children under the age of 11 may receive the incorrect dose of Moderna’s updated COVID-19 vaccine — but said the dosage is not believed to be dangerous.
The FDA said health providers may be confused over the dosage of the vaccine, which is available to children as young as 6 months of age. According to the FDA, a single vial of Moderna’s current vaccine for children 6 months to 11 years old contains “notably more” than the 0.25 mL dosage children should receive.
Roberts said her 5-year-old daughter received the vaccine on Oct. 18. Later, she got a call from her pediatrician’s office. “They called and said, we just want to let you know that we made a mistake while giving your daughter the vaccine. We gave her a double dose instead of a single dose,” Roberts said.
Roberts said her daughter had a fever of 102.5 degrees for about 12 hours after she got her shot. “I understand human error, but this is not like you ordered too many tablecloths or something,” she said. “You injected something into my child that you can’t get out now.
Ozempic and Other Weight-Loss Drugs Will Power the Anti-Obesity Market to 16-Fold Gains by 2030, Goldman Sachs Says
The anti-obesity market is primed for a massive surge over the next six years, according to Goldman Sachs.
Strategists for the bank said in a research note published Tuesday they’re expecting the rise of weight loss drugs, or anti-obesity medications, to power the industry to 16-fold gains by 2030. Such a gain would push its total valuation from $6 billion to as much as $100 billion.
GLP-1 weight-loss drugs such as Ozempic and Wegovy have surged in popularity this year, which analysts believe could create a huge investing opportunity.
Goldman Sachs based its forecast on a scenario where 15 million American adults are taking GLP-1 drugs by 2030, accounting for just under 15% of the overweight or obese population.
A Winter of Low COVID Vaccination Will Probably Seem Fine
Relatively speaking, 2023 has been the least dramatic year of COVID living to date. It kicked off with the mildest pandemic winter on record, followed by more than seven months of quietude. Before hospitalizations started to climb toward their September mini-spike, the country was in “the longest period we’ve had without a peak during the entire pandemic,” Shaun Truelove, an infectious disease modeler at Johns Hopkins University, told me.
So maybe it’s no surprise that, after a year of feeling normal-ish, most American adults simply aren’t that worried about getting seriously sick this coming winter.
They also are not particularly eager to get this year’s COVID shot. According to a recent CDC survey, just 7% of adults and 2% of kids have received the fall’s updated shot, as of October 14; at least another 25% intend to nab a shot for themselves or their children but haven’t yet.
And even those lackluster stats could be an overestimate because they’re drawn from the National Immunization Surveys, which is done by phone and so reflects the answers of people willing to take federal surveyors’ calls.
Separate data collected by the CDC, current as of October 24, suggest that only 12 million Americans — less than 4% of the population — have gotten the new vaccine, according to Dave Daigle, the associate director for communications at the CDC’s Center for Global Health.
The Hunt Quickens for Vaccines and Antibody Therapies Against Opioids
The concept has long tantalized scientists: harnessing the power of antibodies to block the dangerous effects of heroin, cocaine and nicotine, substances that have wrecked or ended millions of American lives.
Despite years of efforts that have failed to yield viable vaccines or lab-made antibody treatments, research is accelerating as the nation grapples with an unprecedented drug crisis — more than 100,000 Americans died of overdoses in each of the past two years, fueled chiefly by the synthetic opioid fentanyl.
Backed by millions of dollars in federal funding, researchers envision vaccines and monoclonal antibody treatments as supplementing opioid treatment and overdose medications, though it could be years before the prospective therapies become available.
The federal government recently awarded an additional $14.8 million for research into a monoclonal antibody that would target fentanyl — the nation’s deadliest street drug — by binding to its molecules before they can invade the brain and shut down breathing. Cessation Therapeutics, a North Carolina biotech company, touts its monoclonal antibody as a way both to prevent overdoses and to treat overdoses and opioid addiction.
House Lawmakers Launch Probe Into FDA’s Response to Nationwide Drug Shortages
As shortages of drugs like amoxicillin, penicillin, Adderall and certain chemotherapies continue to confound doctors and patients in the U.S., two high-ranking Republican lawmakers are pressing the FDA for answers.
In a letter (PDF) to FDA Commissioner Robert Califf, M.D., the chairman of the House Committee on Oversight and Accountability, James Comer, R-Kentucky, and Lisa McClain, R-Michigan, chairwoman of the Subcommittee on Health Care and Financial Services, requested documents and a staff-level briefing to parse through the agency’s shortage mitigation strategies.
At the time of writing, the FDA listed 128 drugs as being in shortage, according to the lawmakers. The medications treat a range of conditions such as infections, respiratory illnesses, heart failure and cancer.
They cite several reasons for the current spate of shortages, apart from pandemic-related supply chain delays. Key among those causes is an “over-reliance” on foreign manufacturing, plus “surging” demand and “diminishing” production of generic medicines. The lawmakers called for more domestic drug manufacturing as one possible remedy to the shortage conundrum.
Shrinking COVID Vaccine Sales Has Moderna Course-Correcting
Moderna’s stock is progressively slumping these days, thanks largely to shrinking sales of COVID-19 vaccines. The company also delayed its flu shot from 2024 to 2025, according to the company’s third-quarter earnings call.
Analysts had initially projected more than $100 million in sales for Moderna’s yet-to-be-approved RSV and flu vaccines as soon as next year, Reuters points out. But that’s no longer the case. Moderna’s stock has dropped about 60% in the last year.
If sales continue to slump, the company may consider out-licensing some of its clinical-stage programs: “If we have to, we will be open, of course, to partnerships [for] some of those programs,” CEO Stéphane Bancel said on an earnings call. The company’s future is no longer COVID. Instead, it will focus more heavily on combination vaccines and cancer, Endpoints says.
New Antibiotic Tackles Drug-Resistant Gonorrhea in Trial
U.S. News & World Report reported:
The first new antibiotic for gonorrhea — the second most common sexually transmitted disease — has shown promise in a clinical trial. That news should come as a relief to public health experts because gonorrhea has become resistant to all but one of the existing antibiotics used to treat it.
This new antibiotic, called zoliflodacin, was seen in the trial to cure uncomplicated gonorrhea infection as effectively as the current go-to, which is an injection of the antibiotic ceftriaxone along with one dose of azithromycin pills.
The drug was developed by U.S.-based Innoviva Specialty Therapeutics and Swiss nonprofit Global Antibiotic Research & Development Partnership.
Breakthrough Antidepressants With Fewer Side Effects Could Help Millions of Americans. Here’s What the Future of Treatment May Look Like
The number of people with depression has reached new highs—and so has antidepressant use. As Americans are increasingly reaching for pharmaceutical solutions for depression — about one in eight U.S. adults takes antidepressants — scientists have been innovating novel treatments for it.
In October, the FDA approved gepirone hydrochloride extended-release tablets (Exxua) from Fabre-Kramer Pharmaceuticals. Rather than targeting serotonin receptors in general like SSRIs, it shoots for one receptor in particular: the serotonin 1A receptor. In clinical trials, the pills eased depression without the sexual side effects that can push some people to quit SSRIs. And there were no adverse effects on weight, blood pressure, heart rate, or liver function. It’s expected to be available in early 2024.
Still, not everyone benefits from drugs that work on monoamines. The development of esketamine (Spravato) has helped shift attention beyond these neurotransmitters altogether.
The FDA approved Johnson & Johnson’s drug for treatment-resistant depression in 2019. Esketamine is derived from a pediatric anesthetic called ketamine. Through research pioneered at Yale University, it was discovered that the drug seemed to lift heavy, recalcitrant depression almost immediately. And it did so without working on monoamines.
People Who Used Recalled Philips Breathing Machines Face Painful Choices
They thought they were getting clean air from the lifelines at their bedsides, coveted nights of healthy sleep that for too long did not come easy.
But in June 2021, Kim Binford, Connie Thompson, Debra Miller and millions of others learned that a defect in the breathing machines they relied on for years had the potential to inflict serious harm, including cancer, kidney and lung problems, and severe respiratory infections.
In announcing a massive recall of ventilators and sleep apnea machines, Philips Respironics acknowledged that an industrial foam placed inside the devices to reduce noise could break apart and send tiny particles and fumes into the noses, mouths and lungs of patients.
As many as 15 million devices from two Pittsburgh-area plants were made with the crumbling material, including the company’s popular DreamStation continuous positive airway pressure, or CPAP, machine used by those with sleep apnea. The disorder causes breathing to stop and start through the night.
