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Moderna Eyes Testing Mpox, Bird Flu Vaccines in Humans This Year
Moderna Inc. is eyeing possible human testing of shots to fight mpox and bird flu this year, as the COVID-19 vaccine maker expands into more public-health immunizations.
The company is exploring messenger RNA vaccines for a number of such pathogens, most of them in the early stages of development, President Stephen Hoge said Monday in an interview. Moderna expects to advance its vaccines for mpox and bird flu to clinical trials after completing initial work on them, he said.
A shot against mpox would be valuable in case outbreaks reemerge, and the company sees bird flu as a “clear threat,” Hoge said. Moderna needs input from regulators and public health officials on how best to advance the vaccines as the need for them might not be immediate, he said.
Moderna could perform early clinical trials just to show the candidates are safe and potentially effective without advancing them through late-stage studies. From that point on, it isn’t clear whether the vaccine candidates would stay in Moderna’s pipeline to go through final studies later, or if governments would license and stockpile the shots based on early data, he said.
Breakthrough for Tuberculosis — One of the World’s Biggest Killers — as New Vaccine Shows Promise in Early Trials
Researchers on Monday announced promising results for a tuberculosis vaccine that can be freeze-dried and safely stored at higher temperatures for months, hailing a major breakthrough in the fight against one of humanity’s biggest killers and a major step towards overcoming one of the big barriers to vaccine distribution in poorer parts of the world.
The temperature-stable vaccine was tested in 45 healthy adults, half of whom were given a different vaccine formula that isn’t stable at higher temperatures and developed by scientists at the Access to Advanced Health Institute (AAHI) in Seattle (formerly the Infectious Disease Research Institute).
The temperature-stable vaccine also generated higher antibody levels in the blood — a sign, but not proof, of protection — compared to the non-stable shot, the researchers found, noting that the finding is not enough to determine which provides the most protection against TB.
Tuberculosis is a bacterial infection that often attacks the lungs. It is spread from person to person through the air, such as when someone with TB coughs or sneezes. It has been documented in humans for thousands of years — albeit under different names including consumption, phthisis and the White Plague — and is one of humanity’s leading killers. It is curable and preventable, though emerging antibiotic resistance could jeopardize this.
Exclusive: India May Issue Alert on Marion Cough Syrup Exports After Toxins Found
India may issue an alert on cough syrup exported by Marion Biotech, whose products have been linked to deaths in Uzbekistan, after tests showed many of the company’s drug samples contained toxins, a drug inspector said on Saturday. Indian police on Friday arrested three Marion employees and are looking for two directors after tests in a government laboratory found 22 of 36 syrup samples “adulterated and spurious.”
New Delhi is pursuing the issue even as the government has pushed back against allegations that cough syrup made by another Indian company, Maiden Pharmaceuticals, led to the deaths of children in Gambia last year.
Vaibhav Babbar, an inspector involved in the Marion probe, told Reuters the samples had been adulterated with ethylene glycol and diethylene glycol — the toxins that the World Health Organization says were found in the products sold by the two companies in the two countries.
As many as 70 children have died in Gambia and 19 in Uzbekistan.
Foundation Charges Cancer Patients $83,000 for Unproven but Promising Experimental Drug
Boston Globe via STAT News reported:
It has been more than 11 years since Julia Young was diagnosed with advanced ovarian cancer, and two years since it spread to her lymph system. By her own account, she has already beaten the odds for how long most women survive the deadly disease.
Still, when doctors told her last year that the cancer was growing despite two operations, radiation therapy and a fifth regimen of chemotherapy, the retired business-meeting facilitator decided to do something unorthodox: spend $83,000 out of pocket on an unproven experimental cancer vaccine.
The vaccine was custom-made for her at the direction of a small, recently established nonprofit with roots in Massachusetts called the Jaime Leandro Foundation for Therapeutic Cancer Vaccines. It works with commercial partners and researchers at the Washington University School of Medicine in St. Louis to create a promising but yet-to-be-approved treatment known as a personalized neoantigen synthetic long peptide vaccine.
Therapeutic vaccines represent the next frontier in cancer medicine. Cambridge-based Moderna recently reported encouraging results from a study of another type of personalized cancer vaccine it developed with the pharmaceutical giant Merck; it uses messenger RNA technology to target advanced melanoma. But more work remains before personalized vaccines can be greenlighted.
So far, 26 cancer patients have ordered vaccines from the foundation, according to the nonprofit, also known as JLF, and it’s unclear whether the series of seven shots has been beneficial. Young is one of six patients currently receiving injections. Another three received them but later died. Four died before shots could be administered, says JLF. Thirteen patients are waiting for their vaccine to be made.
Wider Awareness of Cronobacter Infection Risks Needed After Similac Recall: CDC Researchers Warn
Following last year’s massive Similac recall, a new federal report highlights the need for improved safety practices regarding the storage and preparation of infant formula, as well as the importance of wider awareness about the devastating side effects of Cronobacter infections from baby’s milk.
The concerns were highlighted in a study published by the U.S. Centers for Disease Control and Prevention (CDC) on March 3, in its Morbidity and Mortality Weekly Report (MMWR), which focused on Cronobacter sakazakii infections that caused two infant illnesses: one linked to powdered infant formula and another linked to contaminated breast pump equipment.
Abbott Laboratories recalled Similac, Alimentum and Elecare formula products in February 2022, after discovering powdered formula manufactured at a Michigan facility was contaminated with Salmonella Newport and Cronobacter sakazakii bacteria.
Widespread distribution of the contaminated formula has been blamed for causing hundreds of infant illnesses nationwide, and subsequent investigations have revealed Abbott ignored industry safety standards and best practices at its facility for years, endangering children for the sake of profits.
The Obesity Revolution: New Weight Loss Drugs Are Changing the Narrative on Obesity, With a Push From Pharma
A two-part message is permeating the halls of medicine and the fabric of society, sliding into medical school lectures, pediatricians’ offices, happy hours and social feeds: Obesity is a chronic biological disease — and it’s treatable with a new class of medications.
The condition has long been framed as a result of poor lifestyle decisions and a failure of willpower — eating too much and exercising too little. But a new generation of highly effective obesity medications, and the overt and subtle messaging from the pharmaceutical companies making them, are starting to change the narrative.
History has shown that new blockbuster drugs can alter how people think about health. Valium changed society’s views on anxiety in the 1960s and Prozac on depression in the 80s. People worried about their cholesterol a lot more after ads for Zocor ended up on NFL games. Now, the new obesity drugs are hitting the market, heating up one of the biggest pharmaceutical competitions in history and raising profound questions of cost, equity and cultural bias. And like previous blockbusters, these drugs may also end up changing how people think about what it means to be sick and what it takes to be healthy.
The new obesity drugs are in a class called incretin mimetics or GLP-1 based drugs, which emulate the effects of a hormone called glucagon-like peptide 1 that can help people feel full. They can lead to a startling amount of weight loss, up to a fifth of body mass, but have to be taken regularly by injection to avoid regaining pounds. They could reach staggering numbers of people: the worldwide obesity rate has surged to 13%, nearly tripling since 1975. In the U.S., 42% of adults and 20% of children are estimated to have obesity.
FDA Decision on Preterm Birth Drug’s Withdrawal Nears, Putting Spotlight on Patients, Agency
Nicole’s doctors told her the drug, called Makena, was her only option to prevent preterm labor, which is associated with a higher risk of death and disability for the baby. But none mentioned its approval was conditional, and that its effectiveness was in question.
Nicole took the drug as prescribed and delivered what she calls her “Makena baby” at 38 weeks, just shy of full term. She believes the drug is to blame for lasting bladder and hormonal issues that started during her second pregnancy. And she remains concerned about how the drug affected her child in utero.
When Nicole took Makena, the drug had been on the market for nine years under an accelerated approval granted by the Food and Drug Administration for preterm birth prevention. The clearance was contingent on its maker confirming, in further testing, that Makena did in fact lower the risk of an early labor.
But in 2019 — years after that supporting evidence was due — results from a confirmatory clinical trial comparing Makena to a placebo showed the treatment didn’t work. In the years since, Makena has become a controversial test case of the FDA’s authority to withdraw treatments that have failed in required follow-up testing. The agency’s advisers, as well as some physicians and women who were prescribed the drug, have pressured the FDA to act, citing Makena’s uncertain benefits and known risks.
Harwell Science Campus Chosen for New Moderna Vaccine Base
COVID-19 vaccine manufacturer Moderna has chosen a science campus as its U.K. base for the development of future medicines. The firm said the Innovation and Technology Centre would be built by the year 2025 at Harwell, Oxfordshire.
It said the site would “provide the U.K. public with access to mRNA vaccines for a wide range of respiratory diseases.” Under the agreement, the U.K. has made a commitment to buy Moderna’s vaccines for the next decade.
Darius Hughes, Moderna’s U.K. general manager, said the research and manufacturing base would deliver “innovative vaccines to the U.K. public that address emerging threats to our population.”
New COVID Boosters’ Protection Waned After Two Months, Study Says
COVID-19 bivalent boosters’ protection against death and hospitalization in elderly people began waning as soon as two months after vaccination, according to a preprint study.
The findings build on previous reports about the effectiveness of updated boosters from Moderna Inc. and Pfizer Inc., which showed the shots sharply reduced risks of severe COVID in older adults, but didn’t assess how long protection lasted.
The new report, written by researchers who looked at data from a Finnish patient registry, has not yet been peer-reviewed and was published as a preprint in the server MedRxiv.
The Omicron-targeted shots also did not reduce the risk of severe COVID in chronically ill adults younger than 65, the study found. Only a small proportion of the group — 15% — received an updated booster, which the authors said may have affected the results. In comparison, 52% of the elderly group received an updated booster.
FDA Panel to Reevaluate the Most Common Over-the-Counter Decongestant, Phenylephrine, Criticized as Useless
The Food and Drug Administration plans to ask a panel of its outside advisers to reconsider whether the most common decongestant ingredient available over the counter, phenylephrine, is effective.
There has been a renewed petition to pull it from store shelves over studies showing it was no more effective than a placebo in pills and syrups.
The April meeting of the FDA’s Nonprescription Drugs Advisory Committee will weigh whether the agency should revoke oral phenylephrine’s classification as “Generally Recognized as Safe and Effective” because it may be ineffective.
“Let me be clear, oral phenylephrine is not a safety risk,” Randy Hatton, a pharmacy professor at the University of Florida, told CBS News. “It just doesn’t work.”
Talc Supplier Hit With $29 Million Verdict in South Carolina Trial
A South Carolina jury has ordered former talc supplier Whittaker, Clark & Daniels to pay $29.14 million to a woman who said she developed mesothelioma from being exposed to asbestos-tainted talc in cosmetic products.
The jury in Columbia on Friday also found that talc manufacturer IMI Fabi was not responsible for plaintiff Sarah Plant’s illness, clearing it of liability, according to Jessica Dean, a lawyer for the plaintiff.
Cosmetics company Mary Kay and makeup pigment maker Color Techniques were also defendants but were dropped mid-trial after reaching confidential agreements with Plant. The trial was the first over talc claims against Mary Kay, according to Dean.
