By The Defender Staff

New York Lawmakers Introduce Bills to Protect Statewide Vaccine Access
New York State leaders on March 27 introduced two new bills aimed at protecting access to vaccines. The first bill would require health insurers to cover vaccines recommended by the state Commissioner of Health to the Superintendent of Financial Services, as well as vaccines recommended by the federal Advisory Committee on Immunization Practices (ACIP).
The second bill would remove references to ACIP from several areas of state law, including Public Health Law provisions on school immunization requirements and newborn immunization schedules. It would also apply to education law rules governing which immunizations can be prescribed or ordered by physicians and nurse practitioners and administered by pharmacists. The bill also amends the Social Services Law related to Medicaid coverage, according to Gov. Kathy Hochul’s Office.
In addition, the legislation would expand pharmacists’ authority to offer the COVID-19 vaccine. Under current state law, pharmacists can only administer the vaccine to adults. The proposed change would allow pharmacists to provide the COVID-19 immunization to children ages 2 to 18.
Self-Amplifying mRNA Vaccine Shows ‘Enhanced Immune Function’—but Where Is the Safety Data? A Closer Look at a Phase 3 Substudy
A 2026 study led by Kate S. Levine of the Harvard T.H. Chan School of Public Health, in collaboration with Arcturus Therapeutics, and published in npj Vaccines, evaluates immune responses following a booster dose of the self-amplifying mRNA (saRNA) COVID-19 vaccine ARCT-154 versus Pfizer’s BNT162b2.
This post-hoc analysis of a Phase 3 trial subset reports that ARCT-154 induces more sustained antibody function, particularly Fc receptor–mediated activity and natural killer (NK) cell activation.
While the findings suggest prolonged immune engagement, the study raises key questions: Does enhanced immune signaling translate to clinical benefit—and where is the safety data?
FDA Warns of Fatal Liver Injuries Tied to Drug It Wants Pulled From Market
The FDA on Tuesday warned that postmarketing data has turned up dozens of serious cases of drug-induced liver injury (DILI) associated with avacopan (Tavneos), a vasculitis drug that the agency wants removed from the market.
Eight of the cases were fatal, including three patients who developed vanishing bile duct syndrome (VBDS), a condition that can lead to permanent liver damage where the bile ducts are progressively destroyed before disappearing altogether. “Although hepatotoxicity is a serious adverse reaction for Tavneos identified in premarket clinical trials and described in product labeling, VBDS and DILI cases with fatal outcomes represent new safety concerns,” the FDA said.
Avacopan was approved in 2021 as an adjunctive treatment for adults with severe anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis and microscopic polyangiitis [GPA and MPA]). The oral complement 5a inhibitor is typically used in combination with glucocorticoids and other standard medications.
Misinformation Abounds in Influencers’ Promotion of Prescription Drugs
Don’t expect accuracy and transparency in the promotion of prescription drugs by social media influencers, researchers cautioned. Though evidence was limited in this systematic scoping review, recurrent themes in posts about prescription drugs by influencers included misinformation and blurred lines between personal testimony and paid promotion, with weak regulatory oversight, reported Raffael Heiss, PhD, of the Center for Social and Health Innovation at the MCI Management Center Innsbruck in Austria, and colleagues.
“Collectively, these issues increase the risk that audiences act on misleading or harmful recommendations,” they noted in JAMA Network Open. Drug promotion by social media influencers is rapidly expanding, “yet until now there has been no systematic attempt to map what research actually shows about its risks and regulatory challenges,” Heiss told MedPage Today in an email.
“Influencer-pharma partnerships increasingly involve not only celebrities but also smaller patient influencers with highly engaged audiences, for example, around new GLP-1 weight-loss medications,” Heiss said. “This matters for public health because influencer promotion can shape medication demand, blur the line between personal experience and advertising, and potentially contribute to inappropriate use.”
Use of Newer Antibiotics for Challenging Infections Is Rising, but No Improvement Seen in Death Rates
A new study suggests that newer antibiotics designed for some of the most drug-resistant bacterial infections are being used more frequently but aren’t making a dent in survival rates. The study, published in The Lancet Infectious Diseases, found that, among patients hospitalized with a difficult-to-treat (DTR) gram-negative bacterial infections, initial treatment with one of six antibiotics approved in recent years rose by nearly 300% from 2016 to 2023. But there was no observed reduction in mortality among the patients.
Furthermore, over the entire study period, more than three-quarters of patients with DTR infections received initial treatment with discordant antibiotics — defined as antibiotics that either weren’t active against the pathogen or to which the pathogen was actively resistant. The authors of the National Institutes of Health (NIH)-funded study say the findings suggest that new antibiotics alone aren’t enough to improve survival in patients with highly resistant infections.
“We were hopeful that mortality would have improved over time. However, survival from most if not all infections is also related to the timing of the diagnosis and early initiation of antibiotics,” first author Morgan Walker, MD, a critical care and infectious diseases physician at the NIH Clinical Center, told CIDRAP News.
Fentanyl Vaccine Begins Trial in New Effort to Prevent Overdose
Biotech startup ARMR Sciences Inc. said it has begun a human trial of its anti-fentanyl vaccine in an early study that could one day lead to a shot offering months-long protection from the deadly respiratory effects of the powerful synthetic opioid.
The trial is the culmination of years of research. It aims to show that a vaccine, unlike existing emergency remedies, could prevent a fentanyl overdose from ever happening.
Like a flu shot, the idea is to stimulate the immune system to produce antibodies — except, in this case, the antibodies would work against fentanyl and reduce the drug’s ability to overwhelm the brain and shut down the breathing process.
Although numerous academics have worked on the concept of vaccines against addictive drugs over the years, progress toward bringing such a shot to the market has been limited. Various attempts to vaccinate against nicotine, cocaine and other addictive substances fizzled in clinical trials around a decade ago.
Novo Nordisk Launches Multi-Month Subscriptions for Wegovy Obesity Drugs as It Tries to Catch up With Eli Lilly
Novo Nordisk on Tuesday launched a multi-month subscription program for its Wegovy obesity drug products that aims to ensure cash-paying patients see lower, “predictable” monthly prices. Eligible patients can choose between three-, six- or 12-month subscriptions for the Wegovy injection or the two highest doses of the newly launched pill under the same brand name. Longer plans offer lower monthly pricing, and the company expects people to save up to $1,200 a year on the injection and as much as $600 a year on the pill, relative to paying for their individual dose each month, according to a Novo release.
Patients can expect to pay flat monthly prices, even if they move to different doses, the company said. The subscription program will be available starting Tuesday on several of Novo’s telehealth partners, including Ro, WeightWatchers, LifeMD, Sesame and Hims & Hers, with more expected to be added soon.
The first-of-its-kind offering is “an opportunity to help patients not only start but stay on therapy and help them manage the ups and downs of some of the pricing considerations,” regardless if they are starting treatment or are currently taking the drug, said Ed Cinca, Novo’s head of marketing and patient solutions.
3 Companies Built Their Fortunes on COVID Vaccines, but Only 1 Has a Real Plan for What Comes Next
Moderna generated $1.944B in full-year 2025 revenue (down 39.2% YoY) with negative $2.822B net loss and negative $2.065B free cash flow, settling a $2.25B patent dispute while trading 13.6% above the $43.75 Wall Street consensus target.
Novavax posted profitable results with $0.11 EPS versus negative $0.42 estimates and $147.14M revenue (up 66.6% YoY) driven heavily by Sanofi partnership, though it carries negative shareholder equity and high volatility (beta 2.63). BioNTech reported positive full-year 2025 revenue growth of 4.3% to €2.87B with €17.2B in cash and positive €403M operating cash flow, with 14 analyst Buys and a consensus target of $130.72, implying 52.4% upside from the current price.
The COVID-19 vaccine boom created unsustainable revenue models for all three companies, forcing Moderna and BioNTech to pivot toward oncology while Novavax depends on partnerships for survival, with only BioNTech positioned to fund a multi-year transition backed by a fortress balance sheet and pipeline breadth.
Eli Lilly Reaches $2.75 Billion Deal With Insilico to Bring AI-Developed Drugs to the Global Market
U.S. pharmaceutical giant Eli Lilly has reached a $2.75 billion deal to bring drugs developed using artificial intelligence by Hong Kong-based Insilico Medicine to the global market. The agreement will give Insilico $115 million up front, with the remainder subject to regulatory and commercial milestones, along with royalties on future sales, according to the companies’ announcement Monday.
Insilico has developed at least 28 drugs using generative AI tools, with nearly half already at a clinical stage, Alex Zhavoronkov, founder and CEO of Insilico, told CNBC. The company went public in Hong Kong in December. Its shares are up more than 50% year-to-date.
“In many ways, Lilly is better than us in some areas of AI,” Zhavoronkov said, noting the U.S. pharma giant has “one person” who has brought biology, chemistry and automation under one roof. He added that as part of the deal, Insilico will join Lilly’s Gateway Labs community for biotech development.
The post New York Lawmakers Introduce Bills to Protect Statewide Vaccine Access + More appeared first on Children’s Health Defense.
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