Merck Defeats Appeal by Nearly 1,200 Shingles Vaccine Plaintiffs
Merck has beaten back an appeal by nearly 1,200 plaintiffs who claimed their cases were improperly dismissed by the federal judge overseeing mass torts litigation over its Zostavax shingles vaccine. The 3rd U.S. Circuit Court of Appeals ruled on Tuesday that U.S. District Judge Harvey Bartle of Philadelphia did not abuse his discretion when he dismissed cases by plaintiffs who failed to produce clinical test results in response to a so-called Lone Pine order.
Bartle issued the Lone Pine order in the consolidated Zostavax litigation in early 2022, after granting summary judgment to Merck in five bellwether cases.
The bellwether plaintiffs had sought to hold the company liable without presenting results of a polymerase chain reaction, or PCR, test that would conclusively prove their shingles was caused by exposure to the virus contained in the Merck vaccine and not from past exposure to the chicken pox virus.
Bartle then issued the Lone Pine order calling for all of the other nearly 1,200 plaintiffs who claimed to have developed shingles as a result of receiving the Merck vaccine to produce clinical test results to back up their allegations.
Joe Biden Is Taking Paxlovid, Even Though Doctors Know It Doesn’t Really Work
Another summer outbreak of COVID-19 is here. President Biden announced he is sick with the virus on Wednesday, and he’s in good company. White House Press Secretary Karine Jean-Pierre said in a statement on Wednesday that the president “has received his first dose” of Paxlovid, the antiviral treatment from Pfizer that’s meant to ease COVID-19 symptoms and make the virus less dangerous for high-risk patients.
But some experts wonder why you’d even prescribe this drug, which has been shown in study after study to be lackluster, at best.
Pfizer’s big trial of more than 1200 patients, out in April, suggested that maybe taking Paxlovid can prevent a few hospital admissions among the frailest, most vulnerable patients, but it’s tough to say. Five patients on Paxlovid in that study were hospitalized or died. In the control group (not taking Paxlovid) that number was 10. The difference here wasn’t even statistically significant.
Paxlovid did seem to make hospital stays shorter in the Pfizer study, and ICU visits less likely. But other research from the UK, out in May, showed absolutely no difference in mortality when comparing hospitalized patients taking Paxlovid to those who weren’t on the drug.
Highly Infectious Poliovirus Found in Gaza Sewage Samples
The poliovirus has been found in sewage samples from Gaza putting thousands of people living in crowded displaced persons’ camps at risk of contracting the highly infectious disease that can cause deformities and paralysis.
The Israeli health ministry said poliovirus type 2 was detected in Gaza sewage samples tested in an Israeli laboratory. It said the World Health Organization had made similar findings.
It highlighted “severe overcrowding” and “scarce water” that is becoming contaminated with sewage and the accumulation of rubbish. The ministry said Israel’s refusal to let hygiene supplies into Gaza “creates a suitable environment for the spread of different diseases.”
Pfizer, Valneva Inch Closer to FDA Approval of 1st Lyme Disease Vaccine
Becker’s Hospital Review reported:
Drugmakers Pfizer and Valneva are one step closer to obtaining FDA approval for what would be the first Lyme disease vaccine after publishing positive results from a phase 3 trial, the companies announced on July 17.
The vaccine in development would be given as a series of three doses, followed by an extra booster shot one year after the initial vaccination series. The phase 3 study will monitor participants until 2025, but so far, has revealed positive results.
Upon completion of the trials, Pfizer plans to submit a Biologics License Application to the FDA in 2026 in addition to a Marketing Authorization Application to the European Medicines Agency, according to the news release.
Pfizer and Valneva initiated phase 3 trials for the vaccine candidate in August 2022 and completed recruitment in December 2023. The two have been working together to develop a Lyme disease vaccine since April 2020.
First Gardasil Lawsuit Set for Trial to Begin October 7 in California State Court
Later this year, a California jury will be the first to hear evidence and testimony claiming that the Gardasil HPV vaccine can cause severe autoimmune and neurological disorders, while the first federal bellwether trials are unlikely to begin before late 2025 or early 2026.
Gardasil has been widely used for years, among both young girls and boys, to help protect against HPV infections that can be sexually transmitted and lead to the later development of cervical cancer. Although the vaccine has been widely promoted as safe and effective, Merck currently faces hundreds of product liability lawsuits nationwide, each raising similar allegations that the drug maker failed to disclose the risk of serious autoimmune disorders that may result from the side effects of the Gardasil vaccine.
Lawsuits indicate that a number of teens and young adults have been left with severe and debilitating complications after receiving one or more injections, including postural orthostatic tachycardia syndrome (POTS), neurological problems, premature ovarian failure, idiopathic thrombocyteopenic purpora (ITP), chronic pain, brain fog, fatigue, headaches, nerve damage and other injuries.
Why the Most Prescribed Chemotherapy Drug Can Cause Serious Heart Damage
There’s still much to learn about how doxorubicin, a 50-year-old chemotherapy drug, causes its most concerning side effects. While responsible for saving many lives, this treatment sometimes causes cardiac damage that stiffens the heart and puts a subset of patients at risk for future heart failure.
To better understand and potentially control such complications, Tufts University School of Medicine and Tufts Graduate School of Biomedical Sciences researchers have isolated the immune cells that become overactive when patients take doxorubicin. The team’s findings appear July 17 in the journal Nature Cardiovascular Research.
SHEA Calls for More CDC Funds After Data Show 20% Hike in Resistant Hospital Infections
A fact sheet published by the U.S. Centers for Disease Control and Prevention (CDC) yesterday highlights a 20% rise in hospital-onset infections caused by antimicrobial-resistant pathogens and a fivefold increase in Candida auris infections during the COVID-19 pandemic compared with 2019.
A Society for Healthcare Epidemiology of America (SHEA) statement following the release of the fact sheet calls for continued investment in CDC programs that fight antimicrobial resistance (AMR).
The CDC fact sheet is a follow-up to its latest AMR report in 2020, which described the rising threat of the AMR pathogens carbapenem-resistant Enterobacterales (CRE), carbapenem-resistant Acinetobacter, Candida auris, methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Enterococcus (VRE), multidrug-resistant (MDR) Pseudomonas aeruginosa, and extended-spectrum beta-lactamase (ESBL)-producing Enterobacterales.
The 20% rise in these pathogens from before to during the pandemic peaked in 2021, but in 2022, all pathogens except MRSA remained above pre-pandemic levels.
Paxlovid After a COVID Exposure Fails to Reduce Household Transmission — Nearly All Trial Participants Had Some Level of Immunity at Baseline, However
Nirmatrelvir-ritonavir (Paxlovid) did not prevent people exposed to COVID-infected household members from getting infected with the virus, according to the final results of the phase II/III EPIC-PEP study.
Across more than 2,700 exposed adults in the trial, symptomatic confirmed infections at 14 days occurred in 2.6% of those taking a 5-day course of the antiviral medication, 2.4% of those receiving a 10-day course, and 3.9% of the placebo recipients. Neither of those differences versus the placebo group was statistically significant (P=0.17 and P=0.12, respectively), reported Jennifer Hammond, PhD, head of antiviral development at Pfizer in Collegeville, Pennsylvania, and colleagues.
