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September 23, 2024 Toxic Exposures

Big Pharma NewsWatch

Amid New Mpox Outbreak, Study Suggests Waning Protection of Jynneos Vaccine + More

The Defender’s Big Pharma Watch delivers the latest headlines related to pharmaceutical companies and their products, including vaccines, drugs, and medical devices and treatments. The views expressed in the below excerpts from other news sources do not necessarily reflect the views of The Defender. Our goal is to provide readers with breaking news that affects human health and the environment.

Amid New Mpox Outbreak, Study Suggests Waning Protection of Jynneos Vaccine

CIDRAP reported:

Jynneos vaccine wane significantly over the course of a year, raising new questions about just how protected vaccinated people are against reinfection and if booster doses of the vaccine are needed among at-risk populations.

The study was released alongside an alarming development in the globalization of mpox: More than 21,000 cases of the virus have been recorded in the past year in the Democratic Republic of the Congo (DRC), UNICEF noted yesterday.

On August 14, the World Health Organization declared the DRC outbreak a public health emergency of international concern, in part because around 60% of cases are in children 15 years and under.

In the DRC, children under age 15 account for about half of all suspected cases reported in DRC so far this year but 80% of the deaths, according to UNICEF.

This week Rwanda became the first African country to begin mpox vaccination.

New Migraine Drugs No Better Than Cheap Painkillers: Big Study

MedicalXPress reported:

New, more expensive migraine drugs are no more effective against the throbbing headaches than traditional painkillers, and even performed worse than an older range of treatments called triptans, said a massive global analysis Thursday.

Migraines are severe, often disabling headaches which affect at least one in seven adults globally, according to the World Health Organization.

They are also up to three times more common in women than men.

For decades, cheap and widely available painkillers such as aspirin and ibuprofen have been prescribed for migraines, as well as the more powerful triptans, which change how blood circulates in the brain.

But in recent years, a new generation of migraine drugs called gepants has emerged.

These new drugs have generally been tested against a placebo.

However a new meta-analysis, published in the BMJ journal, brought together 137 previous randomized, controlled trials looking at how 17 different treatments affected a total of nearly 90,000 people.

The newer and more expensive drugs rimegepant and ubrogepant — as well as another called lasmiditan, which can have drowsy side effects — were about as effective as paracetamol and anti-inflammatory painkillers, the study said.

Startup Vicebio Banks $100M in Bid to Make ‘Cost-Effective’ Vaccines

BioPharma Dive reported

Vicebio, a London-based biotechnology startup, has raised $100 million in Series B financing to continue developing a technology it claims has the potential to produce potent vaccines that are easy to manufacture.

The Series B round announced Monday was led by new backer TCG Crossover and involved Goldman Sachs Alternatives, Avoro Ventures and founding investor Medicxi, among others.

The new funds will help advance a portfolio of vaccines for respiratory infections, led by a combination shot for respiratory syncytial virus and human metapneumovirus that recently began Phase 1 testing.

Vicebio says its technology, dubbed “molecular clamp,” has the ability to target viral proteins in their “prefusion” shape, before they’ve latched onto cells.

In an interview with BioPharma Dive, CEO Emmanuel Hanon said this approach should lead to a bigger immune response and enables Vicebio to bypass a cumbersome part of the manufacturing process, making the startup’s shots potentially more cost-effective to produce.

Measles cases rise as vaccine coverage lags

Politico reported

A NEW MEASLES NORMAL?

Measles, once declared eliminated in the U.S., is making an alarming comeback.

With 13 measles outbreaks already reported this year — compared with four last year — public health officials are concerned, Sophie reports.

In the years since the height of the COVID-19 pandemic, measles, mumps and rubella vaccine coverage for kindergarteners fell 2% and hasn’t recovered — meaning that “76,000 more children are not up to date on their vaccinations,” a CDC spokesperson told POLITICO.

The latest data available is from the 2022-2023 school year.

The vaccination coverage rate in kindergarteners has hovered around 93 percent for the past few years — below the 95% that health experts say is needed to maintain herd immunity against the virus.

Behind the shift: Public health officials say some decline could still be a lingering consequence of people staying away from doctors’ offices during the pandemic’s height.

But they also cite vaccine hesitancy as another reason — and some say misinformation around the COVID-19 vaccine exacerbated the issue.

Pre-pandemic, MMR vaccines already attracted a fair amount of skepticism — because of a now-retracted 1998 article in The Lancet that suggested the vaccine was tied to autism.

Researchers ‘Turbocharge’ Vaccine Delivery by Jolting ‘Bystander’ Immune Cells Into Action in Animal Models

MedicalXPress reported:

Monash University researchers have developed a new technique to boost the effectiveness of both traditional and mRNA-based vaccines in animal models.

Published in Immunity, the study found that adding low doses of a vaccine-specific antibody to a COVID-19 vaccine stimulated the immune system’s B cells, which are responsible for generating antibodies to fight viral infections.

The results from this study highlight the potential of antibodies as vaccine components to boost the immune response.

“A key challenge for vaccine design is to ensure sufficient activation and duration of B cell responses to achieve the quantity and quality of antibodies required for protection,” said senior author Dr. Isaak Quast, from Monash University’s Department of Immunology.

Second Health Care Worker Linked to Missouri Bird Flu Case Also Had Symptoms: CDC

MedicalXPress reported:

Another health care worker who was exposed to a Missouri patient who tested positive for bird flu developed respiratory symptoms but wasn’t tested for the flu, U.S. health officials reported Friday.

The news is rekindling worries of person-to-person transmission of the H5N1 bird flu strain.

The week before, the U.S. Centers for Disease Control and Prevention (CDC) reported that a different health care worker who cared for the bird flu patient developed mild respiratory symptoms and tested negative for influenza.

Meanwhile, a person who lives with the Missouri patient also became sick but was not tested for the flu at the time.

The household contact experienced gastrointestinal symptoms, the CDC said, which can be associated with an influenza infection.

FDA Says Drug Makers Will Stop Producing Fentanyl ‘Lollipops’

MedicalXPress reported:

Controversial fentanyl lollipops and similar products will no longer be made by drug makers, the U.S. Food and Drug Administration (FDA) has announced.

Known as Transmucosal Immediate-Release Fentanyl medications, these products contain fentanyl and are used to manage breakthrough pain in cancer patients who have become tolerant to around-the-clock opioid therapy, the FDA said in a statement released this week.

The decision by drug makers to stop selling such medicines follows decades of investigations and lawsuits against the drugmakers that had marketed the fast-acting painkillers too aggressively, CBS News reported.

In 2020, the FDA first tightened prescribing restrictions on the products, in response to data suggesting they were being given to patients who are not opioid-tolerant.

Drugmaker Cephalon had the FDA’s approval to market these drugs for years under brand names like Actiq, a sweetened lozenge on a stick, or Fentora, a tablet that dissolves in the mouth.

Can Our Stockpiles of Tamiflu Protect Against a Bird Flu Pandemic?

Ars Technica reported

Since reports emerged earlier this year that dairy cows across the country had been infected with H5N1 bird flu, the prospect that the virus could evolve to spark another pandemic has stoked serious concern.

But unlike COVID-19, the flu is an old, well-known foe. And health authorities have reassured the public that the U.S. has squirreled away millions of doses of the flu medication oseltamivir, known under the brand name Tamiflu.

As health policy expert Leana S. Wen wrote in a Washington Post opinion piece, the drug “works against seasonal flu and is expected to work well against H5N1.”

While oseltamivir may help in cases of severe flu, some experts are concerned that the U.S. is banking far too much on a so-so drug while failing to prioritize research on new treatments.

J&J Lifts Baby Powder Settlement Bid to More Than $8.2 Billion

Insurance Journal reported

Johnson & Johnson has boosted to more than $8.2 billion its offer to settle thousands of lawsuits by people who say its baby powder gave them cancer, according to people familiar with the matter.

The offer, an increase from the drugmaker’s previous $6.5 billion bid, signals that J&J may have to pay at least $1.7 billion more to resolve all of the claims in the yearslong litigation.

Under the new terms, claimants could get bigger payouts and about $650 million in legal fees covered, said the people, who asked not to be identified discussing the deliberations. J&J declined to comment.

‘We Are Not Testing Enough’: New US Bird Flu Cases Stoke Fears Over Poor Response

The Guardian reported:

After three more herds in California’s Central valley tested positive for bird flu, questions have been raised about whether the true extent of the outbreak in the U.S. is much wider than recognized, given inadequate or nonexistent biosecurity and a persistent lack of testing.

The new cases, revealed by officials at the U.S. Department of Agriculture, bring the total in California to eight affected herds discovered this month.

“We are really not testing enough,” said Meghan Davis, an associate professor at Johns Hopkins Bloomberg school of public health. “The lack of testing has actually been one of the most startling things for me, in terms of watching the response to this outbreak unfold.”

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