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August 14, 2024 Toxic Exposures

Big Pharma News Watch

WHO Declares Mpox Outbreak a Global Health Emergency + 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.

WHO Declares Mpox Outbreak a Global Health Emergency

CNN Health reported:

The World Health Organization on Wednesday declared the ongoing mpox outbreak in Africa a global health emergency. WHO convened its emergency mpox committee amid concerns that a deadlier strain of the virus, clade Ib, had reached four previously unaffected provinces in Africa. This strain had previously been contained to the Democratic Republic of Congo.

Independent experts on the committee met virtually Wednesday to advise WHO Director-General Tedros Adhanom Ghebreyesus on the severity of the outbreak. After that consultation, he announced Wednesday that he had declared a public health emergency of international concern — the highest level of alarm under international health law.

Also known as PHEIC, this is a status given by WHO to “extraordinary events” that pose a public health risk to other countries through the international spread of disease. These outbreaks may require a coordinated international response, according to the organization.

The organization has already signed off on the Emergency Use Listing process for both mpox vaccines and developed a regional response plan requiring $15 million, with $1.45 million already released from the WHO Contingency Fund for Emergencies.

CDC: Vaccine Coverage Still Lags for Some Children — ‘We Need to Do More,’ Says Agency’s Chief Medical Officer

MedPage Today reported:

Despite overall success of the CDC Vaccines for Children (VFC) initiative, vaccine coverage still lagged in multiple areas for VFC-eligible children, according to CDC data.

Although almost 90% of VFC-eligible children born during 2011-2020 received the measles, mumps, and rubella (MMR) vaccine, just 61% to 65% received a combined series of seven pediatric vaccines, “highlighting room for improvement,” reported Madeleine Valier, MPH, of the CDC National Center for Immunization and Respiratory Diseases, and colleagues.

The report “highlights the need to reduce the gaps in vaccination coverage for children living below the poverty level and those without health insurance,” Debra Houry, MD, MPH, CDC chief medical officer, told reporters. “We need to do more.”

Store-Brand Mucinex Maker to Move Away From Using Cancer-Causing Chemical

Bloomberg reported:

The maker of store-brand Mucinex sold by CVS, Walmart and others is reformulating its products to move away from an ingredient that is made with a cancer-causing chemical.

Amneal Pharmaceuticals Inc. plans to submit testing data on its new formulation to the U.S. Food and Drug Administration by the end of the year, the company said in a statement. The company expects to bring the products to market before August 2025.

Bloomberg reported Monday that, according to an analysis of government data, store-brand generic versions of extended-release Mucinex made by Amneal contain an ingredient called a carbomer that is made with the potent carcinogen benzene. Brand-name Mucinex, made by Reckitt Benckiser Group Plc, uses a carbomer without benzene.

U.S. regulators have allowed drugmakers to use benzene for decades, even though international authorities have said they shouldn’t. In recent years, testing has found dangerously high levels of the chemical in some products in the U.S., raising concerns and prompting the FDA last year to push pharmaceutical companies to start phasing out the use of carbomers made with benzene.

Mpox Map Shows U.S. States With Virus in Wastewater as Outbreak Hits Africa

Newsweek reported:

Mpox has been detected in wastewater in the United States after the virus was declared a public health emergency by the African Centers for Disease Control and Prevention as a more deadly strain spreads across the continent.

Testing and monitoring facilities have expanded, and the country has “ample supplies” of the mpox vaccine.

Wastewater surveillance systems are in place across the U.S. to detect mpox activity and track its spread through communities. This data is useful because sewage can be tested to detect traces of infectious diseases circulating in a community, even if people don’t have symptoms.

The case detections in the U.S. were also all consistent with the original strain of the virus from the 2022 outbreak, known as clade II. No detections of the more deadly form of the virus that is currently circulating in the Democratic Republic of the Congo and neighboring countries, known as clade I, have been made in the U.S.

Better Safety Studies Could Restore America’s Confidence in Vaccines

STAT News reported:

In February 2021, I received my second COVID-19 shot — the newly developed vaccine that would eventually save millions of lives worldwide — with great anticipation. It proved to be a life-changing event: Two hours later as I was driving home, the shock of a sudden loud and high-pitched whistling nearly caused me to veer off the road. It was as if an audible dog whistle began blaring right next to me. But it wasn’t a dog whistle. It was the acute onset of tinnitus, a ringing in the ear with no external source.

For several years I had lived with minimal, intermittent tinnitus, but never anything like this, so loud and unrelenting. Could the COVID-19 vaccine have amplified my tinnitus, or was this just a coincidence? I was suspicious, but at that time no data had demonstrated any relationship between the mRNA COVID-19 vaccines and tinnitus.

When I got my third dose in November 2021, the sound became even louder and more bothersome. This new noise level has continued to this day, nonstop, often keeping me from sleep and sometimes bringing me to tears.

Some people, like me, have unexpected effects from vaccines that affect our health and well-being. I say “some” because no one really knows how often vaccine-related injuries occur. Understanding that would be a first step toward reducing these rare risks even further. Are such adverse events predictable, and can they be prevented by identifying risk factors for the onset of a vaccine injury? I believe the answer is yes, but it won’t be achievable without increased funding for vaccine safety research.

Americans’ trust in vaccines has been slowly eroding. It accelerated with the advent of the World Wide Web in the 1990s and has been declining ever since. The COVID-19 outbreak temporarily obscured the problem, as many expressed the desire for a vaccine against this plague and millions got it once it became available.

Moderna Unveils Free Coursera Curriculum on mRNA Medicines to Boost STEM Skills

Fierce Pharma reported:

With analysts estimating that millions of jobs in the STEM fields are currently going unfilled in the U.S., Moderna is doing its part to strengthen the workforce and close that gap.

The drugmaker has teamed up with online educational course provider Coursera to offer a course on its core focus, the use of mRNA technology in medicine, to kick-start the learning process for anyone interested in working in that realm.

The three-part curriculum, dubbed “mRNA as Medicines,” will be available to Coursera users around the world. The trio of modules will teach students about all things mRNA: from its basic structure and makeup to its use in drug development, with an emphasis on its vast potential in vaccines and therapies to prevent and treat tough-to-target diseases.

J&J Has Enough Support From Claimants for $6.5-Billion Talc Settlement, Bloomberg Reports

Reuters reported:

Johnson & Johnson (JNJ.N) has cleared a key threshold of support for its proposed $6.5-billion settlement of tens of thousands of lawsuits alleging its baby powder and other talc products caused cancer, according to a Bloomberg report.

More than 75% of claimants voted in favor of the proposal, according to Bloomberg, a hurdle J&J set for a third attempt at placing a subsidiary in bankruptcy protection to resolve the litigation.

Measles Vaccine Failure Linked to Very Low Transmission Rates

CIDRAP reported:

Measles is far less contagious when spread by someone who has suffered secondary vaccination failure (SVF) compared to an unvaccinated person, according to a new review of 14 studies, including 11 studies. The review was published late last week in Emerging Infectious Diseases.

“Despite the effectiveness of measles-containing vaccines, infection remains possible in immunized persons,” the authors said. “This phenomenon has come to be known as vaccination failure.”

SVF infections tend to be milder than infections in unvaccinated people, with lower fever, less cough, and overall lower viral loads. However, no universally agreed-upon definition for measles SVF exists.

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