Tag: merck

FDA Greenlights Merck’s RSV Shot for Newborns — Clinical Trials Showed 11.71% Rate of Serious Adverse Events, Including Death

The U.S. Food and Drug Administration (FDA) on Monday approved Merck’s new monoclonal antibody shot, which the company said is designed to protect newborns and infants against respiratory syncytial virus (RSV).

The antibody shot, clesrovimab, will be marketed as Enflonsia and launched this coming RSV season to challenge Sanofi and AstraZeneca’s blockbuster Beyfortus shot.

Beyfortus, first approved in 2023, generated $1.8 billion in sales last year, FiercePharma reported.

PR Newswire projected that the global RSV vaccine and antibody market would reach $13.59 billion by 2030.

Merck said its monoclonal antibody has about the same efficacy rate as Beyfortus. In clinical trials, the shot reduced RSV-related hospitalization by 84.3% compared to placebo, and the incidence of RSV that needed to be medically attended by 60.5% versus placebo, through age 5 months in the clinical trials.

The company also said in a press release that the drug’s safety profile was “generally comparable” to placebo. The most common adverse reactions were injection-site erythema or swelling, and a rash 14 days after the dose, all of which were more common in the vaccine group.

However, the clinical trial results posted on the government website ClinicalTrials.gov included other serious neurological adverse reactions that Dr. Peter Selley, a U.K. general practitioner who has closely followed the development of the drugs for RSV, called “concerning.”

These included febrile convulsions, seizures, facial paralysis and brain injury at about three times the rate in the vaccine group (25 of 2,409) as the placebo group (4 of 1,202).

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Court Confirms Merck Lied on Mumps Vaccine Label — But Lets Drugmaker Off the Hook in Antitrust Lawsuit

An appeals court this week ruled that even though Merck misrepresented critical data to the U.S. Food and Drug Administration (FDA) to gain approval for its updated mumps vaccine — and even though the FDA knew about the false claims — because the agency approved the vaccine anyway, Merck can’t be held responsible for unfairly hurting competitors.

The ruling stems from a class action lawsuit brought by a group of physicians and physicians groups who alleged Merck violated the Sherman Antitrust Act by making false claims about the efficacy of its mump vaccine on the product’s label in order to stifle competition and maintain a monopoly in the marketplace.

The Sherman Antitrust Act prohibits companies from conspiring to create a monopoly.

The U.S. 3rd Circuit Court of Appeals didn’t dispute the plaintiffs’ allegations that Merck lied to the FDA about the vaccine’s efficacy.

However, citing the Noerr-Pennington doctrine, the court ruled that because the FDA took no action against Merck after discovering the false claims, it was the FDA’s decision — not Merck’s fraud — that injured competitor GSK and the physicians and physicians groups who bought the ineffective vaccine at inflated prices.

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‘Highly Confidential’: Former FDA Chief Details Fraud in Merck’s Testing, Marketing of Mumps Vaccine

For decades, Merck misrepresented the efficacy of its mumps vaccine, marketing an “adulterated” drug without proven efficacy to millions of American children, according to a recently released expert report by Dr. David Kessler, former head of the U.S. Food and Drug Administration (FDA).

The report — posted in two documents and marked “highly confidential,” for “attorneys’ eyes only” — provides over 800 pages of Kessler’s opinion and analysis about the history and severity of Merck’s regulatory violations over decades, beginning in the late 1990s.

By 1998, regulatory labeling review had revealed that the mumps component of Merck’s measles, mumps rubella vaccine, MMRII, did not maintain the stated potency over its shelf-life, in violation of FDA regulations.

Rather than recalling the vaccine or attempting to develop a different formula, the company spent years trying to develop new and more sensitive ways to test the existing vaccine that would show high efficacy results, so it would still be in compliance with regulatory requirements and allow Merck to maintain its exclusive license.

Merck did this even though its existing data showed the vaccine was significantly less effective than claimed, Kessler wrote.

To temporarily make the drug meet Merck’s efficacy claims while the company developed tests, Merck increased the dosage of virus present in the vaccine — with the FDA’s knowledge — although the higher dosage was never tested in clinical trials for either safety or efficacy.

The company did not inform the vaccine recipients, providers or purchasers — including the Centers for Disease Control and Prevention (CDC), which purchased the drug through its Vaccines for Children Program — that its vaccine was out of compliance.

Merck’s actions, Kessler wrote, had important “public health significance.”

According to the report, starting in 2006 and recurring since then, there has been a resurgence of mumps outbreaks in the U.S. The largest outbreak in 2017 affected more than 10,000 people in 46 states.

The vast majority of the people infected in all of the outbreaks received the recommended two-dose regime of Merck’s MMR vaccine, the report says.

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Merck accused of downplaying early evidence of drug’s brain impact

An early magazine advertisement for Merck’s breakthrough asthma and allergy medicine, Singulair, featured a happy child, hanging upside-down from a tree. Asthmatic kids could now breathe easier, the text assured, and side effects were “usually mild” and “similar to a sugar pill.”

When the drug launched in 1998, its label said the drug’s distribution in the brain was “minimal,” with no mention of psychiatric side effects.

Merck’s early safety claims later faced intense scrutiny amid reports over two decades that patients, including many children, had died by suicide or experienced neuropsychiatric problems after taking the drug. The FDA in 2020 ordered its most serious warning, known as a “black box,” on Singulair’s label. And Merck now faces a raft of lawsuits alleging it knew from its early research that the drug could impact the brain and that it minimized the potential for psychiatric problems in statements to regulators.

The lawsuits cite the research of Julia Marschallinger, a cell biologist who has studied the drug along with colleagues at the Institute of Molecular Regenerative Medicine in Austria. That team found in 2015 that the drug’s distribution into the brain was more significant than its label described. The FDA cited Marschallinger’s work when it ordered Singlair’s black-box warning label.

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Merck’s COVID Drug May Cause Mutated DNA, Birth Defects, Cancer, And Reduced Male Fertility, NYT Reports

Merck’s newly FDA-approved COVID-19 antiviral drug, molnupiravir, may pose severe health consequences despite being purchased in bulk by the Biden administration prior to its approval.

According to the New York Times, the purported wonder drug may have “the potential to cause mutations in human DNA.”

Of particular concern are pregnant women, because researchers say that “the drug could affect a fetus’s dividing cells, theoretically causing birth defects.” One researcher said “there is no circumstance” in which he would advise a pregnant woman to take the drug, as a result.

Buried in the middle of the New York Times article, the author explains that researchers are concerned the drug could “cause errors” in a patient’s DNA, or the DNA of an unborn child.

According to a team of researchers in North Carolina, those “errors” could cause DNA mutations that may “contribute to the development of cancer, or cause birth defects either in a developing fetus or through incorporation into sperm precursor cells.”

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Just Days After Bill Gates Warns of Smallpox Attack, Multiple Vials Labeled Smallpox Found in Merck Lab

During a sit-down interview earlier this month with the chair of the Health Select Committee, Jeremy Hunt, for the think tank Policy Exchange, Bill Gates made an ominous prediction. He said governments need to chuck up a billion dollars a year, to pay for a Pandemic Task Force at the World Health Organization level, to carry out “germ games” to prepare for an ostensibly inevitable bioterrorism attack — particularly smallpox.

“You say, OK, what if a bioterrorist brought smallpox to 10 airports? You know, how would the world respond to that?” Gates asked.

“There’s naturally-caused epidemics and bioterrorism-caused epidemics that could even be way worse than what we experienced today and yet, the advances in medical science should give us tools that, you know, we could do dramatically better.”

As Gates asked for tens of billions in funding, he told Hunt that he hopes his next book will be titled, ‘We ARE ready for the next pandemic’.

There is nothing at all wrong with preparing for potential bio terror attacks. As we learned with COVID-19, ill prepared governments can and will wreak horrifying havoc on the economy, freedom, and health.

While it is unclear what Gates’ plans are for these “germ games,” so long as they don’t involve billions of dollars flowing into “gain of function” research to make viruses spread easier and become deadlier, being prepared is not a bad idea.

But now it’s time to put on your tinfoil hat.

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