by Brenda Baletti, Ph.D., Childrens Health Defense:
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 FDA.
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).
TRUTH LIVES on at https://sgtreport.tv/
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.
“In my opinion, with regard to children immunized in the United States with vaccines manufactured from 1998-2007, no one can determine which of the children, who are now young adults, were immunized from the lots of MMRII for which Merck did not have adequate assurances of the potency,” Kessler wrote.
Read More @ ChildrensHealthDefense.org
