The report was released as two separate documents, this one and this one, and is marked "highly confidential" and "for attorney's eyes only."
The more than 800 pages contained in the report outline Kessler's opinion and analysis of both the history and severity of Merck's many regulatory violations over the years, beginning around the late 1990s.
At issue is Merck's infamous measles, mumps and rubella (MMR) vaccine, also known as MMRII. Kessler reveals with proof how by the year 1998, a regulatory labeling review found that the mumps component of MMRII did not maintain its stated potency over its shelf life, which violates the regulations set forth by the FDA.
Merck should have recalled the adulterated and violative multivalent vaccine immediately, but instead spent years trying to come up with alternative testing methods that would produce the positive results the company wanted. This is known as fraud, and it is a hallmark of the way Merck has been operating with regard to MMRII.
(Related: Did you know that mumps is mostly spread by children who are vaccinated?)
The FDA was complicit in Merck's MMRII fraud
Merck knew all along, says Kessler, that its own internal data showed that MMRII was significantly less effective than claimed. Still, the company tried to tweak the truth rather than come up with a new formulation that met the stated efficacy while complying with FDA guidelines.
Merck did successfully come up with a temporary fix to the problem that involved increasing the dosage of the virus present within the vaccine. The FDA knew Merck did this and allowed it even though the higher dosage was never tested in clinical trials for safety or efficacy.
At no point in time did either Merck or the FDA notify vaccine recipients, providers or purchasers, including the U.S. Centers for Disease Control and Prevention (CDC) which purchased the drug via its Vaccines for Children Program, that anything had changed with the vaccine's formulation, or that it was in breach of FDA compliance.
Kessler wrote in his report that Merck's actions on this matter came with "public health significance" in that starting in 2006 and beyond there was a major resurgence in mumps outbreaks across the United States, the largest occurring in 2017 when more than 10,000 people across 46 states succumbed to the infection.
As is almost always the case with such outbreaks, the vast majority of those who got sick with mumps had previously gotten the recommended two-dose injection series of Merck's MMR vaccine.
"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 says.
Kessler's report was made public as part of the Krahling et al. v. Merck and Co. Inc trial, which saw oral arguments presented in the 3rd Circuit U.S. Court of Appeals in Philadelphia on July 9. Former Merck virologists Stephen Krahling and Joan Wlochowski achieved whistleblower status after they came forward in the 2000s to blow the lid on how Merck's upper management tried to get them to falsify data in company tests to keep the ruse going for as long as possible.
Corporate corruption is rampant in the United States, including at Merck. Find out more at Corruption.news.
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