‘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.
“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.
Krahling v. Merck
Kessler’s report was made public as part of the Krahling et al. v. Merck and Co. Inc trial. On July 9, the 3rd Circuit U.S. Court of Appeals in Philadelphia heard oral arguments in the case.
The case involves former Merck virologists Stephen Krahling and Joan Wlochowski, who became whistleblowers in the early 2000s after alleging upper management tried to get them to falsify data in the tests the company was conducting to show its mumps vaccine maintained high efficacy.
In 2010, Krahling and Wlochowski sued Merck under the False Claims Act, alleging the company falsified data and fraudulently marketed its MMRII vaccine, which was “mislabeled, misbranded, adulterated and falsely certified as having an efficacy rate that is significantly higher than it actually is.”
U.S. District Judge Chad Kenney in July 2023 dismissed the case without ruling on whether there was any fraud. The court found that the alleged misrepresentations were not material to the CDC’s decision to buy the vaccine from Merck.
In other words, the court ruled that even if the fraud allegations were true and Merck had defrauded the U.S. government, physicians and vaccine recipients, the fraud wasn’t a factor in the government’s decision to purchase the vaccines. The plaintiffs couldn’t show that the false claims influenced the government’s decision.
After the July 2023 decision, documents, including the Kessler report, were unsealed and recently made available.
In last week’s oral arguments, plaintiffs’ attorneys argued the appeals court should overturn the dismissal, especially given the revelations in the Kessler report, including that a leading figure in U.S. public health — who was also the architect of the Biden administration’s COVID-19 mass vaccination campaign — determined the fraud and the violations were severe.
Merck disputed the Kessler report in documents the company submitted to the court, the attorneys said.
The fraud
Under the National Childhood Vaccine Injury Act of 1986, vaccine manufacturers are required by law to ensure their vaccines are “safe and effective” and have labeling that is “not false or misleading.”
Companies must update any changes regarding efficacy, duration of protection or other similar issues. Periodically the FDA reviews the labels. In 1996, the agency started reviewing the Merck MMRII vaccine label, Kessler wrote. The agency first licensed the vaccine in 1978.
The vaccines are “live attenuated viruses,” meaning they contain a small amount of live mumps virus that is weakened to reduce its virulence, so the vaccine elicits an immune response, but does not make the recipient sick.
A live attenuated vaccine’s “potency” is the concentration of live virus in a single dose.
Merck’s vaccines were approved at a specific potency, listed on the label. Label potency is set based on the vaccine’s potency when it is first produced — which must be informed by safety data that ensures a vaccine is safe at the release potency — and by how much potency is lost during a vaccine’s shelf life.
Merck’s label claimed the potency of the MMRII vaccine was “20,000 TCID50,” which is the potency clinical trials showed protected against mumps. “TCID50” is a measure of the number of viral particles in a vaccine.
However, by 1998 it was clear that potency did not hold up over the two-year shelf life.
Merck proposed to reduce the label’s mumps potency claim to be in compliance, but it did not have any clinical data that showed the vaccine was effective at the lower level, so the FDA would not allow it.
The company began to prepare a new clinical protocol “protocol 7,” that would produce data showing the vaccine remained 95% effective — as claimed on the label and that guaranteed Merck’s patent rights — even at a lower potency.
To do that, Merck proposed different assays or ways to assess how well the vaccine elicited an immune response than it used previously.
For example, the company first proposed to use an ELISA, or enzyme-linked immunosorbent assay to measure antibodies produced by the vaccine. The test uses enzymes that attach to antibodies in the blood to identify whether they are present.
The FDA rejected the proposal because it said there was no way to correlate it to the “neutralization” assays used in the past. Those measured how well the vaccine could neutralize “wild type strains,” or how well it actually protected children from the mumps disease that circulated in the real world.
Merck then developed a new neutralization assay, but instead of testing whether it could neutralize the wild-type strain, it tested whether it could neutralize the attenuated virus in the vaccine, which gave no information about protection from real-world disease.
While it negotiated with the FDA over what assays it could use, in December 1998, Merck proposed to “overfill” the MMR vaccines — meaning to increase the amount of mumps virus in the vaccine.
This would make it possible for the potency on the label to be present at the end of the drug’s shelf life. The FDA agreed to the overfill for a “short interval” until the clinical study data was ready.
Vaccines produced after September 1999 were overfilled, according to the report.
The FDA informed the company its prior vaccines were “out-of-compliance.” However, some out-of-compliance vaccines remained on the market, because they were still within their expiration period.
Merck left those vaccines on the shelves, and approximately 12 million doses with low potency were released to the public within that period.
“In my opinion, with regard to FDA requirements, a vaccine is adulterated if a manufacturer does not have procedures designed to assure the product has the identity, strength, purity or potency it purports or represents it to have,” Kessler wrote, commenting on those vaccines.
He said the vaccine was adulterated at least between 1998-2007.
Kessler also noted that Merck used faulty data to justify its position that no action was necessary — like a recall — for the out-of-compliance vaccines.
He added that the clinical data showing efficacy were insufficient to support the argument that the lower potency vaccines were effective and that the company was known to have changed raw data “without justification” — the issue at the heart of the lawsuit.
Even after the overfill, it turned out that Merck still didn’t have data that showed the product maintained the potency claimed on the label.
Kessler also wrote that Merck failed to inform the FDA that its assays didn’t test for immunity, that its lots didn’t maintain potency even after overfill and that it didn’t fully investigate the lots on the market known to have questionable potency.
Merck also didn’t take the corrective measures it told the FDA it would, Kessler wrote, like submitting an application to reduce the shelf-life listed on the label. Instead, it attempted to use the faulty protocol 7 data to justify maintaining the label.
In 2007, the FDA accepted Merck’s request to allow its label to reflect a lower potency, but even then Merck did not stop “overfiling” those vaccines.
Kessler said the MMRII label from 2007-2018 — at the time he wrote his report — when continued to be “misleading” because it didn’t report that the efficacy claims were based on tests never shown to demonstrate protection from disease.
And, it still hadn’t completed clinical studies that showed any efficacy at that lower potency.
Nobody did a clinical safety study’
The Kessler report didn’t substantively address the safety issues involved in the overfill, which potentially eclipses problems with mumps vaccine efficacy.
There have been no adequate safety studies for the MMRII vaccine at or above the higher mumps virus levels associated with the overfill.
“Nobody did a clinical safety study of the highest amount Merck was releasing,” plaintiff Krahling stated in his deposition, “that’s why they were concerned about safety.”
According to Krahling, Merck had done a single, small safety study at an upper limit of 150,000 TCID50 mumps. Only 20,000 TCID50 is necessary for mumps immunity.
However, the specification allowed doses to be released as high as 250,000 TCID50, according to a November 2002 email from Merck Research Laboratory’s Executive Director Keith Chirgwin to other Merck officials included in the Kessler report.
This means that 50% of the MMRII vaccine recipients have been “overdosed” with mumps virus in an untested vaccine, Brian Hooker, Ph.D., chief scientific officer for Children’s Health Defense, told The Defender.
Higher virus levels can translate to breakthrough mumps infections caused by the vaccine as well as stronger inflammatory responses, which can lead to cytokine storm, autoimmune reactions, and neurological issues, Hooker added.
“They were doing a wait and see, they were simply relying on [passive] surveillance to see if any kids got hurt from the higher dose. The kids didn’t know they were getting that high of a dose when they got it, nor did their parents,” Krahling testified.
Also, Merck presumably increased measles and rubella virus counts in the vaccine in 1999 as according to FDA, the original (pre-1999) levels were out of specification, Hooker said. High-dose measles vaccines have been associated with female child mortality in Haiti and Senegal.
There is no clear determination of what the maximum levels of any of the three viruses are within any MMR vaccine distributed by Merck, Hooker said. The package insert only reports minimum virus concentrations but not maximums.
“Kessler’s report was written in 2018, but as far as we know, nothing has changed. That means children likely continue to receive the overfilled vaccines even today,” Hooker said.
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