“Fraud, Pure and Simple”: Merck Mumps Vaccine May Contain Up to 4 Times Approved Amount of Live Virus

(The Defender)—Drug manufacturer Merck misrepresented the efficacy of its mumps vaccine for years, “overfilling” the vaccine with live mumps virus to meet efficacy targets despite the lack of safety testing — and the practice may be continuing today.

Merck appears to have concealed the practice from public health agencies, which have taken no action to stop it.

Brian Hooker, Ph.D., chief scientific officer for Children’s Health Defense, joined “The Defender In-Depth” this week to discuss the revelations, which stem from a lawsuit two Merck whistleblowers filed in 2010 under the False Claims Act.

The 3rd Circuit U.S. Court of Appeals in Philadelphia heard oral arguments in the case on July 9.

According to Hooker, the Merck measles, mumps rubella vaccine, MMR II — the only mumps vaccine licensed in the U.S. and listed on the childhood vaccine schedule for 12- to 18-month-olds — may contain up to 4 times the approved concentration of live mumps virus.

A two-part deposition by Dr. David Kessler, former head of the U.S. Food and Drug Administration (FDA), also indicates that Merck, rather than informing regulators that it was “overfilling” its MMR vaccine, relied on passive surveillance — reports from parents regarding vaccine reactions in their children — to identify possible safety signals.

‘We do not know how this is going to affect the body’

In this week’s interview, Hooker emphasized that vaccine dosages with a higher concentration of live mumps virus were never tested for safety or efficacy.

“What is in the Merck MMR II vaccine is not what is being reported,” Hooker said. “This is a live virus vaccine, and these viruses are at higher concentrations. and we know, as far as the mumps vaccine, that the concentrations that are in the vials have never been tested for safety.”

Hooker explained that guidelines for the amount of live virus in the MMR II vaccine were last changed in 1999, “as a result of an FDA action that showed that the mumps portion of the vaccine was losing potency over its sort of two-year [shelf life] before the vaccine expired.”

This prompted Merck to “change the mumps concentration of the vaccine,” Hooker said. However, Merck did so without informing health regulators or the public, gaining regulatory approval or performing safety tests.

“The mumps portion of the vaccine lost its potency to an ineffective and an unacceptable endpoint, and the FDA notified Merck of this in 1998,” Hooker said. “In order to compensate for this, Merck merely did something that is called ‘overfill’ to the virus, overfilled the vials to a higher starting level.”

“They started out with …100,000 TCID50,” Hooker said — referring to the measure of the number of viral particles in a vaccine. “They changed that to 160,000 active virus particles in 1999.”

Hooker added:

“What that means from a production standpoint is that the exact middle concentration of virus is 160,000. The vials can deviate as much as four times over that, and they can be as high as 600,000 viral particles, or they can be as low as 100,000 viral particles.”

This poses a public health risk, Hooker said, because concentrations higher than 160,000 viral particles are “far beyond anything that has ever been tested for safety.”

“Safety testing has only been done to that lower limit of 160,000,” Hooker said. “In order to achieve immunity, according to the FDA, you only need 20,000 … virus particles. So, looking at that, Merck is overfilling the vaccine, and it can be as high as 30 times what is required.”

Hooker said:

“More virus particles mean more problems. It means that you can have a cytokine storm. It means that you can have autoimmune reactions, and this has never ever been tested for safety.

“That’s a serious safety problem because we do not know what will happen without a maximum. There is no cap.”

Cytokine storm refers to “life-threatening systemic inflammatory syndromes involving elevated levels of circulating cytokines and immune-cell hyperactivation,” according to The New England Journal of Medicine. Hooker said this can lead to cellular damage and autoimmune disorders.

Hooker noted that higher concentrations of virus do not just mean a higher level of live virus, but also a higher concentration of “dead virus, RNA particles within the vaccine,” which can also lead to adverse reactions.

Referring to Kessler’s deposition, Hooker said it “came to the conclusion that Merck concealed this information [and that] the packet insert was incorrect. It was nebulous and it did not reflect the higher concentration,” Hooker said. “He basically said Merck is deceiving the public.”

Kessler also testified that this practice continued at least until 2018. Hooker said, “Nothing has changed since 2018 that we know of … If Merck has done anything to change the formulation of the vaccine, it has not told the public, it has not told the FDA.”

This means the practice of “overfilling” might still continue today.

“We’re in no-man’s land,” Hooker said. “We do not know how this is going to affect the body because this has never been tested at this concentration. This was a brand experiment that they foisted on the public of the United States.”

Merck ‘defrauded’ the government and the public

Hooker said the revelations stemming from the whistleblower lawsuit show the FDA was initially unaware that Merck was “overfilling” the MMR II vaccine — calling into question the agency’s capability to perform oversight.

“The only way the FDA found out was when these court documents actually surfaced, because the only thing Merck directly told the FDA was the concentration of mumps virus [was] 160,000 virus particles,” Hooker said. “So, FDA had no idea that they’re going even higher.”

The lawsuit was filed under the False Claims Act — under which whistleblowers can be rewarded for disclosing fraud that results in a financial loss to the federal government.

It’s the same law under which a lawsuit alleging safety deficiencies during clinical trials for the Pfizer-BioNTech COVID-19 vaccine was filed.

The two whistleblowers in the Merck case — Stephen Krahling and Joan Wlochowski, virologists who worked for Merck in the early 2000s — have since become the subject of a recently released film, “Protocol 7,” which chronicles their claims.

According to Hooker, the revelations may lead to further legal implications for the company and may call into question the liability shield it enjoys for its MMR II vaccine.

“Merck not only defrauded the government … Merck defrauded the public,” Hooker said. “From my contention, that would be a very, very good legal argument to opt out of the National Vaccine Injury Compensation Program [because] it is a no-fault program, and it assumes that the vaccine manufacturers acted in good faith.”

Hooker said this “really means that this could be taken to court by … individual petitioners” because Merck was “duplicitous and they have not been forthcoming with the exact concentrations that are in those vials.”

“This is fraud, pure and simple,” Hooker said.

Merck ‘not an entity that we should trust to put things into our bodies’

According to Hooker, the allegations against Merck are indicative of broader corruption among public health agencies and pharmaceutical companies — including a “revolving door” between the two.

Hooker said Merck “is the company that brought us Vioxx, that basically knew that this was going to cause cardiac damage … in individuals that took Vioxx.”

Merck also faces hundreds of lawsuits relating to injuries and deaths connected to Gardasil, its human papillomavirus (HPV) vaccine.

“The first version of Gardasil … that came out in 2007 was then very quickly put on the CDC [Centers for Disease Control and Prevention] schedule,” Hooker said. “And then the CDC director [Dr. Julie Gerberding] … left the CDC in 2008 and started as the president of Merck’s vaccine manufacturing division … in 2009.”

“There’s a revolving door there, and I think that if we really were able to open the coffers in terms of the relationship with Merck and Gerberding while she was at the CDC, we would show that they did quite a few favors,” Hooker added.

“When you look at chief officials at the FDA, in the CDC and in the HHS [U.S. Department of Health and Human Services] … there’s so many conflicts of interest — and the conflicts of interest run not only at the top level, but they get down into the woodwork of the individual workers and scientists,” Hooker said.

Noting that Merck has had an “exclusive license” to distribute MMR vaccines in the U.S. “for many, many years,” Hooker said that this is likely why the company sought to quietly change the concentration of live mumps virus in its vaccine, “even if it meant fudging the books,” to maintain its market exclusivity.

“When you look at Vioxx, when you look at HPV, when you look at the … MMR II vaccine, this is not an entity that we should trust to put things into our bodies,” Hooker said, referring to Merck, adding that agencies like the FDA “are not trustworthy.”

“They are driven very, very much by financial gain directly through incentivization, through the pharmaceutical industry,” Hooker said.

Watch ‘The Defender In-Depth’ here:

Listen to the podcast on Spotify.

‘The Defender In-Depth’ airs on CHD.TV Wednesday at 10 a.m. ET/9 a.m. CT.