We begin today with an incredible story that spans 25 years, so far. It involves the MMR vaccine against Measles, Mumps, and Rubella given to most American babies in two doses. Yet you probably never heard about this controversy. It’s brought to us by a scientist named Stephen Krahling who worked on a project at Merck called “Protocol 7” and was uniquely positioned to blow the whistle on what he learned. In the bigger sense, his account raises questions about what can go on unknown to most of us about products injected into nearly all children.

The following is a transcript of a report from “Full Measure with Sharyl Attkisson.”
Watch the video by clicking the link at the end of the page.

Stephen Krahling was a published cancer researcher when vaccine maker Merck brought him on board as a virologist in 1999. That’s when he says he found himself embroiled in an all-hands-on-deck corporate emergency.

Stephen Krahling: So when I showed up to start work at Merck they were dealing with a potential product recall. And it wasn’t something that was just casually discussed. It was a sky is falling level event.

The crisis surrounded Merck’s blockbuster-selling MMR vaccine against measles, mumps, and rubella — and worries that it might be defective.

Krahling: It was the end of the world for them. I mean, can you imagine if they have to recall, that they have to go to the millions of parents whose kids got ‘out of specification’ vaccine, let ’em know they have to take the MMR vaccine off the shelves and they didn’t have a solution? So they would’ve had to stop selling it, stop distributing it.

To understand Krahling’s part in this scandal, it helps to know something about how the vaccine is designed to work.

Sharyl: So the MMR vaccine is one of the vaccines that contains live virus. Not all vaccines do, but this functions, if I’m stating it correctly, with some live virus in it that triggers an immune response or whatnot?

Krahling: Yeah, all three viruses are live viruses.

Sharyl: And there’s a limit on both ends of how much has to be in there, but no more than whatever for it to be safe and effective?

Krahling: Yeah. And it’s that that upper limit, the maximum amount of virus, live virus that might be in it, has to be safe. And the lowest amount has to be efficacious. But within those parameters is where the product has to fall. So you can’t have a lower amount of live virus and you can’t have a higher amount of live virus.

Though MMR was widely given in the 1970s, the 1980s saw measles, mumps, and rubella outbreaks among many vaccinated children and young adults.

For example, in 1985: 69 measles cases at an Illinois high school with a 99.7% vaccination rate. Ultimately, the CDC recommended all children get a second dose of MMR.

But the tricky part for Merck came in the mid-‘90s when the FDA began a review of vaccines and found the potency of MMR wore off as it sat on shelves.

So the FDA instructed Merck to start putting more virus into the vaccine upfront, that’s called “overfilling,” so it would stay potent for its two year shelf life. Merck started doing that in early 2000 and told us it’s still doing that today.

Krahling: So the problem was that these viruses degrade over time and Merck had to calculate backwards and say we need to add more virus so that the stuff doesn’t degrade. Because the FDA was adamant ‘you cannot keep distributing that vaccine if it’s out of specification,’ they had to do this thing called an overfill, which is the same as if you take a glass of water and pour a lot into it till it overfills. They added more virus, vaccine virus to the vaccine for measles, mumps and rubella.

Sharyl: So that when it degraded over time on the shelf, it would still meet the lowest threshold it had to meet?

Krahling: Exactly.

Sharyl: But what if someone got that vaccine one week into it being on the shelf before it degraded?

Krahling: They’re getting a very high amount of vaccine virus.

Sharyl: If there’s too much live virus in a shot, what are the sorts of problems that could occur that’s a health, that’s a potential safety risk?

Krahling: Well, of course.

Internal documents suggest Merck was concerned that its vaccine was only potent for a year, according to court documents, but didn’t tell the FDA.

The FDA also slapped Merck with warnings for failing to report it had put 23 million doses of MMR vaccine on the market that might not be potent when given. Merck risked losing its license to make the shots and future government contracts worth billions of dollars.

But even with the overfilling, Krahling says the mumps virus was still dying off too fast. So Merck launched a key study known as “Protocol 7”. It aimed to show that the MMR vaccine still worked even with less mumps virus so Merck wouldn’t have to recall those millions of doses already out there.

Sharyl: They had to prove that the lower amount of virus, that people may have been getting or their children may have been getting, they had to try to prove that was effective?

Krahling: Yeah.

Krahling was assigned to Protocol 7. But he says no matter what he and his fellow Merck scientists tried they just couldn’t make the vaccine with less mumps virus stand up to FDA standards.

The big shocker came when Krahling says a Merck lab official started telling them to change the data— to make it look better.

Krahling: And he says, ‘whenever you find this stuff, you just, you have to cross ’em out and write in new numbers.’

Sharyl: Okay, so to be clear, falsifying documents?

Krahling: Oh, absolutely. A hundred percent. Like in the laziest way ever. I mean, just crossing it out. I mean, come on. Who can get on board with that? Yeah, so I, I was like, ‘I’m not doing that.’ It wasn’t so much like some rogue whistleblower or two, it was a mutiny. There were six of us and they just wouldn’t do it. And when, if the boss came around and made ’em change data, like two of these interns from Villanova, they would just go and copy their original accounts and just hand them to me and say, ‘He changed our data. Here’s the original copy’. I’m like, ‘all right, so we’re collecting this.’

Sharyl: Who reported this to the FDA?

Krahling: Ah, it was me.

In 2001, Krahling notified the FDA that: “data was being destroyed” and Merck was “instituting a policy to fraudulently” make the MMR vaccine look more effective. He was surprised when he heard nothing back from the FDA for weeks. While he was waiting, he got a meeting with a high-ranking Merck official who didn’t yet know he’d already contacted the FDA once.

Krahling: I mean I told ’em I was gonna call the FDA unless he could tell me what was going on here. I said, ‘I want a scientific reason for what’s going on.’ And he just said, ‘it’s a business decision. It’s none of your concern.’ I was like, ‘all right.’ And then when I left, the Human Resources guy was right outside the door, telling me, ‘you’re going to jail. If you call the FDA, you’re gonna go to jail.’ And then the next day when I come in, the lab director got there early and he was just taking all these viral plates, which the FDA should have the right to see. And he was just autoclaving ’em, destroying them. They, they’re just destroying evidence. And then I’m like, ‘all right, I gotta call the FDA,’ immediately called the FDA told ’em, ‘get your effing asses in here, do your effing job.’

As a result of Krahling’s calls, the FDA did conduct an inspection. It confirmed that Merck “Spreadsheets used to determine questionable results and retesting had not been validated” and “Raw data was being changed with no justification.”

To Krahling’s surprise— none of that seemed to shake the FDA’s confidence in Merck’s ability to tell the truth about its vaccines. But he’d sealed his fate. He was removed from Protocol 7 and soon resigned.

In 2010, Krahling and another former Merck scientist filed a whistleblower lawsuit against Merck. They allege the company misled the CDC, the largest purchaser of vaccines, and defrauded taxpayers by “omitting, concealing, and misrepresenting material information regarding its mumps vaccines.”

Dr. David Kessler who headed up the FDA under Presidents Clinton and George W. Bush served as an expert witness in support of the case against Merck. In 800 pages of testimony, Kessler repeatedly stated Merck and its MMR vaccine label had been “misleading,” and the vaccine was “adulterated,” and he raised the question of whether MMR’s lack of potency is to blame for mumps outbreaks among vaccinated people.

The case took 14 long years. And finally concluded last year. In the end, the court dismissed the case stating CDC knew about allegations of fraud and potency, but bought the vaccine anyway, so there had been no fraud committed on taxpayers.

“Merck’s misrepresentations as to potency and its Protocol [7] testing” did not impact the CDC’s decision to buy MMR vaccine, said the court. “CDC was aware, through its own studies, that the vaccine proved less effective in the real world than in the clinical trials yet [CDC] continued to purchase and recommend it.” Therefore, government and taxpayers weren’t defrauded.

Merck wouldn’t agree to an interview or answer questions but told us: “Merck was transparent with FDAand acted appropriately at all times; Merck’s MMR-II vaccine was appropriately labeledMerck has disputed and continues to dispute the plaintiffs’ claimsMerck worked with FDA to assure that all of FDA’s concernshad been addressed. Most significantly, Merck raised the potency of the [MMR] vaccine such that the potency was assured to be met throughout the shelf life.”

Meantime, mumps outbreaks have continued.

For example in 2020, the CDC said the vast majority of those infected in a six state outbreak were fully vaccinated. “This raises concerns about waning immunity from childhood mumps immunization,” concluded one analysis.

Fortunately, mumps is typically mild, CDC says, and resolves within two weeks. Rare complications include deafness, or encephalitis—a potentially fatal inflammation of the brain. Those are also, by the way, potential complications from the MMR vaccine.

Today, Krahling says there’s no way for parents or even doctors to know exactly how much live virus is really in Merck’s MMR vaccine at the time its given.

Krahling: And so if you want informed consent, what, what should you be allowed to know? You should be allowed to know what’s in it, how much is in it. And that those amounts and ingredients have been tested in a clinical trial and shown to be safe and effective. And for this one vaccine, nobody can say that’s true. Maybe it’s a greatest vaccine ever made. Maybe it’s perfectly safe and effective. But if I ask you how much is in it and you can’t tell me— that’s a problem. I think it’s a problem.

Sharyl (on-camera): Merck says the MMR-II vaccine has been available for more than 50 years, and the importance of its place in public health can be seen with the decrease in the incidence of these childhood diseases. For more on this story, listen to my podcast Full Measure After Hours.

Watch video here.