Tag: MMR-II

Is the MMR Vaccine Licensing Being Called into Question?

Why do some folks think that the MMR vaccine licensing is being called into question?

Yup. That’s what the usual suspects are trying to make you think.

Is the MMR Vaccine Licensing Being Called into Question?

Taking advantage of the fact that many sites publish all press releases, these folks want you to think that a major news site is following their latest bombshell, which of course is just another dud.

The MMR was licensed in 1971. The ICAN papers are from 1978…

You mean there really isn’t an FDA coverup?

“Clinical studies of 284 triple seronegative children, 11 months to 7 years of age, demonstrated that M-M-R II is highly immunogenic and generally well tolerated.”

MMR II Package Insert

Not only is the package insert very transparent about the studies used to approve the MMR II vaccine they are talking about, since only a minor change was made to the original MMR vaccine, which was approved in 1971, it isn’t surprising that larger trials weren’t required at the time.

So there were earlier, larger trials?

Yup.

But did they use a saline control group?

Nope.

A Vaccinated vs Unvaccinated Study - Stokes et al on Trivalent combined measles-mumps-rubella vaccine. Findings in clinical-laboratory studies.
A Vaccinated vs Unvaccinated Study – Stokes et al on Trivalent combined measles-mumps-rubella vaccine. Findings in clinical-laboratory studies

The control group was actually unvaccinated.

It is also important to keep in mind that this study, and a few other MMR studies, followed much, much larger studies of the individual measles, mumps, and rubella vaccines.

“The large majority of children in the United States have been vaccinated against measles and a sizable portion have been given mumps and rubella vaccines. It is estimated by us based on vaccination distribution that about 41 million children have received measles vaccine, 7 million mumps vaccine, and 21 million rubella vaccine. The combined triple vaccine provides a simple, safe, and effective immunization procedure using a single vaccine dose against three important diseases in children who have not yet been immunized.”

Stokes et al on Trivalent combined measles-mumps-rubella vaccine. Findings in clinical-laboratory studies.

Much larger double-blind, placebo-controlled studies of the individual measles, mumps, and rubella vaccines.

This is why you don’t routinely do vaccinated vs unvaccinated studies anymore. It is unethical to let kids get measles, mumps, rubella or other diseases.

The bottom line is that the measles (1968), mumps (1967), and rubella (1969) vaccines were safe when they were approved by the FDA.

The MMR (1971) was safe when it was approved by the FDA.

And MMR-II (1978) was safe when it was approved by the FDA.

Since then, there have also been studies showing that getting a second dose of MMR-II is safe and effective and that ProQuad, the combination measles, mumps, rubella, and chickenpox vaccine is safe and effective, although it is associated with a small increased risk of febrile seizures if given as a first dose.

There is no FDA coverup. No bombshell.

Just anti-vaccine folks continuing to try and scare you away from vaccinating and protecting your kids.

More on the Licensing of the MMR Vaccine

What’s the Difference Between the MMR and MMR-II Vaccines?

As most folks know, the original MMR vaccine, which combined the separate measles, mumps, and rubella shots, was licensed way back in 1971.

It included the original rubella vaccine, which was made with a duck embryo derivative of HPV-77 that was attenuated by passing it 77 times in monkey kidney cells.

Wait, what?

HPV?

Before the new conspiracy theories start, no, not that HPV.

It stands for High Passage Virus.

What’s the Difference Between the MMR and MMR-II Vaccines?

And while the vaccine worked, it didn’t work as well and caused more side effects than a RA27/3 rubella vaccine that was already approved in Europe

“Over the next decade, accumulating evidence led to changes in the United States. First, the duck embryo and dog kidney vaccine strains caused significant joint reactions [24–27]. Second, reinfection on exposure to wild rubella virus was demonstrated frequently with all strains except the RA 27/3 vaccine [28–30]. Third, the good safety record of the RA 27/3 vaccine in Europe, plus the majority opinion of scientists, led the US Food and Drug Administration to license RA 27/3. Important pressure for this decision came from Dorothy Horstmann at Yale, who was convinced by her comparative studies of rubella vaccines [31], and by Maurice Hilleman at Merck, who sought a better rubella strain for measles-mumps-rubella (MMR) vaccine.”

Stanley Plotkin on The History of Rubella and Rubella Vaccination Leading to Elimination

So that’s it, they just changed out the rubella component for one that was safer and worked better.

The new and improved MMR-II vaccine was approved by the FDA in 1978.
The new and improved MMR-II vaccine was approved by the FDA in 1978.

And of course, they did the appropriate clinical trials and got FDA approval for this updated vaccine.

The control group didn't get a vaccine during the study.
The control group didn’t get a vaccine during the study.

But did they compare the vaccines against a saline placebo?

“The inclusion of a seropositive control group allowed the rates of reaction to be viewed against the background symptoms unrelated to vaccine administration.”

Polk et al on A controlled comparison of joint reactions among women receiving one of two rubella vaccines.

They actually went a little further, in a double-blind, controlled cohort study comparing it to folks who didn’t receive any vaccine at the time of the study!

Why so many joint issues with the vaccine?

The studies were in adults, who seemed to have more side effects with the vaccine. Still, the side effects, including arthritis, were transient.

What about the idea that it was studied long enough before being approved?

Both the rubella component and the MMR-II vaccine were studied both before and after being approved. In fact, the MMR-II vaccine is probably the most studied vaccine in history!

Believe it or not, they include placebo-controlled trials.

A double-blind, placebo-controlled, cross-over MMR study in twins!

What was the placebo in the Finland twin trial?

“The injections consisted of 0.5 ml of vaccine 2-5 or placebo (the same product including neomycin and phenol-red indicator but without the viral antigens) and were administered subcutaneously by the nurse to the left deltoid or gluteal region.”

Peltola et al on Frequency of true adverse reactions to measles-mumps-rubella vaccine. A double-blind placebo-controlled trial in twins.

If that doesn’t sound like a placebo to you, keep in mind that the MMR vaccine doesn’t contain that many ingredients. Remember, MMR doesn’t contain aluminum or thimerosal. And if the placebo didn’t contain the antigens, then it likely didn’t contain all of the things that went into getting those antigens in the vaccine, such as cell cultures and albumin, etc.

Still, some folks aren’t going to be satisfied unless there is a study with a saline placebo.

“The four other vaccines were commercial products of Merck Sharp & Dohme. The placebo consisted of vaccine diluent.”

Lerman et al on Clinical and Serologic Evaluation of Measles, Mumps, and Rubella (HPV-77: DE-5 and RA 27/3) Virus Vaccines, Singly and in Combination

The vaccine diluent?

What’s that?

It depends on the vaccine, but for MMR-II it’s sterile water.

“Placebo DTP consisted of sterile saline which was dispensed into sterile Tubex syringes.”

Deforest et al on Simultaneous Administration of Measles-Mumps-Rubella Vaccine With Booster Doses of Diphtheria-Tetanus-Pertussis and Poliovirus Vaccines

The MMR vaccine was even tested in placebo controlled trials with other vaccines!

And like other vaccines, the MMR vaccine has been found to be safe, with few risks, and is definitely necessary.

More on the the Difference Between the MMR and MMR-II Vaccines