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Originally posted on Fearless Parent
How safe is the combination measles, mumps and rubella (MMR) vaccine? Is the information regarding these vaccines easily accessible to parents for them to make an informed and ultimately important choice? Here is part 1, vaccine safety followed by part 2, looking into the manufacturer Merck & Co.
I've been dismayed by the national brouhaha characterized by the Four "Astroturf" Horsemen of Vaccine Hysteria: Fear, Anger, Blame, Hatred.
- The unvaccinated must be hunted down and punished
- Measles is deadly
- We need a federal mandate for the measles vaccine
- No exemptions for anyone
There's nary a mainstream outlet that hasn't jumped in and piled on. For a group of investigative journalists, health reporters, seasoned writers, and popular bloggers that claims to wrap themselves in the cloak of modern science, there's precious little scientific or even analytic thinking, let alone responsible, measured discussion. It remains to be seen whether mainstream journalism will grow a spine.
In the meantime, however, what concerns me is how little parents know about the combination measles, mumps & rubella vaccine (MMR).
I worry about informed consent.
Part One: MMR Vaccine Safety
Documentation of adverse events following vaccination
Start with the basics:
- MMR package insert
- MMRV / ProQuad package insert
- Observed Rate of Vaccine Reactions – Measles, Mumps & Rubella Vaccines from the World Health Organization
- Vaccine Adverse Events Reporting System
- Vaccine Injury Table of the federal Vaccine Injury Compensation Program
- The Pink Book: Course Textbook, chapter 12 (Measles) from the CDC
- Can Measles Vaccine Cause Injury & Death? from the National Vaccine Information Center
Measles can travel via neurons to your brain
Measles virus can present as three different forms of infection in the central nervous system.
We've known that measles virus can travel via neuronal spread and enter the brain. It's called "axonal transport" and it's as fast as it sounds.
What is not commonly understood, however, is that it's not just the natural contraction of disease that's implicated. Vaccination can carry measles virus to your brain, too. From a study in the peer-reviewed Current Topics in Microbiology and Immunology:
[A]ttenuated vaccine strain can traffic to the brain under conditions of poor immune surveillance.
Injection of MMR vaccine can cause the live measles virus to hop a neurological bullet train to your brain.
The Merck Manual acknowledges that vaccines can cause brain damage:
Encephalitis is inflammation of the brain that occurs when a virus directly infects the brain or when a virus, vaccine, or something else triggers inflammation. The spinal cord may also be involved, resulting in a disorder called encephalomyelitis.
The problem is that we don't know as much as we should, given the way we vaccinate children today. This 2012 peer-reviewed summary in the journal Progress on Health Sciences makes a similar point about the neurologic adverse events following vaccination:
In this study, the measles viruses were researched, but under the immunization program children also receive vaccinations with simultaneous administration of several viral components. What then occurs in the brain of a child? Presently, there are no studies in this area.
When it comes to informed consent on the MMR vaccine, the package insert is a good place to start.
A colleague of mine calculated the average publication date of every piece of science in the package insert and came up with... 1982. We're talking roughly 33 years ago — with some studies much older than that. Does it make you wonder...
How much of today's vaccine policy is based on yesterday's science?
Who's responsible for updating it? Making a case for R&D?
If large numbers of parents are doing this research on their own and calling for more vaccine safety studies, doesn't this make them pro-science?
Who, then, are the anti-science denialists?
Science from one month ago
This new study, "Safety of Measles-Containing Vaccines in 1-Year-Old Children," was quietly published online on January 5, 2015 by Pediatrics, the journal of the American Academy of Pediatrics. Here's the abstract and the full study.
The article compares the administration of MMRV ("ProQuad") versus MMR +Varicella ("Varivax") separately. The authors confirm that there are more febrile seizures in children who get MMRV as a single shot than those who get MMR + V separately but on the same day.
This is significant.
The separation of the shots is not the only variable. In fact, the separation of the shots may not be much of a variable at all since both groups are getting all four vaccine infections simultaneously. It shouldn't matter where on the body you inject the vaccine viruses since all four vaccine virus strains produce systemic, whole body infections, right?
So why is there a difference in health outcomes (i.e., seizures and possibly other sequelae)?
The vaccines are not the same.
MMRV contains nearly 10 times more varicella potency than MMR + V (this is available in the package inserts). The MMRV group is getting a much higher dose. It's the total dose of the vaccine that causes the problem. If MMR + V is safer than MMRV, then that argues that M + M + R is safer than MMR.
Keep reading to find out why combination vaccines require greater viral potency.
Measles vaccine cultured on human tissue
The two versions of the vaccine available in the U.S. are MMR-II and MMRV. Both contain WI-38 human diploid lung fibroblasts. This is significant for several reasons:
First, these cells are cultured on fetal tissue derived from terminated pregnancies (abortions). For some parents, abortion violates their religious beliefs or principles. Parents who oppose abortion and do not want these and other vaccines cultured on human diploid cells should have the right to decline these vaccines for themselves and their children.
Second, injection of human biologics always carries with it the risk of both known and unexpected ("adventitious") agents, including the possibility of viral contamination (i.e., SV40 in the polio vaccine), ERV infection (endogenous retroviruses), and DNA insertion into the host genome.
Buy one, get two free – the history
If measles vaccine is so important, why isn't the monovalent measles vaccine available? A monovalent vaccine contains antigens from a single strain of a microorganism. Why do our children have to get vaccine targeted against three different diseases at the same time?
MERCK STOPPED MAKING IT...
On Christmas Eve 2008, Merck quietly announced on the American Academy of Family Physicians site that it would no longer make separate "monovalent" measles, mumps, and rubella vaccines and would instead be focusing on their combination MMR. shot. This article, which is no longer available on the AAFP, Merck, or any other "establishment" site, read as follows:
Merck & Co. Inc. has stopped production and sales of its monovalent vaccines for measles, mumps and rubella. The manufacturer instead plans to focus on its combination vaccine, MMRII.
Merck spokeswoman Amy Rose said MMRII accounts for 98% of the company's volume for measles, mumps and rubella vaccines...
"The combination vaccine is what's recommended, and it's such a significant portion of the orders we see," said Rose. "It's in the best interest of public health to make more of that rather than dedicate manufacturing capacity to monovalents."
Rose said Merck had not decided when, or if, it might make the monovalent vaccines available for sale in the future.
... THEN THEY FLIP-FLOPPED
Merck received a deluge of complaints from concerned parents. The company responded that it would make them again. This commitment was also documented in this Merck Vaccines Supply Status from 7.20.09 (read the footnote).
This intention was not long-lived. Perhaps Merck had just been testing the waters and determined there would be no lasting brand damage? The pharma giant quietly reneged in October 2009 with this statement:
Based on input from the Advisory Committee on Immunization Practices (ACIP), professional societies, scientific leaders, and customers, Merck has decided not to resume production of ATTENUVAX® ... MUMPSVAX® ... and MERUVAX® II. This science-based decision will support vaccination of the largest group of appropriate individuals. Merck will continue to focus necessary resources to ensure that they can help meet current and future global public health needs... [emphasis mine]
It is interesting that they chose to describe their decision as "science-based" and their focus expands far beyond our country's borders.
Merck hasn't spoken on the matter since. I never saw any public discussion about the merits of this decision. Nearly all press related to this significant public health announcement has been removed from the internet.
"NO HARM IN GETTING ALL THREE"
Doug Campos-Outcalt, MD, MPA., who serves as the AAFP's liaison to the CDC's Advisory Committee on Immunization Practices... said Merck's decision was insignificant in terms of public health... [but] some parents likely will be unhappy.
"The use of the single antigen is pretty limited," he said. "There's no harm if you need one in getting all three. There are some parents out there that want a delayed vaccine schedule. They want the vaccines spread out over a longer period of time and not so many at once. That's a lot of hooey. Alternative schedules have never been proven to be superior."
I'd like to see the scientific support for Campos-Outcalt's statement. Combination vaccines are associated with the lion's share of vaccine injury compensation claims. Scientists acknowledge that combination vaccines have greater "reactogenicity" [Katkocin & Hsieh, p. 57]. Reactogencity is the property of a vaccine to produce common, expected adverse reactions (i.e., injury and death).
PARENTS SPEAK UP
Parents wanted the individual vaccines very badly. Some were in the process of separating the vaccines. I was contacted by dozens who were frantically calling pharmacies and children's hospitals across the country trying to locate the last few remaining doses. I know of parents who traveled overseas with their children to obtain the individual measles vaccine.
Although the monovalents are unlicensed in Britain, private clinics that offer the single vaccines do a brisk business, and parents are willing to pay out of pocket. The "Single measles jab" article in the Daily Mail says it's not illegal to import the vaccines and names private practice doctors who can help.
Demand & Supply
I am not arguing for measles vaccination with the monovalent vaccine. This serious, private medical decision is for parents to make.
But let's examine the logic for a moment. There are some parents who choose not to vaccinate their children with MMR or MMRV who might opt to vaccinate their children against measles if the monovalent measles vaccine were available:
- Maybe they agree with the World Health Organization that rubella is typically a mild, self-limited illness (and chickenpox, too).
- Maybe they don't want the human fetal DNA fragments in the rubella vaccine.
- Maybe their child already has positive titers for mumps and/or rubella.
If the stated public health goal is to prevent measles outbreaks, and vaccination is the proposed solution, why not offer the measles vaccine in all forms that parents are willing to accept?
I offer three possible reasons:
Combination vaccines are more profitable.
Exclusive reliance on combination shots results in more vaccines purchased and administered. Let's use New Jersey's "Minimum Immunization Requirements for School Attendance" to illustrate the point. Children born after 1/1/90 need 1 dose of mumps vaccine, 1 dose of rubella vaccine, and 2 doses of measles vaccine. Since it's not possible to get the measles vaccine separately, children must receive 2 doses of each to meet NJ's mandate for day care and school admission.
#2: INCONVENIENT QUESTIONS
Availability of both individual vaccines and the combination vaccine might prompt parents and clinicians to scrutinize differences and ask Merck some difficult questions:
Q: Why is there so much more scientific literature on the safety of the individual measles vaccine and very little on the combination MMR vaccine?
Q: Are you concerned about immunological interference between components of a combination vaccine?
I found this statement by a Merck scientist about the challenges of making MMRV:
"Numerous studies have shown that when a monovalent dose of varicella vaccine is added to an MMR vaccine the titer of antibody against varicella is reduced by about one-half. This is believed to be due to immunological interference by the measles vaccine."
Q: Can you explain this statement in the Merck's package insert for MMR about multiple simultaneous vaccination?
"Routine administration of DTP (diphtheria, tetanus, pertussis) and/or OPV (oral poliovirus vaccine) concurrently with measles, mumps and rubella vaccines is not recommended because there are limited data relating to the simultaneous administration of these antigens." [page 9]
#3: WHO'S IN CONTROL?
The availability of individual vaccines gives parents and clinicians greater flexibility and control over vaccine selection and timing. If sufficiently large numbers of children are vaccinated using different vaccines and schedules, it could give rise to disconcerting variations in health outcomes. Requiring all children to receive the combination vaccine takes this potential scenario off the table.
Hundreds of millions of children have received Merck vaccines. The combination MMR is its flagship vaccine: profitable and prevalent, with exceptionally consistent and high compliance. Public confidence in vaccines is based upon trust. Parents should know that Merck has every interest in serving up a very simple narrative about vaccine safety and individual choice. It doesn't mean that all parents will choose not to vaccinate. It does mean that they have to work hard to get the information they deserve.
Next up: Part 2 in our series on (Un)Informed Consent and the Measles, Mumps & Rubella Vaccine. What's Going On with Merck?