MMR (Measles, Mumps, Rubella)

The Illnesses:

• Measles: Measles is a mild childhood illness caused by an RNA virus that causes fever and characteristic rash that usually lasts about a week. Rarely, complications in susceptible individuals can lead to infection of the organs, and most concerningly, the brain. Infection results in lifelong immunity. Vitamin A plays a critical role in aiding the body to protect against this virus. In high-risk children with measles, studies have shown that bolus doses of Vitamin A can cut mortality in half.
• Mumps: Mumps is a mild childhood illness caused by an RNA virus that causes fever and characteristic rash that usually lasts about a week. The mumps virus preferentially affects the salivary glands, causing inflammation and swelling. This swelling of the cheeks is characteristic of those infected. Infection results in lifelong immunity. Rarely, complications in susceptible individuals can lead to infection of the organs. Infection in teenage boys can spread to the testis and compromise fertility.
• Rubella: Rubella is a mild childhood illness caused by an RNA virus that causes fever and rash that usually lasts about a week. Infection is generally so mild it goes unnoticed. However, if infection happens during the first trimester of pregnancy, it increases the risk of birth defects known as Congenital Rubella Syndrome (CRS). Even so, this syndrome is extremely rare.

Cost/Benefit: The rationale for instituting universal vaccination against measles and mumps was that it would reduce the number of sick days for children and prevent the severe complications that are a rare side of effect of teenagers contracting the illnesses. For Rubella, vaccination is seen as a way of ensuring pregnant mothers do not contract the illness, resulting in increased risk of birth defects. However, these few benefits come at a cost. Vaccine-generated immunity is NOT lifelong and begins to wear off after 15-20 years, whereas natural immunity is generally lifelong. Importantly, when children still contracted these viruses naturally, women were able to give “passive immunity” to their newborns which protected them from severe infection during their most vulnerable window (from birth to 2 years old).  Vaccine-induced immunity is not strong enough to produce maternal immunity, leaving newborns susceptible to a potentially severe infection with one of these RNA viruses. Vaccination is usually not adequate to protect during this window because the infant immune system is NOT developmentally ready to generate a proper immune response to live viral vaccines, such as MMR, until children are well over 1 year old. Receipt of the vaccine that combines MMR and Varicella (MMRV-Proquad) is associated with a higher risk of seizures and hospitalization post-vaccination. Natural infection with RNA viruses such as measles has been reported to reduce the risk of several adult diseases, most notably, cancer.

Concerningly, these live 3 viral vaccines contain residual human cell debris and DNA/RNA from the cell lines they were grown in. The vaccines are grown in a cell line derived from an aborted male fetus (MCR5). This raises ethical concerns for many people. Medically, the presence of human cell debris can theoretically cause several problems. First, the cell debris and/or the genetic material may stimulate an aberrant immune response. Second, the residual DNA may be taken up by stem cells in the blood and insert into the host DNA, thereby causing insertional mutagenesis. The insertion of viral vaccine DNA into a person’s DNA increases the risk of cancers, specifically blood cancers such as leukemia and lymphoma. Third, residual human cell debris is often contaminated with human retroviruses, such as HERV-K, which are associated with chronic fatigue and cancer.

MMR Vaccine and Autism: In 1998, Dr. Andrew Wakefield published a study demonstrating a potential link between gastrointestinal problems and autism. The fact that he mentioned that many of the parents of his patients claimed that both the onset of the gastrointestinal problems and the regression into autism were co-incident with MMR vaccination eventually set off a firestorm of controversy. Following many anecdotal reports that their children regressed into autism following an MMR vaccine, the CDC commissioned a study to look at the relationship between the timing of the MMR vaccine and rates of autism. They published the results (DeStefano) in 2004 showing that boys vaccinated with the MMR vaccine prior to 36 months were 1.67 times and Black boys were 2.52 times more likely to be diagnosed with autism than those vaccinated after 36 months. However, later, the CDC Senior Scientist Dr. William Thompson came forward as a whistleblower, alleging that significant data were removed from the paper. Re-analysis of the allegedly removed data by Dr. Brian Hooker showed that Black boys were actually 3.86 times more likely to receive an autism diagnosis if they were vaccinated prior to 36 months. The are clear biological reasons that this difference might occur which are detailed in the “Key Susceptibilities” section of the VI-TA website.

The Vaccine: M-M-R®II by Merck is a live viral vaccine that is a combination of the measles, mumps and rubella viruses. A weakened version of the Ender’s attenuated Edmonton strain of the measles virus is grown on tissue culture derived from chick embryos. A weakened version of the Jeryl Lynn™ (B-level) strain of the mumps virus is grown on tissue culture derived from chick embryos. A weakened version of the rubella virus, known as Wistar RA 27/3 strain is grown on human cells derived from an aborted female fetus (WI-38 cells). Concerningly, in 2014, two Merck scientist whistleblowers came forward alleging that the mumps portion of the vaccine was ineffective and that they had been asked to falsify data and claim that it was still 95% effective when it was not effective.

As a result of being grown in cell culture, the final MMR vaccine product WILL contain residual chicken or human cell debris and DNA/RNA. It also contains gelatin and traces of the antibiotic neomycin, which can illicit allergic-type responses in some people. Contraindications include those with previous anaphylactic reactions to the vaccine and those who are immunocompromise. This is a live viral vaccine that sets up a subclinical infection in those who receive it. Some will manifest the clinical symptoms of rash. Thus, there is a risk of substantial infection in those who are immune-compromised and they should be avoided by those recently vaccinated with live viral vaccines, such as this one. Due to the length of time is has been available and the fact that it is a live viral vaccine that can cause an active infection, there are numerous contraindications to vaccination as well as reported cautions and adverse events listed in the vaccine insert that are detailed below.

Age Given: 1 year, and 5 years

Package Insert information can be found here. mmr_ii_pi (merck.com)

Vaccine Ingredients: M-M-R®II by Merck

• Weakened measles, mumps, rubella live viruses
• Sucrose and sorbitol (sugars)
• saline solution
• gelatin
• recombinant human albumin (blood protein)
• residual components of the human fetal lung tissue (WI-38)
• EDTA
• Neomycin (an antibiotic)
• trace quantities of cow fetus serum

As per the vaccine insert (M-M-R®II by Merck), vaccination is contraindicated under the following conditions:

4.1 Hypersensitivity Do not administer M-M-R II vaccine to individuals with a history of hypersensitivity to any component of the vaccine (including gelatin) {3} or who have experienced a hypersensitivity reaction following administration of a previous dose of M-M-R II vaccine or any other measles, mumps and rubella-containing vaccine. Do not administer M-M-R II vaccine to individuals with a history of anaphylaxis to neomycin [see Description (11)].

4.2 Immunosuppression Do not administer M-M-R II vaccine to individuals who are immunodeficient or immunosuppressed due to disease or medical therapy. Measles inclusion body encephalitis {4} (MIBE), pneumonitis {5} and death as a direct consequence of disseminated measles vaccine virus infection have been reported in immunocompromised individuals inadvertently vaccinated with measles-containing vaccine. In this population, disseminated mumps and rubella vaccine virus infection have also been reported.

4.3 Moderate or Severe Febrile Illness Do not administer M-M-R II vaccine to individuals with an active febrile illness with fever >101.3°F (>38.5°C).

4.4 Active Untreated Tuberculosis Do not administer M-M-R II vaccine to individuals with active untreated tuberculosis (TB).

4.5 Pregnancy Do not administer M-M-R II to individuals who are pregnant or who are planning on becoming pregnant within the next month [see Use in Specific Populations (8.1) and Patient Counseling Information (17)].

The vaccine insert (M-M-R®II by Merck), gives the following warning and precautions:

5.1 Febrile Seizure There is a risk of fever and associated febrile seizure in the first 2 weeks following immunization with M-M-R II vaccine. For children who have experienced a previous febrile seizure (from any cause) and those with a family history of febrile seizures there is a small increase in risk of febrile seizure following receipt of M-M-R II vaccine [see Adverse Reactions (6)].

5.2 Hypersensitivity to Eggs Individuals with a history of anaphylactic, anaphylactoid, or other immediate reactions (e.g., hives, swelling of the mouth and throat, difficulty breathing, hypotension, or shock) subsequent to egg ingestion may be at an enhanced risk of immediate-type hypersensitivity reactions after receiving M-M-R II vaccine. The potential risks and known benefits should be evaluated before considering vaccination in these individuals.

5.3 Thrombocytopenia Transient thrombocytopenia has been reported within 4-6 weeks following vaccination with measles, mumps and rubella vaccine. Carefully evaluate the potential risk and benefit of vaccination in children with thrombocytopenia or in those who experienced thrombocytopenia after vaccination with a previous dose of measles, mumps, and rubella vaccine {6-8} [see Adverse Reactions (6)].

5.4 Family History of Immunodeficiency Vaccination should be deferred in individuals with a family history of congenital or hereditary immunodeficiency until the individual’s immune status has been evaluated and the individual has been found to be immunocompetent. 4

5.5 Immune Globulins and Transfusions Immune Globulins (IG) and other blood products should not be given concurrently with M-M-R II [see Drug Interactions (7.2)]. These products may contain antibodies that interfere with vaccine virus replication and decrease the expected immune response. The Advisory Committee on Immunization Practices (ACIP) has specific recommendations for intervals between administration of antibody containing products and live virus vaccines.

As per the vaccine insert (M-M-R®II by Merck), vaccination is an association with vaccination and the following conditions:

6 ADVERSE REACTIONS The following adverse reactions include those identified during clinical trials or reported during post approval use of M-M-R II vaccine or its individual components.

Body as a Whole Panniculitis; atypical measles; fever; headache; dizziness; malaise; irritability. Cardiovascular System Vasculitis. Digestive System Pancreatitis; diarrhea; vomiting; parotitis; nausea.

Hematologic and Lymphatic Systems Thrombocytopenia; purpura; regional lymphadenopathy; leukocytosis.

Immune System Anaphylaxis, anaphylactoid reactions, angioedema (including peripheral or facial edema) and bronchial spasm.

Musculoskeletal System Arthritis; arthralgia; myalgia. Nervous System Encephalitis; encephalopathy; measles inclusion body encephalitis (MIBE) subacute sclerosing panencephalitis (SSPE);

Guillain-Barré Syndrome (GBS); acute disseminated encephalomyelitis (ADEM); transverse myelitis; febrile convulsions; afebrile convulsions or seizures; ataxia; polyneuritis; polyneuropathy; ocular palsies; paresthesia; syncope.

Respiratory System Pneumonia; pneumonitis; sore throat; cough; rhinitis.

Skin Stevens-Johnson syndrome; acute hemorrhagic edema of infancy;

Henoch-Schönlein purpura; erythema multiforme; urticaria; rash; measles-like rash; pruritus; injection site reactions (pain, erythema, swelling and vesiculation).

Special Senses — Ear Nerve deafness; otitis media. Special Senses — Eye Retinitis; optic neuritis; papillitis; conjunctivitis. Urogenital System Epididymitis; orchitis

The Illness: Chickenpox is caused by the Varicella virus. Infection causes fever and spots.

It can be diagnosed by the characteristic spots or a blood test and is transmitted like the common cold. Prior to the mid 1990s there were about 3.5 million cases each year in the US.  Now there are about 50,000 reported cases each year. Chickenpox is NOT generally serious. However, it is more uncomfortable for adults than children.  It is more serious for people with compromised immune systems and it can cause birth defects if contracted during pregnancy. There is an antiviral medication available, but for most cases, the infection is allowed to run it’s course.

Cost/Benefit: The rationale for instituting universal vaccination against chickenpox was that it would reduce the number of sick days for children and prevent the severe complications that are a rare side of effect of teenagers contracting the illness. However, these few benefits come at a cost. Vaccine-generated immunity is NOT lifelong and begins to wear off after 15-20 years, whereas natural immunity is generally lifelong. Moreover, when children still contracted natural chickenpox and exposed their parents and grandparents to the virus (again), it had the effect of “boosting” the immunity of the elders, thus preventing the varicella virus from re-emerging in their bodies as Shingles. Without children with chickenpox to boost the immunity of the elderly, we are seeing an epidemic of Shingles in adults. Due to the fact that the vaccine doesn’t provide as long-lasting immunity as natural immunity, children vaccinated against chickenpox appear to be more susceptible to Shingles infection as well. Thus, we are seeing an increase in young adults and even children with Shingles. Shingles is a more severe illness, manifesting as painful clusters of blisters and postherpetic neuralgia—sever and debilitating pain that can last for weeks, months or years. Thus, we are substituting a painful, debilitating illness for a mild illness that produces robust natural immunity, a dubious tradeoff. Vaccination against chickenpox is associated with higher risks of allergies and a rare blood disorder, called thrombocytopenia. Receipt of the vaccine that combines MMR and Varicella (MMRV-Proquad) is associated with a higher risk of seizures and hospitalization postvaccination. Natural infection with viruses such as chickenpox also reduces the risk of several adult diseases, most notably, cancer.

Concerningly, Chickenpox vaccines contain residual human cell debris and DNA/RNA from the cell line they were grown in. The vaccine is grown in a cell line derived from an aborted male fetus (MCR5). This raises ethical concerns for many people. Medically, the presence of human cell debris can theoretically cause several problems. First, the cell debris and/or the genetic material may bind to Toll-like receptors and activate an aberrant immune response. Second, the residual DNA may be taken up by stem cells in the blood and insert into the host DNA, thereby causing insertional mutagenesis. Insertional mutagenesis will increase the risk of cancers, specifically blood cancers such as leukemia and lymphoma. Third, residual human cell debris is often contaminated with human retroviruses, such as HERV-K, which are associated with chronic fatigue and cancer.

The Vaccine: VARIVAX by Merck) is a live viral vaccine. A weakened version of the chickenpox (varicella) virus is grown on human cells derived for an aborted male fetus (MCR5 cells) to produce the virus. As a result of being grown in human cells, the final vaccine product WILL contain residual human cell debris and DNA/RNA. It also contains monosodium glutamate, gelatin and traces of the antibiotic neomycin, which can both illicit allergic-type responses in some people. Contraindications include those with previous anaphylactic reactions to the vaccine and those who are immunocompromise. This is a live viral vaccine and sets up a subclinical infection in those who receive it. Some will manifest the clinical symptoms of rash. Thus, there is a risk of substantial infection in those who are immunocompromised and they should be avoided by those recently vaccinate with live viral vaccines, such as this one.

Age Given: 1 year, and 5 years

Package Insert information can be found here. https://www.immunize.org/fda/#var

Information concerning adverse events can be found in section 6, which contains information on the clinical trials as well as the post-marketing data.

Vaccine Ingredients: Varivax

• live virus
• sucrose
• saline solution
• gelatin
• monosodium glutamate
• potassium
• residual components of the Merck human diploid cells (MRC-5)
• EDTA
• neomycin
• trace quantities of cow fetus serum

The Illness: Rotavirus is the most common cause of severe diarrhea in kids under two years old. Infection with Rotavirus can result in dehydration as the diarrhea can last more than a few days. IV rehydration is used to treat the dehydration. Rotavirus is transmitted by contact with the stools or saliva of an infected person. Rotavirus is resistant to common disinfectants and antibacterial hand soaps.  A strong antiseptic or alcohol is needed to destroy the virus.

Cost/Benefit Analysis: Rotavirus is most severe in the first year of life, but less problematic after that. Children who are breastfed and not in daycare are at low risk during their first year of life, when risk of severe infection and hospitalization is highest. In the U.S, about 50,000 children per year are hospitalized for rotavirus in order to receive proper hydration. Both vaccines currently on the market are live viral vaccines. Live viral vaccines generally give robust long-term immunity. However, the live Rotavirus vaccine creates an active infection in the gut in order to establish immunity. This could be problematic for those with weakened immune systems. The vaccine strain virus is also shed in the stool and can be passed to others in the household or environment. Both currently available versions of the vaccine are associated with a low risk of intussusception (part of the intestine folding into itself creating a blockage), Kawasaki Disease, Hematochezia (gastrointestinal bleed) and seizure. Current Rotavirus vaccines are live viral vaccines that are grown in VERO (monkey kidney cells that lack anti-viral defenses). VERO cells are known to potentially contain a variety of monkey viruses, retroviruses and possibly other viruses that the cell line may have been used to propagate. Thus, there is a substantial concern that the vaccine may be contaminated with adventitious (unintentional) viruses that could infect the child.

As per the vaccine insert (Rotarix), vaccination is contraindicated under the following conditions:

4.1 Hypersensitivity A demonstrated history of hypersensitivity to any component of the vaccine. Infants who develop symptoms suggestive of hypersensitivity after receiving a dose of ROTARIX should not receive further doses of ROTARIX.

4.2 Gastrointestinal Tract Congenital Malformation Infants with a history of uncorrected congenital malformation of the gastrointestinal tract (such as Meckel’s diverticulum) that would predispose the infant for intussusception should not receive ROTARIX.

4.3 History of Intussusception Infants with a history of intussusception should not receive ROTARIX [see Warnings and Precautions (5.5)]. In postmarketing experience, intussusception resulting in death following a second dose has been reported following a history of intussusception after the first dose [see Adverse Reactions (6.2)].

4.4 Severe Combined Immunodeficiency Disease Infants with Severe Combined Immunodeficiency Disease (SCID) should not receive ROTARIX. Postmarketing reports of gastroenteritis, including severe diarrhea and prolonged shedding of vaccine virus, have been reported in infants who were administered live, oral rotavirus vaccines and later identified as having SCID

Insert Data on risk of Intussusception continues:

5.5 Intussusception Following administration of a previously licensed oral live rhesus rotavirus-based vaccine, an increased risk of intussusception was observed.1

The risk of intussusception with ROTARIX was evaluated in a pre-licensure randomized, placebo-controlled safety study (including 63,225 infants) conducted in Latin America and Finland. No increased risk of intussusception was observed in this clinical trial following administration of ROTARIX when compared with placebo. [See Adverse Reactions (6.1).]

In a postmarketing, observational study conducted in Mexico, cases of intussusception were observed in temporal association within 31 days following the first dose of ROTARIX, with a clustering of cases in the first 7 days. [See Adverse Reactions (6.2).]

Other postmarketing observational studies conducted in Brazil and Australia also suggest an increased risk of intussusception within the first 7 days following the second dose of ROTARIX.2,3 [See Adverse Reactions (6.2).]

In worldwide passive postmarketing surveillance, cases of intussusception have been reported in temporal association with ROTARIX [see Adverse Reactions (6.2)].

The Vaccines: Rotavirus vaccines are made by growing rotaviruses on VERO (monkey kidney) cells that lack anti-viral defenses. In the past, VERO cells have been shown to be contaminated with many monkey viruses as well as retroviruses.

Age Given: 2 months, 4 months, and 6 months

Package Insert information can be found here. https://www.immunize.org/fda/#rota

Information concerning adverse events can be found in section 6, which contains information on the clinical trials as well as the post-marketing data.

Vaccine Ingredients: RotaTeq (Merck)

• five virus strains, live and whole
• sucrose (a sugar)
• sodium citrate, phosphate, and hydroxide
• ploysorbate 80
• cell culture media
• traces of fetal cow blood

Vaccine Ingredients: Rotarix (GlaxoSmithKline)

• Single strain virus, live and whole
• sucrose (a sugar), dextran (a sugar), sorbitol (a sugar)
• Amino acids
• sodium citrate, phosphate, and hydroxide
• calcium carbonate
• xanthum gum
• cell culture media (DMEM)
• sterile water