Rubella Overview

What is Rubella?

Rubella is a contagious respiratory illness caused by a togavirus, genus Rubivirus.  While often referred to as “German measles” or “three-day measles”, this virus is different and not related to the virus that causes measles.  Rubella is contagious and for the majority of cases is a mild viral infection that primarily occurs in childhood but can also affect adults. About 25 to 50 percent of rubella infections are asymptomatic.   

The virus is transmitted through direct contact or contact with respiratory secretions (nasal discharge, coughing, sneezing),  and recovery from rubella usually confers lifelong immunity, although there are rare reports of repeat cases.  Laboratory testing is needed to confirm a diagnosis of rubella because the rash associated with the illness is not easily distinguishable from other rash illnesses.  Click to read more about Rubella…

What is Rubella Vaccine?

Rubella vaccine is a weakened (attenuated) form of the live rubella virus. Currently, rubella vaccine in the U.S. is only available as a combination vaccine. There are two available vaccines for use in the U.S and both vaccines are recommended for children beginning at 12 months of age.    Merck’s vaccine package insert states that the MMRII vaccine should be given one month before or one month after any other live viral vaccines.  Merck’s ProQuad vaccine package insert states that one month should lapse between administration of ProQuad and another measles containing vaccine such as MMRII and at least three months should lapse between ProQuad and any varicella containing vaccine. 

According to Merck, both MMRII and ProQuad rubella containing vaccines are screened for adventitious agents. Each dose of ProQuad also contains aborted fetal WI-38 human diploid lung fibroblasts and MRC-5 cells.    Merck’s MMRII vaccine is a live attenuated virus vaccine propagated in WI-38 aborted diploid lung fibroblasts  derived from the lung tissue of an aborted three-month human female embryo.  Click to learn more about Rubella vaccines…

Rubella Quick Facts
Rubella Infection

• Young adults, especially young women, who are infected with rubella may have swollen glands in the back of the neck and joint pain, swelling and stiffness (arthritis) that lasts for several weeks. Rarely, more serious complications of rubella, including brain inflammation and chronic arthritis, may occur; 
• While rubella is mildly contagious and usually not a serious infection, a pregnant woman infected with rubella during the first three months of pregnancy has a greater chance of miscarriage and of giving birth to a baby with congenital rubella syndrome (CRS) and birth defects. Infants born with CRS can suffer from deafness, blindness, heart defects, developmental delay, small head size and other serious health problems.  Click to read more Rubella Quick Facts…

Rubella Vaccine

• Mild side effects such as redness, rash or pain at the injection site, along with fever and swelling of the glands in the neck or cheeks have been reported following MMR and MMR-V vaccination;   
• More serious side effects following vaccination include shock, encephalitis, convulsions (seizures), encephalopathy, thrombocytopenia purpura, arthritis, optic neuritis, lupus, Guillain-Barre syndrome (GBS), aseptic meningitis, deafness, gastrointestinal disorder, cardiomyopathy, transverse myelitis, and subacute sclerosing panencephalitis.    Click to read more Rubella Quick Facts…

IMPORTANT NOTE: NVIC encourages you to become fully informed about Rubella and the Rubella Vaccine by reading all sections in the Table of Contents, which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

 

What is Rubella?

Rubella is a respiratory illness caused by a togavirus, genus Rubivirus.  While often referred to as “German measles” or “three-day measles”, this virus is different and not related to the virus that causes measles.  Rubella is contagious and is transmitted through direct contact or contact with respiratory secretions (nasal discharge, coughing, sneezing). Persons with rubella are most contagious when the rash first appears but can be contagious for seven days prior to seven days after symptoms appear. In the U.S. and other temperate climates, rubella is usually seen in late winter and early spring. Prior to the introduction of vaccines targeting rubella, epidemics of the illness generally occurred every six to nine years. 

Laboratory testing is needed to confirm a diagnosis of rubella because the rash associated with the illness is not easily distinguishable from other rash illnesses. Secretions from the nose and throat as well as urine and blood can be tested to confirm a diagnosis of rubella.  There are 12 confirmed (1B, 1C, 1D, 1E, 1F, 1G, 1H, 1I, 1J, 2A, 2B, 2C) and 1 provisional (1a) rubella genotypes which belong to 2 distinct clades.  Genotypes 1E, 1G, 1J, and 2B are the most commonly circulating genotypes. 

The rubella virus is easily destroyed by ultraviolet light, low pH, amantadine, lipid solvents, trypsin, formalin, and heat. 

Rubella Symptoms

In children, the first sign of illness is usually a rash that appears on the face then spreads towards the feet. Non-specific symptoms that may occur one to five days before the appearance of the rash include a cough, runny nose, generalized discomfort, headache, low-grade fever, enlarged lymph nodes and swelling or redness to the whites of the eyes.  Symptoms in adults are generally like those experienced by children but up to 70 percent of women may experience arthritis or arthralgia  that may be persistent.    Rare complications of rubella include encephalitis (brain inflammation) and thrombocytopenia purpura (blood clotting disorder).  Up to 50 percent of people with rubella will have no symptoms. 

Rubella in Pregnancy

Rubella is most serious when it occurs in women during their first trimester of pregnancy. Women who develop rubella during this time are at a high risk of miscarriage, still birth, and of giving birth to an infant with congenital rubella syndrome (CRS). 

Infants with CRS can have multiple health issues affecting nearly all organs of the body, including deafness, vision impairments, cardiac defects, microcephaly, neurological abnormalities, developmental delays, and more.  Up to 85 percent of infants exposed to rubella in the first 8 weeks of fetal development are at risk for CRS. By 12 weeks, the risk decreases to 50 percent and by 20 weeks, the risk is essentially zero. 

IMPORTANT NOTE: NVIC encourages you to become fully informed about Rubella and the Rubella vaccine by reading all sections in the Table of Contents, which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

 

Is Rubella contagious?

Rubella is contagious and is transmitted through direct contact or contact with respiratory secretions (nasal discharge, coughing, sneezing). Persons with rubella are most contagious when the rash first appears but can be contagious for seven days prior to or seven days after infection. 

Infants exposed to rubella perinatally may shed the virus for up to nine months after birth. 

IMPORTANT NOTE: NVIC encourages you to become fully informed about Rubella and the Rubella vaccine by reading all sections in the Table of Contents, which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

 

What is the history of Rubella in America and other countries?

Recognition of Rubella

The earliest accounts of rubella in the medical literature date back to the mid-18^th century when clinical symptoms of the illness were described by two German physicians who considered the illness to be a variation of measles or scarlet fever. 

In 1814, another German physician, George de Maton, recognized the illness as unique from measles. By this time, the illness was referred to as ‘German measles’ or rötheln. In 1866, British Army Surgeon Henry Veale renamed the infection to rubella, the Latin term for reddish thing.   

By 1914, rubella infections were assumed to be caused by a virus and in 1938, rubella was found to be transmissible between individuals. This was confirmed by two researchers who exposed children to the nasal washings of individuals infected with rubella. 

In 1941, Norman Gregg, an ophthalmic surgeon from Australia, noted a significant increase in the number of infants with congenital cataracts that were frequently associated with other anomalies. A thorough evaluation of maternal health history would reveal that these cases occurred in mothers who developed rubella in the first trimester of pregnancy. This was the first time a virus was found to be associated with birth defects; however, his findings would not become widely known until 1947, when a comprehensive review of rubella was written by Dr. Conrad Wesselhoeft and published in the New England Journal of Medicine. These congenital anomalies would be referred to as congenital rubella syndrome (CRS). 

Additional information on rubella was gained through testing on human subjects in the early 1950s, but further experiments were halted due to ethical concerns related to human experimentation. 

The virus responsible for rubella was first isolated by two independent research teams in 1962, and vaccine development began shortly after this discovery.  Rubella gamma globulin use also began as a treatment for pregnant women with possible rubella exposure, but early studies questioned the effectiveness of this product for the prevention of CRS. 

Incidence in U.S.

In 1964, an epidemic of rubella occurred in the U.S. and while the illness was not nationally notifiable, 448,796 cases  and 53 deaths  were reported. In the mid-1960’s, most cases occurred among school-aged children between 5-9 years and 10-14 years of age. While public health officials reported that an estimated 20,000 cases of CRS likely occurred during this epidemic, the exact number is not known because CRS did not become nationally notifiable until 1966. 

During the rubella epidemic of 1964, public health officials also discovered that infants exposed prenatally to rubella could shed the virus for the first 6 to 9 months of life. 

In 1966, when rubella and CRS became nationally notifiable illnesses, there were 46,975 cases of rubella and 11 cases of CRS reported. 

Vaccine Introduction

The CDC’s Advisory Committee on Immunization Practices (ACIP) recommended the use of rubella vaccines in April of 1969, prior to vaccine licensing. This vaccine was not developed due to the seriousness of rubella, but rather because of the impact of rubella on the developing infant. 

In 1969, the rubella vaccine was recommended for all children 12 months and older but children in kindergarten and grade school were considered the priority target for vaccination due to the high outbreak rates among this population. ACIP also stated that children previously diagnosed with rubella infection should still be vaccinated and reported that “A history  of rubella illness is usually not reliable enough to exclude  children from immunization.” 

The use of blood testing to confirm a previous diagnosis of rubella was cautioned because the test was “a complex procedure which must be performed by well trained,  experienced individuals.” 

The first vaccine was approved for use in June of 1969 and by June 1970, two additional vaccines became available for use in the U.S. 

In 1975, there were 16,652 reported cases of rubella and 30 reported cases of CRS.  There were also 21 rubella associated deaths. 

Rubella Decline and Eradication Efforts

In 1980, the CDC published a report regarding rubella in the U.S and noted that most of the decline in rubella cases had occurred among persons under 15 years of age; however, in 1977, rubella cases had increased among persons between the ages of 20 and 29 years of age and the highest number of cases had occurred among persons 15 to 19 years of age. Most rubella outbreaks were occurring in high schools, military establishments, workplaces, and hospitals.  These increases among older populations prompted ACIP to update its rubella vaccine recommendations in January of 1979 to emphasize the need to ensure that older individuals, especially women of childbearing age, be vaccinated or have evidence of immunity to rubella. 

In 1980, the U.S. public health service set a goal that by 1990, there would be less than 1,000 cases of rubella in the U.S.  This goal was reached in 1983, and between 1981 and 1990, there were an average of 935 cases of rubella and 9 cases of CRS reported each year. 

In 1989, health officials set a goal of rubella elimination from the U.S. for the year 2000 and one year later, ACIP updated its rubella vaccine recommendation from one dose to two doses. This recommendation was made following the introduction of a 2-dose schedule for the measles-mumps-rubella (MMR) vaccine.   

Rubella was declared eliminated from the U.S. in 2004  and from the western hemisphere in 2015.  Between 2004 and 2011 an average of 10 rubella cases per year were reported in the U.S. Four cases of CRS were also reported, and of those four cases, two occurred in infants born outside the U.S., one occurred in an infant born to a woman with an unknown vaccination status and one was born to a mother who had been previously vaccinated and who had no history of international travel.  Between 2012 and 2018, there were 41 reported cases of rubella (an average of six cases per year) and 13 cases of CRS in the U.S.             

In 2018, there were four reported cases of rubella in the U.S. and between 2009 and 2017, there were an average of five rubella cases per year. There were no reported cases of CRS in the U.S. in 2018.    That same year the World Health Organization (WHO) reported 14,621 rubella cases, with 151 countries reporting. This was documented as a 97 percent decrease from the year 2000, when 670,894 cases were reported from 102 reporting countries. 

IMPORTANT NOTE: NVIC encourages you to become fully informed about Rubella and the Rubella vaccine by reading all sections in the Table of Contents, which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

 

Can Rubella cause injury and death?

Rubella is generally a mild, self-limiting illness and up to 50 percent of infected individuals will have no symptoms. Symptoms that can occur include a rash that begins on the face and spreads towards the feet, a low-grade fever, swollen glands, cough, headache, and swelling and redness to the white of the eyes. 

Up to 70 percent of adult women with rubella infection may develop arthritis or arthralgia, which may persist for up to a month. These symptoms usually occur at the same time or shortly after the rash appears and rarely occurs in children or men. 

One in approximately 3,000 cases of rubella may result in blood disorders that include cerebral, intrarenal, and gastrointestinal hemorrhage as well as thrombocytopenia purpura, a blood clotting disorder. This complication is more frequently seen in children. Encephalitis (brain inflammation) is another rare but serious complication of rubella that occurs in approximately one out of every 6,000 cases and affects adult females at higher rates than children or males. Other rare but serious complications of rubella include orchitis (swelling of the testes) and neuritis. 

While rubella is usually not a serious infection, a woman infected with rubella during the first three months of pregnancy has a greater chance of miscarriage and of giving birth to a baby with Congenital Rubella Syndrome (CRS) and birth defects. Infants born with CRS can suffer from deafness, blindness, heart defects, developmental delay, small head size and other serious health problems.  

In early adolescence, children with CRS can also develop progressive rubella panencephalitis. Symptoms of this rare disorder include seizures, mental deterioration, and muscular issues like ataxia, and progressive spasticity. 

IMPORTANT NOTE: NVIC encourages you to become fully informed about Rubella and the Rubella vaccine by reading all sections in the Table of Contents, which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

 

Who is at highest risk for getting Rubella?

Rubella was declared eliminated in the U.S. in 2004. In 2019, there were six reported cases of rubella in the U.S. and one reported case of CRS in the U.S. 

Rubella is endemic in many countries globally. Those most at risk for rubella are travelers who visit countries where rubella is endemic.  Up to 50 percent of people with rubella will not have any symptoms (asymptomatic) of illness and persons may be exposed to the illness from someone who is contagious but not showing signs of infection. 

IMPORTANT NOTE: NVIC encourages you to become fully informed about Rubella and the Rubella vaccine by reading all sections in the Table of Contents, which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

 

Who is at highest risk for complications from Rubella?

For most people, rubella is a mild, self-limiting illness; however, a woman who develops rubella during the first three months of pregnancy has a greater chance of miscarriage and of giving birth to a baby with congenital rubella syndrome (CRS) and birth defects.  

Infants with CRS can have multiple health issues affecting nearly all organs of the body, including deafness, vision impairments, cardiac defects, microcephaly, neurological abnormalities, developmental delays, and more.  Up to 85 percent of infants exposed to rubella in the first eight weeks of fetal development are at risk for CRS. By 12 weeks, the risk decreases to 50 percent and by 20 weeks, the risk is essentially zero. 

In 2019, there were six reported cases of rubella in the U.S. and one reported case of CRS in the U.S. 

IMPORTANT NOTE: NVIC encourages you to become fully informed about Rubella and the Rubella vaccine by reading all sections in the Table of Contents, which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

 

What are the treatment and prevention options for Rubella?

Practicing cleanliness and good hygiene can assist in preventing rubella infections. This includes: 

• Frequent handwashing;
• Use of a hand sanitizer, if handwashing is not available;
• Refraining from touching your face with your hands, unless your hands are clean;
• Covering your nose and mouth with a tissue or sleeve when sneezing or coughing;
• Avoiding close contact with persons who are sick;
• Refraining from using items that may be contaminated by someone who is ill.

There is no treatment for rubella. For most people, rubella is usually mild and therefore treatment is not necessary. Pregnant women who become infected with rubella can be treated with hyperimmune globulin to decrease the risk of transmitting the infection to the unborn child. 

Congenital Rubella Syndrome (CRS)

Infants born with CRS, due to maternal rubella infection, can have multiple health issues affecting nearly all organs of the body, including deafness, vision impairments, cardiac defects, microcephaly, neurological abnormalities, developmental delays, and more.  Up to 85 percent of infants exposed to rubella in the first eight weeks of fetal development are at risk for CRS. By 12 weeks, the risk decreases to 50 percent and by 20 weeks, the risk is essentially zero.  Infants born with CRS will likely require specialized care specific to individual health needs. There was one reported case of CRS in the U.S. in 2019. 

IMPORTANT NOTE: NVIC encourages you to become fully informed about Rubella and the Rubella vaccine by reading all sections in the Table of Contents, which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

 

What is Rubella vaccine?

Rubella vaccine is a weakened (attenuated) form of the live rubella virus. Currently, there are three available vaccines for use in the U.S. Merck's MMRII and GlaxoSmithKline’s ProQuad both contain measles, mumps and rubella vaccine, live.   Merck's ProQuad (MMRV) contains measles, mumps, rubella and varicella vaccine, live. 

Merck’s MMRII is licensed and recommended for individuals aged 12 months or older. It is a live attenuated virus vaccine propagated in chick embryo cells and cultured with Jeryl Lynn live attenuated mumps virus, and Meruvax II, a live attenuated rubella virus vaccine propagated in WI-38 human diploid lung fibroblasts.  The WI-38 human diploid cell line was derived from the lung tissue of an aborted three-month human female embryo.  The growth medium used was salt solution and ten percent calf (bovine) serum. 

Merck's ProQuad is licensed and recommended for individuals aged 12 months to 12 years of age. ProQuad (Measles, Mumps, Rubella and Varicella Virus Vaccine, Live) is a combined, attenuated, live virus vaccine containing measles, mumps, rubella, and varicella viruses. ProQuad is a sterile lyophilized preparation of the components of M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live): Measles Virus Vaccine Live, and Varicella Virus Vaccine Live (Oka/Merck), the Oka/Merck strain of varicella-zoster virus propagated in MRC-5 cells. MRC-5 cells are derived from a cell line that was developed in 1966 from lung tissue taken from a 14-week aborted fetus and contains viral antigens. 

MMRII and ProQuad Rubella Vaccine Ingredients

The growth medium for measles and mumps for both MMRII  and ProQuad  is a buffered salt solution containing vitamins and amino acids and supplemented with fetal bovine serum containing sucrose, phosphate, glutamate, and recombinant human albumin, and neomycin. The growth medium for rubella is a buffered salt solution containing vitamins and amino acids and supplemented with fetal bovine serum containing recombinant human albumin and neomycin. Sorbitol and hydrolyzed gelatin stabilizer are added to the individual virus harvests. In the ProQuad vaccine,  the Oka/Merck strain of the live attenuated varicella virus, initially obtained from a child with wild-type varicella, introduced into human embryonic lung cell cultures, adapted to and propagated in embryonic guinea pig cell cultures and finally propagated in aborted human diploid cell cultures (WI-38) is added to the MMRII component.

According to Merck, both MMRII and ProQuad vaccines are screened for adventitious agents. Each dose of MMRII contains sorbitol, sodium phosphate, sucrose, sodium chloride, hydrolyzed gelatin, recombinant human albumin, fetal bovine serum, other buffer and media ingredients and neomycin.  Each dose of ProQuad contains sucrose, hydrolyzed gelatin, sorbitol, MSG, sodium phosphate, human albumin, sodium bicarbonate, potassium phosphate and chloride, neomycin, bovine calf serum, chick embryo cell culture, WI-38 human diploid lung fibroblasts and MRC-5 cells.   

The MMRII vaccine package insert states that the MMRII vaccine should be given one month before or one month after any other live viral vaccines.  The ProQuad vaccine package insert states that one month should lapse between administration of ProQuad and another measles containing vaccine such as MMRII and at least three months should lapse between ProQuad and any varicella containing vaccine. 

GlaxoSmithKline’s PRIORIX is licensed and recommended for individuals aged 12 months or older. PRIORIX is made up of the Schwarz strain of live attenuated measles virus and the RIT 4385 strain of live attenuated mumps virus, derived from the Jeryl Lynn mumps strain, both propagated in chick-embryo fibroblasts. It also contains the Wistar RA 27/3 strain of live attenuated rubella virus propagated in MRC-5 human diploid cells. 

These three virus strains are cultured in media containing amino acids, neomycin sulfate and bovine serum albumin. Multiple washings are done to remove the antibiotic and albumin from the media. The attenuated measles, mumps and rubella viruses are then mixed with a stabilizer before lyophilization. After reconstitution, the vaccine is a clear peach- to fuchsia pink-colored suspension. In addition to the measles, mumps, and rubella viruses, each 0.5ml dose also contains amino acids, mannitol, anhydrous lactose, and sorbitol. Each dose may also contain residual amounts of ovalbumin, bovine serum albumin and neomycin sulphate.

The tip caps of the prefilled syringes of diluent for PRIORIX contain natural rubber latex. 

Rubella Vaccine Administration Recommendations

Currently, the CDC recommends that children receive two doses of a rubella containing vaccine, with the first dose administered between the ages of 12-15 months, and the second dose administered between the ages of 4-6 years.  The CDC also recommends that individuals born after 1957 and have no laboratory evidence of immunity or documentation of vaccination should receive at least one dose of MMR vaccine. Two doses of MMR vaccine are recommended for healthcare personnel, students entering college and other post-high school educational institutions, and anyone traveling internationally. 

The CDC also recommends MMR vaccination for infants between 6 and 12 months of age who may be traveling internationally;  however, ProQuad,  MMRII,  and PRIORIX  are only FDA approved for use in children older than 12 months of age. The MMRII vaccine package insert states that the effectiveness and safety of administration of MMRII has not been established in children between the ages of 6 and 12 months of age and if administered to this population, antibodies may not develop.  According to the CDC, an infant vaccinated prior to 12 months of age would still require two additional doses of MMR vaccine. 

IMPORTANT NOTE: NVIC encourages you to become fully informed about Rubella and the Rubella vaccine by reading all sections in the Table of Contents, which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

 

What is the history of Rubella vaccine in America?

Vaccine Development

In 1962, the virus responsible for rubella was isolated by two independent research teams and vaccine development began following this discovery.¹ Also in 1962, scientists from Merck isolated a strain of rubella, the Benoit strain, with the intent of developing a killed rubella vaccine. By 1965, however, they decided that a live virus vaccine would be the better option. This vaccine was developed by using duck embryos, as chicken embryo cells were found to be an unsuitable growth medium for rubella vaccine development.²

At the same time, scientists from the Division of Biologics Standards (DBS) were also actively experimenting with a live attenuated rubella vaccine using bovine kidney cells. By 1966, their vaccine, HPV-77, had been tested on animals and a small number of children.³

In the late 1960’s, Merck began testing their duck-embryo experimental vaccine and in 1969, Meruvax (HPV-77:DE-5) was licensed for use in persons 12 months of age and older. The CDC’s Advisory Committee on Immunization Practices (ACIP) recommended the use of rubella vaccines in April of 1969, prior to the vaccine’s licensing. The vaccine, however, was not developed because rubella was considered a serious illness, but rather because of its impact on the developing infant.⁴

Within a year, two additional rubella vaccines, Rubelogen or HPV-77:DK-12 (developed from dog kidneys) and Cendevax or GMK-3:RK53 (developed from rabbit kidneys) also received approval for use.⁵

Vaccine Introduction and Side Effects

In August 1970, 15 months after approval of the first vaccine targeting rubella, the CDC reported that it had received numerous reports of arthralgia and arthritis in children after vaccine administration. While noting that pre-licensing clinical trials reported that joint problems in children occurred at a rate of less than five percent, health officials stated that “with extensive usage following licensure, many areas were alarmed by a greater frequency and severity of reactions than were expected.”⁶

This report also noted that most side effects usually resolved within one to ten days; however, in some cases joint pain persisted and children required hospitalization for evaluation of rheumatoid arthritis or rheumatic fever.⁷

Children vaccinated with the rubella vaccine derived from dog kidneys (HPV-77:DK-12) had a significantly higher rate of reported joint reactions when compared to children vaccinated with the vaccine derived from duck embryos (HPV-77:DE-5). Other serious events reported after rubella vaccination included transverse myelitis, high fever, ataxia, polyneuritis, aseptic meningitis, temporary paralysis, seizure, and death.⁸ HPV-77:DK-12 was voluntarily removed from the market in 1973.⁹

Combining of Rubella Vaccine with Measles Vaccine

In 1971, the measles-mumps-rubella vaccine (MMR), which combined Merck’s rubella vaccine, HPV-77:DE-5, with its measles and mumps vaccine, received approval for use. Additional rubella combination vaccines also received approval in the 1970s, including a mumps-rubella vaccine (Biavax) and a measles-rubella vaccine (M-R-Vax).

In the 1960s, the Wistar Institute in Philadelphia developed a rubella vaccine, RA27/3, from aborted fetal cells.¹⁰ Testing of the vaccine occurred outside of the U.S. in the late 1960s and by the early 1970s, this vaccine was licensed for use in several countries including Great Britain and Australia.^11 12

In 1978, Merck made the decision to pursue licensing of the RA27/3 rubella vaccine in the U.S. and discontinue use of its HPV-77:DE-5 rubella vaccine.¹³ The RA27/3 rubella vaccine was licensed for use in January 1979 and replaced all previously available rubella vaccines.¹⁴ In 1979, all children 12 months of age and older were recommended to receive a single dose of rubella vaccine. Additionally, ACIP emphasized the need to ensure that women of childbearing age receive the vaccine or have proof of immunity from previous exposure to the virus.¹⁵

Additional Second Dose Recommended for Children

A second dose of rubella vaccine prior to school entry was recommended by ACIP in 1990. This update was made in response to the recommendation that two doses of MMR vaccine be administered because of an increase in measles cases among vaccinated children.^16 17

On October 21, 2009, Merck announced that it was discontinuing production of its monovalent measles, mumps, and rubella vaccines and stated that it would only be producing the combination MMR vaccine.¹⁸

In June 2022, the FDA approved PRIORIX, a live attenuated measles, mumps, and rubella vaccine, manufactured by GlaxoSmithKline.¹⁹ PRIORIX was initially licensed in Germany in 1997 and according to the CDC, the vaccine has been in use globally in nearly 100 countries.²⁰ On June 23, 2022, the CDC’s ACIP voted to approve use of PRIORIX as an option for the MMR vaccine according to the current MMR recommendations and off-label uses.²¹

Currently rubella vaccines are only available in combination with measles and mumps vaccines (MMR), or measles, mumps, and chickenpox vaccines (MMR-V). According to the CDC, 94.6 percent of all children entering kindergarten in the 2019/2020 school year had received 2 doses of MMR vaccine.²²

IMPORTANT NOTE: NVIC encourages you to become fully informed about Rubella and the Rubella vaccine by reading all sections in the Table of Contents, which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

 

How effective is the Rubella vaccine?

The CDC reports that 95 percent of individuals 12 months of age and older who receive one dose of the rubella vaccine (RA 27/3) contained in the MMR vaccine will develop vaccine-acquired immunity to rubella. They also report that more than 90 percent of vaccinated individuals will maintain vaccine-acquired immunity for at least 15 years. 

Waning of Vaccine Acquired Immunity

A 2009 study on the impact of a second dose of MMR vaccine in children previously vaccinated between 12 and 14 months of age found that while rubella antibodies increased significantly post-vaccination, after 12 years, the levels decreased to those lower than what were detected after a single vaccine dose. Researchers cautioned that in the U.S., where wild-type virus boosting does not occur, vaccine-acquired immunity may decrease, and urged continued monitoring of rubella disease to ensure that the disease remains eliminated. 

In 2012, the Cochrane Collaboration published a review of the available medical literature on both the effectiveness of MMR vaccine as well as its safety. In this paper, researchers noted that they could not locate any studies on the effectiveness of MMR vaccine against cases of clinical rubella. 

Evaluation of Immunity with Third Dose

A 2018 CDC study found that rubella titer levels in young adults between 18 and 31 years of age previously vaccinated with two MMR doses and who received a third MMR dose increased 4.5 times on average. This study, however, reported that within one year of receipt of the third MMR dose, 24 percent of vaccine recipients had low positive rubella antibodies. 

In January 2020, Mayo Clinic vaccine researchers published a study evaluating the effects of a third dose of MMR vaccine on women of childbearing age. This study compared the vaccine-acquired antibodies in women who had either high or low- to non-existent levels of vaccine-acquired immunity after two MMR vaccine doses and what effects a third dose of MMR would have on antibody boosting. Researchers found that while all women showed evidence of vaccine-acquired immunity after a third dose, women with low immunity prior to the third dose did not have a significant antibody boost when compared to those who had higher levels prior to vaccination. They concluded that their study suggested that other not yet known immune or biological factors may be involved in the maintenance of vaccine acquired immune responses. 

Recent Effectiveness Evaluation

In April 2020, the Cochrane Collaboration updated their review of the available medical literature on the safety and effectiveness of MMR vaccine. In this updated review, they report the rubella vaccine to be 89 percent effective based on one moderate quality study involving approximately 1,600 children between the ages of nine months and 15 years of age. 

Effectiveness of PRIORIX MMR Vaccine

In June 2022, the FDA approved PRIORIX, a live attenuated measles, mumps, and rubella vaccine, manufactured by GlaxoSmithKline.  PRIORIX was initially licensed in Germany in 1997 and according to the CDC, the vaccine has been in use globally in nearly 100 countries.  On June 23, 2022, the CDC’s ACIP voted to approve use of PRIORIX as an option for the MMR vaccine according to the current MMR recommendations and off-label uses. 

IMPORTANT NOTE: NVIC encourages you to become fully informed about Rubella and the Rubella vaccine by reading all sections in the Table of Contents, which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

 

Can Rubella vaccine cause injury & death?

As of April 1, 2024, there had been 1,397 claims filed in the federal Vaccine Injury Compensation Program (VICP) for injuries and deaths following rubella (MMR, MMR-V, Mumps-Rubella, Rubella) vaccination, including 70 deaths and 1,327 serious injuries. Of that number, the U.S. Court of Claims administering the VICP has compensated 540 children and adults who have filed claims for rubella vaccine injury.

The U.S. government recognizes the following as vaccine injuries related to measles, mumps, and rubella (MMR) vaccine: 

• Anaphylaxis occurring within four hours of vaccine administration;
• Encephalopathy or encephalitis occurring within 5 and 15 days of vaccination;
• Shoulder Injury Related to Vaccine Administration (SIRVA) occurring within 48 hours of vaccination;
• Vasovagal syncope occurring within one hour of vaccination.

The U.S. government also recognizes chronic arthritis with initial symptoms occurring within 7 and 42 days of any rubella containing vaccine as a vaccine injury. 

Federal Vaccine Adverse Events Reports

Even though the National Childhood Vaccine Injury Act of 1986 legally required pediatricians and other vaccine providers to report serious health problems following vaccination to federal health agencies (VAERS), many doctors and other medical workers giving vaccines to children and adults fail to report vaccine-related health problem to VAERS. There is evidence that only between one and 10 percent of serious health problems that occur after use of prescription drugs or vaccines in the U.S. are ever reported to federal health officials, who are responsible for regulating the safety of drugs and vaccines and issue national vaccine policy recommendations.       

As of March 29, 2024, there have been 112,776 reports of adverse events for rubella containing vaccines (MMR, MMR-V, Mumps-Rubella, Rubella) made to the federal Vaccine Adverse Events Reporting System (VAERS), which include hospitalizations, injuries and deaths. Of these reports there are 520 deaths, 8,549 hospitalizations, and 2,190 related disabilities. However, the numbers of vaccine-related injuries and deaths reported to VAERS may not reflect the true number of serious health problems that occur develop after rubella vaccination, due to VAERS passivity.

The Centers for Disease Control (CDC) report minor side effects from the MMR-V and MMR vaccines to include low-grade fever, injection site redness or rash, pain at the injection site, and facial swelling.

Moderate side effects include a full body rash, temporary low platelet count, temporary stiffness and pain the joints, and seizures.    A vaccine strain infection following vaccination may be the cause of the full body rash.       

There is a greater risk of seizures following MMR-V vaccination in comparison to separate doses of MMR and varicella vaccines, especially when given as the first dose of the series.  Rare serious side effects of both MMR-V and MMR include brain damage, coma, chronic seizure disorder, lowered level of consciousness and loss of hearing.   

Serious Complications – ProQuad Vaccines

Serious complications reported by Merck in the ProQuad(MMR-V) package insert during vaccine post-marketing surveillance include: 

• measles;
• atypical measles;
• vaccine strain varicella;
• varicella-like rash;
• herpes zoster;
• herpes simplex;
• pneumonia and respiratory infection;
• pneumonitis;
• bronchitis;
• epididymitis;
• cellulitis;
• skin infection;
• subacute sclerosing panencephalitis;
• aseptic meningitis;
• thrombocytopenia;
• aplastic anemia (anemia due to the bone marrow’s inability to produce platelets, red and white blood cells);
• lymphadenitis (inflammation of the lymph nodes);
• anaphylaxis including related symptoms of peripheral, angioneurotic and facial edema;
• agitation;
• ocular palsies;
• necrotizing retinitis (inflammation of the eye);
• nerve deafness;
• optic and retrobulbar neuritis (inflammation of the optic nerve);
• Bell’s palsy (sudden but temporary weakness of one half of the face);
• cerebrovascular accident (stroke);
• acute disseminated encephalomyelitis;
• measles inclusion body encephalitis;
• transverse myelitis;
• encephalopathy;
• Guillain-Barré syndrome;
• syncope (fainting);
• tremor;
• dizziness;
• paresthesia;
• febrile seizure;
• afebrile seizures or convulsions;
• polyneuropathy (dysfunction of numerous peripheral nerves of the body);
• Stevens-Johnson syndrome;
• Henoch-Schönlein purpura;
• acute hemorrhagic edema of infancy;
• erythema multiforme;
• panniculitis;
• arthritis;

A 2014 published study on the MMR-V vaccine in Canada found the risk of febrile seizures to be double in children receiving the MMR-V vaccine when compared to those receiving the MMR and varicella vaccines separately.  A 2015 meta-analysis found a two-fold increase in febrile seizures between 5 and 12 days or 7 and 10 days following MMR-V vaccination in children between the ages of 10 and 24 months. 

MMR-V vaccine contains albumin, a human blood derivative, and as a result, a theoretical risk of contamination with Creutzfeldt-Jakob disease (CJD) exists. Merck states that no cases of transmission of CJD or other viral diseases have been identified and virus pools, cells, bovine serum, and human albumin used in vaccine manufacturing are all tested to assure that the final product is free of potentially harmful agents.

Serious Complications – MMRII Vaccine

Serious complications reported by Merck in the MMRIIpackage insert during vaccine post-marketing surveillance include: 

• brain inflammation (encephalitis) and encephalopathy (chronic brain dysfunction);
• panniculitis (inflammation of the fat layer under the skin);
• atypical measles;
• syncope (sudden loss of consciousness, fainting);
• vasculitis (inflammation of the blood vessels);
• pancreatitis (inflammation of the pancreas);
• diabetes mellitus;
• thrombocytopenia purpura (blood disorder);
• Henoch-Schönlein purpura (inflammation and bleeding in the small blood vessels);
• acute hemorrhagic edema of infancy (rare vasculitis of the skin’s small vessels occurring in infants);
• leukocytosis (high white blood cell count);
• anaphylaxis (shock);
• bronchial spasms;
• pneumonia;
• pneumonitis(inflammation of the lung tissues);
• arthritis and arthralgia (joint pain);
• myalgia (muscle pain);
• polyneuritis (inflammation of several nerves simultaneously);
• measles inclusion body encephalitis (disease affecting the brain of immunocompromised persons);
• subacute sclerosing panencephalitis (fatal progressive brain disorder caused by exposure to the measles virus);
• Guillain-Barre Syndrome (GBS)(disease where the body’s immune system attacks the nerves);
• acute disseminated encephalomyelitis (ADEM) (brief widespread inflammation of the nerve’s protective covering);
• transverse myelitis (inflammation of the spinal cord);
• aseptic meningitis;
• erythema multiforme (skin disorder from an allergic reaction or infection);
• urticarial rash (hives, itching from an allergic reaction);
• measles-like rash;
• Stevens-Johnson syndrome (severe reaction causing the skin and mucous membranes to blister, die, and shed);
• nerve deafness (hearing loss from damage to the inner ear);
• otitis media (ear infection);
• retinitis (inflammation of the retina of the eye);
• optic neuritis (inflammation of the optic nerve);
• conjunctivitis (pink eye);
• ocular palsies (dysfunction of the ocular nerve);
• epididymitis (inflammation of the epididymis);
• paresthesia (burning or prickling of the skin);
• death.

Serious Complications – PRIORIX Vaccine

Serious complications reported by GlaxoSmithKline in the PRIORIX package insert during vaccine post-marketing surveillance have included: 

• Vasculitis (including Henoch-Schönlein purpura and Kawasaki syndrome);
• Thrombocytopenia and thrombocytopenic purpura;
• Anaphylactic reactions;
• Meningitis;
• “Mumps like” illness;
• “Measles like” illness;
• Orchitis;
• Epididymitis;
• Parotitis;
• Erythema multiforme;
• Arthralgia;
• Arthritis;
• Encephalitis;
• Cerebellitis;
• Cerebellitis-like symptoms (including transient gait disturbance and transient ataxia);
• Guillain-Barré syndrome;
• Transverse myelitis;
• Peripheral neuritis;
• Afebrile seizures;

History of Reported Side Effects

In August 1970, 15 months after approval of the first vaccine targeting rubella, the CDC reported that it had received numerous reports of arthralgia and arthritis in children after rubella vaccine administration. While noting that pre-licensing clinical trials reported that joint problems in children occurred at a rate of less than five percent, health officials stated that with extensive usage following licensure, many areas were alarmed by a greater frequency and severity of reactions than were expected. 

This report also noted that most side effects usually resolved within one to ten days; however, in some cases joint pain persisted and children were hospitalized for evaluation of rheumatoid arthritis or rheumatic fever. 

Children vaccinated with the rubella vaccine derived from dog kidneys (HPV-77:DK-12) had a significantly higher rate of reported joint reactions when compared to children vaccinated with a vaccine derived from duck embryos (HPV-77:DE-5). Other serious events reported after rubella vaccination included transverse myelitis, high fever, ataxia, polyneuritis, aseptic meningitis, temporary paralysis, seizure, and death.  HPV-77:DK-12 was voluntarily removed from the market in 1973. 

Joint reactions following rubella vaccination continued to be reported and in 1980, the CDC reported that Susceptible post pubertal women recipients are at the highest risk of joint symptoms; studies have shown that 23%-58% of this group will experience joint symptoms compared with only 2.5%-10% of children. 

Two syndromes were also reported following rubella vaccination. According to CDC officials: 

“1 syndrome, referred to as the "arm syndrome," affected persons are typically awakened from a sound sleep by paresthesia in the arm and hand. The latent interval ranges from 10-62 days with a mean of 39 days. The symptoms last from 30 seconds to 1 hour and may occur from 1-6 times per night.

In the "catcher’s crouch" syndrome, the symptoms which begin from 29-70 days (mean of 45 days) after vaccination are pain behind the knee and inability to fully extend the knee. Symptoms are worst upon getting up in the morning, and they diminish during the day. The mean interval between vaccination and onset is about 40 days; intervals of 7-99 days have been reported. Usually symptoms last from 1-5 weeks.”

Reoccurrences of both syndromes were reported to occur over long periods of time and more frequently reported in persons who had received the HPV-77:DK-12 rubella vaccine. 

Evaluation of Adverse Events by the Institute of Medicine

In the detailed report evaluating medical evidence, Adverse Effects of Pertussis and Rubella Vaccines, published in 1991 by the Institute of Medicine (IOM), committee members concluded that evidence existed of a causal relationship between rubella vaccines and acute and chronic arthritis in adult women. 

In the comprehensive report evaluating scientific evidence, Adverse Effects of Vaccines: Evidence and Causality,  published in 2012 by the Institute of Medicine (IOM), 30 reported vaccine adverse events following the Measles, Mumps, and Rubella (MMR) vaccine were evaluated by a physician committee.  These adverse events included measles inclusion body encephalitis, febrile seizures, arthritis, meningitis, Guillain-Barre Syndrome (GBS), autism, diabetes mellitus, optic neuritis, transverse myelitis, and more.

In 23 of the 30 measles, mumps, and rubella (MMR) vaccine-related adverse events evaluated, the IOM committee concluded that there was inadequate evidence to support or reject a causal relationship between the MMR vaccine and the reported adverse event, primarily because there was either an absence of methodologically sound published studies or too few quality studies to make a determination.  The IOM committee, however, concluded that the scientific evidence “convincingly supports” a causal relationship between febrile seizures, anaphylaxis, and measles inclusion body encephalitis in immunocompromised individuals and the MMR vaccine and favored acceptance of a causal relationship between transient arthralgia (joint pain) in both children and women and the MMR vaccine. 

The IOM committee also concluded that it favored rejection of a causal association between both autism and the MMR vaccine and Type 1 diabetes and the MMR vaccine, however, both of these conclusions were made following the review of only five epidemiological studies.  Many of study authors had financial conflicts of interests due to pharmaceutical funding and the studies were designed to examine entire populations, not susceptible populations. Further, the studies compared outcomes from several countries, including the US, UK, Denmark, and Sweden, with different vaccines, and vaccine schedules. 

Systematic Reviews of the Medical Literature

In 2012, the Cochrane Collaboration examined 57 studies and clinical trials involving approximately 14.7 million children who had received the MMR vaccine. While the study authors stated that they were not able to detect a significant association between MMR vaccine and autism, asthma, leukemia, hay fever, type I diabetes, gait disturbance, Crohn’s disease, demyelinating diseases or bacterial or viral infections, they reported that The design and reporting of safety outcomes in MMR vaccine studies, both pre- and post-marketing, are largely inadequate.   

In an updated review published in April of 2020, the Cochrane Collaboration reviewed 87 safety studies associated with MMR, MMR-V, and MMR + Varicella vaccine. This review concluded that there was an association between MMR vaccines containing Leningrad-Zagreb and Urabe mumps strains and aseptic meningitis, but no evidence to support this association for MMR vaccines which contain the Jeryl Lynn mumps strains. This conclusion was based on the evaluation of nine studies, all of which were considered low certainty studies. The Cochrane Collaboration reports low certainty studies to be those where their confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. 

An association was also found between MMR vaccines and idiopathic thrombocytopenic purpura (ITP) and MMR, MMR-V, and MMR + Varicella vaccines and febrile seizures and the studies evaluated to make this determination were a combination of both moderate certainty and low certainty studies. Moderate certainty studies are those in which the Cochrane Collaboration are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. 

The Cochrane Collaboration reported that no association was found between MMR vaccine and encephalitis, encephalopathy, cognitive delay, type 1 diabetes, asthma, dermatitis/eczema, hay fever, leukemia, multiple sclerosis, gait disturbance, and bacterial or viral infections; however, all the studies that were evaluated were found to be either low certainty or very low certainty studies. Very low certainty studies are those in which the Collaborative have very little confidence in the effect estimate and that the true effect is likely to be substantially different from the estimate of effect. 

No association was found between autism spectrum disorders and MMR vaccines, and the studies evaluated were a combination of moderate certainty and low certainty studies. The Cochrane Collaboration also reported that there was insufficient evidence to support or reject an association between MMR vaccines and inflammatory bowel disease. 

Research Overview

During the past five decades, there have been many published reports and studies linking rubella-containing vaccines to numerous chronic immune and neurological diseases in children and adults. These include optic neuritis,    retinopathy,  myelitis,        acute disseminated encephalomyelitis,  hearing loss,  thrombocytopenic purpura,            encephalitis,  and chronic arthritis.       

The rubella vaccine is a live virus vaccine and according to the MMR vaccine package insert: 

“Excretion of small amounts of the live attenuated rubella virus from the nose or throat has occurred in the majority of susceptible individuals 7 to 28 days after vaccination. There is no confirmed evidence to indicate that such virus is transmitted to susceptible persons who are in contact with the vaccinated individuals. Consequently, transmission through close personal contact, while accepted as a theoretical possibility, is not regarded as a significant risk. However, transmission of the rubella vaccine virus to infants via breast milk has been documented.”

Persons with primary immunodeficiency deficiencies (PID) who are vaccinated with the live rubella vaccine found in the MMR vaccine are at risk for immunodeficiency related vaccine-derived rubella virus (iVDRV) cutaneous granulomas. Additionally, researchers estimate that thousands of individuals with PID are shedding iVDRV and may put non-immune persons at risk for developing rubella. This shedding may also impact the success of programs aimed at eliminating rubella and congenital rubella syndrome. 

IMPORTANT NOTE: NVIC encourages you to become fully informed about Rubella and the Rubella vaccine by reading all sections in the Table of Contents, which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

Who is at highest risk for complications from Rubella vaccine?

In the U.S., the rubella vaccine is only available in combination with measles and mumps vaccine (MMRII) or measles, mumps, and varicella vaccine (MMR-V). 

According to the MMRII package insert,  persons most at risk for complications from MMRII vaccine include individuals with both primary and acquired immunodeficiency such as AIDS, dysgammaglobulinemic and hypogammaglobulinemic states, and cellular immune deficiencies. Pneumonitis, measles inclusion body encephalitis, and death have also occurred because of being inadvertently vaccinated with a measles containing vaccine.

Persons with thrombocytopenia or history of the condition may also be at greater risk for exacerbation or redevelopment of thrombocytopenia with subsequent doses of MMRII vaccine.

Individuals with a personal history of cerebral injury, personal or family history of seizures, or any other health condition where stress related to fever should be avoided, may also be at greater risk for complications.

As both the live measles and live mumps vaccines are manufactured using chick embryo cell culture, individuals with a history of an immediate reaction, as well as those with anaphylactic and anaphylactoid reactions to eggs may be at greater risk of a reaction from the MMRII vaccine. MMRII contains neomycin and persons who have previously experienced an anaphylactic reaction to either systematic or topical neomycin should not be vaccinated with MMRII due to the risk of reaction and subsequent complications resulting from the reaction.

Merck’s MMR-V (ProQuad) vaccine package insert  states that children between the ages of 12 and 23 months with no history of vaccination or wild-type infection with measles, mumps, rubella, and varicella have a higher risk of fever and febrile seizure between 5- and 12-days following vaccination with MMR-V when compared to children who were vaccinated with separate doses of MMRII and varicella vaccine. Children with a personal or family history of convulsion or a personal history of cerebral illness or medical condition where stress from fever should be avoided may also be at a greater risk of complications from MMR-V.

Individuals most at risk for complications from MMR-V vaccine include persons with both primary and acquired immunodeficiency such as AIDS, dysgammaglobulinemic and hypogammaglobulinemic states, and cellular immune deficiencies. Pneumonitis, measles inclusion body encephalitis, and death have also occurred from being inadvertently vaccinated with a measles containing vaccine. Additionally, reports of disseminated varicella vaccine virus infection occurring in children with underlying immunodeficiency disorders inadvertently with a varicella-containing vaccine have also been documented.

According to the package insert for GlaxoSmithKline’s PRIORIX, individuals most at risk for complications from vaccination include persons with a past history of allergic or anaphylaxis to any ingredient of the vaccine, or to a previous dose of the vaccine. Additionally, pregnant women and individuals who are immunosuppressed who are vaccinated with PRIORIX are at a high risk of suffering complications. 

IMPORTANT NOTE: NVIC encourages you to become fully informed about Rubella and the Rubella vaccine by reading all sections in the Table of Contents, which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

 

Who should not get Rubella vaccine?

Contraindications to receiving the MMRII vaccine documented in Merck’s package insert include: 

• Persons who have experienced a severe allergic reaction or anaphylaxis to any MMR vaccine component, including gelatin and neomycin, should not be vaccinated with MMR;
• Pregnant women should not receive this vaccine, and women seeking to become pregnant should avoid becoming pregnant for three months following MMR vaccination;
• Individuals receiving immunosuppressive therapy. Vaccination with MMR should be delayed for three months following the administration of human immune globulin, blood, or plasma;
• Persons with leukemia, lymphoma, blood dyscrasias and other malignant neoplasms affecting the lymphatic systems or bone marrow;
• Individuals with febrile respiratory illness or other active febrile infection should avoid MMR vaccine;
• MMR and other measles-containing vaccines are not recommended for HIV-infected persons with evidence of severe immunosuppression;
• Persons with a family history of hereditary or congenital immunodeficiency should not be vaccinated with MMR until the immune competence of the recipient has been determined;
• Individuals with untreated tuberculosis should not be vaccinated with MMR vaccine.

Merck’s MMRII package insert also warns that caution should be taken when administering the vaccine to individuals with a history of cerebral injury, family or personal history of convulsions, or any other condition where stress related to fever should be avoided. A person with thrombocytopenia may exacerbate their condition by receiving the MMR vaccine.

Both live measles and mumps vaccine are manufactured in chick embryo cell culture. Extreme caution should be taken when vaccinating individuals with a history of anaphylaxis or immediate hypersensitivity to eggs. Merck advises careful evaluation of the risks and benefits when considering vaccination in this population.

Rubella vaccine virus has been found in the breast milk of nursing mothers and there is documentation that the virus can be transferred to infants. Serological evidence of rubella infection and a case of mild clinical illness typical with an acquired rubella infection has also been documented in a nursing infant. Because of these findings, Merck cautions the use of MMR vaccine in nursing women.

IMPORTANT NOTE: Even though the CDC’s Advisory Committee on Immunization Practices (ACIP) states that Merck’s MMRII vaccine can be administer at the same time as other viral and bacterial vaccines, Merck’s MMRII package information insert states that other live virus vaccines—such as varicella  should NOT be given at the same time as MMR vaccine but rather should be administered one month prior or one month after MMR vaccination. 

Additionally, Merck’s package insert does not recommend giving MMRII at the same time as DTP (diphtheria, tetanus, and pertussis) and/or OPV (oral poliovirus vaccine) even though the Advisory Committee on Immunization Practices (ACIP) has stated that simultaneous administration of the entire recommended vaccine series is acceptable. 

MMRII vaccine is approved for use in persons 12 months of age and older. Despite recommendations by the CDC’s Advisory Committee on Immunization (ACIP) that children between 6 and 12 months traveling or residing abroad be vaccinated with MMR prior to international travel,  Merck’s MMRII package insert states that effectiveness and safety has not been established in this population.  Studies have determined that early vaccination of an infant often results in vaccine failure due to both the infant’s immature immune system response as well as the presence of maternal antibodies that interfere with vaccination. Early vaccination can result in reduced antibodies that persist, despite revaccination. 

Contraindications to receiving MMR-V (ProQuad) vaccine documented in Merck’s package insert include: 

• Persons who have experienced a severe allergic reaction or anaphylaxis to any MMR-V vaccine component, including gelatin and neomycin, should not be vaccinated with MMR-V;

• Febrile illness or active untreated tuberculosis;
• Persons with acquired or primary immunodeficiency status and individuals receiving immunosuppressive therapy. Vaccination with MMR-V should be delayed for three months following the administration of human immune globulin, blood, or plasma;
• Individuals with a family history of hereditary or congenital immunodeficiency;
• Pregnant women;

• Persons with leukemia, lymphoma, blood dyscrasias and other malignant neoplasms affecting the lymphatic systems or bone marrow.

Merck’s MMR-V (ProQuad) package insert warns of a higher incidence of fever and febrile seizures in children between the ages of 12- and 23-months following administration of MMR-V when compared with children who received separate doses of MMR and varicella vaccines. Caution is advised when administering MMR-V in children with a history of seizures, cerebral injury, or any other medical condition where stress from fever should be avoided.

Both live measles and mumps vaccine are manufactured in chick embryo cell culture. Extreme caution should be taken when vaccinating individuals with a history of anaphylaxis or immediate hypersensitivity to eggs. Merck advises careful evaluation of the risks and benefits when considering vaccination in this population.

Merck’s MMR-V vaccine package insert reports that transmission of varicella vaccine virus may occur between vaccine recipients and susceptible contacts, including high risk individuals, resulting in both the development or non-development of varicella-like rash. As a result, Merck cautions that vaccine recipients should attempt to avoid close contact with high risk individuals. This population includes pregnant women who lack a positive history of illness or vaccination, and their newborn infants, any infants born prior to 28 weeks gestation, and any immunocompromised individuals.

Merck also advises careful evaluation of the risks and benefits of vaccination with MMR-V in children with thrombocytopenia or history of the blood disorder as no clinical data on the development or exacerbation of this condition exists. Thrombocytopenia has been reported following vaccination with MMRII, measles vaccine, varicella vaccine and again following an additional dose of both measles and MMRII vaccines.

The safety and efficiency of MMR-V has not been determined in children who are infected with human immunodeficiency virus (HIV).

Children between 12 months and 12 years of age who receive MMR-V vaccine should avoid the use of salicylate (aspirin) or salicylate-containing products for six weeks following vaccination due to the risk of Reyes Syndrome.

MMR-V is approved for use in children 12 months to 12 years of age. Children under 12 months or those older than 12 years should not receive MMR-V vaccine.

Contraindications to receiving the PRIORIX vaccine documented in GlaxoSmithKline’s package insert include: 

• Persons who have experienced a severe allergic reaction or anaphylaxis to any PRIORIX vaccine component, or to a previous dose of any measles, mumps, and rubella vaccine, should not be vaccinated with PRIORIX.
• Pregnancy
• Immunosuppression

The PRIORIX package insert warns that febrile seizures can occur following administration. Thrombocytopenia and thrombocytopenic purpura have also been reported following vaccination. The tip caps of prefilled syringes contain natural latex and may cause allergic reactions. As with all injectable vaccines, PRIORIX may cause syncope (fainting), which could lead to serious harm. Precautions should be taken to ensure the safety of individuals receiving vaccines. 

PRIORIX is approved for use in individuals 12 months of age and older. Children under the age of 12 months should not receive PRIORIX. 

IMPORTANT NOTE: NVIC encourages you to become fully informed about Rubella and the Rubella vaccine by reading all sections in the Table of Contents, which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

 

What questions should I ask my doctor about Rubella Vaccine?

NVIC’s If You Vaccinate, Ask 8! Webpage downloadable brochure suggests asking eight questions before you make a vaccination decision for yourself, or for your child. If you review these questions before your appointment, you will be better prepared to ask your doctor questions.  Also make sure that the nurse or doctor gives you the relevant Vaccine Information Statement (VIS) for the vaccine or vaccines you are considering well ahead of time to allow you to review it before you or your child gets vaccinated. Copies of VIS for each vaccine are also available on the CDC's website and there is a link to the VIS for MMR and MMR-V vaccines on NVIC's “Quick Facts” at the top of this page.

It is also a good idea to read the vaccine manufacturer product insert that can be obtained from your doctor or public health clinic because federal law requires drug companies marketing vaccines to include certain kinds of vaccine benefit, risk and use information in product information inserts that may not be available in other published information. Vaccine product inserts are located on the Food and Drug Administration’s website and linked in NVIC’s Disease and Vaccine Quick Facts.

Other questions that may be useful to discuss with your doctor before getting the rubella (MMR or MMR-V) vaccine are: 

• If other vaccines in addition to MMR/MMR-V vaccine are scheduled for my child at this office visit, am I allowed to modify the schedule so fewer vaccines are given at once?
• What should I do if my child has a high fever or appears very ill after vaccination?
• What other kinds of reaction symptoms should I call to report after MMR/MMR-V vaccination?
• If the MMR/MMR-V vaccine doesn’t protect my child, do I have any other options for preventing rubella infection?

Under the National Childhood Vaccine Injury Act of 1986, doctors and all vaccine providers are legally required to give you vaccine benefit and risk information before vaccination; record serious health problems following vaccination in the permanent medical record; keep a permanent record of all vaccines given, including the manufacturer’s name and lot number; and report serious health problems, injuries and deaths that follow vaccination to VAERS.

Remember, if you choose to vaccinate, always keep a written record of exactly which shots/vaccines you or your child have received, including the manufacturer’s name and vaccine lot number. Write down and describe in detail any serious health problems that develop after vaccination and keep vaccination records in a file you can access easily.  

It also is important to be able to recognize a vaccine reaction and seek immediate medical attention if the reaction appears serious, as well as know how to make a vaccine reaction report to federal health officials at the Vaccine Adverse Reporting System (VAERS). NVIC’s Report  Vaccine Reactions—It’s the Law webpage can help you file a vaccine reaction report yourself to VAERS if your doctor fails or refuses to make a report.

IMPORTANT NOTE: NVIC encourages you to become fully informed about Rubella and the Rubella vaccine by reading all sections in the Table of Contents, which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

 

 

NVIC Press Releases, Statements & Commentaries Related to Rubella

NVIC’s Website

• What Is Going On With Measles? The Science and Politics of Eradicating Measles. May 25, 2019.
• CDC Wants to Expand Power to Eliminate Measles: What You Need to Know and Do Now. Sept. 12, 2016.

• Measles in Disneyland: Third MMR Shot, Vaccine Exemption Ban? Jan. 28, 2015.
• The Emerging Risks of Live Virus and Virus Vectored Vaccines: Vaccine Strain Infection, Shedding and Transmission``. Nov. 2014.
• NVIC Remove Vaccine Safety Oversight from DHHS. Sept. 1, 2014.
• NVIC Press Release: National Vaccine Information Center Supports Three of Five Recommendations of New IOM Report on U.S. Child Immunization Safety and Calls for Transparency. Jan. 16, 2013. (Also see 2013 IOM published report, The Childhood Immunization Schedule and Safety: Review of Scientific Findings. 75-98).
• Statement of the National Vaccine Information Center on the Institute of Medicine Report “Adverse Effects of Childhood Vaccines: Evidence and Causality.” 25, 2011. (Also see published IOM report, Adverse Effects of Childhood Vaccines: Evidence and Causality: Measles, Mumps and Rubella Vaccine.Pgs. 103-238).NVIC. NVIC Questions Interpretation of IOM Report on Autism and MMR Vaccine. Apr. 24, 2001.
• Parent Groups and Vaccine Policymakers Clash Over Research into Vaccines, Autism & Intestinal Disorders. Mar. 3, 1998.
• Fisher BL. Autism & Vaccines: A New Look at an Old Story.

The Vaccine Reaction

• TVR Staff. Ugandan Boy Dies of Stevens-Johnson Syndrome After Getting Measles-Rubella, Polio Vaccines.  Dec. 15, 2019.
• TVR Staff. India High Court Halts Mandatory Measles-Rubella Vaccinations for Children. Jan. 25, 2019.
• TVR Staff. Baby Girls Die in India Two Days After Getting Measles-Rubella Vaccine. Jan. 9, 2019.
• TVR Staff. Two Children Die in Gujarat, India Days After Measles-Rubella Vaccination. Sept. 4, 2018.

Bibliography & Resource Links 

Institute of Medicine Committee. Adverse Effects of Pertussis and Rubella Vaccines The National Academies Press 1991.

Institute of Medicine Committee. Evaluating Biological Mechanisms for Adverse Events: Increased Susceptibility. In: Adverse Effects of Vaccines: Evidence and Causality. The National Academies Press 2012.

LeBaron CW, Forghani B, Matter L et al. Persistence of rubella antibodies after 2 doses of measles-mumps-rubella vaccine. J Infect Dis Sep. 2009; 200(6):888-99.

Demicheli V, Rivetti A, Debalini MG, et al. Vaccines for measles, mumps and rubella in children. Cochrane Database Syst Rev Feb. 2012; (2):CD004407.

McLean HQ, Fiebelkorn AP, Ogee-Nwankwo A et al. Rubella virus neutralizing antibody response after a third dose of measles-mumps-rubella vaccine in young adults. Vaccine Sept. 2018; 36(38):5732-5737.

Haralambieva IH, Ovsyannikova IG, Kennedy RB et al. Rubella virus-specific humoral immune responses and their interrelationships before and after a third dose of measles-mumps-rubella vaccine in women of childbearing age. Vaccine Jan 2020; 38(5):1249-1257.

IMPORTANT NOTE: NVIC encourages you to become fully informed about Rubella and the Rubella vaccine by reading all sections in the Table of Contents, which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

 

Selected Medical Literature & Resource Links

• Institute of Medicine Committee. Adverse Effects of Pertussis and Rubella Vaccines  The National Academies Press 1991.
• Institute of Medicine Committee. Evaluating Biological Mechanisms for Adverse Events: Increased Susceptibility. In: Adverse Effects of Vaccines: Evidence and Causality. The National Academies Press 2012.
• LeBaron CW, Forghani B, Matter L et al. Persistence of rubella antibodies after 2 doses of measles-mumps-rubella vaccine. J Infect Dis September 2009; 200(6):888-99.
• Demicheli V, Rivetti A, Debalini MG, et al. Vaccines for measles, mumps and rubella in children. Cochrane Database Syst Rev February 2012; (2):CD004407.
• McLean HQ, Fiebelkorn AP, Ogee-Nwankwo A et al. Rubella virus neutralizing antibody response after a third dose of measles-mumps-rubella vaccine in young adults. Vaccine September 2018; 36(38):5732-5737.
• Haralambieva IH, Ovsyannikova IG, Kennedy RB et al. Rubella virus-specific humoral immune responses and their interrelationships before and after a third dose of measles-mumps-rubella vaccine in women of childbearing age. Vaccine January 2020; 38(5):1249-1257.

IMPORTANT NOTE: NVIC encourages you to become fully informed about Rubella and the Rubella vaccine by reading all sections in the Table of Contents, which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

 

Rubella & Rubella vaccine quick facts

 

Quick Facts 

Rubella

• Rubella, also known as German measles or three-day measles, is a mild viral infection that primarily occurs in childhood but can also affect adults. Symptoms may begin with a mild fever, runny nose, sore throat, swollen lymph nodes and progress to a pink rash that starts on the face and spreads to the neck, arms, chest and sometimes the legs, disappearing as it moves downward on the body. The rash is not as red or blotchy as measles and generally fades by the third to fifth day. About 25 to 50 percent of rubella infections are asymptomatic;   
• Young adults, especially young women, who are infected with rubella may have swollen glands in the back of the neck and joint pain, swelling and stiffness (arthritis) that lasts for several weeks. Rarely, more serious complications of rubella, including brain inflammation and chronic arthritis, may occur; 
• Rubella is a respiratory infection that is spread from person-to-person through coughing and sneezing.  The virus can be found in an infected person’s throat, nose, urine, cerebral spinal fluid and blood;  
• Incubation period from exposure to symptoms is 12 to 23 days.  Recovery from rubella usually confers lifelong immunity, although there are rare reports of repeat cases; 
• While mildly contagious and usually not a serious infection for the majority of individuals, women infected with rubella during the first three months of pregnancy are at higher risk for miscarriage and of giving birth to a baby with congenital rubella syndrome (CRS) and birth defects. Infants born with CRS can suffer from deafness, blindness, heart defects, developmental delay, small head size and other serious health problems.  

Rubella Vaccine

• There are three rubella vaccines currently in use in the United States. Two vaccines, MMRII,  manufactured by Merck, and PRIORIX,  manufactured by GlaxoSmithKline, are combination measles-mumps-rubella (MMR) live virus vaccines. The third, ProQuad, manufactured by Merck, is a combination measles-mumps-rubella-varicella (MMR-V) live virus vaccine.  The CDC recommends children receive the first dose of MMR vaccine between 12 and 15 months of age, and the second dose between four and six years of age.  
• Mild side effects such as redness, rash or pain at the injection site, along with fever and swelling of the glands in the neck or cheeks have been reported following MMR and MMR-V vaccination.   
• Serious vaccine side effects include shock, encephalitis, convulsions (seizures), encephalopathy, thrombocytopenia purpura (blood clot disorder), arthritis, optic neuritis, lupus, Guillain-Barre syndrome (GBS), aseptic meningitis, deafness, gastrointestinal disorder, cardiomyopathy, transverse myelitis, and subacute sclerosing panencephalitis;     
• As of April 1, 2024, there have been 1,397 claims filed in the federal Vaccine Injury Compensation Program (VICP) for injuries and deaths following rubella (MMR, MMR-V, Mumps-Rubella, Rubella) vaccination, including 70 deaths and 1,327 serious injuries.

• Using the MedAlerts search engine, as of March 29, 2024, there have been 112,776 reports of rubella vaccine (MMR, MMR-V, Mumps-Rubella, Rubella) reactions, hospitalizations, injuries and deaths following rubella vaccinations made to the federal Vaccine Adverse Events Reporting System (VAERS), including 520 related deaths, 8,549 hospitalizations, and 2,190 related disabilities. Nearly 64 percent of rubella vaccine-related adverse events occurred in children under the age of six years.

NVIC “Quick Facts” is not a substitute for becoming fully informed about Rubella and the Rubella vaccine. NVIC recommends consumers read the more complete information contained the vaccine manufacturer product information inserts, the links provided in our Quick Facts, and speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child.

Food & Drug Administration (FDA) 

• Measles, Mumps and Rubella Virus Vaccine, Live (MMRII). Product Insert & Licensing Information
• Measles, Mumps and Rubella Vaccine, Live (PRIORIX). Product Insert & Licensing Information
• Measles, Mumps, Rubella and Varicella Virus Vaccine Live (ProQuad). Product Insert & Licensing Information

Centers for Disease Control (CDC)

• CDC on Rubella Disease
• CDC on Rubella Vaccination
• Rubella Vaccine Information Statement (VIS) MMR
• Rubella Vaccine Information Statement (VIS) MMRV

Vaccine Reaction Symptoms & Ingredients

Our Ask 8, If You Vaccinate webpage contains vaccine reaction symptoms and more. 

Search for Vaccine Reactions

NVIC hosts MedAlerts, a powerful VAERS database search engine. MedAlerts examines symptoms, reactions, vaccines, dates, places, and more.

Reporting a Vaccine Reaction

Since 1982 NVIC has operated a Vaccine Reaction Registry, which has served as a watchdog on VAERS. Reporting vaccine reactions to VAERS is the law. If your doctor will not report a reaction, you have the right to report a suspected vaccine reaction to VAERS.

IMPORTANT NOTE: NVIC encourages you to become fully informed about Rubella and the Rubella vaccine by reading all sections in the Table of Contents, which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

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