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What is the History of Rubella Vaccine in America?


Rubella

Rubella 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

Rubella 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

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, 94.7 percent of all children entering kindergarten in the 2018/2019 school year had received 2 doses of MMR vaccine.19

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.

« Return to Vaccines & Diseases Table of Contents

References

1 Lee JY, Bowden DS. Rubella virus replication and links to teratogenicity. Clin Microbiol Rev October 2000; 13(4):571-87.

2 Galambos L, Sewell JE. Networks of Innovation: Vaccine Development at Merck, Sharp & Dohme, and Mulford, 1895-1995. Cambridge University Press 1997.

3 Galambos L, Sewell JE. Networks of Innovation: Vaccine Development at Merck, Sharp & Dohme, and Mulford, 1895-1995. Cambridge University Press 1997.

4 U.S. Department of Health, Education, and Welfare. Recommendation of the Advisory Committee on Immunization Practices. MMWR Apr. 12 1969; 18(15):124.

5  Communication and Education Branch, National Center for Immunization and Respiratory Diseases (NCIRD) and the Centers for Disease Control (CDC). Rubella. In: Epidemiology and Prevention of Vaccine-Preventable Diseases. 13th ed. Centers for Disease Control (CDC) 2015; Pg. 328. Updated December 2020. Accessed April 3, 2021.

6 U.S. Centers for Disease Control. Rubella Surveillance. August 1970; no. 2: 1-26.

7 U.S. Centers for Disease Control. Rubella Surveillance. August 1970; no. 2: 1-26.

8 U.S. Centers for Disease Control. Rubella Surveillance. August 1970; no. 2: 1-26.

9 U.S. Centers for Disease Control and Prevention. Rubella Surveillance June 1976 to December 1978. May 1980.

10 Blume S, Tump J. Evidence and policymaking: The introduction of MMR vaccine in the Netherlands. Soc Sci Med. September 2010; 71(6):1049-55.

11 Macdonald H, Tobin JO, Cradock-Watson JE, et al. Antibody titres in women six to eight years after the administration of RA2713 and Cendehill rubella vaccines. J Hyg (Lond) June 1978; 80(3):337-47.

12 Menser MA, Forrest JM, Bransby RD, et al. Rubella vaccination in Australia: 2. Experience with the RA27/3 rubella vaccine and results of a double-blind trial in schoolgirls. Med J Aust. July 1978; 2(3):85-8.

13 Blume S, Tump J. Evidence and policymaking: The introduction of MMR vaccine in the Netherlands. Soc Sci Med September 2010; 71(6):1049-55.

14 Communication and Education Branch, National Center for Immunization and Respiratory Diseases (NCIRD) and the Centers for Disease Control (CDC). Rubella. In: Epidemiology and Prevention of Vaccine-Preventable Diseases. 13th ed. Centers for Disease Control (CDC) 2015; Pg. 328. Updated December 2020. Accessed April 3, 2021.

15 U.S. Centers for Disease Control and Prevention. Morbidity and mortality weekly report, Vol. 27, no. 46, November 17, 1978. MMWR November 1978; 27(46); 451-460.

16 U.S. Centers for Disease Control and Prevention. Measles Prevention: Recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR December 1989; 38(S-9):1-18.

17 U.S. Centers for Disease Control and Prevention. Rubella Prevention -- Recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR November 1990; 39(RR15):1-18.

18 U.S. Centers for Disease Control and Prevention. Q&As about Monovalent M-M-R Vaccines. In: Healthcare Providers/Professionals. Oct. 26, 2009.

19 Seither R, Loretan C, Driver K et al. Vaccination Coverage with Selected Vaccines and Exemption Rates Among Children in Kindergarten — United States, 2018–19 School Year. MMWR October 2019; 68(41):905–912.


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