The MMR vaccine drug-related accident was a drug-related accident in which infants who were vaccinated with a combination of dry, weakly toxic measles (M), mumps (M), and rubella (R) vaccine developed acute encephalitis and suffered severe sequelae. Although this vaccine became a routine vaccination in April 1989, two months later it was pointed out by the Maebashi Medical Association that aseptic meningitis was occurring at a high frequency among vaccinees. However, the government failed to take action, and by the time of the “suspension of vaccinations for the time being” in 1993, approximately 1,800 people had been affected. Subsequently, it was revealed that the manufacturing method of mumps vaccine stock solution had been changed by a pharmaceutical company without being reported to the government.
| 1989 | Damage occurred (April 1989 (regular vaccination) – April 1993) Report by Maebashi Medical Association |
| 1993 | Three Families File Lawsuit Against State and Drug Company Vaccination suspended for the time being by the government |
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1. mumps vaccine
The MMR vaccine is a combination of measles (M), mumps (M), and rubella (R), and was once approved as an “in-house strain vaccine” made by mixing vaccines from different companies. However, in order to make vaccination legal in Japan, the former Ministry of Health and Welfare had the “unified strain vaccine” made by mixing vaccines from companies whose efficacy had been approved. Of these vaccines, the mumps vaccine produced by the Osaka University Microbial Disease Research Group caused aseptic meningitis. Although the production of the MMR vaccine with the united strain should have been discontinued by the time the in-house strain was introduced, the expired in-house strain was used in the united strain vaccine, and in an attempt to further improve the efficacy of the vaccine, the unauthorized changes were made to the unapproved method of culturing the stock solution.
The decision to legally administer the MMR vaccine was made in 1989, but at that time there were reports of damage caused by the MMR vaccine in Canada and in Japan. In addition, although the Immunization Committee of the former Ministry of Health and Welfare at the time had raised doubts about the vaccine production method, the vaccine was being produced without using a more accurate method.
Immediately after the introduction of the statutory MMR vaccine, many young children developed aseptic meningitis with fever, vomiting, and convulsions, which became a social problem.
In June 1989, immediately after the introduction of the statutory vaccination, the Maebashi Medical Association’s Immunization Committee began collecting data on adverse reactions and reported that meningitis had occurred in one out of every 217 persons. However, the former Ministry of Health and Welfare did not take any action in response to this report, nor did it publish the results of the report; in October 1989, the former Ministry issued a notice requesting that the MMR vaccine be administered “with caution,” but it was not until 1993 that the MMR vaccination was discontinued. It is said that an informal meeting of the Immunization Committee was held during this period to discuss the discontinuation of the legal vaccination, but it is believed that the committee knew of the adverse reactions and concealed the data, delaying the decision to discontinue the vaccine. There were approximately 1.83 million infants who received the MMR vaccine between 1989 and 1993, of which 1,754 cases of aseptic meningitis were reported.
2. trial by family
In 1993, three families of infants who developed aseptic meningitis as a result of the MMR vaccine brought a lawsuit against the government and the pharmaceutical company. Of the 33 infants, two were found to be causally related to the vaccination, but the claim against the remaining infant was dismissed. However, the company did not appeal, but instead apologized outside the courtroom and signed an agreement, which in effect was considered an admission of liability. Both parents and the government appealed, the remaining family members filed ancillary appeals, and the parents’ appeal to the second trial court in 2006 was dismissed, ending a 13-year struggle.
In the judgment, the government and the pharmaceutical companies were found liable for compensation because the companies changed their manufacturing methods without the government’s permission, which was identified as the cause of the high incidence of damage, and the government’s responsibility for guidance and supervision was recognized. However, the government was not found liable for the failure of the government to stop the MMR vaccine at an early stage. The plaintiffs demanded an apology from the government, but the government has refused to apologize, saying that the verdict is unacceptable.
3. subsequent issues
The massive outbreak of aseptic meningitis caused by the MMR vaccine and the decision to discontinue vaccination have greatly reduced the public’s confidence in immunization. The measles vaccine immunization coverage in Japan has declined significantly, and Japan is said to have an exceptionally high incidence of measles cases among developed countries.
However, the government has refused to apologize to the bereaved families and has not taken any measures to get to the bottom of the MMR vaccine adverse events or prevent their recurrence. This raises concerns that misperceptions about MMR vaccine drug-related harm are also being perpetrated in the pharmaceutical administration. In recent years, various vaccines have been introduced, such as HPV vaccine and vaccines against new coronavirus infection, etc. It is now required to utilize the lessons learned from the MMR vaccine drug injury.
References
- Foundation for Pharmaceuticals and Medical Devices Regulatory Science, 2012, “Lessons Learned from Drug Injury: Voices from Victims Hoping for the Prevention of Recurrence,” Pharmaceutical Affairs Daily, Inc.
- Japan Association for Public Publications, 2011, “Knowledge of Drug Hazards You Should Know–To Prevent Health Damage Caused by Drugs,” Jiho.