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Adverse events associated with MMR vaccines in Japan
M Kimura1, H Kuno-Sakai, S Yamazaki
1School of Medicine, Tokai University, Isehara, Japan.
Acta Paediatrica Japonica : Overseas Edition
|June 1, 1996
Summary
This study monitored 38,203 children receiving Measles-Mumps-Rubella (MMR) vaccines in Japan. The standard MMR vaccine showed higher rates of aseptic meningitis and convulsions compared to other MMR vaccines. Manufacturing consistency of the mumps component is questioned.
Area of Science:
- Pediatrics
- Vaccinology
- Public Health
Background:
- The Measles-Mumps-Rubella (MMR) vaccine is a critical public health tool for preventing widespread infectious diseases.
- Ensuring vaccine safety and manufacturing consistency is paramount for maintaining public trust and vaccine efficacy.
- Previous concerns regarding aseptic meningitis associated with specific mumps vaccine strains necessitated further investigation.
Purpose of the Study:
- To conduct the largest nationwide active surveillance of four Measles-Mumps-Rubella (MMR) vaccines in Japan.
- To compare the safety profiles, specifically focusing on aseptic meningitis and other adverse events, of different MMR vaccine formulations.
- To investigate potential manufacturing inconsistencies in the mumps component of the MMR vaccine.
Main Methods:
- A nationwide active surveillance study involving 1255 pediatricians from the Japanese Pediatric Society.
- 38,203 recipients were administered one of four MMR vaccines (three manufacturer-specific and one standard) and observed for 35 days.
- Adverse events, including virologically confirmed aseptic meningitis, convulsions, and parotid swelling, were systematically recorded and analyzed.
Main Results:
- The standard MMR vaccine exhibited the highest incidence rates of aseptic meningitis (16.6/10,000) and convulsions (15-35 days post-vaccination).
- The Takeda MMR vaccine showed the lowest incidence of parotid swelling.
- Significant differences in aseptic meningitis rates were observed between the standard MMR and Biken MMR vaccines, raising questions about the Urabe Am9 mumps virus vaccine's manufacturing consistency.
Conclusions:
- The study highlights significant variations in the safety profiles of different MMR vaccines, particularly concerning aseptic meningitis.
- Discrepancies in the Urabe Am9 mumps virus component between the standard and Biken MMR vaccines suggest manufacturing inconsistencies.
- Further investigation into the manufacturing processes of mumps vaccines is warranted to ensure product consistency and public safety.