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Correlation Study of the Most Important Environmental Influencing Factors on the Razi MMR Vaccine
1Razi Vaccine and Serum Research Institute, Agricultural Research Education and Extension Organization (AREEO), P.O. Box 31975-148, Karaj, Iran.
Abstract:
Measles, mumps, and rubella (MMR) are among the most important viral infectious diseases in Iran and neighboring countries. After using a trivalent vaccine for these three diseases for a long time, in recent years, these diseases have been significantly controlled in Iran. One of the important points of storing the vaccine is that the vaccine strains are highly temperature-sensitive viruses. Due to tropical climatic conditions in Iran, the cold chain may not be achievable during the storage and transmission of the MMR vaccine. Therefore, the efficacy of the vaccine may be affected. This study aimed to evaluate the MMR vaccine potency at different temperatures (stress tests) and frequent light exposures. All quality control tests in the form of stability studies were performed on the samples from three consecutive batches produced during a full-scale Razi production. The samples were stored at 2-8, 22-25, 35-37, and 42-45°C in specific time intervals, exposed to frequent light, and underwent freezing/thawing conditions. According to the results, the storage of the vaccine at high temperatures caused a decrease in potency and increased moisture content in the vaccine vials. The best temperature for maintenance and transportation of MMR is 2-8°C. The time and frequency of light exposure may affect the vaccine potency. Based on the sensitivity of the vaccine strains to environmental conditions, the development of plans for storage and transportation of vaccines in different situations and training the vaccine injection staff seem necessary.
Insights
Maintaining the measles, mumps, and rubella (MMR) vaccine's cold chain is crucial. High temperatures and light exposure can reduce MMR vaccine potency, emphasizing the need for proper storage and handling protocols.
Area of Science:
- Immunology
- Vaccinology
- Virology
Background:
- Measles, mumps, and rubella (MMR) are significant viral infectious diseases in Iran and surrounding regions.
- Effective control of these diseases has been achieved through long-term use of a trivalent MMR vaccine.
- Maintaining the cold chain for temperature-sensitive MMR vaccine strains is challenging in Iran's tropical climate, potentially impacting efficacy.
Purpose of the Study:
- To evaluate the impact of different temperatures and light exposure on the potency of the MMR vaccine.
- To assess the stability of MMR vaccine batches under various stress conditions.
Main Methods:
- Stability studies were conducted on three consecutive batches of Razi-produced MMR vaccine.
- Vaccine samples were stored at temperatures including 2-8°C, 22-25°C, 35-37°C, and 42-45°C.
- Samples were also subjected to frequent light exposure and freeze/thaw cycles.
Main Results:
- Storage at elevated temperatures led to a reduction in MMR vaccine potency.
- High temperatures also resulted in increased moisture content within the vaccine vials.
- Light exposure duration and frequency may negatively influence vaccine potency.
Conclusions:
- The optimal temperature for MMR vaccine storage and transportation is 2-8°C.
- The study highlights the sensitivity of MMR vaccine strains to environmental factors like temperature and light.
- Developing specific storage and transportation plans, alongside staff training, is essential for maintaining vaccine efficacy.
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