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Reactogenecity of indigenously produced measles vaccine
I Bhargava1, B C Chhaparwal, M A Phadke
1Serum Institute of India Research Foundation, Pune.
Insights
The indigenously produced measles vaccine from EZ strain is safe and well-tolerated in children. Mild side effects were observed, with neurological events being rare and without sequelae.
Area of Science:
- Immunology
- Vaccinology
- Pediatrics
Background:
- Measles vaccination is crucial for public health.
- Assessing the safety and reactogenicity of new vaccine strains is essential.
Purpose of the Study:
- To evaluate the safety and reactogenicity of an indigenously produced measles vaccine derived from the EZ strain.
- To compare its safety profile with existing vaccines.
Main Methods:
- A longitudinal clinical follow-up study was conducted.
- 12,470 children aged 9-15 months received the EZ strain measles vaccine.
- Clinical and neurological examinations were performed at multiple time points post-vaccination.
Main Results:
- 31% of children experienced mild side effects, predominantly within the first two weeks.
- Common side effects included coryza, fever, cough, and diarrhea.
- Only two cases of convulsions with no sequelae were reported.
Conclusions:
- The Indian-manufactured measles vaccine using the EZ strain is safe.
- Its reactogenicity, including neurological aspects, is lower than the Schwarz strain vaccine previously reported in India.
Objective:
To assess the safety and reactogenecity of indigenously produced measles vaccine derived from EZ strain.
Design:
A longitudinal clinical follow up after vaccination.
Setting:
Hospital based and home follow up, as required.
Subjects:
12,470 children, 9 to 15 months old, immunized with measles vaccine of EZ strain, in accordance with the National Immunization Schedule, at five centers.
Methods:
A clinical follow up of children at 1 day, 1 week, 2 weeks, 3 weeks and 6 weeks after measles vaccination. A detailed clinical neurological examination in children showing side effects.
Results:
Mild side effects were documented in 31%. Of these, 90% were seen in the first two weeks, out of which two thirds were seen during the first week. Commonest side effects were coryza (10%), fever (9.8%), cough (3.2%) and diarrhea (3.2%). Convulsions, with no later sequelae were documented in 2 cases only.
Conclusions:
Measles vaccine manufactured in India, using EZ strain is a safe vaccine. It has a level of reactogenecity including neurological aspects, lower than that reported in India with the Schwarz strain vaccine.