Zydus Lifscience Gets CDSCO Panel Nod to Study Measles and Rubella Vaccine
New Delhi: The drug major Zydus Lifscience has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the phase IV clinical trial of the vaccine Measles and Rubella Vaccine (Live) I.P. (Freeze Dried).
This came after the firm presented the Phase IV clinical trial protocol of Measles and Rubella Vaccine (Live) I.P. (Freeze Dried) titled “A prospective, randomized, parallel, single-blind, four-arm, active-controlled, multicentre, Phase IV clinical trial to evaluate the immunogenicity and safety of Measles and Rubella Vaccine (Live) I.P. compared to Measles and Rubella vaccine (Live) I.P. (Freeze Dried) of M/s Serum Institute of India Pvt. Ltd. and to evaluate lot-to-lot consistency of Measles and Rubella vaccine (Live) I.P. (Freeze Dried) of M/s Zydus Life sciences Ltd. in healthy infants aged 9-12 months. "
Measles and Rubella Vaccine (Live) I.P. (Freeze Dried) is a sterile, white, dull appearance to a very light pinkish-colored cake, cake turns into clear solution of red to purple colour after reconstitution with diluent.
It's a live-attenuated viral vaccine that consists of the Edmonston Zagreb strain of measles virus and RA27/3 strain of rubella virus propagated on Human Diploid Cells. The vaccine meets the requirements of I.P. and WHO when tested by the methods outlined in I.P. and WHO, TRS 840 (1994).
Measles causes fever, cough, runny nose, and red, watery eyes, commonly followed by a rash that covers the whole body. It can lead to seizures (often associated with fever), ear infections, diarrhea, and pneumonia. Rarely, measles can cause brain damage or death.
Rubella causes fever, sore throat, rash, headache, and eye irritation. It can cause arthritis in up to half of teenage and adult women. If a person gets rubella while they are pregnant, they could have a miscarriage, or the baby could be born with serious birth defects.
The measles and rubella virus vaccine live is an active immunizing agent used to prevent infection by the measles and rubella viruses. It works by causing the body to produce its own protection (antibodies) against the viruses.
At the recent SEC meeting for Vaccine held on July 31, 2024, the expert panel reviewed the Phase IV clinical trial protocol of Measles and Rubella Vaccine (Live) I.P. (Freeze Dried) presented by the drug Zydus Lifscience.
After detailed deliberation, the committee recommended approval to conduct the Phase-IV clinical trial as per the presented protocol.
Also Read: Justify proposed dose and rationality: CDSCO Panel Tells Lupin on FDC Sacubitril plus Valsartan
