Bharat Biotech’s Covaxin Found To Be Safe, Induced Immune Response In Phase-1: Data
New Delhi: Bharat Biotech’s coronavirus vaccine Covaxin has been found to be well-tolerated and produced an immune response, says the Phase-1 interim data published by the company in the peer-reviewed British medical journal Lancet, MoneyControl reported.
In Phase-1, potential vaccines are tested on healthy human volunteers to check for the safety or potential side-effects of the vaccine and the immunogenicity, or the immune response that enables the body to fight an infection.
Covaxin has been developed by the Hyderabad-based biotechnology firm in collaboration with the Indian Council of Medical Research and the National Institute of Virology. The vaccine is now undergoing phase-3 trials. Phase 2 trials are being analysed.
- Bharat Biotech conducted the Phase-1 study between July 13 and 30, 2020.
- The company said it screened 897 individuals but ended up enrolling 375.
- The participants were between 18 and 55 years of age.
- The duration of the study is 12 months.
- All the participants will be followed-up during this period.
The most common adverse event was pain at the injection site followed by headache, fatigue, and fever, the study said, according to MoneyControl.