The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) on July 29, 2021, recommended granting permission to Christian Medical College in Vellore for conducting trials of mixing COVID-19 vaccines – COVAXIN and COVISHIELD.
The Christian Medical College (CMC) based in Vellore, Tamil Nadu had moved the application of the interchangeability study protocol of COVAXIN and COVISHIELD. “The Phase 4 trials for mixing doses of COVAXIN and COVISHIELD will be conducted soon on healthy 300 volunteers,” CMC said.
What is the purpose of CMC’s study of mixing COVAXIN and COVISHIELD?
•The study will assess if whether a person can be administered with two different vaccine shots of COVAXIN and COVISHIELD to be fully vaccinated against COVID-19.
Bharat Biotech to study mixing of COVAXIN and adenoviral intranasal vaccine BBV154
•The CDSCO has also recommended granting approval to Bharat Biotech for conducting an interchangeability study on COVAXIN and adenoviral intranasal vaccine BBV154.
Hyderabad-based Biological E not approved for vaccine trials in children
•The SEC did not give its recommendation on the application by Hyderabad-based pharmaceutical company Biological E for conducting trials of its vaccine CORBEVAX in children aged 5 to 17 years.
•The SEC has asked to submit the additional safety and immunogenicity data from the ongoing clinical trials of its vaccine CORBEVAX on adults to the CDSCO.
•Biological E is a pharmaceutical company based in Hyderabad that has begun manufacturing its RBD protein sub-unit vaccine CORBEVAX against coronavirus. The company is currently conducting Phase 3 trials of the vaccine on 1,268 healthy volunteers aged 18 to 80 years.
•The company aims to get an Emergency Use Authorization from the Government by August 21, 2021, after which it will manufacture up to 300 million doses of its vaccine. The company further expects to supply 100 plus million doses per month from February 2022 onwards.
Johnson & Johnson withdraws its application to conduct vaccine trials in India
•The SEC was also scheduled to discuss the application by Johnson & Johnson (J&J) to conduct Phase-3 trials of its COVID-19 vaccine in India, however, the company has withdrawn its application.
•J&J earlier was seeking approval to conduct Phase-3 trials of its vaccine Jansen on 600 volunteers in two groups, one between 18 to 59 years and another in those above 60 years.