New Delhi: The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) on Thursday recommended granting permission for trials of mixing COVID-19 vaccines–Covaxin and Covishield–said sources.
As per sources, the application of the interchangeability study protocol of Covishield and Covaxin was moved by Christian Medical College (CMC) in Vellore.
“The Phase 4 trials for mixing doses of Covaxin and Covishield will soon take place soon on healthy 300 volunteers,” they stated.
They explained that the purpose behind the study is to see whether a person can be given two different vaccine shots of Covishield and Covaxin to complete the inoculation course.
The expert group also discussed the application by Biological E for conducting phase two and three clinical trials of its COVID-19 vaccine on the paediatric population aged 5 to 17 years, along with the safety and immunogenicity data (after the first vaccine dose) from the ongoing phase two and three clinical trials on adult.
“The expert committee has further recommended that the safety and immunogenicity data from phase 2– part of phase two and three clinical trials– on adults should be submitted to the CDSCO,” added sources.
The sources further informed that the expert panel also recommended giving approval to Bharat Biotech for carrying out a study on the interchangeability of Covaxin and adenoviral intranasal vaccine candidate BBV154.
According to the sources, the US-based pharmaceutical company Johnson and Johnson is not going to participate in the trials for the single-dose COVID Janssen vaccine in India.