New Delhi: Amid discussion on vaccine ‘cocktail’, the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) on Thursday (July 30, 2021) recommended granting permission for trials of mixing COVID-19 vaccines- Covaxin and Covishield--said sources.
According to the news agency ANI report, the sources said that 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.
The SEC also explained that the motive behind the study is to see whether an individual can be given two different COVID-19 vaccine shots of Covishield and Covaxin to complete the inoculation course.
Additionally, the expert group also discussed the application by Biological E for conducting phase two and three clinical trials of its vaccine against COVID-19 on the pediatric 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," the sources added.
At last, the report quoted the sources as saying 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. 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.
(With ANI inputs)