Combination of Covaxin and Covishield shots: Expert panel approves trials
New Delhi: According to sources, the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) recommended granting permission for trials of mixing COVID-19 vaccines—Covaxin and Covishield—on Thursday (July 30, 2021).
According to ANI, the application of the interchangeability study protocol of Covishield and Covaxin has been moved by Christian Medical College (CMC) in Vellore.
“The Phase 4 trials for combining Covaxin and Covishield doses will begin soon on healthy 300 volunteers,” they said.
The SEC also stated that the study’s goal is to see if an individual can complete the inoculation course after receiving two different COVID-19 vaccine shots, Covishield and Covaxin.
The expert group also discussed Biological E’s application to conduct phase two and three clinical trials of its vaccine against COVID-19 on children aged 5 to 17 years, as well as the safety and immunogenicity data (after the first vaccine dose) from the ongoing phase two and three clinical trials on adults.
“The expert committee has also recommended that the CDSCO receive safety and immunogenicity data from phase 2–part of phase two and three clinical trials—on adults,” the sources added.
Finally, the report cited sources as saying that the expert panel also recommended that Bharat Biotech be granted permission to conduct a study on the interchangeability of Covaxin and adenoviral intranasal vaccine candidate BBV154. Johnson & Johnson, based in the United States, will not take part in the trials for the single-dose COVID Janssen vaccine in India.
