New Delhi: The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO), recommended giving approval for trials of combining COVID-19 vaccines — Covaxin and Covishield — on Thursday.
According to sources, Christian Medical College (CMC) in Vellore has advanced the application of the interchangeability research procedure for Covishield and Covaxin. “The Phase 4 trials for mixing doses of Covaxin and Covishield will soon take place soon on healthy 300 volunteers,” they said as noted by Mint.
They added that the goal of the trial is to investigate if a person can complete the immunisation course by receiving two separate vaccine shots, Covishield and Covaxin.
The expert committee also considered Biological E’s application to perform phase two and three clinical trials of its COVID-19 vaccine on children aged 5 to 17, as well as the safety and immunogenicity data (after the first vaccine dose) from adult phase two and three clinical trials, which are currently underway.
“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,” a person close to the development stated requesting anonymity, as reported by Livemint.
The expert group also suggested that Bharat Biotech be granted permission to conduct research on the interchangeability of Covaxin and the adenoviral intranasal vaccine candidate BBV154.
As speculated, the US-based pharmaceutical company Johnson and Johnson, would not be participating in the single-dose COVID Janssen’s Indian vaccination trials.
Some investigations on the impact of combining Covid-19 vaccines have already been conducted outside of India. A person is given multiple doses of the same vaccine in typical immunisation programmes employing a multi-dose regimen.
However, in the vaccine mixing method, the first dosage of ‘Vaccine A’ is given first, followed by ‘Vaccine B’. The goal of this research is to see if combining two Covid-19 vaccinations can lead to greater and longer-lasting immunity to the virus.
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