Insight Bureau: The Drugs Controller General of India (DCGI) has approved a research in India using the combination of Covaxin and Covishield Covid-19 vaccines. Christian Medical College, Vellore, will undertake this investigation and related clinical trials.
The study was recommended by a Subject Expert Committee of the Central Drugs Standard Control Organisation (CDSCO) on July 29. The expert group suggested that CMC, Vellore be granted permission to undertake a Phase-4 clinical trial involving 300 healthy volunteers to combine Covid-19 vaccines Covaxin and Covishield.
The focus of this research is to see if a person can complete the immunisation course by receiving two distinct vaccine doses, one of Covishield and one of Covaxin.
This proposed study would vary from a recent study done by the Indian Council of Medical Research (ICMR) on a group of vaccination users in Uttar Pradesh who were unintentionally administered doses of different Covid-19 vaccines earlier this year.
In a research which is yet to be peer-reviewed, the ICMR claims that combining dosages of Covaxin and Covishield improved immunity against the virus that causes Covid-19. The research was carried out in Uttar Pradesh between May and June. According to the ICMR, the study found that immunising with a combination of an adenovirus vector platform-based vaccination and an inactivated whole virus vaccine was not only safe but also provided superior protection against coronavirus variations.
The expert panel had also suggested mixing Covaxin and a nasal vaccine candidate (BBV154) that is being developed by Bharat Biotech, in addition to the research on mixing Covaxin and Covishield.
The committee, on the other hand, had requested that Bharat Biotech remove the phrase “interchangeability” from the research title and submit a new study protocol for clearance. The new protocol, according to sources, has been filed. The DCGI has yet to draw a conclusion regarding the same.