The Drugs Controller General of India (DCGI) has accepted a proposal for research to analyse mixing of Covishield and Covaxin vaccines. “The research studies for which permission was sought has been granted. In my knowledge, there was a proposal for mixed vaccine combination for study at CMC Vellore,” said Dr VK Paul, Member Health, Niti Aayog, in reply to a question at a media briefing yesterday. DCGI also sets standards for manufacturing, sales, import, and distribution of drugs in India.
The Subjects Experts Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) had, on July 29, recommended granting permission to CMC, Vellore, for conducting the Phase-4 clinical trial. It proposed that the trial be conducted on 300 volunteers being administered a dose each of Covaxin and Covishield.
The study will examine whether two separate vaccine doses could be administered for a person for full vaccination against Covid-19 instead of the existing practice of administering twin shots of the same vaccine.
The exercise, however, is different from a recent research conducted by the Indian Council of Medical Research (ICMR) which concluded that combining two different shots was “safe and effective”. The ICMR research had analysed an “accidental” mixing of Covishield and Covaxin in Uttar Pradesh’s Siddharthnagar in April-May. In this alarming case of negligence, a group of 20 people initially received shots of Covishield and then Covaxin six weeks later. After analysing this accidental mixing of doses, the ICMR found that “combining two different Covid-19 vaccines gives better immune response than two doses of the same vaccine”.
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