In an important development, Serum Institute of India (SII) has started phase two and three clinical trials of its coronavirus vaccine to assess its safety and immune response on Indian adults, according to news agency ANI. According to the report, as many as 1,600 participants, aged 18 and above, will be joined in the study. The pharma company received approval from the Drugs Controller General of India (DCGI) in August.
According to ANI, the volunteers will be split into two groups - one with 400 participants and the other with 1,200 - and randomised to be injected with Covishield or a placebo for comparison. The other participants will be allotted, again in a 3:1 ratio, to get either COVISHIELD or the placebo, respectively. Covishield will be administered as two doses on day one and 29 as a 0.5 ml dose intramuscularly, according to the Clinical Trial Registry India.
The participants will be asked to fill the written form of consent and they have to reside in the study area while also obeying with the protocol. According to the report, participants will be excluded if they have acute illness with or without fever at the time of vaccine administration.
Recently, Adar Poonawalla had stated that if these trials are successful, the COVID-19 vaccine would be available for immunisation in India by December.