Mumbai: The world’s largest vaccine manufacturer, Pune-based Serum Institute of India (SII), is likely to manufacture the COVISHLD’ (SII-ChAdOx1 nCoV-19) vaccine developed by developed by Oxford University’s Jenner Institute. The Drugs Controller General of India has given the SII a nod to conduct phase 2 and 3 human trials in 1,600 healthy volunteers in the country. The trials will be a randomized controlled study that aims to determine the safety and immunogenicity of the vaccine.
“As per the study design, each subject will be administered two doses four weeks apart (first dose on day one and second dose on day 29) following which the safety and immunogenicity will be assessed at predefined intervals,” an official told Press Trust of India.
The highly anticipated trial results for the COVID-19 vaccine, which is licensed to the multinational pharmaceutical company AstraZeneca, are out. Phase-1 and Phase-2 trials showed no adverse side-effects and generated an immune response among health participants.
“Both Phase 1 and 2 show encouraging results but do not give any indication on how successful they will be in the real world. A single shot gave a perfect immune response in healthy adults, and there is no need for any concern regarding serious adverse effects. As for India, this can be said after we do the trials on a large scale, covering both genders and different age groups. The process can take up to six months,” Dr Giridhara R Babu tells The Better India. He is the professor and Head of Lifecourse Epidemiology department at the Indian Institute of Public Health in Bengaluru.
Happy with the promising results shown by the Oxford developed-vaccine, the SII aims to apply for its manufacturing license.
“The trials have shown promising results, and we are extremely happy about it. We will be applying for the licensure trials to the Indian regulator in a week’s time. As soon as they grant us permission, we will begin with the trials for the vaccine in India. In addition, we will soon start manufacturing the vaccine in large volumes,” SII Chief Executive Officer Adar Poonawalla said.