Balram Bhargava, director-general of the Indian Council of Medical Research (1), confirmed on Tuesday that the Covishield vaccine trials have started. The University of Oxford and Astrazeneca have jointly developed the Covishield COVID-19 vaccine. For phase 2 and 3 clinical trials with around 1,600 participants, ICMR is the secondary sponsor.
In clinical trials, sites can begin screening and patient enrolments after getting the ethics committee approval of the hospital. Out of the 14 locations for Oxford COVID-19 vaccine clinical trials, seven hospitals have received the ethical committee’s approval as per the clinical trial registry of the Indian government.
The seven hospitals that have received the ethical committee’s approval include BVDU, Jehangir Clinical Development Center, KEM Hospital, King George Hospital, Rajendra Memorial Research Institute of Medical Sciences. All of these hospitals are soon to start the patient screening by the end of the week. As per an anonymous source, the hospital will begin giving vaccine doses to patients about 2 to 3 days after the approval.
Serum Institute India to Supply 1 Billion Oxford COVID-19 Doses
Earlier in June, Serum Institute has signed an agreement with AstraZeneca, a British-Swedish multinational pharmaceutical company. Notably, the Serum Institute is the largest vaccine manufacturer globally by volume. As per the agreement, the Serum Institute would provide an additional 1 billion doses for low and middle-income countries.
The company has secured the Indian drug regulator’s regulatory approval to conduct phase II and III clinical trials. Serum Institute is the third firm to conduct human tests of the COVID-19 vaccine in India. In the previous month, Bharat Biotech, Covaxin, and Zydus Cadila for ZyCoV-D initiated the phase I and II clinical trials last month.
The interim data of a clinical study of the Oxford vaccine showed that it was safe and provided dual immunity for highly infectious diseases in respiratory. The data were published last month in The Lancet journal (2).
To support the coronavirus vaccine’s manufacturing of the University of Oxford and Novavax at the Serum Institute of India, Bill Gate’s foundation; the Bill & Melinda Gates Foundation will provide the 150 million USD fund. However, the condition of at-risk funding is that the firm prices the two vaccines at 3 USD per dose at a maximum.