COVID-19 Pune: Serum Institute’s COVISHIELD vaccine gets nod for human trials

Pune: The Union Ministry of Health & Family Welfare (MoH&FW) has informed that Drugs Controller General of India (DCGI) has given approval to Pune-based Serum Institute of India (SII) for conducting phase 2 and 3 clinical trials of Oxford University-AstraZeneca COVID-19 vaccine ‘COVISHIELD’ in the country.

 The approval decision was tweeted by the Ministry of Health on its twitter handle @MoHFW_INDIA at 7.21am on Monday. The tweet says, “Drugs Controller General of India has given approval to Serum Institute of India, Pune to conduct Phase II and III clinical trials of Oxford University-AstraZeneca #COVID19 vaccine (COVISHIELD) in India.”

The Central Drugs Standard Control Organisation (CDSCO) expert committee had asked SII to make changes in its first proposal in eight parameters, including distribution of sites and dropout rate. The company had then sent the revised proposal within a few hours on July 31.

The subject expert committee of CDSCO went through the data and protocol submitted for the trial. It was satisfied with the results and based on their opinion the DCGI permitted the phase 2 and 3 trials in the country. The phase 2 and 3 trials are expected to begin in India within two weeks.

SII is the largest vaccine manufacturer globally. SII’s Chief Executive Officer Adar Poonawalla had earlier announced that as soon as the DCGI grants permission, trials for the vaccine will begin in India. “We will soon start manufacturing the vaccine in large volumes,” Poonawalla had said. Oxford University, UK government and AstraZeneca have collaborated to produce the vaccine on a mass scale if the final results are positive.

SII was founded by Cyrus Poonawalla in 1966. SII will be manufacturing the vaccine shots developed by Oxford and its partner AstraZeneca once it gets ready. SII had said that it has taken a risk by starting manufacturing the vaccine even before the approvals in order to be ready with sizable volumes once the vaccine gets all permissions.