COVID-19 Vaccine Updates: An expert committee, which was looking into Pune-based Serum Institute’s proposal to start phase 2 and 3 trial of the Oxford vaccine, has now asked the firm to revise its protocols. Reports said the committee has suggested eight amendments to the firm’s proposal. Also Read - Sputnik Light Likely to be First Single-Dose Covid Vaccine in India, Talks Soon
Serum Institute sought to conduct a trial on 1,600 participants. The committee has sought additional information on this. It has also asked for more pan-India trials. Also Read - First Dose of Sputnik V Covid Vaccine Administered in India: Dr Reddy's Laboratories
The firm has already submitted its revised protocols to avoid any delay. Also Read - Covid Vaccines, Charity: How Melinda Gates Plans to Spend Life After Divorce From Bill Gates
“The company on Tuesday was asked to clearly define phase 2 and phase 3 part of the protocol and resubmit their application for evaluation by the SEC,” an official source said.
Serum Institute has partnered with AstraZeneca for manufacturing the Oxford vaccine candidate for COVID-19 had submitted its application to the DCGI on Friday, seeking permission for conducting the phase 2 and 3 trials of the potential vaccine ‘Covidshield’.
“According to the application, it would conduct an observer-blind, randomised controlled study to determine the safety and immunogenicity of ‘Covishield’ in healthy Indian adults. The firm said that around 1,600 participants of more than 18 years would be enrolled in the study,” a PTI report said.
Initial results of the first two-phase trials of the vaccine conducted in five trial sites in the UK showed it has an acceptable safety profile and homologous boosting increased antibody responses, a PTI report said.
These vaccines will be for India and middle and low-income countries across the world (GAVI countries). The firm plans to start phase 2 and 3 human trials in India in August.
Oxford University recently had announced satisfactory progress with the vaccine, making it one of the leading ones among the dozens of vaccine candidates being developed around the world.