Serum Institute Seeks Nod To Start Human Trials Of Oxford’s Covid Vaccine
Serum Institute of India has sought permission from the drug regulator to conduct human clinical trials for a covid vaccine being developed by Oxford University of the U.K. and Swedish drugmaker AstraZeneca Plc.
The Pune-based, Adar Poonawalla-led company has partnered with AstraZeneca for manufacturing the vaccine candidate in India. The vaccine has shown promising results in early human testing and is now set to move into larger trials.
According to sources, Serum Institute submitted its application to the Drug Controller General of India on Friday seeking permission for conducting the trials of 'Covidshield'.
"According to the application, it would conduct an observer-blind, randomised controlled study to determine the safety and immunogenicity of 'Covidshield' (Covid-19) in healthy Indian adults. The firm said that an around 1,600 participants of more than 18 years would be enrolled in the study," a source said.
Initial results of the first two-phase trials of the vaccine conducted in five trial sites in the U.K. showed it has an acceptable safety profile and homologous boosting increased antibody responses, the source said.
"Serum Institute of India has entered a manufacturing partnership with AstraZeneca to produce and supply one billion doses of the Covid-19 vaccine being developed by Oxford University,” Poonawalla had said earlier. These vaccines will be for India and middle and low income countries across the world, he had said.
The firm plans to start the Phase 2 and 3 human trials in India in August.