Serum Institute seeks DCGI permission for phase 2 and 3 clinical trials of Oxford's Covid-19 vaccine
Serum Institute of India (SII), which has partnered with AstraZeneca for manufacturing the Oxford vaccine candidate for Covid-19, has sought permission from the Drugs Controller General of India (DCGI) for conducting phase 2 and 3 human clinical trials of the potential vaccine.
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 an around 1,600 participants of more than 18 years would be enrolled in the study.
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, the source said.
India will ensure regulatory facilitation and actively consider supplementing resources if needed for expediting the Serum Institute of India's phase 3 trial of a vaccine for Covid-19 developed by Oxford University. With the trials of Covid-19 vaccine being developed by AstraZeneca and Oxford University showing encouraging results, Serum Institute of India (SII) said it will apply for license from the Indian regulator to start clinical trials of the shot in a week's time. SII, the largest vaccine manufacturer in the world, has been chosen by Oxford and its partner AstraZeneca to manufacture the vaccine once it gets ready. To introduce the vaccine, SII, the world's largest vaccine maker by number of doses produced and sold, has signed an greement to manufacture the potential vaccine developed by the Jenner Institute (Oxford University) in collaboration with British-Swedish pharma company AstraZeneca.
On the partnership with AstraZeneca, SII CEO Adar Poonawalla had said, "Serum Institute of India has entered a manufacturing partnership with AstraZeneca to produce and supply 1 billion doses of the Covid-19 vaccine being developed by Oxford University.
These vaccines will be for India and middle and low income countries across the world (GAVI countries), he had said. The firm plans to start the phase 2 and 3 human trials in India in August.
Source: Deccan Herald