New Delhi: Serum Institute of India (SII) has partnered with ‘AstraZeneca’ for manufacturing the Oxford vaccine candidate for COVID-19. Serum Institute now has sought permission from the Drugs Controller General of India (DCGI) for conducting phase 2/3 human clinical trials of the potential vaccine. This information was given Saturday by sources who are acquainted with the developments.
The sources told this agency that the Pune-based drug firm submitted its application Friday to the DCGI. Serum Institute in the application sought 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 ‘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,” a source said.
Initial results of the first two-phase trials of the vaccine have been conducted in five trial sites in the United Kingdom. The trial showed that the vaccine has an acceptable safety profile and homologous boosting increased antibody responses, the source said.
To introduce the vaccine, SII has signed an agreement 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 earlier 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).”
The firm plans to start the phase 2 and 3 human trials in India in August. Oxford University announced Monday satisfactory progress with the vaccine, making it one of the leading ones among the dozens of vaccine candidates being developed around the world.
According to a report in ‘The Lancet’, the initial trial results showed that the vaccine is safe and prompts protective immune response.