Serum Institute of India applies to DCGI for phase 2/3 clinical trial of Oxford’s COVID-19 vaccine candidate
New Delhi: The Serum Institute of India (SII) has now asked for permission from the Drugs Controller General of India (DCGI) to conduct phase 2/3 human clinical trials for a potential vaccine ‘Covishield’.
The domestic pharma company has already partnered with AstraZeneca for the manufacture of the Oxford vaccine candidate. An observer-blind, randomised controlled study will be performed by the company. This is to determine the safety and immunogenicity of ‘Covishield’ in healthy Indian adults. The firm plans to enroll 1,600 participants aged more than 18 for the study.
The drug showed an acceptable safety profile and homologous boosting instant antibody responses in the initial result of the first two-phase trials. This was conducted in five trial sites in the UK.
SII, the world’s largest vaccine maker by the number of doses produced and sold, was selected to introduce the vaccine. The pharma company signed an agreement to manufacture the potential vaccine against COVID-19. The vaccine is developed by the Jenner Institute (Oxford University) in collaboration with AstraZeneca, a British-Swedish pharma company.
“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)," Adar Poonawalla, CEO of SII, told the media on the partnership.
Additionally, with regards to the distribution of the COVID-19 vaccine, he had said that it will be done in the most ethical way possible. This means that the elderly and the immune-compromised population will get the vaccine first along with the frontline healthcare workers. As for the pricing, Poonawalla commented that it will be a bit early to state on this matter.
The firm is planning to conduct phase 2 and phase 3 clinical human trials in August. Additionally, on Monday, Oxford University announced that the progress of the vaccine is satisfactory. Moreover, according to a report in The Lancet, the initial trial results have shown that the vaccine is safe and prompts the required immune response.