NEW DELHI :
Serum Institute of India’s phase 2 and 3 bridging study of 1,600 participants for the covid-19 vaccine Covovax has started at one of the trial sites in Pune, with at least one more site expected to begin screening as early as Tuesday, two people aware of the development said, on condition of anonymity.
“The trials have started at a hospital in Pune on Thursday. More will start enrolling soon,” one of the sources said.
Another clinical trial site Hamdard Institute of Medical Sciences and Research at New Delhi will begin screening of some participants on Tuesday, another source said.
A spokesperson for Serum Institute decline to comment on the commencement of Covovax trials.
Covovax is Serum Institute’s version of the covid-19 vaccine developed by US-based Novavax, which earlier this month had announced that the jabs have an efficacy of 96% against the original strain determined in a phase 3 trial conducted in the UK. This is the highest efficacy so far achieved for a covid-19 vaccine against the original strain of the coronavirus.
However, efficacy of the vaccine dropped to 86.3% against the mutant variant that is now the dominant strain in the UK. On average, the efficacy of the vaccine was 89.7%, the company had said.
In another phase 2 trial conducted in South Africa, where another mutant variant is dominant, the overall efficacy dropped to 48.6%.
While the efficacy is lower against the mutant strains, the vaccine still has shown better results as compared to the jab co-developed by AstraZeneca plc and University of Oxford. In a trial result published with the New England Journal of Medicine earlier this month, the vaccine was found to have only a 10.4% efficacy against the South Africa variant of the coronavirus.
Serum Institute also contract manufactures the AstraZeneca vaccine under the brand Covishield, which is the most-widely available jab in India as well as World Health Organization-led Covax.
The Pune-based company expects to launch Covovax by August, but will start stockpiling the vaccine from April, chief executive officer Adar Poonawalla had said at the Bloomberg Equity Summit earlier this month. The company will be manufacturing 1 billion doses of the vaccine, which will be supplied to both India and Covax.
The trial of 1,600 participants will be conducted at 19 sites across the country, including the Hamdard Institute and All India Institute of Medical Sciences at Delhi, Sahyadri Super speciality Hospital, Noble Hospital and Dr. D. Y. Patil Medical College, Hospital and Research Centre at Pune and School of Tropical Medicine at Kolkata.
Under the trial protocol, 460 participants will be part of a cohort to determine whether the vaccine manufactured by Serum Institute provides the same immune response as the one developed by Novavax. While three-fourths of these will get Covovax, the remaining will be administered Novavax’s vaccine.
The 1,140 participants will be in the cohort for determining safety of the vaccine, with three-fourths getting Covovax, and the rest a placebo.
This article is auto-generated by Algorithm Source: www.livemint.com