Supreme Court to hear on Nov 29 plea seeking disclosure of data on COVID-19 vaccines' clinical trials
Solicitor General Tushar Mehta strongly opposed the submission and said the petitioner wants a mandate that vaccines should not be administered.
Phase III clinical trials conducted; drug reduces viral load in five days in patients with mild or moderate symptoms.
The company is required to get approval from the Drug Controller General of India, following which the Reliance Life Sciences can commence Phase 1 trials of the COVID-19 vaccine.
Phase III clinical trials were conducted at different sites across the country and involved 741 mild Covid-19 patients, and early clinical improvement was observed among the patients on Molnupiravir.
The global, randomised, double-blind Phase 3 study will include more than 35,000 volunteers aged 18 years and older across sites in the US, Asia, Africa and Latin America.
In its submission, the company claimed that in the interim analysis, based on 90 confirmed Covid-19 cases, no moderate, severe disease or deaths were reported in those vaccinated with ZyCoV-D.
MSN will start its clinical trials in more than 40 sites across India and the first dosing is expected to begin soon.
The trials were conducted on about 360 healthy subjects in the age group of 18- 65 years.