Government to set guidance document for trials of vaccines, treatment

Several pharmaceutical companies across India are currently working towards potential vaccines to prevent coronavirus disease (COVID-19). Five of these candidates have entered the early stages of human trials. As per a report by The Hindu, the Government of India is now preparing a document for these companies and institutions as guideline for COVID-19 vaccines.

The report quotes Secretary in the Department of Biotechnology Dr Renu Swarup as saying that there is likely to be a guidance document for COVID-19 vaccines in a couple of days, issued by the Central Drug Standards and Control Organisation.

“The guidance document outlines how to maintain rigour while also fast-tracking the process,” Swarup told the daily, adding that trials underway in India were “adaptive”.

She added that no process in vaccine development trials would be skipped, but regulators may be given approvals to carry out multiple phases of trials parallelly.

Currently, there are five promising candidate vaccines from India including Covaxin, from Bharat Biotech, and from Zydus Cadilla which have received clearance by the Drug Controller General of India for early human trials.

As per a report by NDTV, the government on Sunday gave approval for human clinical trials for two made-in-India COVID-19 vaccine candidates COVAXIN and ZyCov-D. Both have got a nod for phase two and phase three trials.

A letter by the Ministry of Science and Technology said that there were more than 100 vaccine candidates in the world currently, of which 11 were in human trials.

The first two phases of drug trials test for safety, the report said. The third tests the medicine’s efficacy. Each phase can take several months, or even years, to be completed.

So far, India has reported more than 7 lakh 44 thousand cases of COVID-19. The pandemic has claimed the lives of more than 20,600 people in the country till date. – First Post