Centre says approval for vaccine human trials marks 'beginning of the end'

The central government said on Sunday (July 5) that the approval for human trials for two indigenous COVID-19 vaccines — COVAXIN and ZyCov-D — marks the “beginning of the end” for the COVID-19 pandemic.

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

“Six Indian companies are working on a COVID-19 vaccine. Along with two Indian vaccines, COVAXIN and ZyCov-D, world over 11 out of 140 vaccine candidates are in human trials,” the ministry said in its letter, according to NDTV.

“The nod by Drug Controller General of India, CDSCO (Central Drugs Standard Control Organisation), for conduct of human trial for vaccines, marks the beginning of the end,” the letter mentioned.

The ministry also said two other firms producing vaccines — AZD1222 (manufactured by AstraZeneca, a British firm) and MRNA-1273 (by US-based Moderna) — had signed production agreements with Indian companies if their vaccines proved to be effective and safe.

Both vaccines by these companies have been approved for Phase II and Phase III trials.

The first two phases of any drug trial generally tests for safety while the third trial checks the medicine’s efficacy. Each phase can usually take months, or even years, to be completed.

The ministry’s statement came amid a debate over a letter by the ICMR (Indian Council for Medical Research) setting August 15 as the deadline for releasing a vaccine.

Medical experts and opposition parties claimed the date was set to help Prime Minister Narendra Modi score political points ahead of crucial elections in Bihar later this year. They also warned that rushing drugs through trials could pose serious health risks.

On Saturday the ICMR defended its letter and said it had only sought to “cut unnecessary red tape, without bypassing any necessary process” in the recruitment of participants for the trial.

“ICMR’s process is exactly in accordance with globally accepted norms to fast-track vaccine development…,” the agency said.

COVAXIN, developed by Hyderabad-based Bharat Biotech, and ZyCov-D, developed by Zydus Cadila, were approved for Phase I, II trials this week.

Dozens of vaccine candidates are at various stages of development around the world to tackle the coronavirus pandemic.