Source :- NDTV
Science Ministry’s statement comes amid a row over a letter by the ICMR setting
August 15 – Independence Day – as the target for releasing a novel corona virus vaccine
Approval for human clinical trials for two made-in-India COVID-19, corona virus vaccine candidates
– COVAXIN and ZyCov-D – marks the “beginning of the end”
for the novel coronavirus pandemic that has infected over 1.12 crore people worldwide,
left more than 5.3 lakh dead, the government said on Sunday.
Striking an optimistic note, a letter by the Ministry of Science and Technology said
there were more than 100 vaccine candidates in the world currently, of which 11 were in human trials.
“The nod by Drug Controller General of India, CDSCO (Central Drugs Standard Control Organisation),
for the conduct of human trial for corona virus vaccines, marks the beginning of the end,” the ministry’s letter added.
“Six Indian companies are working on a COVID-19, coronavirus 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.
The ministry also said manufacturers of two of the leading candidates – AZD1222 (British firm AstraZeneca) and MRNA-1273 (US-based Moderna)
had signed production agreements with Indian companies should their vaccines prove safe and effective.
Two Phases of Trails
Typically, the first two phases of drug trials test for safety while the third tests the medicine’s efficacy. Each phase can take months, or even years, to be completed.
The ministry’s statement comes amid a row over a letter by the ICMR (Indian Council for Medical Research) setting
August 15 – Independence Day – as the target for releasing a coronavirus vaccine.
An earlier version of the letter included this line: None of these (the 11 coronavirus vaccines undergoing human trials) are likely to be ready for mass use before 2021″.
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 corona virus vaccines 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.
Phase I trials for COVAXIN, which was developed in association with the ICMR, are scheduled to be completed in 28 days – which would put the vaccine candidate on track for an August 15 release.
However, it is unclear how it can be launched without completion of Phase II, III trials.
Developer Bharat Biotech’s application, accessed by NDTV, lists 15 months as the estimated duration of clinical trials; this is in line with the 2021 estimate by the Ministry of Science.
Dozens of vaccine candidates are at various stages of development around the world to tackle the coronavirus pandemic.