None of the 11 COVID-19 vaccine candidates currently in human clinical trials worldwide, including India-made COVAXIN and ZyCov-D, are likely to be ready for mass use before 2021, the Ministry of Science and Technology said Sunday afternoon.
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 developing and releasing a viable novel coronavirus vaccine.
Medical experts and opposition parties have claimed the date was set to help Prime Minister Narendra Modi score political points ahead of crucial elections in Bihar later this year. They have also warned that rushing drugs through clinical trials could pose serious health risks for the public.
“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. None of these are likely to be ready for mass use before 2021,” 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.
Both have been approved for Phase II, III trials.
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. Although drug trials are often fast-tracked, completion of all three phases (and roll-out to the public) within the timeline given by the ICMR would be unprecedented.
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.
India, a leading manufacturer of vaccines and generic medicines, is expected to play a key role in this race.
The country is among the four worst affected by the COVID-19 virus, with more than 6.7 lakh confirmed cases so far. Worldwide there are 1.12 crore cases, including more than 5.3 lakh deaths.