Coronavirus vaccine India: Covaxin to be available by early 2021, says AIIMS doctor

Even as Oxford University's vaccine candidate, AZD1222, one of the most promising ones in the race hit a pause after safety concerns, Indian authorities raised hopes that all is not lost. India's homegrown vaccine candidate, Covaxin, which is currently in its second phase of testing will most probably be cleared for public use in the early months of 2021, according to a leading doctor from All India Institute of Medical Sciences, New Delhi.

If this timeline is true, it might give us a clearer view of India's fight against the pandemic. With high surges in the number of daily infections, one of the biggest in the world, vaccine inoculation might be one of the ways to defeat the wave of COVID-19.

Speaking at a recent briefing, Sanjay Rai, Professor, Community Medicine, and Principal Investigator for Covid-19 vaccine trial at AIIMS announced that phase II trials for COVAXIN will wrap by October and soon enough, be pushed into phase III, making way for public use by early 2021:

"Phase 1 trial has been successfully completed. Phase 2 trial is most likely to get completed sometime in October. After this, the Phase 3 trial will begin. Covaxin may be launched in early 2021 (after completion of all trial stages)."

Covaxin, developed by Hyderabad based Bharat Biotech International Limited, National Institute of Virology (NIV), Pune in collaboration with Indian Council of Medical Research (ICMR) headed into the trial phase in early July after completing pre-clinical work. It was one of the fastest vaccine trials in India.

While it was earlier speculated that the vaccine will only be made available in the later months of 2021, speedy clinical trials and success rates could make COVAXIN available for early use in the country, which is now the second-worst affected, globally.

Praising the strong positive data achieved from early clinical trials, Dr Rai also said that the homegrown vaccine has stronger odds of working and promises more safety than Russia's Sputnik V, which became the first COVID-19 to be registered for public use (August 12).

"All rules and regulations are being followed...nothing is being done in a rush."

"The companies involved in vaccine production see the beginning of Phase 3 trials as a positive sign in the development of the vaccine, to take a risk and begin production."

Interestingly though, incessant claims have been raised about the Russian vaccine's safety and efficacy; there are also talks about India getting priority access to the vaccine in terms of production and procurement.

Trials for the indigenous vaccine are being conducted and profiled pan India. In phase I, nearly 350 volunteers were recruited and now, in the second phase, another 300-400 volunteers will be dosed with the experimental vaccine, developed out of an inactive virus strain.

An inactivated vaccine, like Covaxin, works by eliciting an immune response, building fighter antibodies which kill the virus without compromising on other vital functions.

Phase II, which will test the vaccine on the sample population will also be a randomized controlled blind trial, which will be done to monitor crucial safety, reactogenicity, immune and tolerance response of the vaccine.

While doctors refused to comment on the exact status and reports from the current phase of testing, early observatory data has revealed that COVAXIN, is indeed safe and led to a spike in the antibodies in volunteers. Doctors investigating the trial at one of the centres, Post-Graduate Institute (PGI) of Medical Sciences, Rohtak also said that no adverse side-effects were witnessed so far.

It needs to be noted that the dosing schedule, age group it will be most effective on, the number of doses or adjuvants needed is still unclear. However, experts have pointed out that despite being a late entrant in the race, Covaxin is very much safe and at pace with global competitors.