India may look at compassionate use of the Covid-19 vaccine for its front line workers after human trials pass phase 2.
Indigenously developed Bharat Biotech’s vaccine candidate Covaxin is entering human trials on Wednesday.
Industry sources say more vaccines may enter human trials in July.
The vaccine completing phase 3 clinical trials and getting marketing approval is at least a year away, say experts. Phase 1 trials, which test primarily the toxicity of a vaccine candidate on a small population, usually take a month or so, and phase 2 trials, which look at efficacy and determine the dosage, may take around six months.
If all goes well, at least a couple of vaccine candidates may complete phase 2 human trials by end of this year, say experts.
“There is a possibility that after the phase 2 trials are completed, at least front line workers, especially doctors and other health care professionals, may be given the vaccine on compassionate use grounds,” said an industry source.
The phase 3 trials can continue side by side. However, even if a vaccine is used on compassionate grounds, it would not be available before March next year, local industry says.
A senior government official said no decision had been taken yet on this.
“We are observing the situation. The front line workers need to be protected. Also, plasma therapy is being used on compassionate grounds while the trials are on. So, we will take a call once the data from the human trials comes in,” he said.
E Sreekumar, chief scientific officer at the Rajiv Gandhi Centre for Biotechnology, said compassionate use of medicines had been taken up and it might be done in the case of high-risk groups. “Even if it is done, it can be taken up for consideration after the phase 2 trials,” he added.
The industry says the vaccination drive in India is a mammoth exercise. Even if 10 per cent of the population is vaccinated, it is 130 million doses. If the vaccine needs two shots, it is 260 million. “It will easily take a few years before the entire India can be covered,” said a vaccine manufacturer.
Bharat Biotech has indicated it will start human trials on Wednesday and would soon come back with data from the phase 1 trials. The company did not give timelines.
On Monday the company said the Drug Controller General of India gave the nod to initiate Phase 1 and 2 human clinical trials after the company submitted the results from pre-clinical (animal) studies, which demonstrated safety and the immune response. The SARS-CoV-2 strain was isolated in the National Institute of Virology, Pune, an institute under the Indian Council of Medical Research (ICMR), and transferred to Bharat Biotech.
Other key players who are chasing a Covid-19 vaccine include Ahmedabad’s Cadila Healthcare, Delhi-based Panacea Biotec (with Refana), and Pune’s Serum Institute (with AstraZenca for the Oxford vaccine). Globally, Oxford-AstraZeneca, Moderna, and China’s Sinovac Biotech are entering the large-scale trial phase in July.
An industry source indicated that the Drug Controller General of India (DCGI) has given the nod for phase 1 and 2 trials for Bharat Biotech’s vaccine together, which is an indication that the government too wants to speed it up. Panacea Biotech had indicated to Business Standard it would start making trial batches of its whole inactive virus-based vaccine candidate in September.
Cadila Healthcare is finishing its pre-clinical studies and is prepared to start human trials in July.
Serum Institute Chief Executive Officer Adar Poonawalla has said he will start making a few million doses even before the clinical trials end.