Former Indian Council of Medical Research (ICMR) chief NK Ganguly said a good vaccine usually takes at least 18 months, before rolling it out for production after fast-tracking all the mandatory regulatory approvals.
Ganguly, while speaking on India’s indigenous COVID-19 vaccine Covaxin said, “The strain of the virus was given to BBIL in May end, and human trials have been scheduled in July.”
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It may be mentioned here that Covaxin may be released on August 15 under a fast-track mechanism.
According to ICMR, a dozen institutes have been selected for clinical trials of vaccine (BBV152 COVID vaccine).
Explaining further on the extensive process involved in vaccine development, Ganguly said, “After spending many months and infusing a lot of funds, the uncertainty continues to linger. It may be difficult to say whether the vaccine is successful or not.”
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It is worth mentioning here that the ICMR in a letter said, “It is envisaged to launch the vaccine for public health use latest by August 15, after completion of all clinical trials.”
“Bharat Biotech International Limited (BBIL) is working expeditiously to meet the target, however, the final outcome will depend on the cooperation of all clinical trial sites involved in this project,” the letter added.
“Before human trials, challenge studies of a vaccine are done on mice and monkey,” Ganguly said.
“After that a toxicology report is prepared, to check if the developed vaccine produces harm to cells, and it takes at least three to four months to finalize this report,” Ganguly added.
Adding further he said, “After this phase, a vaccine is tested on two rodents and a large animal and after successful completion of this stage the vaccine is ready for human trials.”
“In Phase 1, the age group profiling is done (wherein vaccine study is done on people in different age groups),” Ganguly added.
He further said that nearly 600 to 700 people are vaccinated in Phase 2 and if the vaccine performs successfully in this phase only then it progresses into Phase 3.
“Phase 3 is called the efficacy study, where thousands of people are enrolled,” the former ICMR chief added.
“Even after fast-tracking regulatory approvals, it will take at least 18 months to develop a good vaccine,” Ganguly reiterated.
He further informed that the vaccine being developed by Moderna (RNA vaccine is set to begin Phase 3 trials later this month and targets a vaccine by 2021) and BioNTech-Pfizer (Phase 3 trial is expected to begin in July).
“Genova biopharmaceutical is also working on a vaccine and it looks positive,” he said.