World Health Organization chief scientist Soumya Swaminathan has said that the development of a potential coronavirus vaccine must show efficacy and safety, adding that the completion of its trials could take six to nine months, The Hindu reported on Sunday.
Her comments came after the Indian Council for Medical Research said its decision to fast-track development of a vaccine was in line with international standards. Health experts have raised concerns about the clinical research agency’s letter to all 12 hospitals and medical institutions to speed up the trial process of Bharat Biotech’s vaccine and to launch Covaxin by August 15 for public use.
The vaccine, being jointly developed by a Hyderabad-based pharmaceutical company Bharat Biotech and ICMR, is one of several candidates being tested globally to fight the coronavirus pandemic. So far, no vaccine has been approved for commercial use against the infection.
“A realistic (but very optimistic) timeline from the start of Phase I to the completion of Phase III could be about six to nine months (if all goes exactly according to plan),” Swaminathan told The Hindu.
The Drug Controller General of India has only approved Bharat Biotech’s application to conduct a Phase I and II clinical human trial of Covaxin. To launch the vaccine by August 15 would involve either skipping or rushing through the Phase III trial, which tests the efficacy of the vaccine on a large number of participants and takes the longest time to complete.
The health body’s chief scientist stressed on the need for Phase III of the trial before launching any vaccine. “Any vaccine that is going to be used at large scale must demonstrate efficacy and safety,” Swaminathan said. “The WHO has offered our support to vaccine developers all over the world to enable that the best science is performed, and to facilitate multi-country clinical trials.”
She said the coronavirus pandemic calls for unprecedented efforts to develop a vaccine and suggested that performing trials in areas and among groups with a high risk of infection will help in accumulating the necessary endpoints in a shorter time. “While clinical trials need to be performed with scientific rigour and demonstrate efficacy and safety, timelines can be shortened by investing in manufacturing upfront, preparing sites in advance, regulatory harmonisation, collaboration between the different government agencies and anticipating the next steps,” Swaminathan added.
Swaminathan further said that it is encouraging to see that at least seven Indian companies are developing potential vaccines. “All of them must be tested, through the various phases, in collaboration with the DBT [Department of Biotechnology] and the ICMR, and till we see results from these trials, we cannot predict which of them will be successful. Having a regulatory standard and clear criteria for advancing vaccines through the various stages, will be very helpful…”
Covaxin was the first indigenous vaccine to get permission for human trials by the Drug Controller General of India, on June 29. The letter signed by ICMR Director General Balram Bhargava and sent to clinicians at 12 hospital sites selected to test a potential vaccine became controversial after it was seen as exhorting scientists to speed up the processes. Medical experts expressed concern the trials would compromise patient safety and ethics. However, the ICMR on Saturday claimed that the letter was meant to “cut unnecessary red tape” and “speed up recruitment of participants”.
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