ICMR sets Aug 15 vaccine deadline
NEWDELH:i India’s topmost medical research body ICMR said on Friday that it is attempting to launch the world’s first Covid-19 vaccine on August 15, triggering disbelief among scientists who say the process requires painstaking trials and analysis and cannot reliably be completed in the six weeks that remain for the deadline.
NEWDELHI: Scientists are sceptical about the Indian Council of Medical Research’s (ICMR) plan to compress three phases of clinical trials into five weeks to develop an indigenous coronavirus disease (Covid-19) vaccine for public use by August 15, with some saying any conclusions drawn from trials done in such a short period would be highly suspect.
Vaccine development, on average, takes 10.71 years from the pre-clinical phase, and a vaccine under development has a mere 6% chance of entering the market, according to a study in journal PLOS One that highlights the challenges and complications in developing a vaccine. In a pandemic scenario, the process can be expedited but is still expected to take 12-18 months.
“For a vaccine for which preclinical development is still ongoing, as per the letter itself, how can clinical trial recruitment be starting on July 7? And that the vaccine will be launched on August 15? A vaccine trial completed in little over a month, efficacy pre-decided?” said Anant Bhan, a bioethics and global health expert, in a tweet on Friday.
The challenges in vaccine development stem from the vast amount of bioengineering, experimentation and analysis involved. The process starts with creating the vaccine in a lab and testing it in animals – the preclinical stage that the Bharat Biotech and ICMR’s Covaxin vaccine is in at present. It is followed by several rounds of clinical trials in which it is assessed for safety, how much dosage is required and to ultimately determine, with certainty, that it is indeed effective.
Covaxin was granted drugs controller’s approval for human trials on June 29.
“In one month, it is possible to determine immediate safety, tolerability and immunogenicity of a candidate vaccine. This is sufficient to determine whether the approach has some promise or not. However, promising at this stage means just that, not effectiveness in preventing infections,” said Dr Anurag Agrawal, director, CSIR- Institute of Genomics and Integrative Biology, Delhi.
“You do not usually find a perfect dose in one go; and finding the right dose is important for the second round of trials as you need to inject the right dosage. All this takes time. Ideally, by letting nature take its course, September or October would be the time to know the status of antibodies. Efficacy studies take longer and in India we don’t follow human challenge experiments, wherein you expose a person to the target virus as there are ethical issues involved since we don’t pay trial participants. We look at probably a year at least by following most ethical ways,” said Agrawal.
According to Bhan, developing an effective vaccine is a time-consuming process. “Recruitment of participants in itself can take months even if we try to expedite everything like we are doing for Covid-19. Each of the phases— one, two and three— should take at least a few months as it is not just one centre but multiple centres that are involved in conducting trials to determine safety and efficacy of a vaccine,” he said.
“Then there is time required to transport the vaccine vials to these centres to inject people, for seeking ethics committee approvals individually, and to seek an informed consent of each participant, then data will be generated and analysed; all this will take at least a year,” said Bhan. “If you ask me, 30-45 days can go only in establishing the safety of the drug, if everything falls in place. Efficacy trials take longer as it requires recruiting larger sample size, and you have to not just generate data but also need time to analyse it properly,” Bhan added.
The Central Trials Registry of India has registered the trial on July 1 for phase 1 and 2, and experts say the best case scenario on August 15 would be to announce that it has made a promising start.
Clinical trial data is closely scrutinised before approvals are given, said an official at the Central Drugs Standards Control Organisation (CDSCO) under the Ministry of Health and Family Welfare. “The animal testing results for Covaxin were promising and approvals for phase 1 and 2 human trials was given on that basis. We have subject experts who closely review data, including animal, human, chemical and stability data before approving a vaccine. Companies can claim what they want, but all protocols will be followed as we are responsible for not just national but also international supply chains,” said a CDSCO official, requesting anonymity.
According to the timeline that experts are drafting as a run-up to the August 15 deadline, the participants will be injected the vaccine a few days after July 7 when their recruitment is expected to be complete. By end of July or early August antibody titers will be measured, and by 15th it will be determined whether the vaccine is safe.
In a recent interview with HT, Bharat Biotech’s chairman and managing director, Dr Krisha Ella, said for him, animal trials are crucial in the process of developing a vaccine. “For me animal trials are going to be delayed because I have to establish safety and efficacy but human trials will be very fast. My worry is only the animal trials as I want to establish the safety and efficacy, that’s extremely critical.”