Tribune News Service
New Delhi, January 10
Ahead of the national Covid vaccine drive rollout from January 16, the Indian Council of Medical Research (ICMR) today emphatically said made in India Covaxin was “absolutely and totally safe” and “as good as Serum Institute of India’s Covishield.” The country’s apex health research body, which has collaborated with Bharat Biotech to develop Covaxin, also categorically said the reported death of a volunteer in the vaccine’s ongoing phase 3 trial in Bhopal had no relation to the trial.
“The death of a trial participant in Bhopal was duly reported to the institutional ethics committee on the trial site, the vaccine’s data safety and monitoring board and the Drug Controller General of India. There is no preliminary scientific evidence to show the death is linked to the vaccine trial. In-depth assessment is also underway,” Dr Samiran Panda, head of ICMR’s Epidemiology and Communicable Disease Division and chief ICMR scientist on the Covaxin project told The Tribune today.
The scientist lamented that the “propensity to prejudge unfortunate events and link them to vaccine trials without scientific basis is growing.”
“It bothers us that no one is asking scientific questions about whether the death had any causal link with the trial. We need to go by science. I for my part can say that Covaxin is absolutely and totally safe for anyone to use. I am also keenly awaiting a call to be administered the Covid vaccine shots,” Panda said.
He made it clear that Covaxin was no back-up vaccine and was, like Covishield, safe to use in the inoculation drive. “The selection of vaccines in the national programme will depend on supplies and the government’s decision on which one to use and where,” he said.
His remarks come days after AIIMS, New Delhi, chief Randeep Guleria called Covaxin a back-up shot and acclaimed vaccine researcher Gagandeep Kang said she would not take Covaxin until phase 3 efficacy data was available.
Stages of vaccine trial
- Pre-clinical, animal studies: Establishes if a vaccine candidate is safe andf not toxic
- Ph 1 human trial: Tests safety, tolerability and toxicity at different doses in a small number of healthy volunteers
- Phase 2: Tests immunogenicity and whether the vaccine helps the body generate immune response to the virus
- Ph 3: Tests percentage reduction of disease among vaccinated versus unvaccinated groups
- Ph 4 (Post-market surveillance): Tests if the vaccine is working in real life situations when everyone is being administered the shots in an uncontrolled environment