Awaiting funds, PGIMER yet to start trial of Covid vaccine-mixing
The PGIMER study, sponsored by ICMR, aims to discover how a person fully vaccinated with either Covishield or Covaxin responds to a booster of the other Covid vaccine
The Post Graduate Institute of Medical Education and Research (PGIMER) is yet to start the clinical trials to find out if mixing vaccines for the booster dose is more effective than administering the same one even after six months of getting the approvals.
The Drugs Controller General of India (DCGI) had given the approval to conduct clinical trials in January this year, but the Centre is yet to release funds to the institute for the trials.
The study, which is sponsored by Indian Council of Medical Research (ICMR), aims to discover how a person fully vaccinated with either Covishield or Covaxin responds to a booster of the other vaccine (heterologous vaccination). It will also compare how people respond to a third dose of the same vaccine (homologous vaccination).
“The study is an investigator-initiated (academic) Phase 4 trial, authorization of which was given in January 2022. In the study, we were supposed to vaccinate 1028 healthy males or females, with 18 years of age or above. The purpose was to administer a third dose of Covaxin to those people who had taken two doses of Covishield, at least 12 months before, and vice versa”, said Dr Madhu Gupta, professor, Community Medicine and School of Public Health, and principal investigator of the project.
She added, “Though the DCGI had approved the project, the ICMR and central government had not released the funds for the study. Due to delay in funds, the project, which was supposed to take around a year for completion, has been delayed for six months. We will start the project as soon as we get the funds.”
India is presently using the same vaccine (primary vaccine) for precautionary, or booster dose as experts await data on mixing of vaccines among the Indian population.
Three more medical colleges in the country were conducting the same research while the preliminary scientific evidence submitted by the Christian Medical College, Vellore, to the DCGI in march this year, revealed that administering Covishield after two doses of Covaxin boosts immunity by 6 times.
In addition to Covishield and Covaxin mixing study, effects of mixing Corbevax, Covavax and Biotech’s intranasal vaccine is also being studied.
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