No major side-effect seen in India's first mRNA vax: Experts

PUNE: Investigators undertaking Phase-3 trials for HGCO19, India's first mRNA vaccine, told TOI on Friday that almost 90% of volunteers have not experienced any side-effect after receiving either one or two doses of the shot so far. HGCO19 is being developed by Pune-based Gennova Biopharmaceuticals Limited.

Dr Ashish Bavdekar, one of the principal investigators heading the vaccine trials at Pune's KEM Hospital Research Center, said the Phase-1 data on HGCO19 immunogenicity was also very encouraging. "Side-effects, which have been reported only in a minority of volunteers, were very mild and non-significant. Quite a few volunteers have also reported no side-effects," he said. Dr Bavdekar said the minor side-effects reported were mild fever or headache.

He said, " However, it is after the Phase 3 trials that the real picture will come out clearly, because the sample size was also much larger for this phase."

Dr Sidram K Raut, director of Noble Hospitals, Pune, one of the trial sites for HGCO19, told TOI that the Phase III trial was likely to be completed by around December 22.

Dr Prakash Shende, principal investigator of the HGCO19 vaccine trial at the Dr D Y Patil Hospital, Pimpri, said, "We have recruited over 40 participants for the Phase III trial. We have received enough safety data on the vaccine after the first two phases, hence almost 4,000 participants were enrolled for the Phase III trials. The follow up will last for a year."

He said, "As far as the Phase 1-2 trials were concerned, side effects included injection site pain, a couple of volunteers reporting allergy-like rash at the injection site, body ache and mild fever. These side effects were auto-recoverable in some patients while the rest could get easily treated by medication."