No serious adverse events in Covaxin Phase 1 trials

No serious adverse events in Covaxin Phase 1 trials


New Delhi: Bharat Biotech‘s indigenously developed Covid-19 vaccine, Covaxin, was well tolerated and did not report any serious adverse events during the study conducted in phase 1 trials, as per results published in The Lancet, the prestigious British medical journal. “BBV152 (Covaxin) led to tolerable safety outcomes and enhanced immune responses. The vaccine was well tolerated in all dose groups with no vaccine-related serious adverse events,” said the authors of the study.

All adverse events were mild and moderate and were more frequent after the first dose. One adverse event was reported but was unrelated to the vaccine. The article said further efficacy trials were warranted. “Because this is an interim report, we are not reporting any data on the persistence of vaccine-induced antibody responses or longterm safety outcomes. The results reported here do not permit efficacy assessments.”


“The analysis of safety outcomes requires more extensive phase 2 and 3 clinical trials,” it added. Covaxin, which is currently undergoing phase 3 clinical trials, was approved for emergency use by the drug controller earlier this year. Concerns have been raised by public health experts over the ‘rushed approval’ given to the homegrown vaccine, without waiting for the efficacy data. Many health workers have shown reluctance to take the Covaxin jab during the ongoing vaccination drive. The government on its part has maintained that the vaccine is totally safe.

The randomised phase 1 trial to assess the safety and immunogenicity of BBV152 was carried out at 11 hospitals across India. Adults aged 18-55 years who were deemed healthy by the investigators were eligible. Between July 13 and 30 last year, 827 participants were screened, of whom 375 were enrolled. Among the enrolled participants, 100 each were randomly assigned to the three vaccine groups, and 75 participants were randomly assigned to the control group.

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