Covaxin: No serious adverse events found, Bharat Biotech Phase 1 result shows
Bharat Biotech's Phase 1 data said that Covaxin was 'successful in inducing a robust immune response without any serious adverse events'
India's first indigenous Covid-19 vaccine Covaxin, developed by Bharat Biotech in association with Indian Council of Medical research, was found to be "well tolerated in all dose groups with no vaccine-related serious adverse events," stated the interim findings of phase 1 trial of Covaxin.
The data also states that first vaccination, "local and systemic adverse events were predominantly mild/moderate in severity & resolved rapidly, without prescribed medication."
The trials were conducted on 375 volunteers, the research paper stated.
"All three vaccine formulations resulted in robust immune responses comparable to a panel of convalescent serum," it said..
It also said that most common adverse event was pain at the injection site which resolved spontaneously.
Currently, the Hyderabad-based Bharat Biotech is in phase three of clinical trial with over 22,000 volunteers at 18 sites across the country. It has also applied for emergency use authorisation.
However, an expert committee of the Central Drugs Standard Control Organisation (CDSCO) had earlier sought additional safety and efficacy data for its COVID-19 vaccine candidate after deliberating upon their applications seeking emergency use authorisation for the shots, officials said.
Earlier, Suchitra Ella, joint managing director of Bharat Biotech had informed that Covaxin will be available in the first quarter of next year, reported news agency ANI.
Besides, Covaxin, four other vaccines are under different phases of clinical trial in India with the Serum Institute of India conducting phase-three trial of the Oxford-Astrazeneca COVID-19 vaccine while the indigenously developed vaccine by Zydus Cadila has completed phase-two clinical trial in the country.
Dr Reddy's Laboratories will soon start combined phase two and and three clinical trials of the Russian COVID-19 vaccine Sputnik V in India. Also, Biological E. Ltd has started early phase 1 and 2 human trials of its COVID-19 vaccine candidate, officials had said last week