Bharat Biotech's Covaxin 'well tolerated' in all dose groups, no serious adverse events in phase 1 trials
Bharat Biotech's Covaxin was "well-tolerated" in all dose groups, the company said Wednesday as it released interim findings of phase 1 trials. There were no vaccine-related serious adverse events, it said.
After the first vaccination, local and systemic adverse events were predominantly mild/moderate in severity and resolved rapidly, without prescribed medication, the company said in a statement. The most common adverse event was pain at the injection site which resolved spontaneously, it added.
Earlier this month, the Hyderabad-based pharmaceutical firm had applied to the central drug regulator seeking emergency use authorization for its COVID-19 vaccine Covaxin. The vaccine is being indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR). Bharat Biotech had presented its proposal for grant of EUA of its COVID-19 vaccine Covaxin along with the interim safety and immunogenicity data of phases 1 and 2 clinical trials carried out in the country before the committee.
Meanwhile, an expert committee of the Central Drugs Standard Control Organisation (CDSCO) had sought additional safety and efficacy data for COVID-19 vaccine candidates of Serum Institute of India and Bharat Biotech after deliberating upon their applications seeking emergency use authorisation for the shots.
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