New Delhi: In a significant development, the interim findings from phase 1 trial of Covaxin stated that the vaccine induced an immune response and registered no serious adverse events. This was announced by the company itself on Wednesday. Also Read - Awaiting Centre's Instructions: Delhi Govt on 'Free Vaccine For All' Promise
“After first vaccination, local and systemic adverse events were predominantly mild/moderate in severity and resolved rapidly, without prescribed medication. Most common adverse event was pain at injection site which resolved spontaneously,” Hyderabad-based Bharat Biotech, which developed the vaccine in association with the ICMR, said in its statement. Also Read - Pakistan Approves Russian COVID-19 Vaccine Sputnik V For Emergency Use
The interim findings from the phase 1 trial of Covaxin further stated that the vaccine was well tolerated in all dose groups with no vaccine-related serious adverse effect. Also Read - Over 15 Lakh Vaccinated, 11 Hospitalised Across India So Far, 6 Deaths Unrelated: Govt
The company also stated that the vaccine induced neutralising antibody and was well-tolerated in all dose groups with no vaccine-related serious adverse events.
“After the first vaccination, local and systemic adverse events were predominantly mild or moderate in severity and resolved rapidly, without any prescribed medication. The most common adverse event was pain at the injection site, which resolved spontaneously,” it added.
The company said that a patient was vaccinated on July 30 had a fever and headache five days later. Looking at the phase 1 trail, the company said the emergency use approval of the vaccine can be granted if there is sufficient evidence to suggest that it is safe and effective. However, the final approval is granted only after completion of the trials and analysis of full data.
Notably, a committee of health experts had last month rejected Bharat Biotech’s emergency use request, and asked for more data on vaccine efficacy and safety. On the other hand, the company has yet to release efficacy data, which is needed for the emergency use request to be granted.