HYDERABAD: The co-founder and JMD of Hyderabad-based Bharat Biotech, Suchitra Ella, tweeted on Friday that the results of the Phase-I clinical trial of Covaxin have been published in the well-known scientific journal The Lancet Infectious Diseases. She said this is the first clinical trial publication on the COVID-19 vaccine from India.
As per the publication, Covaxin was found safe among those who received it, among all age groups. The vaccine was administered as part of the Phase-I clinical trial to 300 people of the 375 who enrolled for the study, with 75 persons forming the control group.
Among those who received Covaxin, the study reported that only one serious adverse event was reported which was found to be unrelated to the vaccine. Moderate and mild adverse events were reported among a few, mostly after the first dose, which included injection site pain, headache, fatigue, fever and nausea or vomiting. These findings were earlier reported in the media when they were available in a pre-print research paper.
The interpretation of the published findings said that Covaxin "led to tolerable safety outcomes and enhanced immune responses" among the recipients.
Suchitra Ella also announced on Friday that 13,000 volunteers have been administered the second dose of Covaxin, the COVID-19 vaccine being developed by the firm.
She tweeted, "13,000 volunteers have been successfully administered the 2nd dose in the Phase-3 Clinical Trials of Covaxin. My heartfelt thanks to all of them for their pro-vaccine public health volunteerism. Thank you India!"
Covaxin is a two-dose vaccine given 28 days apart. Last year, Bharat Biotech had announced that the Phase-III clinical trial will be conducted on 26,000 people.