India’s first indigenous Covid-19 vaccine, Covaxin, developed by Bharat Biotech in partnership with the Medical Research Council of India, was found to be “well tolerated in all dose groups with no serious vaccine-related adverse events “stated the interim findings from the phase 1 trial of Covaxin.
The data also indicate that at the first vaccination, “local and systemic adverse events were predominantly mild / moderate in severity and resolved rapidly, without prescription drugs.”
The trials were conducted on 375 volunteers, according to the research article.
“All three vaccine formulations resulted in robust immune responses comparable to a panel of convalescent serum,” he said.
He also said that the most common adverse event was pain at the injection site that resolved spontaneously.
Currently, Hyderabad-based Bharat Biotech is in phase three of the clinical trial with more than 22,000 volunteers at 18 sites across the country. You have also requested emergency use authorization.
However, a committee of experts from the Central Medicines Standard Control Organization (CDSCO) had previously sought additional safety and efficacy data for its COVID-19 vaccine candidate after deliberating on its applications to obtain an emergency use authorization. for injections, authorities said.
Previously, Suchitra Ella, deputy general manager of Bharat Biotech, had reported that Covaxin will be available in the first quarter of next year, the ANI news agency reported.
In addition, Covaxin, four other vaccines are in different phases of clinical trial in India with the Serum Institute of India conducting the phase three trial of the COVID-19 Oxford-Astrazeneca vaccine, while the vaccine developed indigenously by Zydus Cadila has completed clinical phase two. trial in the country.
Dr Reddy’s Laboratories will soon begin combined phase two and three clinical trials of the Russian COVID-19 Sputnik V vaccine in India. Additionally, Biological E. Ltd has begun the first phases 1 and 2 of human trials of its COVID-19 vaccine candidate, officials said last week.
.
