Covaxin: No Serious Adverse Events Found, According to Bharat Biotech Phase 1 Results


India’s first indigenous Covid-19 vaccine, Covaxin, developed by Bharat Biotech in association with the Indian Council of Medical Research, has been shown to be “well tolerated across all dose groups, with no serious vaccine-related adverse events” , according to interim results from the Phase 1 trial of Covaxin.

The data also indicates that the first vaccination, “Local and systemic adverse events were mostly mild/moderate in severity and resolved quickly, without prescribed medication.”

The trials were conducted on 375 volunteers, the research paper states.

“All three vaccine formulations elicited robust immune responses comparable to a convalescent serum panel,” he said.

He also indicated that the most common adverse event was pain at the injection site which resolved spontaneously.

Currently, Hyderabad-based Bharat Biotech is in phase three clinical trials with over 22,000 volunteers at 18 sites across the country. He also requested an emergency use authorization.

However, an expert committee from the Central Drugs Standard Control Organization (CDSCO) had previously sought additional data on the safety and efficacy of its candidate COVID-19 vaccine after deliberating on their applications for authorization of use. emergency for injections, officials said.

Earlier, Suchitra Ella, co-CEO of Bharat Biotech informed that Covaxin would be available in the first quarter of next year, ANI news agency reported.

In addition, Covaxin, four other vaccines are in various stages of clinical trials in India, with the Serum Institute of India conducting a phase three trial of the Oxford-Astrazeneca COVID-19 vaccine while the locally developed vaccine by Zydus Cadila has completed the clinical phase of two trials in the country.

Dr. Reddy’s labs 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 phase 1 and 2 human trials of its COVID-19 vaccine candidate, officials said last week.

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