India’s first COVID-19 vaccine COVAXIN appears safe in early trials, to begin phase 2 study in Sept:

India’s first COVID-19 vaccine COVAXIN appears safe in early trials, to begin phase 2 study in Sept: Report

Preliminary results of the phase 1 human clinical trial suggest that COVAXIN, India’s first indigenously developed coronavirus vaccine, is safe.

New Delhi: Preliminary results of the phase 1 human clinical trial suggest that India’s first indigenously developed vaccine against novel coronavirus, is safe, according to a report. COVAXIN, an inactivated vaccine against SARS-CoV-2 (the virus that causes COVID-19 disease), developed by Bharat Biotech in partnership with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV) is expected to enter the next phase of testing next month.

A report in The Economic Times, citing Dr Savita Verma, the principal investigator who is leading the trial at PGI, Rohtak, said that no adverse events have been observed in volunteers who received the vaccine at the site, indicating that COVAXIN is safe. According to the report, trial investigators are collecting blood samples to assess the vaccine’s immunogenicity while volunteers are being vaccinated with the second dose.

“As of now, we know that it is safe. The second step is to know how effective the vaccine is for which we have started collecting the samples,” said Verma.

The phase 1 trial involving 375 volunteers being conducted at 12 sites across the country is expected to be completed by the end of August. If trials succeed, the vaccine could be ready in the first half of 2021, another investigator told the paper.

“We are in the process of giving a second dose to the healthy volunteers and so far, we have not seen anything unusual event in patients. It is safe,” Sanjay Rai, the principal investigator at All India Institute of Medical Sciences, Delhi, was quoted as saying by the publication. The phase 1 trials are underway at AIIMS, Delhi.

Meanwhile, an India Today report stated that the trial sites are now gearing up for the phase 2 studies scheduled to to start in the first week of September - with most centres having completed the phase 1 trial. According to the report, findings from the phase 1 trials will be submitted soon.

The Health Ministry had said that three vaccine candidates against COVID-19 are currently in different phases of clinical testing – this includes Bharat Biotech-ICMR’s COVAXIN, Zydus Cadila’s ZyCoV-D, and the Oxford/AstraZeneca’s candidate ChAdOx1 nCoV-19 (called Covishield in India) being tested and manufactured by the Pune-based Serum Institute. Serum Institute has been granted permission by the DCGI to conduct the phase 2/3 clinical trials in India and the world’s largest vaccine maker is likely to start the trial soon.

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