India’s COVAXIN is safe; Phase 2 trials expected in September

India’s first indigenously developed vaccine against COVID-19, COVAXIN has been reportedly found to be safe as per preliminary results of phase 1 human clinical trials conducted in the country. 

The inactivated vaccine against SARS-CoV-2 (the virus that causes COVID-19 disease), co-developed by Hyderabad-based Indian biotechnology firm, Bharat Biotech, the Indian Council of Medical Research (ICMR) and the Pune-based National Institute of Virology (NIV) is expected to enter the next phase of testing next month.

Dr. Savita Verma, the principal investigator who is leading the trial at PGI, Rohtak has been cited by reports saying that no adverse events have been recognized in volunteers who received the vaccine at the site, indicating that COVAXIN is safe.

According to the report, trial analysts 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 human trial which began mid-july involving 375 volunteers is being conducted at 12 sites across the country is expected to be completed by the end of August. If successful, the vaccine could be ready in the first half of 2021, another investigator reportedly told media.

Sanjay Rai, the principal investigator at All India Institute of Medical Sciences AIIMS), Delhi, where the phase 1 trials are underway, was cited as saying “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,”

With most test centers closing on the completion of the Phase 1 trials, preparations have begun to facilitate phase 2 studies scheduled to start in the first week of September.  Findings from phase 1 trials are expected to be submitted soon.

Three vaccine candidates against COVID-19 are currently in different phases of clinical testing in India. Bharat Biotech-ICMR’s COVAXIN, Zydus Cadila’s ZyCoV-D, and the Oxford/AstraZeneca’s candidate ChAdOx1 nCoV-19 (called Covishield in India) are 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.