India's first coronavirus vaccine appears safe in early human trials
New Delhi : Preliminary results of the Phase 1 human trials of India's first coronavirus vaccine appears safe, said a report. COVAXIN, an inactivated vaccine against COVID-19, developed by Bharat Biotech in partnership with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV) is likely to start the next phase of trials in September.
A report by the Economic Times, quoted Dr Savita Verma, the principal investigator who is leading the trial at PGI, Rohtak. She said, 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.
During Phase 1, the vaccine was given to around 374 volunteers at 12 sites spread across the nation. The phase of trials will end in August and if the results remain positive then the vaccine can be released in the first half of 2021.
“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.
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.