India's First COVID-19 Vaccine 'COVAXIN' Appears Safe In Early Trials, Phase 2 Begins In Sept
COVAXIN is a vaccine against SARS-COV-2 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.
In the race of COVID-19 vaccine, ¡®COVAXIN¡¯ phase 1 human clinical trial suggests that India's first indigenously developed vaccine against novel coronavirus is safe according to a report from Times Now.
COVAXIN is a vaccine against SARS-COV-2 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.
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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, including that COVAXIN is safe, as reported by The Economic Times.
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 trials in the Phase 1 including 375 volunteers, the trail has been conducted at 12 sites across the country and is expected to end by August. If these trials succeed, the vaccine could be ready in the half of 2021, as suggested by 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 in patients. It is safe,¡± Sanjay Rai, the principal investigator at All India Institute of Medical Sciences, Delhi, was quoted as saying by the newspaper. The phase 1 trials are underway at AIIMS, Delhi.
An India Today report suggested that the trial sites are now prepping up for the phase 2 trials and are scheduled to start in the first week of September.
According to the report, findings from the phase 1 trials will be submitted soon.
The Health Ministry has also said that three vaccines are in line for COVID-19 and are right now in different phases of the trials. This includes Bharat Biotech -ICMR¡¯s COVAXIN, Zydus Cadila¡¯s ZyCoV-D and the Oxford /Astra Zeneca¡¯s ChAdOx1 nCoV-19 which is called Covishield in India.
