Bharat Biotech’s Covid-19 vaccine is the first domestic vaccine to secure India’s regulatory approval for trials. Credit: Jernej Furman.

India-based Bharat Biotech’s Covid-19 vaccine candidate, Covaxin, has demonstrated an encouraging safety profile in a Phase I clinical trial conducted in the country.

Developed in alliance with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV), Covaxin is an inactivated vaccine candidate.

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India’s regulatory agency granted approval for Phase I and II trials of the vaccine in June.

According to local media reports, preliminary Phase I trial results showed that the vaccine is safe. The trial’s principal investigator Dr Savita Verma at Post-Graduate Institute (PGI) of Medical Sciences, Rohtak said that no adverse events were reported in subjects vaccinated at the site.

Trial investigators are said to be collecting blood samples to analyse the vaccine’s immunogenicity. Meanwhile, participants are receiving the second dose.

Verma said: “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.”

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The Phase I study involves 375 volunteers at 12 sites across the country, including PGI and All India Institute of Medical Sciences (AIIMS), Delhi. It is expected to be completed by the end of this month.

AIIMS principal investigator Sanjay Rai was quoted as adding: “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.”

News reports added that the trial sites are preparing for the Phase II trials, which are set to commence in the first week of next month.

Apart from Covaxin, Zydus Cadila‘s ZyCoV-D and the Oxford/AstraZeneca’s ChAdOx1 nCoV-19 are being tested in India as potential Covid-19 vaccines.