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 has obtained regulatory approval to advance its Covid-19 vaccine candidate, Covaxin, into Phase II clinical trials from today.

Developed in partnership with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV), Covaxin is an inactivated vaccine designed to trigger antibodies against the virus.

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The Phase II trials will enrol 380 participants, said the Joint Drugs Controller of India Dr S Eswara Reddy in a letter sent to Bharat Biotech.

According to the Joint Drugs Controller, the directorate had no objection to performing an adaptive, Phase I, followed by Phase II randomised, double-blind, multi-centre study.

The study is intended to assess the safety, reactogenicity, tolerability and immunogenicity of the whole-virion inactivated Covid-19 vaccine in healthy participants.

A statement from the Directorate General of Health Service read: “This is to inform you that the subject proposal was examined in consultation with SEC (Covid-19) experts held through virtual meeting on 3 September, wherein the committee recommended for the conduct of Phase II part of clinical trials with 380 participants subject to the condition that time for screening the participants should be revised in four days.”

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In June this year, Bharat Biotech secured approval from the Drug Controller General of India (DCGI) to conduct clinical trials of Covaxin, marking the first regulatory nod for the country’s domestic vaccine to enter trials.

Last month, the company reported that the vaccine candidate demonstrated an encouraging safety profile in a Phase I trial.

The Phase I trial involved 375 volunteers at 12 sites across the country, including Post-Graduate Institute (PGI) of Medical Sciences and All India Institute of Medical Sciences (AIIMS), Delhi.

Trial investigators collected blood samples from the participants to analyse the vaccine’s immunogenicity.

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

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