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NEW DELHI : Covaxin, India’s first indigenously developed covid-19 vaccine, is yet to undergo strict evaluation by the Central Drugs Standard Control Organisation (CDSCO) to come out of the “clinical trial mode" in India’s mass vaccination programme against coronavirus.

Hyderabad-based pharma company Bharat Biotech, which developed the drug that has shown an efficacy of 81% in initial phase 3 trial analysis, would submit the clinical trial data to the government in the coming days for review, said a senior official at CDSCO, which is under the Drugs Controller General of India (DCGA).

“Bharat Biotech is expected to submit the clinical trial data in 2-3 days. After the company submits the data, the subject expert committee (SEC) will review and evaluate the data for granting it emergency use authorization, which is currently restricted to clinical trial mode," said the official on condition of anonymity. Clinical trial mode means that a person will receive the vaccine after a written consent and this will be followed up to see if the vaccine has led to any side-effects.

The phase 3 trial of the vaccine, which is yet to be peer reviewed, involved 25,800 people between 18 and 98 years of age. “The company should present age-specific data on safety and efficacy. As covid-19 affects elderly the most, India has started vaccinating senior citizens and people aged above 45 with co-morbidites. Covaxin should be safe and efficacious, especially for this age group," the official said.

The chances of granting emergency use authorization without clinical trial mode is likely, but the SEC will take a strict view before deciding, the official added.

There is rigorous assessment of laboratory and clinical trial data, including data on quality, safety, production of protective antibodies and efficacy, before emergency use authorization—which is aligned with global guidelines—is granted, the official said. Safety is a particularly critical aspect of this scrutiny and a risk-versus benefit evaluation is done in the context of a public health emergency. Full licensure is obtained when the vaccine manufacturer submits the complete data.

The SEC in January had granted permission to Covaxin for restricted use in an emergency situation in public interest as an abundant precaution, in clinical trial mode, especially in the context of infection by a mutant strain.

The vaccine is effective against some of the new and more dangerous variants of coronavirus, said Krishna Ella, chairman and managing director of Bharat Biotech.

The Indian Council of Medical Research has also said that an analysis from the National Institute of Virology (NIV) indicated that the vaccine can neutralize the UK variant and some other strains. Bharat Biotech did not respond to Mint’s queries on the timelines of submission of the data to the government and peer review.

The company faced criticism after it got emergency licensure from DCGA despite not having efficacy data, following which administration of the vaccines started on 16 January. India started the first phase of the drive with Covaxin and Covishield, the vaccine developed by AstraZeneca Plc and Oxford University and manufactured by the Serum Institute of India.

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