Covaxin emergency use authorisation approval a significant landmark: Dr Ella

While this vaccine addresses an unmet medical need during this pandemic, our goal is to provide global access to populations that need it the most. Covaxin has generated excellent safety data with robust immune responses

Hyderabad: Expressing delight on the Ministry of Health & Family Welfare announcement and the statement from DCGI – Central Standards Control Organization (CDSCO) on grant of permission for emergency use of its Covid-19 vaccine, the Chairman and Managing Director of Bharat Biotech Dr Krishna Ella said, “The approval of Covaxin for emergency use is a giant leap for innovation and novel product development in India.”

“While this vaccine addresses an unmet medical need during this pandemic, our goal is to provide global access to populations that need it the most. Covaxin has generated excellent safety data with robust immune responses to multiple viral proteins that persist,” Dr Ella added.

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The Subject Expert Committee (SEC) of Central Drugs Standards Control Organization (CDSCO) makes recommendations in respect of Accelerated Approval Process requests. The Subject Expert Committee of CDSCO met on 1st and 2nd January, 2021 and made the recommendations for the consideration and final decision of the Drugs Controller General of India.

Phase III efficacy trial

The Phase III human clinical trials of Covaxin began mid-November, targeted to be done in 26,000 volunteers across India, this is India’s first and only phase III efficacy study for a Covid-19 vaccine, and the largest phase III efficacy trial ever conducted for any vaccine in India.

The vaccine has been evaluated in approximately 1,000 subjects in phase I and phase II clinical trials, with promising safety and immunogenicity results, with acceptance in international peer reviewed scientific journals.

Covaxin by Bharat Biotech is developed in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV). This indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech’s BSL-3 (Bio-Safety Level 3) bio-containment facility.

Immune response

The evaluation of Covaxin has resulted in several product characteristics including long-term persistence of immune responses to multiple viral proteins, as opposed to only the spike protein, and has demonstrated broad spectrum neutralising capability with heterologous SARS-CoV2 strains, thus potentially reducing or eliminating escape mutants.

The vaccine has also shown to generate memory T cell responses, for its multiple epitopes, indicating longevity and a rapid antibody response to future infections. Its most critical characteristic is the demonstrated safety profile, which is significantly lower than several other vaccines with published data.

The publication of phase II trial data is undergoing the peer review process. As a part of our regulatory guidelines, all data has been submitted to the DCGI and CDSCO.

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