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There was no external pressure to accelerate the development of Covaxin, its Covid-19 vaccine, Bharat Biotech International said on Thursday.
The Hyderabad-based vaccine maker was responding to a “targeted narrative against Covaxin, put forth by a select few individuals and groups in online publications and social media.
“We condemn the targeted narrative against COVAXIN put forth by a select few individuals and groups who have no expertise in vaccines or vaccinology,’‘ the company said in a statement.
“There was no external pressure to accelerate development of Covaxin. The pressure was all internal to develop a safe, and effective vaccine for the Covid-19 pandemic, to save lives and livelihoods in India and globally,’‘ it said.
Covaxin was evaluated in about 20 preclinical studies, including three challenge trials and nine human clinical studies, more than any other Indian Covid-19 vaccine. “These trials have clearly demonstrated the safety and efficacy of Covaxin,’‘ the statement added.
The product development and clinical studies were executed in line with global guidelines and submitted worldwide. Data from Covaxin has resulted in more than 20 publications, documenting every aspect of its development.
The phase I study for Covaxin was one of the `largest’ in the world, resulting in both the 3 and 6 mcg doses, demonstrating safety and comparable immunogenicity. “The decision to proceed to phase III trials was taken based on data from phase I studies and results from successful animal challenge trials,’‘ Bharat Biotech said.
The phase II studies were designed to determine if the lower dose of 3 mcg would be effective, instead of the 6 mcg dose, which would have doubled our manufacturing capacity. In the interest of public health, it was decided to proceed with the 6 mcg dose for phase III clinical trials, it added.
In a separate release, the Centre said: “It is clarified that Government of India and the national regulator, CDSCO, have followed a scientific approach and prescribed norms in approving COVID-19 vaccines for emergency use authorisation. The Subject Expert Committee (SEC) of Central Drugs Standard Control Organisation (CDSCO) met on 1st and 2nd January, 2021 and after due deliberations made recommendations in respect of proposal for Restricted Emergency Approval of Covid vaccine of Bharat Biotech.’‘
Before Covaxin was approved for restricted emergency use in January 2021, the Subject Expert Committee reviewed the data on safety and immunogenicity of the vaccine and recommended for grant of permission for restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode, to have more options for vaccinations, especially in case of infection by mutant strains, it said.
The SEC’s approval for commencement of the phase 3 clinical trial of the proposed dose of Covaxin was based on scientific data presented by Bharat Biotech and established practices in this regard., the statement added.
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