<p>The Union Health Ministry and vaccine major Bharat Biotech on Thursday trashed reports alleging that the Hyderabad-based company was virtually compelled to speed up clinical trials of home-grown Covaxin under “political pressure” and skip certain processes and commit irregularities in the clinical trial process.</p>.<p>While the ministry described the report as “completely misleading, fallacious and ill-informed”, the company said it condemned the targeted narrative put forth by a select few individuals and groups with no expertise in vaccines or vaccinology.</p>.<p>The company said it was under no external pressure to accelerate the 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 noted.</p>.<p><strong>Read | <a href="https://www.deccanherald.com/science-and-environment/covaxin-booster-effective-against-emerging-covid-19-variants-study-1128485.html" target="_blank">Covaxin booster effective against emerging Covid-19 variants: Study</a></strong></p>.<p>The responses come in the wake of a news report that quotes one of the top company officials saying there was political pressure on the firm. “We were getting criticized for being late and there was pressure in the country. … Some of these were political and some of these were scientific. … I think the decision to move (from Phase-1 to Phase-3) was fairly rigorous," Krishna Mohan, a Bharat Biotech director, was quoted in a report by <em>statnews.com.</em></p>.<p>The firm didn’t deny what Mohan said, but noted that critics were unable to comprehend global product development and licensure processes. Also, it conceded that clinical trials were moved from phase-1 to phase-3 without conducting phase-2 as is the norm, but argued that such a step was taken on the basis of “data from phase I studies and results from successful animal challenge trials.”</p>.<p>“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.”</p>.<p>The vaccine, Bharat Biotech said, was evaluated in nearly 20 pre-clinical studies, including three challenge trials and nine human clinical studies, more than any other Indian Covid-19 vaccine. “These trials have clearly demonstrated safety and efficacy of Covaxin,” it said.</p>.<p>More than 36 crore doses of Covaxin have been administered in India so far. But the World Health Organisation accorded emergency use approval to the Indian vaccine in November 2021, and suspended its supply to the international market in April 2022 after a WHO inspection team found certain deficiencies in the manufacturing process.</p>.<p>The ministry said that the regulator – Central Drug Standards Control Organisation – followed a scientific approach and prescribed norms in approving Covaxin. The approvals were on the basis of recommendations from the Subject Expert Committee consisting of experts from the fields of pulmonology, immunology, microbiology, pharmacology, paediatrics and internal medicine.</p>.<p>“With several hundred million doses administered worldwide, Covaxin has demonstrated an excellent safety record with minimal adverse events and no vaccine associated cases detected for myocarditis or thrombocytopenia,” Bharat Biotech said.</p>
<p>The Union Health Ministry and vaccine major Bharat Biotech on Thursday trashed reports alleging that the Hyderabad-based company was virtually compelled to speed up clinical trials of home-grown Covaxin under “political pressure” and skip certain processes and commit irregularities in the clinical trial process.</p>.<p>While the ministry described the report as “completely misleading, fallacious and ill-informed”, the company said it condemned the targeted narrative put forth by a select few individuals and groups with no expertise in vaccines or vaccinology.</p>.<p>The company said it was under no external pressure to accelerate the 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 noted.</p>.<p><strong>Read | <a href="https://www.deccanherald.com/science-and-environment/covaxin-booster-effective-against-emerging-covid-19-variants-study-1128485.html" target="_blank">Covaxin booster effective against emerging Covid-19 variants: Study</a></strong></p>.<p>The responses come in the wake of a news report that quotes one of the top company officials saying there was political pressure on the firm. “We were getting criticized for being late and there was pressure in the country. … Some of these were political and some of these were scientific. … I think the decision to move (from Phase-1 to Phase-3) was fairly rigorous," Krishna Mohan, a Bharat Biotech director, was quoted in a report by <em>statnews.com.</em></p>.<p>The firm didn’t deny what Mohan said, but noted that critics were unable to comprehend global product development and licensure processes. Also, it conceded that clinical trials were moved from phase-1 to phase-3 without conducting phase-2 as is the norm, but argued that such a step was taken on the basis of “data from phase I studies and results from successful animal challenge trials.”</p>.<p>“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.”</p>.<p>The vaccine, Bharat Biotech said, was evaluated in nearly 20 pre-clinical studies, including three challenge trials and nine human clinical studies, more than any other Indian Covid-19 vaccine. “These trials have clearly demonstrated safety and efficacy of Covaxin,” it said.</p>.<p>More than 36 crore doses of Covaxin have been administered in India so far. But the World Health Organisation accorded emergency use approval to the Indian vaccine in November 2021, and suspended its supply to the international market in April 2022 after a WHO inspection team found certain deficiencies in the manufacturing process.</p>.<p>The ministry said that the regulator – Central Drug Standards Control Organisation – followed a scientific approach and prescribed norms in approving Covaxin. The approvals were on the basis of recommendations from the Subject Expert Committee consisting of experts from the fields of pulmonology, immunology, microbiology, pharmacology, paediatrics and internal medicine.</p>.<p>“With several hundred million doses administered worldwide, Covaxin has demonstrated an excellent safety record with minimal adverse events and no vaccine associated cases detected for myocarditis or thrombocytopenia,” Bharat Biotech said.</p>
