<p>In an inexplicable U-turn, a regulatory expert panel has changed its opinion on Bharat Biotech’s Covid-19 vaccine from a product that needs “updated immunogenicity, safety and efficacy data for further consideration” to “a vaccine that has been found safe and effective” within four days.</p>.<p>On Dec 30, the firm presented updated recruitment status and safety data including serious adverse effect data of the ongoing phase III clinical trial before the panel comprising experts from pulmonology, immunology, microbiology, pharmacology, paediatrics, internal medicine and other related fields.</p>.<p>"After detailed deliberation, the committee recommended that firm (Bharat Biotech) should update and present immunogenicity, safety and efficacy data for further consideration,” noted the subject expert committee constituted by the Central Drug Standards Control Organisation, India’s drug regulator.</p>.<p>Two days later, the company presented more data from the phase-I and II of the trial as well as data from phase-III of the trial, but the panel observed that the “vaccine’s efficacy was yet to be demonstrated”.</p>.<p>“After detailed deliberation, the committee recommended that the firm should try to expedite the recruitment and may perform interim efficacy analysis for further consideration of restricted emergency use approval.”</p>.<p>Surprisingly, a day later when the panel heard the company for the third time in four days, there was a reversal.</p>.<p>“The data generated so far demonstrates a strong immune response and in-vitro viral neutralization. The ongoing clinical trial is a large trial on 25,800 Indian subjects in which already 22,500 subjects have been enrolled including subjects with comorbid conditions as well which has demonstrated safety till date. Moreover, the firm has presented the safety and efficacy data from non-human primate challenge study where the vaccine has been found to be safe and effective,” it said.</p>.<p>“In view of above, after detailed deliberation, the committee recommended for grant of permission (for Covaxin) 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,” the panel said.</p>.<p>The minutes of the three meetings have been uploaded on the CDSCO website on Tuesday.</p>.<p>"We are perplexed at the abrupt change in thinking of the SEC from the first two meetings to the third day on which the approval was recommended while apparently discounting the need for efficacy data as the condition of the approval," commented Malini Aisola from All India Drug Action Network, patient right group.</p>.<p>On Tuesday, Balram Bhargava, director general of Indian Council of Medical Research pointed out that there were special provisions in the Clinical Trial Rules of 2019 under which a company can apply for an emergency approval based on phase-II clinical trial data under extraordinary circumstances.</p>.<p>But what was the need for invoking such a provision when the epidemic was on a decline? There is no answer from the government.</p>
<p>In an inexplicable U-turn, a regulatory expert panel has changed its opinion on Bharat Biotech’s Covid-19 vaccine from a product that needs “updated immunogenicity, safety and efficacy data for further consideration” to “a vaccine that has been found safe and effective” within four days.</p>.<p>On Dec 30, the firm presented updated recruitment status and safety data including serious adverse effect data of the ongoing phase III clinical trial before the panel comprising experts from pulmonology, immunology, microbiology, pharmacology, paediatrics, internal medicine and other related fields.</p>.<p>"After detailed deliberation, the committee recommended that firm (Bharat Biotech) should update and present immunogenicity, safety and efficacy data for further consideration,” noted the subject expert committee constituted by the Central Drug Standards Control Organisation, India’s drug regulator.</p>.<p>Two days later, the company presented more data from the phase-I and II of the trial as well as data from phase-III of the trial, but the panel observed that the “vaccine’s efficacy was yet to be demonstrated”.</p>.<p>“After detailed deliberation, the committee recommended that the firm should try to expedite the recruitment and may perform interim efficacy analysis for further consideration of restricted emergency use approval.”</p>.<p>Surprisingly, a day later when the panel heard the company for the third time in four days, there was a reversal.</p>.<p>“The data generated so far demonstrates a strong immune response and in-vitro viral neutralization. The ongoing clinical trial is a large trial on 25,800 Indian subjects in which already 22,500 subjects have been enrolled including subjects with comorbid conditions as well which has demonstrated safety till date. Moreover, the firm has presented the safety and efficacy data from non-human primate challenge study where the vaccine has been found to be safe and effective,” it said.</p>.<p>“In view of above, after detailed deliberation, the committee recommended for grant of permission (for Covaxin) 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,” the panel said.</p>.<p>The minutes of the three meetings have been uploaded on the CDSCO website on Tuesday.</p>.<p>"We are perplexed at the abrupt change in thinking of the SEC from the first two meetings to the third day on which the approval was recommended while apparently discounting the need for efficacy data as the condition of the approval," commented Malini Aisola from All India Drug Action Network, patient right group.</p>.<p>On Tuesday, Balram Bhargava, director general of Indian Council of Medical Research pointed out that there were special provisions in the Clinical Trial Rules of 2019 under which a company can apply for an emergency approval based on phase-II clinical trial data under extraordinary circumstances.</p>.<p>But what was the need for invoking such a provision when the epidemic was on a decline? There is no answer from the government.</p>
