<p>Amidst a row on the trials of Covid-19 vaccines in India, a Parliamentary panel has asked the government to “ensure highest level of ethical and procedural standards” during vaccine evaluations notwithstanding the urgency to develop a vaccine against the rampaging epidemic.</p>.<p>The panel’s report comes at a time when one of the country’s leading vaccine manufacturers, Serum Institute of India, demanded Rs 100 crore in damages from a 40-year-old vaccine recipient who had developed serious neurological conditions after receiving the vaccine and sought Rs 5 crore compensation from the firm.</p>.<p>While the company’s move came under criticism from several quarters, India’s drug regulator the Drugs Controller General of India remained silent even after six weeks of the reporting of the serious adverse effect.</p>.<p>Though unrelated to the present controversy, the Parliamentary panel’s report underscored the importance of following high ethical standards in vaccine research.</p>.<p>“The Committee understands the urgency among the global scientific community for development of a vaccine against Covid-19. However, the Committee strongly emphasizes the need to ensure the highest level of ethical and procedural standards in the vaccine research studies. The vaccine should pass the strictly regulated route of all phases of clinical trials and the data should be made available in the public domain,” the Parliamentary Standing Committee on Health and Family Welfare said in its report on the Covid-19 outbreak.</p>.<p>The lawmakers asked the Union Health Ministry to follow a transparent approach so that any irregularity in the approval or production process of the vaccine could be avoided.</p>.<p>Meanwhile, a patients' rights organisation on Monday asked the DCGI to explain why it did not halt the Serum Institute’s trial of Covid-19 vaccine or release the probe findings.</p>.<p>“We are shocked at this blatant attempt at intimidation of a clinical trial participant by the SII, which is attempting to divert public scrutiny of its trial. Bear in mind that in SII’s Phase 2/3 trial, safety is one of the primary endpoints in addition to immunogenicity. The company’s attempt to threaten a trial participant in this manner is unacceptable,” said All India Drug Action Network in a statement.</p>.<p>“An ICMR official has gone on record to say that a decision on the serious adverse effect from DCGI is awaited. Given that the adverse effect took place in October, it is of serious concern that DCGI did not pause the trial to investigate the incident when it was reported. The silence from the DCGI which granted permission for the trial is deafening.”</p>
<p>Amidst a row on the trials of Covid-19 vaccines in India, a Parliamentary panel has asked the government to “ensure highest level of ethical and procedural standards” during vaccine evaluations notwithstanding the urgency to develop a vaccine against the rampaging epidemic.</p>.<p>The panel’s report comes at a time when one of the country’s leading vaccine manufacturers, Serum Institute of India, demanded Rs 100 crore in damages from a 40-year-old vaccine recipient who had developed serious neurological conditions after receiving the vaccine and sought Rs 5 crore compensation from the firm.</p>.<p>While the company’s move came under criticism from several quarters, India’s drug regulator the Drugs Controller General of India remained silent even after six weeks of the reporting of the serious adverse effect.</p>.<p>Though unrelated to the present controversy, the Parliamentary panel’s report underscored the importance of following high ethical standards in vaccine research.</p>.<p>“The Committee understands the urgency among the global scientific community for development of a vaccine against Covid-19. However, the Committee strongly emphasizes the need to ensure the highest level of ethical and procedural standards in the vaccine research studies. The vaccine should pass the strictly regulated route of all phases of clinical trials and the data should be made available in the public domain,” the Parliamentary Standing Committee on Health and Family Welfare said in its report on the Covid-19 outbreak.</p>.<p>The lawmakers asked the Union Health Ministry to follow a transparent approach so that any irregularity in the approval or production process of the vaccine could be avoided.</p>.<p>Meanwhile, a patients' rights organisation on Monday asked the DCGI to explain why it did not halt the Serum Institute’s trial of Covid-19 vaccine or release the probe findings.</p>.<p>“We are shocked at this blatant attempt at intimidation of a clinical trial participant by the SII, which is attempting to divert public scrutiny of its trial. Bear in mind that in SII’s Phase 2/3 trial, safety is one of the primary endpoints in addition to immunogenicity. The company’s attempt to threaten a trial participant in this manner is unacceptable,” said All India Drug Action Network in a statement.</p>.<p>“An ICMR official has gone on record to say that a decision on the serious adverse effect from DCGI is awaited. Given that the adverse effect took place in October, it is of serious concern that DCGI did not pause the trial to investigate the incident when it was reported. The silence from the DCGI which granted permission for the trial is deafening.”</p>
