Latest news with #EmergencyUseAuthorisation
India Today
13 hours ago
- Health
- India Today
Siddaramaiah, Biocon founder spar over vaccine safety amid rise in Hassan deaths
A public exchange between Karnataka Chief Minister Siddaramaiah and Biocon founder Kiran Mazumdar Shaw has brought national attention to the state's investigation into a series of sudden deaths in Hassan district. The debate between the two public figures is centred on whether Covid-19 vaccines might be linked to the rise in heart-related her latest post on July 4, the Biocon founder while agreeing with the Chief Minister's position on seeking scientific clarity reiterated that vaccines developed in India were approved through due process. advertisement'My response was that due process was followed as prescribed by WHO for safety and efficacy for EUA. Losing lives in a sudden manner is always tragic and I am glad an investigation is being conducted in Hassan district,' she wrote on X. This came in response to Siddaramaiah's post on July 3 on the social media platform, where he clarified that asking questions about vaccine safety was a governance responsibility, not misinformation. 'When parents lose their young children or families lose breadwinners without warning, seeking clarity is not misinformation; it is an act of governance rooted in empathy.' Citing multiple peer-reviewed studies, he added that some Covid-19 vaccines had been linked to rare cardiac events, and that global regulators, including the World Health Organisation (WHO), had acknowledged the emergency rollouts involved 'calculated risks'.Siddaramaiah defended his earlier remarks on July 1 suggesting that 'hasty' vaccine approvals could not be ruled out as a factor in the increase in heart attacks. 'It cannot be denied that the hasty approval and distribution of the Covid-19 vaccine to the public could also be a reason for these deaths, as several studies worldwide have recently indicated,' he had Shaw had earlier countered that Indian vaccines were approved under the Emergency Use Authorisation framework, adhering to international safety and efficacy norms. 'To suggest that these vaccines were 'hastily' approved is factually incorrect and contributes to public misinformation,' she wrote on July 3. 'These vaccines have saved millions of lives and, like all vaccines, may cause side effects in a very small number of individuals.'In response, Siddaramaiah stated, 'Haste is not a sin when saving lives, but acknowledging potential unintended consequences is wisdom.' The Chief Minister's comments followed reports that more than 20 people had died of heart attacks in Hassan district in the past month. In response, the state government has formed a high-level expert committee under Dr Ravindranath, Director of the Jayadeva Institute of Cardiovascular Sciences and Research, to investigate the deaths and submit a report within ten is the same panel that was tasked in February 2025 with studying the cause of sudden deaths among young people in Karnataka and whether there could be any link to Covid-19 vaccination. Siddaramaiah said the panel would continue evaluating cardiac cases and deliver its findings, based on which the government would take further action.'We too value the lives of children, youth, and innocent people who have their entire lives ahead of them, and we share the concerns of their families,' he said. He also condemned the BJP for allegedly politicising the deaths. 'Before BJP criticise us on this matter, they should ask their conscience,' he said.- Ends IN THIS STORY#Karnataka
The Hindu
16 hours ago
- Health
- The Hindu
Karnataka CM's remarks on Covid vaccines 'factually incorrect' says Biocon chief Kiran Mazumdar-Shaw, Siddaramaiah hits back
Biocon founder Kiran Mazumdar-Shaw on Thursday (July 3, 2025) opposed Karnataka Chief Minister Siddaramaiah's remarks linking Covid-19 vaccines with a spate of heart attack deaths in the state's Hassan district, saying such claims are 'factually incorrect' and 'misleading'. Siddaramaiah had suggested that the recent heart attack deaths in Hassan district may be linked to the vaccination drive. He had also claimed the vaccines were 'hastily' approved. COVID-19 vaccines developed in India were approved under the Emergency Use Authorisation framework, following rigorous protocols aligned with global standards for safety and efficacy. To suggest that these vaccines were 'hastily' approved is factually incorrect and contributes to… — Kiran Mazumdar-Shaw (@kiranshaw) July 3, 2025 In a social media post, Shaw said 'Covid-19 vaccines developed in India were approved under the Emergency Use Authorisation framework, following rigorous protocols aligned with global standards for safety and efficacy. To suggest that these vaccines were 'hastily' approved is factually incorrect and contributes to public misinformation.' "These vaccines have saved millions of lives and, like all vaccines, may cause side effects in a very small number of individuals. It is important to acknowledge the science and data-driven processes behind their development, rather than engage in retrospective blame," Shaw, Executive Chairperson of the pharma company, said. Not misinformation, but governance rooted in empathy Responding to Shaw, in a post on X, Siddaramaiah said that as chief minister, 'I have a duty to respond to the genuine concerns of people who have lost loved ones unexpectedly. When parents lose their young children or families lose breadwinners without warning, seeking clarity is not misinformation; it is an act of governance rooted in empathy.' Pointing out that several studies and even admissions by manufacturers have acknowledged rare but serious adverse events, he said 'Scientific caution is not anti-science. Many peer-reviewed studies (such as Nature, Circulation, Journal of the American College of Cardiology) have discussed myocarditis and cardiac arrest risk, particularly among young adults post-vaccination, he said. Publicly funded stakeholders must acknowledge both the benefits and the potential risks without fear or favour.' "When I said 'hastily', it reflects the unprecedented speed of emergency rollouts globally without complete long-term data, acknowledged even by WHO and global regulatory agencies, who termed it a 'calculated risk' during a pandemic. Haste is not a sin when saving lives, but acknowledging potential unintended consequences is wisdom. Seeking answers is not retrospective blame. It is the duty of a government that values every life," the CM said. As Chief Minister, I have a duty to respond to the genuine concerns of people who have lost loved ones unexpectedly. When parents lose their young children or families lose breadwinners without warning, seeking clarity is not misinformation; it is an act of governance rooted in… — Siddaramaiah (@siddaramaiah) July 3, 2025 Replying to his post again, Ms. Shaw said that while she concurs with the CM about asking questions and seeking answers in science, she clarified that her comments were related to whether Covid vaccines were approved in haste. 'My response was that due process was followed as prescribed by WHO for safety n efficacy for EUA. Losing lives in a sudden manner is always tragic n I am glad an investigation is being conducted in Hassan District (sic),' she said. CM's statement The Chief Minister had said on July 1 that over 20 people had died of heart attack in Hassan district in the past month alone, and that the state government was taking the matter seriously. He announced the formation of an expert committee led by Dr. Ravindranath, Director of Jayadeva Institute of Cardiovascular Sciences and Research, to investigate the deaths. The committee has been instructed to submit its report within ten days. The CM said a similar directive had been issued in February to study sudden deaths among young people across the state and whether Covid-19 vaccines could have had any adverse effects. "It cannot be denied that the hasty approval and distribution of the covid vaccine to the public could also be a reason for these deaths, as several studies worldwide have recently indicated that covid vaccines could be a cause for the increasing number of heart attacks," Siddaramaiah had said. Union Health Ministry's clarification On Wednesday (July 2), the Union Health Ministry had dismissed the CM's statement, saying extensive studies by ICMR and AIIMS have conclusively established no linkages between coronavirus vaccines and sudden deaths. Studies by the Indian Council of Medical Research (ICMR) and National Centre for Disease Control (NCDC) affirm that Covid-19 vaccines in India are safe and effective, with extremely rare instances of serious side effects, it said. Sudden cardiac deaths can result from a wide range of factors, including genetics, lifestyle, pre-existing conditions, and post-covid complications, the ministry had said in a statement.
New Indian Express
17 hours ago
- Health
- New Indian Express
Karnataka CM Siddaramiah's claims on Covid vaccine factually wrong, says Biocon founder
BENGALURU: Refuting Chief Minister Siddaramaiah's remark that the Covid-19 vaccine might be a reason for a sudden spike in heart attack-related deaths, Biocon founder Kiran Mazumdar-Shaw on Wednesday said that the vaccines were approved under the 'Emergency Use Authorisation' framework, adding that the CM was factually incorrect, contributing to public misinformation. On July 1, Siddaramaiah had claimed that it cannot be denied that the hasty approval and distribution of the Covid-19 vaccine to the public could also be a reason for heart attack deaths. Immediately, the Union Health Ministry took objection to his statement, and dismissed the Covid vaccine link with heart attack deaths. 'Covid-19 vaccines developed in India were approved under the Emergency Use Authorisation framework, following rigorous protocols aligned with global standards for safety and efficacy,' Kiran said on Wednesday, in her reply to the CM's X post. 'To suggest that these vaccines were 'hastily' approved is factually incorrect and contributes to public misinformation,' the Biocon founder stated. She further went on to say that these vaccines have saved millions of lives and, like all vaccines, may cause side effects in a very small number of individuals. 'It is important to acknowledge the science and data-driven processes behind their development, rather than engage in retrospective blame,' she ended.
Time of India
a day ago
- Health
- Time of India
Doctors, experts back govt stand on safety of Covid-19 vaccines
NEW DELHI: Top doctors, industry experts and pharma promoters have joined the Union govt in denying any potential link between Covid-19 vaccination and sudden deaths in the country, days after Karnataka CM Siddaramaiah said that hasty approval and administration of Covid vaccines could be the reason behind such incidents. Dr Randeep Guleria, former director of AIIMS Delhi, said there is no evidence of a link between Covid-19 vaccination and sudden heart attacks. Siddaramaiah's remarks came in the wake of a spate of sudden cardiac deaths in Karnataka's Hassan district in recent weeks. Pharma promoters who compete fiercely in the market all rallied behind domestically manufactured vaccines, including those for Covid-19 and polio. Biocon founder Kiran Mazumdar-Shaw said such claims are "factually incorrect" and "misleading". "Covid-19 vaccines developed in India were approved under Emergency Use Authorisation framework following rigorous protocols aligned with global standards for safety and efficacy. To suggest that these vaccines were 'hastily' approved is factually incorrect and contributes to public misinformation," Shaw said on social media. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like La rutina de abs que necesitas [Descubre] VIDA FIT Leer más Undo She added: "These vaccines have saved millions of lives and, like all vaccines, may cause side effects in a very small number of individuals. It is important to acknowledge the science and data-driven processes behind their development, rather than engage in retrospective blame". Satish Reddy, chairman of Dr Reddy's Laboratories, Dilip Shanghvi, promoter and CMD of Sun Pharma, Pankaj Patel, chairman and promoter of Zydus Lifesciences, and Torrent Pharma chairman Samir Mehta - industry leaders known for their media reticence - each took to social media platforms to endorse India-made vaccines. "They helped end polio and fight Covid. At a time when India is seen as a vaccine leader, let's build trust in science, not doubt it. Public health must stay above politics," Reddy said in a post on X. Patel said on X that there are "other multiple reasons, like age, environmental factors, genetics, lifestyle, etc, that could be the leading cause of heart attacks in people. Several scientific studies globally and in India have conclusively shown that the risk of heart attack or myocarditis is greater after SARS-CoV-2 infection. It has been proven beyond doubt that vaccination remains the most effective and preventive healthcare strategy to reduce deaths and disabilities". Indian Pharmaceutical Alliance (IPA), without naming Siddaramaiah, said, "Misinformation and distortion of facts endanger public health and undermine the trust built on science and patient care globally".
NDTV
a day ago
- Health
- NDTV
Covid Vaccines Not Behind Sudden Deaths, Suggests Top Medical Body Study
New Delhi: None of the Covid vaccine doses are linked to heart attacks and deaths, said Dr Sudheer Arava from AIIMS, who is part of the research currently underway by the Indian Council of Medical Research (ICMR) and the All India Institute of Medical Sciences (AIIMS). Speaking to IANS, he noted that preliminary data so far has shown no indication between heart attack and Covid jabs, developed in the country. "Till now, our study data says that the vaccine has no effect on the cause of death, whether it is a first dose, second dose or third dose, there is no difference in it," Arava added. His comments amid concerns over several heart attack deaths being seen in the country. About the study, Arava, from AIIMS' Department of Pathology, said that it was launched by the ICMR, in the aftermath of deaths happening in the country after the arrival of Covid. Initial results, soon to be published, indicate that 50 per cent of the deaths caused among individuals between 18 to 45 years are due to heart attacks. The other finding is "unexplained death, in which we could not ascertain the cause". Further, to understand whether the deaths match with those during pre-COVID days, they analysed previous data but found no difference in the cause of death. "We found out that the pattern of death rate among young individuals in pre-COVID times is similar to that of during COVID. We did not find any effect of the vaccine in this... There is no clear-cut indication saying that the vaccine causes sudden death in young individuals," Arava told IANS. "The benefits of vaccines far outweigh the very small possible side effects," added Dr Rajiv Narang from the Department of Cardiology, AIIMS. He added that "people should be aware that a heart attack is not a simple issue -- there can be many causes for sudden cardiac arrest". Meanwhile, the Indian Vaccine Manufacturers Association (IVMA) also issued a statement assuring the safety of the Covid vaccines developed in the country. "Covid-19 vaccines of India were developed and manufactured with the highest safety and quality standards," IVMA Director General, Dr G.V.J.A. Harshavardhan, said. "All Covid-19 vaccines in India were approved for Emergency Use Authorisation (restricted use in emergency situations of the WHO guidelines)," he added. Harshavardhan noted that the approvals were based on extensive evaluation in preclinical studies and human clinical trials. He stated that the Indian vaccines not only helped "control the Covid-19 pandemic and restrict its impact on lives, livelihoods, but most importantly, enabling India's economic activity and GDP to rebound and grow to new heights globally". Harshavardhan said that the benefits of India-made Covid jabs were also extended to several countries worldwide, under the government's Vaccine Maitri programme. "We hereby reassure the public on the safety and efficacy of Covid-19 vaccines," he said.
