Latest news with #EmergencyUseAuthorization
Time of India
2 days ago
- Health
- Time of India
Govt Reaffirms COVID Vaccine Safety as Private Hospitals Stay Quiet—Raising Questions
New Delhi: As concerns about sudden cardiac deaths among young adults continue to make headlines, the Indian government and top pharmaceutical voices have reiterated that COVID-19 vaccines are safe, effective, and not linked to heart-related fatalities. However, a curious silence from leading private hospitals and senior doctors—who played a central role in the nationwide vaccination drive—is beginning to raise questions about transparency and public engagement. Private hospitals, which were deeply involved in the vaccination rollout, remaining silent at this juncture cannot be taken lightly. This silence is not necessarily an admission of doubt, but the absence of their voice in the public domain—especially when scientific clarity is most needed—has not gone unnoticed. Health authorities maintain that India's vaccines have undergone rigorous testing and regulatory scrutiny. Dr. G.V.J.A. Harshavardhan, Director General of the Indian Vaccine Manufacturers Association, in an official statement, reaffirmed:'COVID-19 vaccines of India were developed and manufactured with the highest safety and quality standards. Patient safety and product quality are always prioritized during the vaccine development and its manufacture.' He added that all vaccines were approved for Emergency Use Authorization (EUA) based on extensive preclinical and clinical trials demonstrating safety, efficacy, and immunogenicity. 'Prior to their release, all COVID-19 vaccines are tested extensively for safety by the manufacturers and are also provided Batch Release Certification by the Central Drugs Laboratory (CDL), Kasauli, Himachal Pradesh, of the Ministry of Health and Family Welfare,' he said. 'The strengths of innovation and large-scale high-quality manufacturing are the hallmarks of the Indian vaccine ecosystem.' India's Global Vaccine Leadership During the pandemic, India supplied vaccines to over 90 countries under its Vaccine Maitri initiative. Officials cite this as proof of international confidence in Indian-made vaccines. Sudarshan Jain, Secretary General of the Indian Pharmaceutical Alliance, echoed this sentiment and raised concerns about the harmful impact of misinformation. 'The Indian pharmaceutical industry is a knowledge-driven sector and plays a vital role in global health. India accounts for 60 per cent of global vaccine production. These vaccines have been well documented and rigorously tested as per regulatory processes,' he said. 'Misinformation and distortion of facts endanger public health and undermine the trust built on science and patient care globally.' Private Hospitals, Key Vaccination Partners, Maintain Silence as Questions Mount Despite these strong assurances, prominent private hospitals and top medical experts associated with them have largely refrained from commenting on the rising concerns related to post-vaccination adverse events . ETHealthworld reached out to several hospital networks involved in mass immunization, but most declined to comment or said they had no official position at this time. This silence is puzzling. These institutions were once highly vocal during the vaccine rollout, actively conducting drives, issuing FAQs, and promoting vaccine awareness. Their muted response today, amid public anxiety, is being seen as a missed opportunity to educate and reassure. 'We're not blaming hospitals,' said a senior public health expert, 'but their absence in this conversation is noticeable. If the data supports vaccine safety—as government and pharma leaders insist—then trusted medical institutions should lead from the front, explaining how adverse events are monitored and managed. Silence only deepens doubt.' Experts say the role of private hospitals is critical not just in vaccine delivery, but in reinforcing public trust. With vaccine hesitancy rising globally, communication gaps—especially from frontline players—risk allowing misinformation to fill the void. Why Transparency Now Matters More Than Ever? In an age where misinformation travels faster than facts, silence can be dangerous. Transparency—even when dealing with rare or uncomfortable adverse events—is essential to preserving long-term confidence in scientific interventions. India's COVID-19 vaccination program has been widely praised for its scale and speed. But success in public health doesn't end with delivery—it continues through open dialogue, education, and the courage to confront evolving narratives head-on. As the debate around vaccine safety intensifies, it is essential that all stakeholders—government bodies, pharmaceutical leaders, and healthcare institutions—participate in a unified, fact-based public conversation. Rebuilding and reinforcing public trust isn't just a policy goal. It's a shared responsibility.
CNN
4 days ago
- Politics
- CNN
House committee subpoenas Pfizer executive in probe of alleged Covid vaccine delay
The House Judiciary Committee has subpoenaed a former Pfizer executive who is considered central to its investigation into an allegation that clinical testing related to the development of the company's Covid-19 vaccine was purposefully delayed until after the 2020 presidential election, according to documents obtained by CNN Monday. The demand for documents and a deposition from Dr. Philip Dormitzer, first obtained by CNN, comes after the committee says Dormitzer has failed to comply with requests to appear voluntarily and turn over records. Dormitzer is a key figure in the legislative probe. The committee has alleged that it had information the former Pfizer executive, after going to work for British drugmaker GSK, told his colleagues that Pfizer had delayed announcing its Covid vaccine was effective until after the election. The Wall Street Journal reported that GSK brought those claims to federal prosecutors in Manhattan. But Dormitzer disputed that there had been any delay in seeking approval for the vaccine. He told the newspaper, 'My Pfizer colleagues and I did everything we could to get the FDA's Emergency Use Authorization at the very first possible moment,' and that 'any other interpretation of my comments about the pace of the vaccine's development would be incorrect.' CNN reached out to Dormitzer and his representative for comment. In issuing him a subpoena, the Judiciary Committee noted his importance to the probe. 'Based on the information we have obtained to date, the Committee believes your testimony is critical for our oversight,' the letter said. Pfizer's announcement about the effectiveness of its Covid-19 vaccine came nearly a week after Election Day, but Pfizer CEO Albert Bourla has said the timing had nothing to do with politics. In an interview with CNN Chief Medical Correspondent Sanjay Gupta after the election in 2020, Bourla threw cold water on the idea that there was any political motivation behind releasing the news after voters in the United States chose their candidate for president. GSK is a rival drugmaker. The committee has said it received information from GSK about Dormitzer's November 2024 interactions with a GSK human resources representative. The committee highlighted information GSK provided, but CNN has not reviewed the full GSK letter. CNN has reached out to the committee to request the letter. 'As the human resources representative recalls, in their meeting, Dr. Dormitzer was visibly upset; he requested that he be relocated to Canada due to concerns that he could be investigated by the incoming Trump Administration over his role in developing Pfizer's COVID-19 vaccine,' GSK said, according to a letter from House Judiciary Chair Jim Jordan. 'According to the human resources representative, when asked what prompted his request, Dr. Dormitzer made a comment to the effect of: 'Let's just say it wasn't a coincidence, the timing of the vaccine',' the letter adds. Jordan also quoted GSK's claim that Dormitzer told his former colleagues at the company 'in late 2020, the three most senior people in Pfizer R&D were involved in a decision to deliberately slow down clinical testing so that it would not be complete prior to the results of the presidential election that year.' The committee has also sought information from Pfizer directly, but has not issued the company a subpoena.
The Hill
10-06-2025
- Health
- The Hill
Trump administration vs. mRNA vaccines
The Big Story President Trump once heralded the speedy development of an mRNA vaccine, but his new administration is casting doubts and fostering speculation over their use. © AP The Department of Health and Human Services (HHS) in late May canceled $766 million awarded to Moderna through the Biomedical Advanced Research and Development Authority (BARDA) to develop a potential mRNA vaccine for bird flu. This came soon after HHS Secretary Robert F. Kennedy Jr. announced COVID-19 mRNA vaccines would no longer be recommended for children and pregnant women, though the Centers for Disease Control and Prevention (CDC) kept the shot on its schedule of childhood vaccinations. The vaccines marked a breakthrough in medical technology, drastically reducing the timeline for development of targeted vaccines and even showing promise in cancer research. Trump called mRNA the 'gold standard' when he rolled out the first COVID-19 vaccines. In remarks in December 2020, the same month the first COVID-19 vaccines were deployed, Trump praised Operation Warp Speed's ability to develop a SARS-CoV-2 vaccine at a 'breakneck speed,' adding, 'the gold standard vaccine has been done in less than nine months.' According to Joseph Varon, president and chief medical officer of the Independent Medical Alliance, the concerns for mRNA vaccine skeptics are the expedited timeline and the conditions in which the COVID-19 vaccine was approved. 'The biggest concern is that this rushed treatment still remains in use, even under an Emergency Use Authorization in some cases. It needs to be sent back through proper studies and vetting,' Varon told The Hill. In a move that could prevent future mRNA vaccines from receiving approval, Kennedy on Tuesday announced he was removing every member of the independent panel advising the CDC on vaccines. In a Wall Street Journal op-ed, he wrote, 'A clean sweep is needed to re-establish public confidence in vaccine science.' Welcome to The Hill's Health Care newsletter, we're Nathaniel Weixel, Joseph Choi and Alejandra O'Connell-Domenech — every week we follow the latest moves on how Washington impacts your health. Did someone forward you this newsletter? Subscribe here. Essential Reads How policy will be impacting the health care sector this week and beyond: Senators grill NIH director in budget hearing: 4 takeaways National Institutes of Health Director Jay Bhattacharya faced questions from senators during an Appropriations subcommittee hearing Tuesday, as the federal government agency has taken hits to its staffing levels and grant-making ability since under President Trump. Senators focused on the Trump administration's requested 2026 budget, which calls for cutting NIH's funding by $18 billion from 2025 levels. … States sue 23andMe over genetic data sales More than two dozen states, along with the District of Columbia, are suing biotechnology company 23andMe over plans to auction off personal genetic information without their customers' knowledge or consent. 'The Pitt' actor Noah Wyle to make push for health care workers at Capitol Noah Wyle is heading to the pit of political power, with a visit to Capitol Hill to push for funding for programs aimed at improving mental health services for health care workers. 'The Pitt' and former 'ER' star will touch down in Washington on Thursday to lead a panel discussion at the Cannon House Office Building focused on the 'daily mental health, financial, and bureaucratic challenges for … In Other News Branch out with a different read: Collins calls Kennedy's firing of vaccine experts 'excessive' Sen. Susan Collins (R-Maine) on Monday called Health and Human Services Secretary Robert F. Kennedy Jr.'s firing of all 17 experts on the U.S. Centers for Disease Control and Prevention's (CDC) vaccine panel 'excessive,' but she cautioned she needs to learn more about the decision. Kennedy announced the decision in an op-ed for The Wall Street Journal, catching many GOP lawmakers by surprise. 'I did not know that that had happened,' … Around the Nation Local and state headlines on health care: What We're Reading Health news we've flagged from other outlets: What Others are Reading Most read stories on The Hill right now: Judge declines to block Trump's Corporation for Public Broadcasting firings but allows board members to stay Correction: A previous version of this article gave incorrect names of the fired CPB board members. They are Laura Ross, Diane Kaplan and Thomas Rothman. … Read more Newsom asks judge for emergency intervention in Trump troop deployment in LA California Gov. Gavin Newsom (D) asked a federal judge to immediately intervene on Tuesday to limit President Trump's deployment of the National … Read more You're all caught up. See you tomorrow! Thank you for signing up! Subscribe to more newsletters here
Yahoo
10-06-2025
- Health
- Yahoo
Why Trump turned against ‘gold standard' mRNA vaccines
President Trump's administration has slammed the brakes on development of messenger RNA (mRNA) vaccines, which proved their lifesaving potential during the COVID-19 pandemic but have come under increasing scrutiny among skeptics of mainstream science. The vaccines marked a breakthrough in medical technology, drastically reducing the timeline for development of targeted vaccines and even showing promise in cancer research. Trump called mRNA the 'gold standard' when he rolled out the first COVID-19 vaccines. But now they are under assault by Trump's Health and Human Services (HHS) secretary, longtime anti-vaccine advocate Robert F. Kennedy Jr., and his allies in the 'make America healthy again' movement. HHS in late May canceled $766 million awarded to Moderna through the Biomedical Advanced Research and Development Authority (BARDA) to develop a potential mRNA vaccine for bird flu. HHS spokesperson Andrew Nixon said of the decision, 'This is not simply about efficacy — it's about safety, integrity, and trust.' 'The reality is that mRNA technology remains under-tested, and we are not going to spend taxpayer dollars repeating the mistakes of the last administration, which concealed legitimate safety concerns from the public,' he added. Unlike traditional vaccines that contain fragments or weakened versions of a virus, mRNA vaccines send messenger ribonucleic acid into cells to teach the immune system to recognize proteins connected to virus cells. According to Joseph Varon, president and chief medical officer of the Independent Medical Alliance (IMA), the concerns for mRNA vaccine skeptics are the expedited timeline and conditions in which the COVID-19 vaccine was approved. 'The biggest concern is that this rushed treatment still remains in use, even under an Emergency Use Authorization in some cases. It needs to be sent back through proper studies and vetting,' Varon told The Hill. 'There needs to be an established database of vaccine injuries that can be accurately quantified with full transparency, without politics or big money pressure influencing the data,' he added. 'There's a growing body of peer-reviewed studies that indicate the spike proteins are causing havoc in certain recipients.' The IMA, previously known as Front Line COVID-19 Critical Care Alliance, launched a campaign in support of Kennedy's nomination to be HHS secretary. The group drew controversy when its founders promoted ivermectin as a 'miracle drug' for COVID-19. Myocarditis, or inflammation of the heart muscle, is of particular concern among mRNA vaccine opponents. An analysis published in 2022 found that myocarditis occurred in about 31.2 cases per 1 million second doses of the Moderna COVID-19 vaccine, or 0.003 percent. Rates of myocarditis are significantly higher among people with COVID-19 infections than immunizations, however. The development of the COVID-19 mRNA vaccine was aided by the Trump administration's Operation Warp Speed, something Trump has boasted about at numerous points. In remarks in December 2020, the same month the first COVID-19 vaccines were deployed, Trump praised Operation Warp Speed's ability to develop a SARS-CoV-2 vaccine at a 'breakneck speed,' adding 'the gold standard vaccine has been done in less than nine months.' Though research on mRNA and its potential uses has been ongoing for decades, use of the vaccines in humans is relatively new. The first mRNA vaccine candidate tested in humans was for rabies in 2013, but it wouldn't be until the COVID-19 pandemic in 2020 that this technology would achieve commercial viability and widespread use. To Kennedy, this is too much of a coincidence. In his book 'The Wuhan Cover-Up: And the Terrifying Bioweapons Arms Race,' published in 2023, Kennedy suggests it was more than just happenstance that allowed for the deployment of Moderna's mRNA technology to coincide with the global pandemic. He pointed to a meeting attended by Dr. Anthony Fauci and former BARDA Director Rick Bright in which the officials met with virologists months before the COVID-19 pandemic broke out. The fact that attendees discussed the need for innovation in influenza research and vaccines became a point of conspiracy online. Kennedy noted that Bright called for something 'completely disruptive, that's not beholden to bureaucratic strings and processes,' writing, '[Bright] hinted that only a global crisis — like a pandemic — could induce government and industry to commit the billions of dollars necessary to create a new generation of 'plug-and-play' mRNA vaccines.' In the conversation Kennedy references, Bright was discussing the challenges of making influenza research 'sexy' for Ph.D. and postdoctoral students, surmising that something 'completely disruptive' would be needed to incite excitement in the field. Proponents of the mRNA technology point to its deployment in the COVID-19 pandemic and its role in reducing transmission as evidence of safety and efficacy. 'In the U.S., you know, we have a lot of real-world experience now with huge numbers of doses given. We have been following for significant or serious adverse events for a long time, and the rate of those serious adverse events is on par with what we see for other vaccines,' E. John Wherry, director of the Institute for Immunology and Immune Health at the University of Pennsylvania, said of mRNA vaccines. As Wherry notes, all vaccines have adverse side effects, but their safety compared with the diseases they inoculate against is 'incontrovertible.' And while critics take issue with the speed at which mRNA vaccines are developed, Wherry said this difference is precisely what sets these shots apart from older generations. 'mRNA vaccines have a couple of key benefits or features that really stand out compared to other vaccine platforms. One, they can be generated very, very quickly. So, you can adapt to changes very rapidly. This is much easier with an mRNA vaccine, where the COVID strain or flu strain mutates and changes from year to year,' Wherry said. 'The second is that it's relatively simple. So, we don't have to worry about, you know, impurities in, you know, an egg-grown vaccine or a cell-based grown vaccine synthesizing mRNA. There are very few components that go into it, and it can be synthesized with high purity.' Such mRNA vaccines are also potentially applicable for numerous conditions or even multiple different strains of the same virus, giving it more flexibility than traditional vaccinations. 'So, there are substantial benefits in flexibility, in speed, in simplicity of manufacturing and that probably also affects the cost of goods at the end of the day, which is perhaps a last advantage,' Wherry added. Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
The Hill
10-06-2025
- Health
- The Hill
Why Trump turned against ‘gold standard' mRNA vaccines
President Trump's administration has slammed the brakes on development of messenger RNA (mRNA) vaccines, which proved their lifesaving potential during the COVID-19 pandemic but have come under increasing scrutiny among skeptics of mainstream science. The vaccines marked a breakthrough in medical technology, drastically reducing the timeline for development of targeted vaccines and even showing promise in cancer research. Trump called mRNA the 'gold standard' when he rolled out the first COVID-19 vaccines. But now they are under assault by Trump's Health and Human Services (HHS) secretary, longtime anti-vaccine advocate Robert F. Kennedy Jr., and his allies in the 'make America healthy again' movement. HHS in late May canceled $766 million awarded to Moderna through the Biomedical Advanced Research and Development Authority (BARDA) to develop a potential mRNA vaccine for bird flu. HHS spokesperson Andrew Nixon said of the decision, 'This is not simply about efficacy — it's about safety, integrity, and trust.' 'The reality is that mRNA technology remains under-tested, and we are not going to spend taxpayer dollars repeating the mistakes of the last administration, which concealed legitimate safety concerns from the public,' he added. Unlike traditional vaccines that contain fragments or weakened versions of a virus, mRNA vaccines send messenger ribonucleic acid into cells to teach the immune system to recognize proteins connected to virus cells. According to Joseph Varon, president and chief medical officer of the Independent Medical Alliance (IMA), the concerns for mRNA vaccine skeptics are the expedited timeline and conditions in which the COVID-19 vaccine was approved. 'The biggest concern is that this rushed treatment still remains in use, even under an Emergency Use Authorization in some cases. It needs to be sent back through proper studies and vetting,' Varon told The Hill. 'There needs to be an established database of vaccine injuries that can be accurately quantified with full transparency, without politics or big money pressure influencing the data,' he added. 'There's a growing body of peer-reviewed studies that indicate the spike proteins are causing havoc in certain recipients.' The IMA, previously known as Front Line COVID-19 Critical Care Alliance, launched a campaign in support of Kennedy's nomination to be HHS secretary. The group drew controversy when its founders promoted ivermectin as a 'miracle drug' for COVID-19. Myocarditis, or inflammation of the heart muscle, is of particular concern among mRNA vaccine opponents. An analysis published in 2022 found that myocarditis occurred in about 31.2 cases per 1 million second doses of the Moderna COVID-19 vaccine, or 0.003 percent. Rates of myocarditis are significantly higher among people with COVID-19 infections than immunizations, however. The development of the COVID-19 mRNA vaccine was aided by the Trump administration's Operation Warp Speed, something Trump has boasted about at numerous points. In remarks in December 2020, the same month the first COVID-19 vaccines were deployed, Trump praised Operation Warp Speed's ability to develop a SARS-CoV-2 vaccine at a 'breakneck speed,' adding 'the gold standard vaccine has been done in less than nine months.' Though research on mRNA and its potential uses has been ongoing for decades, use of the vaccines in humans is relatively new. The first mRNA vaccine candidate tested in humans was for rabies in 2013, but it wouldn't be until the COVID-19 pandemic in 2020 that this technology would achieve commercial viability and widespread use. To Kennedy, this is too much of a coincidence. In his book 'The Wuhan Cover-Up: And the Terrifying Bioweapons Arms Race,' published in 2023, Kennedy suggests it was more than just happenstance that allowed for the deployment of Moderna's mRNA technology to coincide with the global pandemic. He pointed to a meeting attended by Dr. Anthony Fauci and former BARDA Director Rick Bright in which the officials met with virologists months before the COVID-19 pandemic broke out. The fact that attendees discussed the need for innovation in influenza research and vaccines became a point of conspiracy online. Kennedy noted that Bright called for something 'completely disruptive, that's not beholden to bureaucratic strings and processes,' writing, '[Bright] hinted that only a global crisis — like a pandemic — could induce government and industry to commit the billions of dollars necessary to create a new generation of 'plug-and-play' mRNA vaccines.' In the conversation Kennedy references, Bright was discussing the challenges of making influenza research 'sexy' for Ph.D. and postdoctoral students, surmising that something 'completely disruptive' would be needed to incite excitement in the field. Proponents of the mRNA technology point to its deployment in the COVID-19 pandemic and its role in reducing transmission as evidence of safety and efficacy. 'In the U.S., you know, we have a lot of real-world experience now with huge numbers of doses given. We have been following for significant or serious adverse events for a long time, and the rate of those serious adverse events is on par with what we see for other vaccines,' E. John Wherry, director of the Institute for Immunology and Immune Health at the University of Pennsylvania, said of mRNA vaccines. As Wherry notes, all vaccines have adverse side effects, but their safety compared with the diseases they inoculate against is 'incontrovertible.' And while critics take issue with the speed at which mRNA vaccines are developed, Wherry said this difference is precisely what sets these shots apart from older generations. 'mRNA vaccines have a couple of key benefits or features that really stand out compared to other vaccine platforms. One, they can be generated very, very quickly. So, you can adapt to changes very rapidly. This is much easier with an mRNA vaccine, where the COVID strain or flu strain mutates and changes from year to year,' Wherry said. 'The second is that it's relatively simple. So, we don't have to worry about, you know, impurities in, you know, an egg-grown vaccine or a cell-based grown vaccine synthesizing mRNA. There are very few components that go into it, and it can be synthesized with high purity.' Such mRNA vaccines are also potentially applicable for numerous conditions or even multiple different strains of the same virus, giving it more flexibility than traditional vaccinations. 'So, there are substantial benefits in flexibility, in speed, in simplicity of manufacturing and that probably also affects the cost of goods at the end of the day, which is perhaps a last advantage,' Wherry added.
