Latest news with #Prasad
Chicago Tribune
31 minutes ago
- Health
- Chicago Tribune
FDA vaccine official restricted COVID vaccine approvals against the advice of agency staff
WASHINGTON — The government's top vaccine official working under Health Secretary Robert F. Kennedy Jr. recently restricted the approval of two COVID-19 vaccines, disregarding recommendations from government scientists, according to federal documents released Wednesday. The new memos from the Food and Drug Administration show how the agency's vaccine chief, Dr. Vinay Prasad, personally intervened to place restrictions on COVID shots from vaccine makers Novavax and Moderna. Both vaccines were approved by the FDA in May after months of analysis by rank-and-file FDA reviewers. But internal correspondence show Prasad disagreed with staffers who planned to approve the shots for everyone 12 and older, similar to previous COVID vaccines. The scientists had concluded the benefit from the vaccines and the risk of COVID-19 outweighed the risk of possible side effects, which are rare. Instead Prasad decided the shots should be limited to those who face special risks from the virus— seniors or children and adults with underlying medical issues. Prasad explained that the COVID vaccine benefits must be reconsidered in light of falling rates of death and hospitalization and the possibility for vaccine side effects. It's the latest in a series of vaccine restrictions imposed by officials working under Kennedy, who has long questioned the benefits of vaccines. 'Even rare vaccination related harms both known and unknown now have higher chance of outweighing potential benefits' Prasad wrote in a five-page memo explaining his decision. COVID-19 remains a public health threat, resulting in 32,000 to 51,000 U.S. deaths and more than 250,000 hospitalizations since last fall, according to the Centers for Disease Control and Prevention. Most at risk for hospitalization are seniors and children under 2 — especially infants under 6 months. Top FDA leaders are typically not involved in the review of individual products. Officials like Prasad can overrule staffers, but such cases are rare and often controversial. News of the FDA documents was first reported by the New York Times. Prasad was hired to lead the FDA's vaccine center in May, after the previous director, Dr. Peter Marks, was forced to resign over disagreements with Kennedy. An academic researcher specializing in cancer therapies, Prasad came to prominence during the pandemic for criticizing public health measures, including the FDA's approval of COVID boosters for healthy adults and children. Since arriving at the agency he has worked with FDA Commissioner Mark Makary on new guidelines that will limit approvals of future COVID boosters to higher-risk Americans, mainly seniors and those with medical conditions like asthma and obesity. Those limits match the terms FDA recently approved for Novavax's shot, Nuvaxovid and Moderna's mNexspike. Novavax's vaccine is the only protein-based coronavirus vaccine available in the U.S. Moderna's vaccine is an updated, lower-dose version of its existing mRNA-based vaccine. The review team for the Novavax vaccine pointed to data from a study in 30,000 adults, concluding that 'the risk-benefit assessment for this vaccine technology remains favorable.' FDA staff reached a similar conclusion for the Moderna vaccine, deeming it similar in safety and effectiveness to the company's original shot. Last week, the FDA finalized new warning labeling about the risk of myocarditis, a rare form of heart inflammation, on shots from Moderna and Pfizer, the other maker of an mRNA-based shot for COVID. In his 'override memo,' reversing FDA staff's decision on the Moderna shot, Prasad pointed to the ongoing risk of myocarditis and questions about its frequency. The agency ordered Moderna to conduct further studies of the risk as a condition for the approving its updated shot. A spokesman for the administration said Prasad 'has raised serious concerns' about the issue. 'We will not ignore these risks and will ensure that the gold standard of science is used for any decisions,' said Andrew Nixon, in an emailed statement. Outside researchers have noted that cases of the heart condition tend to resolve quickly and are less severe than those associated with COVID infection itself, which can also cause myocarditis.
Winnipeg Free Press
43 minutes ago
- Health
- Winnipeg Free Press
FDA vaccine official restricted COVID vaccine approvals against the advice of agency staff
WASHINGTON (AP) — The government's top vaccine official working under Health Secretary Robert F. Kennedy Jr. recently restricted the approval of two COVID-19 vaccines, disregarding recommendations from government scientists, according to federal documents released Wednesday. The new memos from the Food and Drug Administration show how the agency's vaccine chief, Dr. Vinay Prasad, personally intervened to place restrictions on COVID shots from vaccine makers Novavax and Moderna. Both vaccines were approved by the FDA in May after months of analysis by rank-and-file FDA reviewers. But internal correspondence show Prasad disagreed with staffers who planned to approve the shots for everyone 12 and older, similar to previous COVID vaccines. The scientists had concluded the benefit from the vaccines and the risk of COVID-19 outweighed the risk of possible side effects, which are rare. Instead Prasad decided the shots should be limited to those who face special risks from the virus— seniors or children and adults with underlying medical issues. Prasad explained that the COVID vaccine benefits must be reconsidered in light of falling rates of death and hospitalization and the possibility for vaccine side effects. It's the latest in a series of vaccine restrictions imposed by officials working under Kennedy, who has long questioned the benefits of vaccines. 'Even rare vaccination related harms both known and unknown now have higher chance of outweighing potential benefits' Prasad wrote in a five-page memo explaining his decision. COVID-19 remains a public health threat, resulting in 32,000 to 51,000 U.S. deaths and more than 250,000 hospitalizations since last fall, according to the Centers for Disease Control and Prevention. Most at risk for hospitalization are seniors and children under 2 — especially infants under 6 months. Top FDA leaders are typically not involved in the review of individual products. Officials like Prasad can overrule staffers, but such cases are rare and often controversial. News of the FDA documents was first reported by the New York Times. Prasad was hired to lead the FDA's vaccine center in May, after the previous director, Dr. Peter Marks, was forced to resign over disagreements with Kennedy. An academic researcher specializing in cancer therapies, Prasad came to prominence during the pandemic for criticizing public health measures, including the FDA's approval of COVID boosters for healthy adults and children. Since arriving at the agency he has worked with FDA Commissioner Mark Makary on new guidelines that will limit approvals of future COVID boosters to higher-risk Americans, mainly seniors and those with medical conditions like asthma and obesity. Those limits match the terms FDA recently approved for Novavax's shot, Nuvaxovid and Moderna's mNexspike. Novavax's vaccine is the only protein-based coronavirus vaccine available in the U.S. Moderna's vaccine is an updated, lower-dose version of its existing mRNA-based vaccine. The review team for the Novavax vaccine pointed to data from a study in 30,000 adults, concluding that 'the risk-benefit assessment for this vaccine technology remains favorable.' FDA staff reached a similar conclusion for the Moderna vaccine, deeming it similar in safety and effectiveness to the company's original shot. Last week, the FDA finalized new warning labeling about the risk of myocarditis, a rare form of heart inflammation, on shots from Moderna and Pfizer, the other maker of an mRNA-based shot for COVID. In his 'override memo,' reversing FDA staff's decision on the Moderna shot, Prasad pointed to the ongoing risk of myocarditis and questions about its frequency. The agency ordered Moderna to conduct further studies of the risk as a condition for the approving its updated shot. Monday Mornings The latest local business news and a lookahead to the coming week. A spokesman for the administration said Prasad 'has raised serious concerns' about the issue. 'We will not ignore these risks and will ensure that the gold standard of science is used for any decisions,' said Andrew Nixon, in an emailed statement. Outside researchers have noted that cases of the heart condition tend to resolve quickly and are less severe than those associated with COVID infection itself, which can also cause myocarditis. ___ The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
San Francisco Chronicle
an hour ago
- Health
- San Francisco Chronicle
FDA vaccine official restricted COVID vaccine approvals against the advice of agency staff
WASHINGTON (AP) — The government's top vaccine official working under Health Secretary Robert F. Kennedy Jr. recently restricted the approval of two COVID-19 vaccines, disregarding recommendations from government scientists, according to federal documents released Wednesday. The new memos from the Food and Drug Administration show how the agency's vaccine chief, Dr. Vinay Prasad, personally intervened to place restrictions on COVID shots from vaccine makers Novavax and Moderna. Both vaccines were approved by the FDA in May after months of analysis by rank-and-file FDA reviewers. But internal correspondence show Prasad disagreed with staffers who planned to approve the shots for everyone 12 and older, similar to previous COVID vaccines. The scientists had concluded the benefit from the vaccines and the risk of COVID-19 outweighed the risk of possible side effects, which are rare. Instead Prasad decided the shots should be limited to those who face special risks from the virus— seniors or children and adults with underlying medical issues. Prasad explained that the COVID vaccine benefits must be reconsidered in light of falling rates of death and hospitalization and the possibility for vaccine side effects. It's the latest in a series of vaccine restrictions imposed by officials working under Kennedy, who has long questioned the benefits of vaccines. 'Even rare vaccination related harms both known and unknown now have higher chance of outweighing potential benefits' Prasad wrote in a five-page memo explaining his decision. COVID-19 remains a public health threat, resulting in 32,000 to 51,000 U.S. deaths and more than 250,000 hospitalizations since last fall, according to the Centers for Disease Control and Prevention. Most at risk for hospitalization are seniors and children under 2 — especially infants under 6 months. Top FDA leaders are typically not involved in the review of individual products. Officials like Prasad can overrule staffers, but such cases are rare and often controversial. News of the FDA documents was first reported by the New York Times. Prasad was hired to lead the FDA's vaccine center in May, after the previous director, Dr. Peter Marks, was forced to resign over disagreements with Kennedy. An academic researcher specializing in cancer therapies, Prasad came to prominence during the pandemic for criticizing public health measures, including the FDA's approval of COVID boosters for healthy adults and children. Since arriving at the agency he has worked with FDA Commissioner Mark Makary on new guidelines that will limit approvals of future COVID boosters to higher-risk Americans, mainly seniors and those with medical conditions like asthma and obesity. Those limits match the terms FDA recently approved for Novavax's shot, Nuvaxovid and Moderna's mNexspike. Novavax's vaccine is the only protein-based coronavirus vaccine available in the U.S. Moderna's vaccine is an updated, lower-dose version of its existing mRNA-based vaccine. The review team for the Novavax vaccine pointed to data from a study in 30,000 adults, concluding that 'the risk-benefit assessment for this vaccine technology remains favorable.' FDA staff reached a similar conclusion for the Moderna vaccine, deeming it similar in safety and effectiveness to the company's original shot. Last week, the FDA finalized new warning labeling about the risk of myocarditis, a rare form of heart inflammation, on shots from Moderna and Pfizer, the other maker of an mRNA-based shot for COVID. In his 'override memo,' reversing FDA staff's decision on the Moderna shot, Prasad pointed to the ongoing risk of myocarditis and questions about its frequency. The agency ordered Moderna to conduct further studies of the risk as a condition for the approving its updated shot. A spokesman for the administration said Prasad 'has raised serious concerns' about the issue. 'We will not ignore these risks and will ensure that the gold standard of science is used for any decisions,' said Andrew Nixon, in an emailed statement. Outside researchers have noted that cases of the heart condition tend to resolve quickly and are less severe than those associated with COVID infection itself, which can also cause myocarditis. ___ The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
Hans India
11 hours ago
- Politics
- Hans India
‘Silent emergency': TN BJP on cases against Murugan devotees meet participants
Chennai: The Tamil Nadu unit of the Bharatiya Janata Party (BJP) on Tuesday accused the ruling DMK government of imposing a 'silent emergency' in the state, following police action against participants of the Murugan Devotees' Conference held in Madurai last month. BJP spokesperson A.N.S. Prasad strongly condemned the filing of police cases against several leaders, including Tamil Nadu BJP President Nainar Nagendran, former party chief K. Annamalai, and Hindu Munnani leader Kadeswara Subramanian. The cases were registered in connection with their participation in the June 22nd devotional gathering, which saw the attendance of over 5 lakh devotees. Prasad questioned the rationale behind the police action, stating that the event was conducted in an exceptionally peaceful and disciplined manner. 'Even critics of the BJP in the media had to acknowledge the flawless organisation of the event. There were no law-and-order issues, no traffic disruptions, and no reports of public inconvenience. Devotees even cleaned the venue themselves after the event,' he said. He alleged that the DMK government had remained silent for 10 days before launching a politically motivated crackdown aimed at appeasing minority vote banks, using the pretext of 'external instigation.' Prasad said the state's law and order situation had deteriorated drastically under Chief Minister M.K. Stalin's leadership. 'There is growing fear that Tamil Nadu is descending into lawlessness, where the police act like gangs of thugs. Even the DMK's own MLA, Inigo Irudayaraj, has publicly stated that 'police turned into beasts' and beat temple guard Ajithkumar to death.' The alleged custodial death of Ajithkumar in Sivaganga district has further fuelled criticism of the government. Initially, the state attempted to downplay the incident, but video footage of the police assault and scathing remarks from the Madras High Court forced a CBI inquiry. 'The DMK government's response has been mere theatrics - with a minister sent for damage control and the Chief Minister making a staged phone call to the victim's family,' said Prasad. The BJP also slammed the DMK for what it called 'anti-Hindu' actions and rhetoric. Prasad pointed to recent remarks by DMK Deputy General Secretary and former Union Minister A. Raja, who allegedly used derogatory language against Union Home Minister Amit Shah. Protests against Raja erupted across the state, and during one such demonstration at Chepauk in Chennai, BJP State Vice President Narayanan Thirupathi was allegedly manhandled and arrested. The BJP also accused the police of brutality against women protestors, alleging multiple human rights violations. 'Since Union Home Minister Amit Shah confirmed the AIADMK-BJP alliance and visited Tamil Nadu twice, the DMK has lost its peace of mind,' said Prasad. 'Fearing defeat in the upcoming Assembly elections, the ruling party has resorted to suppressive tactics and widespread intimidation,' he added. The BJP has demanded that the state government immediately withdraw what it calls 'false cases' and restore democratic norms. 'The people of Tamil Nadu are watching. In this age of social media, truth cannot be hidden. The consequences of this authoritarianism will soon be reflected in the ballot boxes,' Prasad warned.
Time of India
a day ago
- Business
- Time of India
Ras-Al-Khaimah (RAK) govt moves Telangana HC: Accuses Nimmagadda Prasad of fresh 2,500 crore fraud; despite ongoing legal cases
HYDERABAD: The govt of Ras-Al-Khaimah (RAK), an emirate of the United Arab Emirates, has approached the Telangana high court alleging that businessman Nimmagadda Prasad has once again committed fraud against its investment arm, the Ras-Al-Khaimah Investment Authority (RAKIA), despite ongoing legal proceedings. The dispute pertains to an earlier partnership between RAKIA and the Andhra Pradesh govt, which had invited RAKIA to invest in the development of the Vanpic Port and Industrial Corridor. RAKIA alleged that after teaming up with Prasad, it became a victim of large-scale misappropriation and cheating through companies linked to him. According to RAKIA, Prasad acquired large tracts of land, including govt-assigned lands, under the pretext of investment. These transactions were probed by the CBI and the Enforcement Directorate, both of which filed detailed chargesheets outlining the alleged wrongdoing. Criminal proceedings related to these investigations are still pending in India. You Can Also Check: Hyderabad AQI | Weather in Hyderabad | Bank Holidays in Hyderabad | Public Holidays in Hyderabad In the high court, RAKIA argued that it has once again become a victim of concealment and deceit, claiming that companies involved in fundraising activities worth ₹2,500 crore were using Prasad's name while denying his formal association. Prasad and the companies, however, have denied any wrongdoing, asserting that he is not connected with any of the companies in question. The matter was extensively argued before Justice K Lakshman, who has now reserved judgment. RAKIA had also filed a civil suit in the UAE and obtained a judgment worth over ₹600 crore against Prasad. It then sought to enforce the foreign decree in the Commercial Court in Hyderabad. However, the execution failed after Prasad claimed before the court that he had insufficient assets to satisfy the decree. RAKIA has now alleged that Prasad continues to control multiple companies indirectly, and has parked assets in them to avoid enforcement. When RAKIA learned that some of these companies were planning to transfer or dissipate assets, it rushed to the Commercial Court to restrain such actions. One such company, IQuest, reportedly gave an undertaking not to proceed with any transaction. Despite this, RAKIA informed the court that Prasad allegedly breached this undertaking by proceeding with transactions, including the buyback of a company previously sold to Mylan. RAKIA has now filed a contempt petition against Prasad, stating that his actions amount to wilful disobedience of court's order. Get the latest lifestyle updates on Times of India, along with Doctor's Day 2025 , messages and quotes!
