Latest news with #EmergencyUseAuthorization
UPI
6 days ago
- UPI
Georgia officials identify gunman in shooting near CDC, Emory University
Police identified the suspected gunman an attack that killed a police officer near the Centers for Disease Control and Prevention's Roybal Campus on Clifton Road in Atlanta. Photo by CDC Newsroom Aug. 9 (UPI) -- The suspected gunman in the attack that killed a police officer near the Emory University campus and the Centers for Disease Control and Prevention's headquarters was identified Saturday morning. One day after the shooting on Friday night, the Georgia Bureau of Investigation said that Patrick Joseph White, 30, of Kennesaw, Ga., was the killer. WXIA-TV posted video from outside the home of the suspected shooter on Friday night where there was crime scene tape. GBI is the lead investigator, and has been working with the Atlanta, DeKalb County and Emory police, DeKalb County Sheriff's Office, FBI and Bureau of Alcohol, Tobacco, Firearms and Explosives. Emory, with an enrollment of 5,727, was on lockdown for a few hours, while the CDC had a shelter in place order at its Roybal Campus until the late evening. The school said Saturday there will be increased police presence throughout the weekend. David Rose, a 33-year-old police officer for the DeKalb department, died while responding to the shooting. Rose, who joined the department in September and was a retired U.S. Marine, had two children with his wife, who is pregnant. "This officer responded to the call as he did, as he was trained to do, and during that incident he received gunfire and he lost his life in this incident," interim Police Chief Gregory Padrick said. "He was committed to serving the community. It's a noble profession we all do. We answer the call to serve our community and he gave his life with a commitment to serve others." Rose was the only person shot during the attack, which started just before 5 p.m. at the Emory Point CVS drugstore on Clifton Road. White was found dead from a gunshot wound on the second floor. It wasn't disclosed whether he was shot by law enforcement or whether it was self-inflicted. The shooting occurred across the street from the CDC campus, where there were bullet holes in windows and shattered glass on the floor. Some rounds of ammunition also flew just above office cubicles. CDC Director Susan Monerez told employees to work remotely while a "security assessment" is conducted at the campus. Atlanta Mayor Andre Dickens said Friday the suspect was "known to have some interest in certain things that I can't reiterate right now with any confidence until the investigation is fully conducted." CNN reported the shooter was upset about health problems blamed on the Covid-19 vaccine recommended by the CDC and approved by the Federal Drug Administration in 2020 with Emergency Use Authorization and full approval for certain ages in 2021 for Pfizer-BioNTech and in 2022 for Moderna.
The Hill
10-07-2025
- Health
- The Hill
FDA gives full approval to Moderna COVID shot for at-risk kids
The Food and Drug Administration (FDA) granted full approval on Thursday to Moderna's COVID-19 vaccine for children, making it the first COVID shot for kids aged 6 months to 11 years old that is no longer administered under an Emergency Use Authorization. Infants under 6 months are too young to be vaccinated. But the vaccine is only available for children with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19, the FDA said, in line with a change made by health secretary Robert F. Kennedy Jr. 'COVID-19 continues to pose a significant potential threat to children, especially those with underlying medical conditions. Vaccination can be an important tool for protecting our youngest against severe disease and hospitalization,' Stéphane Bancel, Chief Executive Officer of Moderna, said in a statement. Moderna said it expects to have its updated vaccine available for eligible populations in the U.S. for the 2025-2026 respiratory virus season. Doses of COVID shots from Moderna and Pfizer have been available to all kids regardless of risk. But Kennedy in May said the Department of Health and Human Services would no longer recommend the coronavirus vaccine for healthy pregnant women or healthy children. Following his announcement, the Centers for Disease Control and Prevention recommended the vaccines based on 'shared clinical decision-making' between parents and their children's provider. But the new licensing stipulation could make it harder for parents who want to get their healthy children vaccinated against COVID to do so, because that is now effectively an off-label use of the vaccine. Leading medical groups led by the American Academy of Pediatrics earlier this week sued Kennedy over the new vaccine restrictions.
Time of India
03-07-2025
- 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
30-06-2025
- 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
