Latest news with #NovavaxCovid-19
Miami Herald
21-05-2025
- Health
- Miami Herald
FDA approves Novavax's COVID-19 vaccine with limitations
The U.S. Food and Drug Administration approved Novavax's COVID-19 vaccine with age restrictions after a six-week delay. The agency approved the vaccine only for people 65 and older and those 12 and older with at least one underlying condition in which they are at a higher risk of severe illness. The company is based in Gaithersburg, Maryland. The conditions include older age, asthma, diabetes, lung disease, obesity and pregnancy. 'Market research and US C.D.C. statistics indicate that older individuals and those with underlying conditions are the populations most likely to seek out COVID-19 vaccination seasonally,' Novavax President and CEO John Jacobs said in a statement Saturday to CNN. 'This significant milestone demonstrates our commitment to these populations and is a significant step towards availability of our protein-based vaccine option.' The Novavax Covid-19 vaccine has had emergency use authorization since 2022 and an updated version was approved in August 2924. The brand name is Nuvaxovid. The FDA granted Pfizer-BioNTech full approval for those 12 and older in August 2021 and Moderna in January 2022. They remain available under emergency use authorization for children as young as 6 months. Novavax uses more traditional protein-based technology than the mRNA vaccines of Pfizer and Moderna. Pfizer was the first COVID-19 vaccine to receive emergency approval in December 2020 and Moderna was followed on week later. The first COVID-19 case was reported in the United States on Jan. 20, 2020. The CDC no longer tracks cases but examines SARS-CoV-2 levels in sewage, and limited data from hospitals and states. Cases now are hard to track because most people get tests at home, and the results are not reported to state health agencies. About 23% of U.S. adults are estimated to be up to date with the vaccine, according to the CDC through April. For children 6 months and up to 18 it is an estimated 13.0%, the CDC reported. With Robert F. Kennedy Jr., a vaccine skeptic, leading Health and Human Services, the FDA and CDC are giving greater scrutiny to the shots. The FDA delayed the decision on the vaccine as it sought more data, a source told CNN. In the approval letter issued Friday, Novavax must conduct postmarketing studies looking at the risk of myocarditis and pericarditis in people who receive the vaccine. These are inflammation of the heart muscle and the membrane surrounding the heart. Only a few cases were reported in the 30,000-person clinical of the Novavax vaccine, the CDC notes. But the CDC and its Advisory Committee on Immunization Practices have said the benefits of the vaccination outweigh the rare risk of heart inflammation in all groups recommended for vaccination. The CDC is considering whether to only recommend yearly vaccines for older people or ones with a compromised immune function. Everyone 6 months of age and older are now recommended to get the yearly dose. Copyright 2025 UPI News Corporation. All Rights Reserved.
Yahoo
19-05-2025
- Politics
- Yahoo
Monday's Mini-Report, 5.19.25
Today's edition of quick hits. * A discouraging ruling: 'The Supreme Court on Monday granted the Trump administration's emergency request to end deportation protections for hundreds of thousands of Venezuelan migrants. The administration had asked the justices to lift a federal judge's order that blocked Homeland Security Secretary Kristi Noem from terminating Biden-era protections. Justice Ketanji Brown Jackson noted her dissent from the order that blocks the lower court judge's ruling pending further litigation.' * An encouraging ruling: 'A federal district judge on Monday tossed out the takeover of the U.S. Institute of Peace by the Trump administration and the Department of Government Efficiency, declaring that actions by 'illegitimately-installed leaders' were 'unlawful' and had to be declared 'null and void.'' * In Romania: 'In a setback for Europe's surging nationalist forces, Nicusor Dan, a centrist mayor and former mathematics professor, on Sunday won the presidential election in Romania, defeating a hard-right candidate who is aligned with President Trump and has opposed military aid to Ukraine.' * The latest on the Palm Springs bombing: 'Investigators on Sunday identified a 25-year-old man as the suspect in the bombing outside a fertility clinic in Palm Springs, Calif., as they searched for the motive behind the blast that damaged several blocks downtown and, they believe, killed him as well.' * The more Trump says Putin wants peace, the more we're confronted with evidence to the contrary: 'Nine people were killed and seven were injured on Saturday in a Russian drone attack on a bus carrying civilians in northeastern Ukraine, according to local officials. ... The attack occurred near the town of Bilopillia, in Sumy Oblast, a Ukrainian region bordering Russia. Ukrainian police confirmed the strike and released photos of the bus, whose roof was torn off by the explosion.' * Fortunately, the dispute was short-lived: 'The New Jersey Transit rail strike will end after the Brotherhood of Locomotive Engineers and Trainmen and NJ Transit managers reached a tentative agreement Sunday.' * Another one? 'We have another screwy deportation case under the Trump administration. At this point in Donald Trump's second term, it's necessary to distinguish among these cases to know which one we're talking about.' * A case we've been keeping an eye on: 'A politically fraught investigation opened by the Trump administration into a Biden-era Environmental Protection Agency grant program has so far failed to find meaningful evidence of criminality by government officials, according to people familiar with the matter.' * Keep an eye on this one: 'The Food and Drug Administration on Friday approved the Novavax Covid-19 vaccine, but only for older adults and for others over age 12 who have at least one medical condition that puts them at high risk from Covid.' * The consequences of Trump gutting USAID are ongoing: 'Food rations that could supply 3.5 million people for a month are moldering in warehouses around the world because of U.S. aid cuts and risk becoming unusable, according to five people familiar with the situation. The food stocks have been stuck inside four U.S. government warehouses since the Trump administration's decision in January to cut global aid programs, according to three people who previously worked at the U.S. Agency for International Development and two sources from other aid organizations.' * I meant to flag this one last week: 'The Trump administration on Thursday fired nearly 600 employees at Voice of America, a federally funded news network that provides independent reporting to countries with limited press freedoms. The layoffs targeted contractors, most of them journalists but also some administrative employees, and amounted to over a third of Voice of America's staff.' * Kacsmaryk strikes again: 'A MAGA judge in Texas has issued a sweeping ruling that destroys workplace discrimination protections for LGBTQ+ people in the United States. Judge Matthew Kacsmaryk, who holds a reputation for being a far-right activist judge, declared that while Title VII of the Civil Rights Act does not protect LGBTQ people from workplace harassment based on their sexual or gender orientation.' * A brutal diagnosis: 'Former President Joe Biden thanked well-wishers Monday for their support after his personal office announced he has cancer. ... The former president's personal office shared Sunday that Biden had been diagnosed with an aggressive form of prostate cancer, prompting an outpouring of support from politicians and allies.' See you tomorrow. This article was originally published on
Time of India
18-05-2025
- Health
- Time of India
FDA nod for Novavax Covid vax, with stricter new conditions
Representative image The Food and Drug Administration on Friday approved the Novavax Covid-19 vaccine, but only for older adults and for others older than 12 who have at least one medical condition that puts them at high risk from Covid. Scientific advisers to the Centers for Disease Control and Prevention, who typically make decisions on who should get approved shots and when, have been debating whether to recommend Covid shots only to the most vulnerable Americans. The FDA's decision appeared to render at least part of their discussion moot. The new restriction will sharply limit access to the Novavax vaccine for people younger than 65 who are in good health. The vaccine had previously been authorised under emergency use. Covid vaccines developed by Pfizer and Moderna, which are more widely used by Americans, were granted full approval in 2022. For companies working on updated shots for the fall, the new riders portend a more restrictive approach from the FDA. The FDA's new restrictions appear to reflect the high degree of skepticism about vaccines from Robert F Kennedy Jr, the health secretary, and the other leaders he has appointed at health agencies.
Yahoo
26-04-2025
- Health
- Yahoo
FDA may ask Novavax to conduct additional trials of its Covid-19 vaccine to receive full approval
The US Food and Drug Administration has discussed with vaccine-maker Novavax the need for an additional trial of its Covid-19 vaccine as a post-approval commitment, a source familiar with the matter told CNN. The terms need to be negotiated before Novavax's vaccine could be granted full approval, the source said, declining to be named because they weren't authorized to speak on behalf of the FDA. Novavax had anticipated full approval of its vaccine by April 1, but the FDA delayed the decision because it sought more data, a source told CNN at the time. 'We can confirm we have responded to the FDA's Post Marketing Commitment (PMC) request and are awaiting feedback from the agency,' Novavax said in a statement Friday. 'PMCs are not unusual with many approved drugs / biologics having at least one PMC or requirement. We continue to believe that our application is approvable, and we look forward to our continued engagement with the FDA about their request for a PMC and to moving to approval as soon as possible.' A spokesperson for the US Department of Health and Human Services, the FDA's parent agency, said Friday that it 'remains committed to our promise: ensuring products are safe for the American people and grounded in gold-standard science.' The Novavax Covid-19 vaccine, which uses more traditional protein-based technology than the newer mRNA vaccines from Pfizer/BioNTech and Moderna, has been subject to emergency use authorization since 2022. But with FDA action, it would be the third vaccine against Covid-19 to receive full FDA approval, which could provide additional reassurance to people seeking the shot. The missed deadline came at the same time the FDA named Dr. Scott Steele acting director of the Center for Biologics Evaluation and Research, which oversees vaccine regulation, days after former director Dr. Peter Marks was forced out. In his resignation letter, Marks cited 'efforts being advanced by some on the adverse health effects of vaccination' that he called 'concerning.' HHS Secretary Robert F. Kennedy Jr., a longtime anti-vaccine advocate, has falsely called vaccines for Covid-19 'the deadliest vaccine ever made' and more recently made misleading statements about the safety of the measles vaccine amid a deadly outbreak centered in West Texas.
CNN
26-04-2025
- Health
- CNN
FDA may ask Novavax to conduct additional trials of its Covid-19 vaccine to receive full approval
The US Food and Drug Administration has discussed with vaccine-maker Novavax the need for an additional trial of its Covid-19 vaccine as a post-approval commitment, a source familiar with the matter told CNN. The terms need to be negotiated before Novavax's vaccine could be granted full approval, the source said, declining to be named because they weren't authorized to speak on behalf of the FDA. Novavax had anticipated full approval of its vaccine by April 1, but the FDA delayed the decision because it sought more data, a source told CNN at the time. 'We can confirm we have responded to the FDA's Post Marketing Commitment (PMC) request and are awaiting feedback from the agency,' Novavax said in a statement Friday. 'PMCs are not unusual with many approved drugs / biologics having at least one PMC or requirement. We continue to believe that our application is approvable, and we look forward to our continued engagement with the FDA about their request for a PMC and to moving to approval as soon as possible.' A spokesperson for the US Department of Health and Human Services, the FDA's parent agency, said Friday that it 'remains committed to our promise: ensuring products are safe for the American people and grounded in gold-standard science.' The Novavax Covid-19 vaccine, which uses more traditional protein-based technology than the newer mRNA vaccines from Pfizer/BioNTech and Moderna, has been subject to emergency use authorization since 2022. But with FDA action, it would be the third vaccine against Covid-19 to receive full FDA approval, which could provide additional reassurance to people seeking the shot. The missed deadline came at the same time the FDA named Dr. Scott Steele acting director of the Center for Biologics Evaluation and Research, which oversees vaccine regulation, days after former director Dr. Peter Marks was forced out. In his resignation letter, Marks cited 'efforts being advanced by some on the adverse health effects of vaccination' that he called 'concerning.' HHS Secretary Robert F. Kennedy Jr., a longtime anti-vaccine advocate, has falsely called vaccines for Covid-19 'the deadliest vaccine ever made' and more recently made misleading statements about the safety of the measles vaccine amid a deadly outbreak centered in West Texas.
