Latest news with #WilliamSchaffner
Yahoo
28-05-2025
- Business
- Yahoo
FDA's Surprising COVID Vaccine Change Impacts Millions—What You Need to Know
The FDA has updated COVID-19 vaccine regulations. Only people aged 65 and up, along with certain groups, will be eligible to receive booster shots. FDA officials are asking for more data around the vaccine's effectiveness for people who are otherwise healthy. The U.S. Food and Drug Administration made a surprising move last week, announcing that the agency will limit the use of the COVID-19 vaccine to certain groups. The changes are expected to go into effect in the fall. Just this week, the Centers for Disease Control and Prevention (CDC) will no longer recommend that pregnant people and healthy children get the COVID-19 vaccine (note: The CDC still lists pregnant people as high-risk for COVID-19 complications—more on this below). The new regulations were laid out in an article published in The New England Journal of Medicine titled, 'An Evidence-Based Approach to Covid-19 Vaccination.' In the article, FDA vaccine division chief Vinay Prasad, M.D., and FDA commissioner Martin Makary, M.D., wrote that the American policy with COVID-19 booster shots is the 'most aggressive' compared with policies in European nations. 'The U.S. policy has sometimes been justified by arguing that the American people are not sophisticated enough to understand age- and risk-based recommendations,' the article reads. 'We reject this view.' The FDA usually authorizes or approves vaccines for use, while the Centers for Disease Control and Prevention (CDC) specifies recommendations on how they should be used under the guidance of the Advisory Committee on Immunization Practices (ACIP). The FDA dictating how vaccines should be used is a different approach, points out William Schaffner, M.D., an infectious disease specialist and professor at the Vanderbilt University School of Medicine. Meet the experts: Thomas Russo, M.D., professor and chief of infectious disease at the University at Buffalo in New York, William Schaffner, M.D., an infectious disease specialist and professor at the Vanderbilt University School of Medicine; infectious disease specialist Amesh Adalja, M.D., senior scholar at Johns Hopkins University Center for Health Security The change seems to be political, given that there is a new administration in place and no new data has been released on side effects, safety, or effectiveness of these vaccines. But what are the new FDA COVID vaccine regulations, and what does this mean for the future of COVID care? Here's the deal. Until now, government health agencies have recommended that everyone over the age of 6 months get an annual COVID-19 vaccine. The vaccine is tweaked each year to try to match up with circulating strains of the virus and to provide the most protection. But the new regulations will limit the use of the vaccine to people aged 65 and up, along with people over the age of 6 months who have certain medical conditions. The list of qualifying medical conditions is long, and includes more obvious things like asthma, cancer, pregnancy, and chronic lung diseases. But it also includes things like physical inactivity and mood disorders, opening the vaccine up to a wide range of people. The FDA may now require more studies before approving COVID-19 vaccines for healthy Americans under the age of 65, according to the paper. The article makes the argument that these changes are more in line with what the rest of the world is doing. 'All other high-income nations confine vaccine recommendations to older adults (typically those older than 65 years of age), or those at high risk for severe COVID-19,' the FDA officials write. 'The United States has adopted a one-size-fits-all regulatory framework and has granted broad marketing authorization to all Americans over the age of 6 months.' 'The strategy in the paper aligns with what other countries have done with updated COVID vaccines in the current context of a heavily immune population,' says infectious disease specialist Amesh Adalja, M.D., senior scholar at Johns Hopkins University Center for Health Security. 'It importantly demarcates high-risk from low-risk individuals when it comes to how to think about the value of COVID vaccines and what types of studies are most likely to answer questions about that value in these populations.' Other than those over 65 years of age, the FDA specifically flagged these groups and conditions, among others not listed, as qualifying for the COVID-19 vaccine in the future: Asthma Cancer Cerebrovascular disease Chronic kidney disease Chronic lung disease Chronic liver disease Cystic fibrosis Diabetes (type 1 and type 2) Gestational diabetes Disabilities, including Down syndrome Heart conditions HIV Mental health conditions Dementia Parkinson's disease Obesity Physical inactivity Pregnancy and recent pregnancy Primary immunodeficiency Smoking, current and former Solid organ or blood stem-cell transplantation Tuberculosis Use of corticosteroids or other immunosuppressive medications Note: While the CDC still specifies pregnancy as a condition that puts people at high risk for COVID complications, the CDC will no longer recommend routine COVID shots for pregnant women and healthy children, Health and Human Services Secretary Robert F. Kennedy Jr. recently announced on X. Yes, the COVID vaccines are still considered safe. This paper did not conduct or call out any new research around these vaccines. 'This vaccine is extremely safe,' says Thomas Russo, M.D., professor and chief of infectious disease at the University at Buffalo in New York. According to the CDC, the most common side effects of both Pfizer and Moderna vaccines include pain at the injection site, fatigue, headache, muscle and joint pain, and fever. 'During the COVID-19 pandemic, COVID-19 vaccines underwent the most intensive safety analysis in U.S. history,' the CDC's website reads. 'COVID-19 vaccines continue to be monitored for safety, even after FDA approval, to make sure they continue to meet FDA's standards for safety and effectiveness.' There hasn't been recent data on the effectiveness of the COVID-19 vaccines, but data from clinical trials when the vaccines were first released (which now dates back five years) showed that the Pfizer vaccine was 95% effective at preventing COVID-19, while the Moderna vaccine was 94.1% effective. Studies conducted on the Novavax vaccine found that it was 90% effective at preventing people from developing the virus and 100% effective at protecting people from severe disease. There is a mixed reaction, although doctors as a whole don't seem shocked. 'We have to look at the reality: In 2024-2025, only a very small portion of the population availed themselves of the vaccine,' Dr. Schaffner says. As a result, he says that changing the requirements to get the vaccine is unlikely to have a big impact on the population. 'If the goal is to prevent severe disease, targeting vaccines to high-risk individuals is the optimal strategy,' Dr. Adalja says. 'For lower risk individuals, the goal has always been less clear as protection against infection is transient and as they don't have a risk for severe disease, the cost-effectiveness of a vaccine that, at this stage, chiefly protects against severe disease doesn't apply.' But Dr. Adalja says that the initial COVID-19 vaccine series 'should be part of routine childhood immunization.' He also points out that it's 'unclear' if new clinical trials will be needed to show that there's value for young children to receive the vaccine. Dr. Russo has concerns that the new regulations seem to have a 'double standard that's not based in science' for the COVID-19 and influenza vaccines, both of which target viruses that change seasonally. 'Interestingly, this does nothing for the influenza vaccination, and we get annual boosters for that to target the circulating strains,' he says. 'They seem to think it's fine for influenza but, when you compare it to influenza, COVID remains a more severe disease.' It's not clear at this point if the FDA plans to alter regulations around other vaccines in the future. If you want to get the COVID-19 vaccine in the future but you don't fall into a vulnerable group, doctors say you probably still can. 'It will likely be the case, as it is for other vaccines, that they can be administered off-label to those who want them—with an out-of-pocket charge,' Dr. Adalja says. Dr. Russo points out that the criteria for getting the vaccine is 'fairly liberal,' though. 'The way this is phrased, most Americans can make claims to this vaccine if they really want it,' he says. Again, this is an unusual approach to recommendations around vaccination in the U.S. But the next meeting of the ACIP is in late June, and will likely address next steps on how the COVID vaccine will be used. 'We just have to wait until June,' Dr. Schaffner says. As of this second, though, the CDC still recommends that everyone over the age of 6 months get vaccinated against COVID-19. This article is accurate as of press time. However, as guidelines evolve, some of the information may have changed since it was last updated. While we aim to keep all of our stories up to date, please visit online resources provided by the CDC, WHO, and your local public health department to stay informed. Always talk to your doctor for professional medical advice. You Might Also Like Can Apple Cider Vinegar Lead to Weight Loss? Bobbi Brown Shares Her Top Face-Transforming Makeup Tips for Women Over 50
The Herald
28-05-2025
- General
- The Herald
US drops Covid-19 vaccine recommendation for healthy children, pregnant women
'The recommendation is coming down from the secretary, so the process has just been turned upside down,' said William Schaffner, professor of infectious diseases at Vanderbilt University Medical Centre and a consultant to the Acip. Schaffner said the CDC's panel was to vote on these issues at a June meeting, where he had expected them to favour more targeted shots instead of a universal vaccine recommendation, 'but this seems to be a bit preemptory'. Dorit Reiss, professor of law at UC Law San Francisco, said in a Facebook post going around the advisory committee might hurt the agency in the case of potential litigation. Studies with hundreds of thousands of people around the world show Covid-19 vaccination before and during pregnancy is safe, effective and beneficial to the pregnant woman and the baby, according to the CDC's website. But Makary said in the video there was no evidence that healthy children need routine Covid-19 shots. Most countries have stopped recommending it for children, he added. Covid-19 vaccine makers Moderna and Pfizer did not respond to requests for comment. Dr Cody Meissner, professor of paediatrics at Dartmouth, who co-wrote an editorial with Makary during the Covid-19 pandemic against masks for children, said he agreed with the decision. He believed the US had been overemphasising the importance of the Covid-19 vaccine for young children and pregnant women and previous recommendations were based on politics, adding the severity of the illness generated by the virus seems to have lessened over time in young children. Reuters
Hindustan Times
28-05-2025
- Health
- Hindustan Times
NB.1.81 Covid variant spreads to US: What are the symptoms and should you be worried?
A new, highly infectious strain of Covid-19 has been detected in the United States, including in New York City, the Centers for Disease Control and Prevention has confirmed. The new NB.1.81 variant led to a spike in hospitalizations in China before being detected in the US. The new variant was first found in the US in late March and early April. It was detected among international travelers who arrived at airports in California, Washington State, Virginia and New York City. Some cases were also found in Ohio, Rhode Island and Hawaii. According to the CDC, there are not many cases in the US yet and thus they cannot be properly tracked in the agency's variant estimates. However, experts have warned that the virus' run in China indicates that it spreads rapidly, in fact, quicker than other dominant strains of the infection. 'CDC is aware of reported cases of COVID-19 NB.1.8.1 in China and is in regular contact with international partners. There have been fewer than 20 sequences of NB.1.8.1 in the U.S. baseline surveillance data to date, so it has not met the threshold for inclusion in the COVID Data Tracker dashboard,' a CDC spokesperson told Fortune. 'We monitor all SARS-CoV-2 sequences, and if it increases in proportion, it will appear on the Data Tracker dashboard.' Dr. William Schaffner, Vanderbilt University School of Medicine professor of medicine and preventive medicine, said that the new variant is 'kind of scattered about the U.S. at the moment, in small numbers,' and appears to be a variant of the Omicron family. 'So it's not a dangerous new mutant, but the latest cousin,' he added. Schaffner told the outlet that the new variant does not have any unique characteristics and causes only mild symptoms, including congestion or a runny nose, cough, fatigue, headache, body aches, and fever or chills. Schaffner noted that even though the variant is contagious and will possibly continue to spread, more than 95% of the US population has either had COVID or the vaccine or both, so now they have 'extraordinary population immunity.' 'Now, this is not to say that Omicron is trivial, because there are on the order of 200 to 300 deaths that are occurring weekly, still due to COVID infection,' Shaffner said. 'Of course, those are in highly vulnerable populations—older persons and people with chronic underlying medical conditions—by and large.' Explaining why it is important to track the strains, Schaffner noted that 'we want to be sure that the vaccines we offer are going to provide reasonable protection against severe disease caused by these various strains.' It is currently believed that the vaccines on offer are going to protect against the new strain.
WebMD
19-05-2025
- Health
- WebMD
COVID Vaccine Guidance May Change: 3 Things to Know Right Now
May 19, 2025 – COVID-19 vaccines are making headlines, as government officials appear poised to scale back recommendations and the FDA approved the Novavax vaccine with new limitations. Here's what infectious disease doctors are saying and how any of this could affect you. 1. Your yearly COVID booster recommendation may change. A weekend FDA approval of the COVID vaccine Novavax, and some behind-the-scenes signals from Washington last week, suggest that the government may stop recommending annual fall COVID shots for some people, including children. Novavax, used under emergency authorization since 2022, now has full approval for adults 65 and older and high-risk people ages 12 and up. The approval came after TheWall Street Journal reported on Thursday that the U.S. Department of Health and Human Services plans to stop recommending routine COVID shots for pregnant people and children, citing people familiar with the matter. "Even if they go that route – and I don't know that they will – but even if they do, there will always be a proviso that says any parent who wishes their child to be protected against COVID can receive the vaccine," said William Schaffner, MD, a professor of preventive medicine and infectious diseases at Vanderbilt University School of Medicine. Scientists have debated whether to keep recommending the vaccine for everyone. In September, the World Health Organization said that healthy adults and children with at least one vaccination dose no longer needed routine revaccination. If guidelines change, insurers could drop coverage for those no longer recommended, though they may choose to continue it. A meeting of independent advisers to the CDC in June will likely be the next clue about what's ahead. 2. Chances are you need a COVID shot now, anyway. Another summer COVID surge is predicted. Last year, positive COVID tests skyrocketed starting in mid-May, peaking at nearly 18% in August. That's the second highest weekly test positivity rate on record at the CDC. "We all know about the winter surge, but there's also a summer surge, which can be just as high," said Schaffner. "There are standing recommendations from the CDC's Advisory Committee on Immunization Practices that people who are at high risk should actually receive two doses a year." If you're 65 or older or you have a chronic medical condition, you "should think seriously about getting a COVID vaccine now and then another one in the fall," Schaffner said. The CDC list of chronic medical conditions includes: Diabetes Lung conditions Liver disease Kidney disease Obesity Heart disease Mental health problems Cancer Worth noting: The list of conditions warranting twice-yearly COVID shots is so broad that much of the U.S. population qualifies – and would likely continue to qualify even if vaccine guidance changes. "All those persons, should they become infected with COVID, have a greater likelihood of developing more serious illness. And by serious, we mean requiring hospitalization," Schaffner said. At the height of last summer's COVID surge, there were more than 1,300 weekly deaths. 3. If you're pregnant, you should consider a COVID shot now, too. "My crystal ball is cloudy, I can't anticipate how my colleagues will vote, but I suspect that the recommendation will continue" for pregnant people, Schaffner said. That's because babies from newborn to 6 months old are among those most often hospitalized for severe COVID. COVID vaccination during pregnancy cuts hospitalization risk by 52%. When a pregnant person gets vaccinated, antibodies travel through the placenta and are passed to the fetus, protecting the newborn during the first critical months of life. Pregnant people are also at high risk of severe COVID, "which can make them more susceptible to pregnancy complications and even death," said Christopher Zahn, MD, chief of clinical practice for the American College of Obstetricians and Gynecologists. "Vaccination remains the best way for them to protect themselves and their pregnancy."
Yahoo
12-05-2025
- Health
- Yahoo
Could COVID Boosters Be Delayed This Fall Because Of The Trump Admin? Experts Weigh In.
Every fall since 2021, new COVID-19 shots have been available to protect folks from the latest COVID-19 strains. This is because, just like the flu, COVID-19 mutates quickly and vaccines need to be updated to ensure the season's shot is targeting the right virus strain. This happens for both the flu shot and the COVID-19 shot, which is why new jabs are available roughly every September. But in recent weeks, the future of the anticipated fall COVID-19 boosters has been questioned. There are rumors of a potential delay in distribution due to testing changes that many experts call unnecessary, and potential changes to the recommendations regarding who actually needs the shots. This is all part of the Trump administration's major changes to health care infrastructure. It's worth knowing that COVID booster shot uptake in the U.S. has been very low, but the shots remain an important protection measure for everyone, especially for older adults and immunocompromised people who are more at risk of death or hospitalization from a COVID infection. While the future of COVID boosters is not clear right now (so, don't panic), experts say a delay in vaccine availability or narrowing of eligibility could be dangerous. Here's why: As mentioned above, COVID shots are updated every season (just like flu shots), so they best protect against the virus strain that's currently circulating. 'The plans were, as we did last year, to update the COVID vaccine to keep up with the changing COVID virus. This has been done very efficiently because we have enough information about the vaccines and how they work so that we don't have to do a prospective clinical trial with the influenza vaccine, and we have not, at least in the past, had to do that with COVID vaccine,' said Dr. William Schaffner, a professor of preventive medicine in the department of health policy at Vanderbilt University Medical Center in Nashville, Tennessee. But it's now been suggested by Health and Human Services Secretary Robert F. Kennedy Jr. and Food and Drug Administration Commissioner Marty Makary that there isn't enough data on COVID vaccines and that additional testing may be required before the shot is available. 'To do that with the COVID vaccine, I think that notion would be disputed by most of the people in the vaccine community, including myself,' Schaffner noted. This is problematic because additional trials and testing take more time, so by the time the testing is done and analyzed, we could be way past the optimal time for COVID vaccination, which is the fall, he said. More, a certain kind of testing that RFK Jr. is calling for, known as placebo testing, goes against medical ethical standards when it comes to the COVID booster (plus, the original COVID shot was already placebo tested). 'It does not meet our ethical standards to enroll people into a trial and say, we're going to give half of you nothing, withhold a vaccine from you, and the other people are going to get a vaccine when we already know the vaccine works, and we've got years worth of data to support that,' said Dr. Jodie Guest, the senior vice chair of the department of epidemiology at Emory University's Rollins School of Public Health in Atlanta. 'So that violates our human subject research ethics, and ultimately, it will delay vaccine for everyone,' Guest noted. 'Now, if the COVID vaccine were to be delayed or unavailable ... that would put a large segment of the population at risk of COVID,' Schaffner said. This is particularly the case for people over 65 and those who are immunocompromised, added Guest. 'It will mean more hospitalizations. It will certainly mean more sickness. And we know that people in those categories are more likely to need hospital support if they do get COVID and get sick,' said Guest. Deaths could increase, too. This past January when COVID levels were higher, there were nearly 1,000 deaths each week in the United States, added Guest. And currently, more than than 6,000 people have died of COVID in the U.S. in the past three months, said Katrine Wallace, an epidemiologist and assistant professor at the University of Illinois Chicago. 'A lot of people are not at risk for those severe complications from COVID, but there are a lot of people who are, and we are all going to know and love people who are in those higher-risk categories. And we really need to be thinking about that,' Guest said. What's also unclear is who would be eligible for a new COVID shot this fall. Meaning, the recommendation guidelines could change. The committee that decides who's eligible for the COVID vaccine (and any immunization, for that matter) is debating whether the COVID vaccine recommendations should stay as-is (everyone 6 months and older can get the jab) or if the recommendations should focus on high-risk people instead, Schaffner said. He noted that some other countries handle COVID vaccinations this way, and the committee is looking at that data. Guest said that with less severe disease and complications from COVID, she's not surprised that there is talk of changing vaccine recommendations. 'I don't think we should restrict who is eligible for COVID vaccine boosters, but I do think we should be prioritizing who we want to make sure get them. And that's a very common thing to do,' Guest said. Once again, it's unclear whether the vaccine recommendations will change at all, but if they do, Wallace said, she's concerned about what that would mean for health insurance coverage for those who want the vaccine but aren't eligible since health insurance doesn't cover things you aren't eligible for. 'So, that would be a problem for some people who want it,' Wallace added. 'There's also the issue of long COVID, right?' Wallace said. 'We have post-COVID conditions that happen to young people. That's not something that only happens to the elderly or people with pre-existing conditions.' 'Anybody can get long COVID, and it's really hard to predict who's going to get it,' Wallace said. One thing that does decrease the likelihood of long COVID is the COVID vaccine, which is concerning if recommendations are changed to exclude some folks. The current conversations from the leaders at Health and Human Services, the FDA and more are only sowing distrust in the vaccines. 'It's making people question if they really need them or not. And we want to ask questions appropriately all the time in science, but we don't want to intentionally sow distrust,' Guest said. 'We want to be really careful about how we're eroding the way people think about it, and how important these vaccines have been, and how remarkable they have been in saving our lives,' she noted. 'All of these conversations are going to discourage the uptake of vaccines ... the current conversations about questioning the need for the vaccines and changing the way they're testing them, or what they might require, suggests that things were not done correctly originally, and that's not accurate,' Guest added. 'And it's going to sow further distrust in the vaccines, and that is going to be a very unfortunate outcome,' Guest said. 'I would just reiterate that we have now given the available vaccines against COVID in the millions upon millions of doses around the world,' Schaffner said. 'Put aside the notion that they are 'new' or 'experimental' — no, they're not. They have been studied as carefully as any other vaccine that was ever used around the world,' he added. Regardless of any fall COVID shot changes, wearing a mask in crowded spaces, washing your hands and staying home when you are sick remain the best ways to keep yourself and others protected from COVID-19. It's also a good idea to test before gatherings, particularly if you're going to be around high-risk folks, Wallace said. Schaffner added that if you are at high risk of severe disease or take care of someone who is, you can consider getting another COVID shot this spring or summer (before the new fall shots come out) for additional protection. If you're considering getting another COVID shot, it's best to talk to your doctor for guidance. FDA Chief Downplays COVID Boosters After Suggesting No Updated Shots This Season 5 Things Doctors Never, Ever Do During Cold And Flu Season White House Replaces COVID-19 Information Site With 'Lab Leak' Theories
