Latest news with #boosters
CNET
2 days ago
- Business
- CNET
Will I Have to Pay for a COVID Vaccine and How Much Will It Cost?
Under the direction of Health and Human Services Secretary Robert F. Kennedy Jr., government policies surrounding the COVID-19 vaccine have changed dramatically, casting new doubts on its availability and cost in the coming months. This past week, Kennedy announced that the Centers for Disease Control and Prevention was pulling its recommendation for routine COVID booster shots for "healthy" pregnant women and children. This came not long after the agency also pulled the recommendation for any adults younger than 65 without at least one condition that puts them at high-risk for a more severe infection. How the government defines "healthy" in this context is still unclear. Notably, pregnancy is considered a high-risk condition in and of itself. Other conditions currently include asthma, cancer and diabetes. The CDC later contradicted Kennedy's announcement, stating that healthy children, ages 6 months to 17 years old, can get COVID shots after receiving "the clinical judgment of a health-care provider." Set against the broader concern about Kennedy's history of anti-vaccine beliefs, these moves have caused renewed concern about the ability of Americans who want them to get COVID boosters, especially ahead of fall and winter when infection rates are known to increase. According to data from the CDC itself, about 70% of Americans were considered fully vaccinated against COVID as of May 2023. These boosters are still desirable for many Americans, however, particularly for those who might be considered healthy themselves but live with high-risk friends or family. Putting barriers in the way of COVID vaccination could also increase the risks of variant strains developing and spreading among more individuals. If you're concerned or intrigued about what these moves against vaccine recommendations might mean for you, keep reading. For more, find out what Novavax might mean for the cost of COVID-19 vaccines. What does ending COVID vaccine recommendations mean? Hearing that the government has ended certain vaccine "recommendations" might seem a little vague but there are a few important ramifications to keep in mind. For starters, ending the recommendation for a vaccine would remove it from the required immunization schedule for children, although the CDC's contradiction of Kennedy's initial announcement has muddied things on this count. For the time being, it seems that the ability of kids to get updated COVID shots is nominally safe. More pressingly for most healthy adults who might want to get regular booster shots, government recommendations are typically used by health insurance companies to decide which shots they will cover and for whom. So in effect, you might still be able to seek out a booster shot for yourself or your child, but now it could cost you. How much will a COVID-19 booster shot cost? It's hard to say for certain how every individual insurance company will react to these decisions from the CDC but should your provider choose to end coverage for booster shots, you'll have to pay to get one. As for how much that will cost you, that's another thing we can't know for sure right now, but you should expect it to be in the ballpark of a couple hundred dollars. According to CVS's webpage, the pharmacy chain charges at least $199 for a COVID vaccine shot that is not covered by insurance. For the time being, the company says they are free of charge with insurance. For more info about staying safe, find out how to check if your at-home COVID tests are expired.
Medscape
27-05-2025
- Health
- Medscape
FDA Advisers Recommend No Changes to COVID Vaccine for Fall
US Food and Drug Administration (FDA) advisers recommended that manufacturers make no changes to the COVID-19 vaccine that will be available for boosters later this summer. The Vaccines and Related Biological Products Advisory Committee (VRBAC) voted 9-0 that the 2025-26 vaccines should stay the same, containing a single JN.1 strain, which has been dominant globally since 2024. 'There is efficacy,' said Panel Member Eric J. Rubin, MD, PhD, editor-in-chief of The New England Journal of Medicine and adjunct professor of immunology and infectious diseases at the Harvard T.H. Chan School of Public Health, Boston. 'It's not fantastic. It's not what it was originally,' he said, adding but that in a population that has broad immunity to the SARS-COV-2 virus, 'it wasn't bad.' The agency usually follows its panels' advice, but nothing is certain for the vaccines this fall. As reported by Medscape Medical News , FDA Commissioner Martin Makary, MD, and FDA Center for Biologics Evaluation and Research Director Vinay Prasad, MD, in a 'town hall' on May 20 and in a paper in TheNew England Journal of Medicine said the agency planned to start requiring randomized, controlled trials for approval of COVID vaccines in healthy Americans who are younger than 65 years. Approvals of boosters over the last 4 years have been based on observational data, and the vaccines have been recommended for all Americans aged 6 months or older. The FDA has not held any further meetings nor issued a final rule or policy to clarify whether this year's COVID vaccine boosters would be required to conduct new trials. The agency may have signaled where it is headed with its May 17 full approval for Novavax's COVID-19 vaccine, which previously only had emergency use authorization. The FDA limited the vaccine's use to adults older than 65 years and anyone older than 12 years at high risk. Some panelists were concerned that a randomized trial requirement might cause delays. 'Is there a possibility that if we choose a different vaccine [strain], it is actually going to be different regulatory measures that are taken that would delay the vaccine getting to the market?' asked Stanley M. Perlman, MD, PhD, chair of microbiology and immunology at Carver College of Medicine, University of Iowa, Iowa City, Iowa. Rubin said he believes the observational data presented by COVID vaccine makers 'has a lot more richness,' than a randomized trial, given the various exposures to illness and vaccines in a widely varied population. 'I don't think the randomized, controlled trial is feasible,' said Rubin. David C. Kaslow, MD, director of the Office of Vaccines Research and Review at FDA, said that although the agency is still discussing how it will regulate COVID vaccines, 'I think there's a shared desired outcome for the timely availability of vaccines to prevent COVID-19.' Kaslow said the proposed new regulatory framework could be a 'potential topic for a future VRBPAC meeting.' Representatives from Pfizer, Moderna, and Novavax all said they would have vaccines ready for the fall. 'We look forward to working with the agency to ensure timely provision of appropriate data to support COVID-19 vaccine approval for those who need it most,' said Kayvon Modjarrad, MD, PhD, executive director of Viral Vaccines and Immunology Vaccine Research and Development at Pfizer. Continuing Burden, Low Vaccine Uptake At the meeting, US Centers for Disease Control and Prevention (CDC) officials and vaccine makers said that COVID-19 is still dangerous, especially for those at highest risk, primarily individuals older than 75 years and children younger than 6 months. The CDC estimates that 30,000-50,000 people have died from COVID since October. Few Americans choose to get a COVID vaccine, hovering around 25% for adults aged 18 years to 64 years, rising to 50% for those older than 75 years, said Ruth Link-Gelles, PhD, MPH, of the CDC's National Center for Immunization and Respiratory Diseases. Vaccine effectiveness against hospitalization and critical illness in immunocompetent adults older than 65 years was around 40%-50%, said Link-Gelles. It was the same or slightly lower for immunocompromised adults in the same age group. Pfizer estimated that COVID vaccines prevented some 107,000 hospitalizations and 6700 in-hospital deaths in 2024. The vaccine makers argued that their products are safe and effective. 'Our vaccines are among the most extensively-monitored products licensed,' said Pfizer's Modjarrad. The FDA, however, has recently instructed Pfizer and Moderna also to update labeling to expand a warning about myocarditis and pericarditis. Pfizer's label warned of an elevated risk in men 12- to 17-year-olds, Moderna's in men 18- to 24-year-olds. Both will now cite an elevated risk for men aged 16 years to 25 years. In its letter, the agency cited data from a Lancet study of patients with COVID-19- vaccine–associated myocarditis 'showing persistence of abnormal cardiac magnetic resonance imaging findings that are a marker for myocardial injury at a median follow-up of approximately 5 months.' Some Call for Withdrawal, Others for More Access During the hour-long public hearing portion of the meeting, most speakers asked the FDA to immediately recall all COVID vaccines, citing a variety of harms — many of them unproven. 'Rewind now and pull these shots,' said Brian Hooker, PhD, the chief scientific officer of Children's Health Defense — the organization formerly run by current Health and Human Services Department Secretary Robert F. Kennedy, Jr. Hooker cited myocarditis as a concern. 'Based on this alone, the product should have been completely withdrawn,' said Hooker. He also said that COVID vaccines 'have been also strongly associated with clotting disorders, including stroke, pulmonary embolism,' and other disorders. Kaitlin Sundling, MD, PhD, assistant professor of pathology and laboratory medicine at the Wisconsin State Lab of Hygiene, said COVID vaccines should be more widely available. 'All people, regardless of age and medical history, need broad access to regularly updated COVID vaccine formulations,' said Sundling, who added she was concerned about the FDA's potential requirement for randomized trials and to limit vaccine approvals to those older than 65 years or at high risk. Noting that the panel had essentially been asked to not talk about that proposed new COVID regulatory framework at the meeting, Sundling said 'There is a very real concern that this committee is being used as a pawn to eliminate vaccine access for the US population.'
The Independent
22-05-2025
- Health
- The Independent
FDA panel debates COVID vaccine recipe as questions swirl about fall shots
Government advisers are meeting Thursday to decide if COVID-19 vaccines need updating to improve protection this fall and winter — even as a new Trump administration policy has thrown into question who may be eligible for a shot. The Food and Drug Administration's outside experts have met regularly since the launch of the first COVID-19 vaccines to discuss tweaking their recipes to stay ahead of the virus. Thursday's meeting is the group's first since President Donald Trump took office. But it comes just two days after FDA leaders upended the prior U.S. policy of recommending annual COVID-19 boosters for all Americans ages 6 months and older. Instead, the FDA said routine approval of COVID-19 boosters will be limited to seniors and to younger people who are at high risk of severe infection. Manufacturers will need to do new studies to show whether seasonal shots still benefit healthy people younger than 65. That raises big implications for next fall's vaccination campaign, with uncertainty over whether healthy people still could get a vaccine even if it's not recommended for them — or whether insurers will keep paying for the shots for everyone. Nor is it clear what the policy means for babies who have never been vaccinated. 'This is a mess,' said Michael Osterholm, a University of Minnesota infectious disease expert. 'The one thing we don't want to do is put a barrier in place that prevents parents from getting their children vaccinated if they want to.' FDA's independent advisers may raise those issues Thursday, but the changes are not the focus of the meeting, which was scheduled before FDA's announcement. Instead, the panel is set to recommend whether the virus has mutated enough to warrant strain updates for shots from Pfizer, Moderna and Novavax. 'We are asking for guidance to help the FDA decide what strain to select for COVID-19 vaccines going forward,' FDA vaccine chief Dr. Vinay Prasad said in comments opening the meeting. Prasad added that the agency wants 'to give people a little more time to digest,' the new policy on vaccines and is open to feedback. Last fall's recipe was tailored to omicron descendants on the JN.1 branch of the virus family tree. Novavax brewed shots targeting the parent JN.1 variant while Pfizer and Moderna opted for a subtype called KP.2. That JN.1 family still dominates, although it continues to evolve. The question is whether last fall's shots still offer enough cross-protection or if manufacturers instead should match today's most common subtype, called LP.8.1. The World Health Organization recently said last year's version was OK but that vaccine makers could choose an update. The European Medicines Agency instead recommended targeting the newest subtype. FDA officials didn't express a preference in documents posted online ahead of Thursday's meeting. suggested earlier in the week that the government should move away from yearly updates. 'Instead of having a COVID-19 strategy that's year-to-year where we change things every single year, why don't we let the science tell us when to change?' Prasad said. Debating that science is what the FDA's vaccine advisers do each year. If they recommend leaving the shots unchanged — and the FDA agrees — it's possible that healthy adults and children may still get access to a fall booster, since this week's policy changes suggest new studies would be required only if manufacturers switch strains or introduce a completely new vaccine. Those would be large, six-month studies, and vaccine experts question if their cost and logistics could make them unfeasible. Still, the FDA's strain decision normally isn't the final word on recommendations about who should be vaccinated. The Centers for Disease Control and Prevention's own advisory panel meets in June to make recommendations about the fall shots. Among its options are keeping universal access or recommending vaccination for high-risk groups but still giving lower-risk people the choice in getting a shot. Prasad and FDA Commissioner Marty Makary were both outspoken critics of the government's handling of COVID-19 shots during the pandemic, particularly the recommendation for use in young, healthy adults and children. Before joining government, they each garnered attention from Health Secretary Robert F. Kennedy Jr., who built a national following by casting doubt on the safety and benefits of vaccines. In a medical journal editorial outlining the FDA's new approach, they criticized the U.S.'s 'one-size-fits-all' approach, saying it has long been out of step with Europe and other places with more limited recommendations for boosters. ___ The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Science and Educational Media Group and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
Associated Press
22-05-2025
- Health
- Associated Press
FDA panel debates COVID vaccine recipe as questions swirl about fall shots
WASHINGTON (AP) — Government advisers are meeting Thursday to decide if COVID-19 vaccines need updating to improve protection this fall and winter — even as a new Trump administration policy has thrown into question who may be eligible for a shot. The Food and Drug Administration's outside experts have met regularly since the launch of the first COVID-19 vaccines to discuss tweaking their recipes to stay ahead of the virus. Thursday's meeting is the group's first since President Donald Trump took office. But it comes just two days after FDA leaders upended the prior U.S. policy of recommending annual COVID-19 boosters for all Americans ages 6 months and older. Instead, the FDA said routine approval of COVID-19 boosters will be limited to seniors and to younger people who are at high risk of severe infection. Manufacturers will need to do new studies to show whether seasonal shots still benefit healthy people younger than 65. That raises big implications for next fall's vaccination campaign, with uncertainty over whether healthy people still could get a vaccine even if it's not recommended for them — or whether insurers will keep paying for the shots for everyone. Nor is it clear what the policy means for babies who have never been vaccinated. 'This is a mess,' said Michael Osterholm, a University of Minnesota infectious disease expert. 'The one thing we don't want to do is put a barrier in place that prevents parents from getting their children vaccinated if they want to.' FDA's independent advisers may raise those issues Thursday, but the changes are not the focus of the meeting, which was scheduled before FDA's announcement. Instead, the panel is set to recommend whether the virus has mutated enough to warrant strain updates for shots from Pfizer, Moderna and Novavax. 'We are asking for guidance to help the FDA decide what strain to select for COVID-19 vaccines going forward,' FDA vaccine chief Dr. Vinay Prasad said in comments opening the meeting. Prasad added that the agency wants 'to give people a little more time to digest,' the new policy on vaccines and is open to feedback. Last fall's recipe was tailored to omicron descendants on the JN.1 branch of the virus family tree. Novavax brewed shots targeting the parent JN.1 variant while Pfizer and Moderna opted for a subtype called KP.2. That JN.1 family still dominates, although it continues to evolve. The question is whether last fall's shots still offer enough cross-protection or if manufacturers instead should match today's most common subtype, called LP.8.1. The World Health Organization recently said last year's version was OK but that vaccine makers could choose an update. The European Medicines Agency instead recommended targeting the newest subtype. FDA officials didn't express a preference in documents posted online ahead of Thursday's meeting. suggested earlier in the week that the government should move away from yearly updates. 'Instead of having a COVID-19 strategy that's year-to-year where we change things every single year, why don't we let the science tell us when to change?' Prasad said. Debating that science is what the FDA's vaccine advisers do each year. If they recommend leaving the shots unchanged — and the FDA agrees — it's possible that healthy adults and children may still get access to a fall booster, since this week's policy changes suggest new studies would be required only if manufacturers switch strains or introduce a completely new vaccine. Those would be large, six-month studies, and vaccine experts question if their cost and logistics could make them unfeasible. Still, the FDA's strain decision normally isn't the final word on recommendations about who should be vaccinated. The Centers for Disease Control and Prevention's own advisory panel meets in June to make recommendations about the fall shots. Among its options are keeping universal access or recommending vaccination for high-risk groups but still giving lower-risk people the choice in getting a shot. Prasad and FDA Commissioner Marty Makary were both outspoken critics of the government's handling of COVID-19 shots during the pandemic, particularly the recommendation for use in young, healthy adults and children. Before joining government, they each garnered attention from Health Secretary Robert F. Kennedy Jr., who built a national following by casting doubt on the safety and benefits of vaccines. In a medical journal editorial outlining the FDA's new approach, they criticized the U.S.'s 'one-size-fits-all' approach, saying it has long been out of step with Europe and other places with more limited recommendations for boosters. ___ The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Science and Educational Media Group and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
Khaleej Times
21-05-2025
- Health
- Khaleej Times
US limits Covid boosters to over-65s or those at high risk
The United States will limit Covid-19 boosters to people over 65 or those at risk of serious illness, while requiring vaccine makers to run fresh clinical trials before offering shots to younger and healthier individuals, officials said Tuesday. Writing in the New England Journal of Medicine, the Food and Drug Administration's Vinayak Prasad and Commissioner Martin Makary framed the policy shift as "evidence-based" and would align the United States more closely with guidance in Europe. But it comes as Health Secretary Robert F. Kennedy Jr., a longtime vaccine skeptic, pushes to remake federal public health policy. Kennedy previously led a nonprofit that was critical of immunisation programmes, and during the pandemic petitioned the FDA to revoke Covid vaccine authorisations, citing rare side effects including heart inflammation. Prasad and Makary praised the initial Covid-19 vaccine rollout as "a major scientific, medical, and regulatory accomplishment," but argued that the benefits of repeated boosters for low-risk individuals are uncertain. They criticised the US approach of recommending boosters for all adults regardless of age or health status, calling it a "one-size-fits-all" model based on the mistaken belief that Americans couldn't handle more nuanced, risk-based advice. Rather than building public trust, they wrote, it had backfired — fueling vaccine hesitancy that has spilled over into skepticism toward childhood shots, including those for measles. The FDA said it would rely on lab test results to approve boosters for people who are over 65, or over six months old with at least one underlying condition. But for healthy individuals between six months and 64 years, regulators will now require data from randomized trials. "We simply don't know whether a healthy 52-year-old woman with a normal BMI (body mass index) who has had Covid-19 three times and has received six previous doses of a Covid-19 vaccine will benefit from the seventh dose," they wrote. Some infectious disease experts welcomed the shift. Amesh Adalja of Johns Hopkins University said it matched with the approach taken by other countries in a population that already carries significant immunity. "For lower-risk individuals, the goal has always been less clear, as protection against infection is transient and they don't have a high risk of severe disease," he told AFP. But others voiced concern about the practical consequences. Paul Offit, a leading vaccine expert at the Children's Hospital of Philadelphia, said it could limit access for people who still want boosters. "Any use, say in a healthy 35-year-old, would be considered off-label, and you wonder whether an insurance company would pay for it," he told AFP. Not like annual flu shot Under the revised framework, companies like Pfizer and Moderna will be encouraged to test updated boosters in adults aged 50 to 64. These studies should measure whether the vaccines reduce symptomatic infections, hospitalizations and deaths. Rather than comparing new shots to earlier formulations, Prasad and Makary suggested placebo-controlled trials -- with saline as the comparator -- to better evaluate both benefit and potential side effects. The proposal, first floated by Kennedy earlier this month, has proved divisive. Critics argue that using a placebo -- when authorized vaccines already exist -- could expose participants to unnecessary harm. "Imagine if there was a death or two in the placebo group," said Offit. "I don't see how you conscience that." Supporters of continued Covid-19 boosters often draw parallels to annual flu shots. But Makary and Prasad pushed back on that comparison, arguing the genetic changes in Covid variants haven't been significant enough to justify automatically updating the vaccine each year. The FDA officials also sought to reassure Americans concerned they might lose access to boosters under the new framework. The Centres for Disease Control and Prevention's (CDC) definition of risk factors is "vast, including obesity and even mental health conditions such as depression," they wrote, noting that between 100 million and 200 million Americans would likely still qualify.
