FDA approves expanded use of Moderna's RSV shot, but uncertainty remains
The Food and Drug Administration (FDA) expanded the approval of Moderna's RSV vaccine late Thursday to include people 18 to 59 years old who are at increased risk for severe illness from respiratory syncytial virus, the company said.
The vaccine was previously only licensed for adults 60 years and older.
'RSV poses a serious health risk to adults with certain chronic conditions, and today's approval marks an important step forward in our ability to protect additional populations from severe illness from RSV,' said Stéphane Bancel, Moderna's CEO, in a statement.
The expanded approval was a much-needed win for the company, which has experienced setbacks due to Trump health officials' distrust of messenger RNA-based (mRNA) vaccines.
The Department of Health and Human Services (HHS) recently canceled more than $750 million in contracts for Moderna to develop and test mRNA vaccines to protect against pandemic flu.
Moderna's RSV shot was the first non-COVID-19 mRNA vaccine to be approved in the United States.
The Centers for Disease Control and Prevention's (CDC) independent vaccine panel, the Advisory Committee on Immunization Practices (ACIP), previously voted to recommend an RSV vaccine for adults aged 50 to 59 who have medical conditions that increase their risk of severe illness from the virus.
But the recommendation needs to be endorsed by the CDC director for it to take effect; there currently is no CDC director. Susan Monarez, who was acting director, is awaiting Senate confirmation and isn't allowed to serve as acting director at the same time.
HHS Secretary Robert F. Kennedy Jr. has the power to endorse the recommendation in the absence of a CDC director, but he has not signed off on it since the committee voted more than two months ago. He has also not acted on the other recommendations from the same meeting, including the use of a meningitis vaccine.
He endorsed the panel's recommendations for chikungunya vaccines in May.
Without an officially accepted ACIP recommendation, insurers don't have to cover the vaccine for the expanded population.
Kennedy fired all 17 members of ACIP earlier this week, arguing a 'clean sweep' was needed to purge conflicts of interest and help restore trust in vaccinations and public health.
On Wednesday, he named eight handpicked replacements, including some vocal vaccine critics. A scheduled late June meeting is still expected to occur.
Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
The Hill
an hour ago
- The Hill
Delaware governor signs executive order protecting gender-affirming care
On Friday, Delaware Democratic Gov. Matt Meyer signed an executive order increasing protection for receivers and providers of gender-affirming care. 'In Delaware, we cherish privacy, dignity and the right to make personal medical decisions. Everyone deserves the freedom to access healthcare rooted in science and compassion,' said Meyer. The executive order prohibits any state agency from providing 'medical records, data or billing information, or utilize state resources' that could help any criminal or civil investigation against someone receiving or providing gender-affirming care. It also dictated that the state professional regulations board cannot disbar healthcare professionals only due to providing gender-affirming care. California, New York, Illinois and 11 other states, and Washington, D.C., have enacted similar legislation to shield patients and doctors from aggressive legislation in states where gender-affirming care is highly restricted. Patients can now travel to shield states to receive their care without fear of retribution in their home states. This comes after a Supreme Court decision on June 18 that upheld Tennessee's decision to ban puberty blockers and hormone treatments for transgender minors. 'This ruling undermines doctors in delivering care to some of the most vulnerable patients in our country,' Rep. Sarah McBride (D-Del.), the nation's first openly transgender member of Congress, said Wednesday on the social platform X. Since President Trump took office transgender rights have increasingly been limited. Trump signed an executive order recognizing only two genders, has tried to ban transgender troops from the military, has refused requests to change the gender of passports and has tried to defund gender-affirming medical care. Delaware has a long history of tolerance for LGBTQ populations. According to the order, the state hosts 40,000 LGBTQ individuals and 6,300 transgender adults. In 2013, it legalized same sex marriage and implemented anti-discrimination laws in housing, employment and public accommodation. 'We will do everything in our power to protect transgender families in the state of Delaware and throughout the country,' the Executive Committee of the Delaware Democratic Party PRIDE Caucus said in a press statement earlier this week. 'We call on every legislator, from the state and county level to the federal level, to speak out and step up. This is the moment to act – not with caution, but with courage.'
Yahoo
4 hours ago
- Yahoo
UnitedHealth Group (NYSE:UNH) Announces Debt Financing Totalling US$3 Billion
UnitedHealth Group recently completed a substantial debt financing deal, raising $3 billion through the issuance of various Notes. This move comes amid a period of legal settlements, such as the $69 million ERISA case, and operational restructuring, including exploring bids for its Latin American operations. Despite these significant developments, the company's stock price remained relatively flat over the last month, reflecting broader market trends which also showed minimal movement. The dividend increase and shareholder discussions on executive compensation may have subtly influenced sentiment, but overall, these events seemed to align with the market's flat performance. UnitedHealth Group has 1 possible red flag we think you should know about. Trump has pledged to "unleash" American oil and gas and these 22 US stocks have developments that are poised to benefit. UnitedHealth Group's recent $3 billion debt financing and restructuring efforts, such as evaluating bids for its Latin American operations, are significant developments. While the near-term stock price remained relatively stable amid these changes, over the past five years, the company's total shareholder return, including dividends, was 13.61%. This reflects a steady growth trajectory, although in the last year, UnitedHealth underperformed the US Healthcare industry. The current share price sees a slight discount from the analyst consensus price target of $547.65, which is 28% higher than the present value. Despite recent legal settlements and compensation discussions, the company's aggressive push towards digital tools and Medicare adjustments might bolster future earnings and revenue. UnitedHealth's projected earnings per share and revenue growth is positioned slightly behind broader market expectations over the next few years, yet planned improvements in operational efficiencies could bridge this gap over time. Learn about UnitedHealth Group's future growth trajectory here. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include NYSE:UNH. This article was originally published by Simply Wall St. Have feedback on this article? Concerned about the content? with us directly. Alternatively, email editorial-team@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
The Hill
5 hours ago
- The Hill
Why tariffs are already driving some healthcare premiums higher
Related video above: How patients and doctors can reduce healthcare costs (NEXSTAR) – Despite the focus on the price of cars, iPhones and other consumer goods, the Trump administration's tariffs are starting to drive up prices in an entirely different industry – healthcare. On Monday, Matt McGough, with nonprofit health policy organization KFF, wrote that several individual insurance companies have already notified state regulators that they will be raising premiums to offset the potential impact of tariffs on pharmaceuticals. Trump hasn't yet targeted pharmaceuticals with tariffs, but has repeatedly brought it up, including on Monday aboard Air Force One. 'We're going to be doing pharmaceuticals very soon,' Trump said, according to Reuters. 'That's going to bring all the companies back, into America.' In a May filing, the Independent Health Benefits Corporation (IHBC) said it was submitting a premium rate change of 38.4% for 2026, 'primarily due to increased costs due to inflation and tariffs, and changes in risk adjustment.' An IHBC spokesperson told Axios that roughly 3% of that increase was to directly account for the impact of tariffs, specifically on drug prices. McGough notes that there are other insurers who either haven't specifically mentioned the potential effect of tariffs or who declined to include an offsetting increase in 2026 premium rates. 'A large proportion of medical goods currently comes from international sources, including pharmaceuticals, medical devices and personal protective equipment, as well as other low-margin, high-use essentials like syringes, needles and blood pressure cuffs,' Tina Freese Decker, board chair of the American Hospital Association, wrote in a May post. 'Tariffs on these items could impact patient care by jeopardizing the availability of vital medications and essential health care devices. They also could raise costs for hospitals and heighten shortages and supply chain disruptions.' Meantime, millions of Affordable Care Act (ACA) enrollees could see an over 75% average increase in premiums if Biden-era subsidies aren't extended by Congress before they expire at the end of the year, according to KFF estimates. How much tariffs are weighing on the calculations of insurers will become a bit more clear on Aug. 1, Axios notes, when proposed 2026 premium rates are posted.
