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Gulf Today
04-07-2025
- Health
- Gulf Today
Vaccine panel is turning misinformation into policy
Lisa Jarvis, Tribune news Service Health and Human Services Secretary Robert F. Kennedy's dismantling of Americans' trust in — and ultimately, access to — vaccines isn't happening with one sweeping policy that grabs the public's attention. It's unfolding quickly and quietly, in bland conference rooms where hand-picked appointees make decisions that will have far-reaching consequences for our health. Inside one of those nondescript rooms last week, the Advisory Committee on Immunization Practices (ACIP), an independent panel that makes vaccine recommendations to the Centers for Disease Control and Prevention, offered a glimpse of what's to come. The group, few of whom have any expertise in vaccines, infectious diseases or epidemiology, at times cast aside evidence-based science and sowed doubt in some of our most valuable public health tools. This panel of seven replaced the 17 ACIP members Kennedy fired last month in order to stack the committee with members who share his anti-vaccine agenda. Their lack of expertise and, for some, even basic knowledge of epidemiology, were evident throughout the two-day meeting. Some were unfamiliar with the Vaccines for Children Program, which provides free shots to those eligible. (The program has provided some 71.5 billion doses to kids since 1994.) At least one member appeared to struggle to understand the distinction between a vaccine's efficacy and its effectiveness. It's a wonky, but important distinction referring to how well a vaccine works in a trial versus the real world. Some seemed not to take seriously the risk that infections like RSV and the flu can pose to even healthy children. One member suggested that the 250 children who died from the flu last season — a recent high — was a 'modest' number. But this group isn't just unqualified — it's dangerous. Its decisions directly influence insurance coverage and access to vaccines, affecting health outcomes for all Americans. The stakes are particularly high when it comes to protecting children against preventable diseases. Yet the tone of the panel's first formal meeting suggested many members are more intent on sowing doubt about routine immunisations. Even worse, their actions could impede access to these important medicines. 'That whole meeting was a travesty,' says Fiona Havers, a physician and epidemiologist. After the ACIP firings, Havers resigned from the CDC, where she was considered one of its leading experts on vaccine policy. Kennedy's oft-repeated claim is that the COVID-19 response caused vaccine hesitancy in the US and that his drastic changes at the CDC are a necessary step in rebuilding the public's trust. Martin Kulldorff, a former Harvard epidemiologist and chair of the panel, echoed that sentiment during the meeting's opening, emphasizing the importance of 'rebuilding trust in sound science,' and again at the end, when he commended participants for discussing vaccines in an 'unbiased, open and transparent way.' It's a convenient — and inaccurate — framing. It elides the role Kennedy's Make America Healthy Again movement played in spreading vaccine misinformation during the pandemic. It provides cover for their 'just asking questions' approach to evaluating vaccine policy. The problem, of course, is when people given the CDC's imprimatur are asking questions that are purposely crafted to sow doubt. That became clear from the outset when Kuldorff announced that the committee would evaluate the cumulative effects of the childhood vaccine schedule, as well as any immunizations that had not been considered in the last seven years, including the hepatitis B shot given to newborns. The implication is that the CDC has been ignoring some unknown dangers of shots that have been safely used for years. Kuldorff, who was fired from Harvard, was a vocal critic of COVID vaccine mandates during the pandemic and refused the shot. 'The claims that were framed as efforts to increase vaccine confidence actually do the opposite — they undermine vaccine confidence,' says Sean O'Leary, the American Academy of Pediatrics' liaison to ACIP. He called the meeting 'a really long couple of days for science.' A discussion of flu vaccines was a disturbing preview of what 'rebuilding trust' might look like under Kennedy's CDC — and how that mantra could be used to disrupt access to vaccines. After a thankfully routine vote to recommend that Americans get their fall flu shots, the panel stated that those vaccines should not contain thimerosal, a mercury-containing preservative that decades ago came under scrutiny for a now-disproven link to autism. It was a disturbing development that upended the panel's normally measured process for evaluating vaccines. The discussion was added to ACIP's agenda at the last minute, but more alarming was that thimerosal was being discussed at all. The preservative's safety has been thoroughly studied, but was removed from all childhood vaccines in 2001 to try to address parents' hesitancy. Today, it is used sparingly— the single-dose flu vaccines that the majority of Americans receive don't contain it, but it's still used as a preservative in multi-dose vials, which just 4-5% of patients in the US receive. Most troubling was that the 'evidence' against thimerosal was presented by Lyn Redwood, a nurse and former head of the Children's Health Defense, the anti-vaccine group founded by Kennedy. She used her time to make a series of false claims about the preservative's risks. Her original presentation cited a fake study on the risks of thimerosal — a reference removed after the media raised concerns. Pediatrician Cody Meissner, one of two rational members, questioned the purpose of her presentation and its contents. (Meissner was often the lone voice of reason and expertise on the panel during the two-day meeting.) Ultimately, when it came time to vote on recommending the preservative be removed from flu shots, Meissner was also the only member to vote against it. The vote has real consequences. It means some Americans will lose out on their shots. The vaccine is more commonly used outside the U.S., and there's concern about how ACIP's decisions could ripple into global health. And vaccine hesitancy experts worry that re-litigating a settled topic could undermine broader confidence in immunisations. And perhaps most alarming is the precedent set by the committee bypassing the CDC's normal review process to push through what seemed like a preordained decision. Typically, a CDC working group comprised of internal staff and subject matter experts would spend months developing recommendations that are presented to ACIP in a public forum. They would examine hard data on a vaccine within the broader context of its real-world use, considering, for example, the magnitude of the public health problem it addresses, challenges to implementing a rollout, and its impact on health equity, Havers explains. Before considering removing a shot like the thimerosal-containing flu vaccine, the working group would first study the public health consequences of the decision. 'None of that happened, which is why this was a complete farce,' Havers says. That's the antithesis of transparency. And it's a sign for what we can expect from this group. After watching the panel railroad a vote on settled science, it's fair to worry about their future plans. The next effort to 'rebuild trust' could have far-reaching health consequences — and, without a doubt, will cost lives.
The Hill
01-07-2025
- Business
- The Hill
Our elected officials are bankrupting the government
The U.S. national debt has reached $37 trillion. To keep the federal government from exceeding its congressionally mandated debt ceiling and continue to pay its bills, the U.S. Department of Treasury is using what it calls 'extraordinary measures' (also known as accounting manipulations) to prevent the government from falling over its fiscal cliff. Without congressional action, it may occur in late summer. The recently proposed spending bill by the House (labelled the 'One Big Beautiful Bill Act') does nothing to address the budget deficits that have plagued our nation for decades. Members of both parties are culpable for such irresponsibility. If the U.S. government were a private-sector company, it would have filed for bankruptcy long ago to wash away its debt. But bankruptcy is not an option for sovereign nations, and 'default' is an ugly word. And the Treasury can always print money to pay the government's bills, although that runs the risk of creating inflation problems that the Federal Reserve has worked diligently to avoid. If the U.S. is to get its fiscal house in order, cutting federal spending alone is not the answer. Any such cuts must be accompanied by investments to increase gross domestic product, currently around $29 trillion annually, such that it exceeds the national debt. One challenge in doing this is that government spending represents 23 percent of the GDP; hence any cuts in federal spending will also reduce the GDP unless offset by private-sector growth. A deep dive into the federal budget shows that Social Security, Medicare, interest on debt, health, and national defense spending are the biggest spending categories. With interest rates that have increased significantly over the last five years, interest payments have become one of the largest components of government spending, and are likely to be so for the foreseeable future. That is why President Trump continues to criticize the Federal Reserve for keeping interest rates at their current levels, since lower interest rates would reduce these borrowing costs. In contrast, the Federal Reserve believes that interest rates at their current level are necessary to keep the economy growing while limiting the risk of inflation and managing the uncertainty around the Trump tariffs. To get the nation's fiscal house in order, every program must be on the table for discussion, including Social Security, which politicians remain reticent even to discuss, let alone touch. Government spending comes in many shapes and flavors. Some can be viewed as investments that carry a positive return, hence effectively reducing the national debt. For example, the Vaccines for Children Program provides vaccines that prevent numerous childhood diseases. Studies have shown that every dollar spent on childhood immunization returns between $3.30 and $10.90 in benefits over a 30-year period, providing a 4 percent to 8 percent annual return on investment. The same holds with investments by the National Science Foundation. Its $9 billion annual budget is less than one-sixth of 1 percent of the federal budget, yet new technologies and concepts that emerge from its investments return many times more than what was spent. I know this from personal experience. I have received several NSF grants during my career, totaling just over $2.3 million. Two of these grants centered around aviation security, with the research output providing the technical foundations for risk-based security used to support the design of TSA PreCheck. Independent analysis has shown that the TSA Precheck program saves the government around $110 million annually, in perpetuity — a sizeable return on investment. Cuts to USAID, AmeriCorps and Voice of America may not provide such direct positive returns. Yet these agencies build goodwill with the U.S. across the globe. For example, investments to halt the spread of infectious diseases globally, such as HIV, will further protect our shores and our citizens. Ends to such programs may save money in the short term but are certain to cost our country significantly over time. Every government expenditure should be viewed as an investment. Some will have measurable returns, while others provide support to maintain a minimal standard of living for all. Some are easy to quantify, while others are more nuanced. Yet it should be the responsibility of elected representatives to use such information in determining how to invest and allocate government resources. The 'One Big Beautiful Bill Act' is not only irresponsible; it is an embarrassment. Rushing to get it signed by July 4 is symptomatic of the subterfuge that has become the hallmark of elected officials in power. If this is the best that our elected officials can do for the country, then we are in far worse condition than indicated by the $37 trillion national debt and the recent bond rating downgrade by Moody's. Getting our nation's fiscal house in order should be a top priority for every person in Congress. The 2026 midterm elections are the best time to hold those running for election accountable and force them to take a position on the issue. If they then renege on their commitments, voters will have a chance in 2028 to show them that they noticed. Without such accountability, our elected officials will continue to bankrupt our nation, to everyone's detriment, even if the government can never go bankrupt. Our citizens deserve better. Sheldon H. Jacobson, Ph.D., is a computer science professor in the Grainger College of Engineering at the University of Illinois Urbana-Champaign. A data scientist, he uses his expertise in risk-based analytics to address problems in public policy.
Business Wire
26-06-2025
- Health
- Business Wire
ACIP Recommends Use of Merck's ENFLONSIA™ (clesrovimab-cfor) for Prevention of Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease in Infants Younger than 8 Months of Age Born During or Entering Their First RSV Season
RAHWAY, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) voted to recommend ENFLONSIA™ (clesrovimab-cfor) as an option for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in infants younger than 8 months of age who are born during or entering their first RSV season. The ACIP also voted to include ENFLONSIA in the Vaccines for Children Program—an important step in ensuring broad access to this preventive option for infants. ENFLONSIA is a preventive, long-acting monoclonal antibody (mAb) designed to provide direct, rapid and durable protection through 5 months, a typical RSV season, with the same dose regardless of weight. A typical RSV season usually spans autumn to spring of the next year. ENFLONSIA should not be administered to infants with a history of serious hypersensitivity reactions, including anaphylaxis, to any component of ENFLONSIA. See additional Selected Safety Information below. 'Ahead of the 2025-2026 RSV season, we are proud to offer ENFLONSIA as a new preventive option designed to protect healthy and at-risk infants from RSV disease across a spectrum of severity, including worsening disease requiring hospitalization,' said Dr. Richard M. Haupt, vice president, head of global medical & scientific affairs, vaccines and infectious diseases, Merck Research Laboratories. 'The Committee's recommendation is an important step forward in efforts to help reduce the significant burden RSV continues to place on infants, families and health care systems.' The U.S. Food and Drug Administration (FDA) approved ENFLONSIA earlier this month based on clinical data from the Phase 2b/3 CLEVER and Phase 3 SMART trials. Merck plans to make ENFLONSIA available for ordering by physicians and health care administrators in July 2025, with shipments to be delivered before the start of the 2025-2026 RSV season. The ACIP's recommendation for ENFLONSIA is provisional and will be official once reviewed and finalized by the CDC Director or the Health and Human Services Secretary (in the absence of a CDC Director). About ENFLONSIA™ (clesrovimab-cfor) ENFLONSIA is Merck's extended half-life monoclonal antibody (mAb) indicated for passive immunization for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants who are born during or entering their first RSV season. ENFLONSIA is administered using the same dose regardless of weight (105 mg/0.7 mL in a prefilled syringe) and is designed to provide direct, rapid and durable protection through 5 months, a typical RSV season. For infants born during the RSV season, ENFLONSIA is to be administered within the first week of life. For infants born outside of the RSV season, ENFLONSIA should be administered shortly before the RSV season begins. For infants undergoing cardiac surgery with cardiopulmonary bypass during or entering their first RSV season, an additional 105 mg dose is recommended as soon as the infant is stable after surgery. ENFLONSIA has a 30-month shelf life. Selected Safety Information for ENFLONSIA™ (clesrovimab-cfor) Do not administer ENFLONSIA to infants with a history of serious hypersensitivity reactions, including anaphylaxis, to any component of ENFLONSIA. Serious hypersensitivity reactions, including anaphylaxis, have been observed with other human immunoglobulin G1 (IgG1) monoclonal antibodies. If signs or symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, initiate appropriate medications and/or supportive therapy. The most common adverse reactions were injection-site erythema (3.8%), injection-site swelling (2.7%) and rash (2.3%). About RSV Respiratory syncytial virus (RSV) is a contagious virus that causes widespread seasonal infections and can lead to serious respiratory conditions such as bronchiolitis and pneumonia. According to the CDC, two to three out of every 100 infants under 6 months of age are hospitalized with RSV annually. As the leading cause of hospitalization among infants in the U.S., there is persisting unmet need for RSV preventive options for both healthy and high-risk infants born during or entering their first RSV season. RSV season is the time of year when RSV infections are most common, usually occurring fall/autumn through spring of the next year. RSV typically peaks in the winter in most regions of the United States, but timing and severity in a given community or region can vary year to year. About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn. Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA This news release of Merck & Co., Inc., Rahway, N.J., USA (the 'company') includes 'forward-looking statements' within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company's management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company's Annual Report on Form 10-K for the year ended December 31, 2024 and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site ( Please see Prescribing Information for ENFLONSIA (clesrovimab-cfor) at and Patient Information/Medication Guide for ENFLONSIA at
NBC News
22-06-2025
- Health
- NBC News
Outside groups organize to form unbiased, independent vaccine panel
In the wake of Health Secretary Robert F. Kennedy Jr.'s decision to shake up a key federal vaccine advisory committee, outside medical organizations and independent experts are looking for alternate sources of unbiased information and even considering forming a group of their own. A leading contender is a new group led by Michael Osterholm, an infectious disease expert and the director of the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota. Osterholm is launching the Vaccine Integrity Project at CIDRAP as a potential alternative to the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices. 'We've always just taken for granted that routine child immunizations and other vaccines would be readily available and that they would be supported by the public health system,' Osterholm said. 'Now that's in question.' Earlier this month, Kennedy fired all 17 members from ACIP, appointing in their place eight new members, many of whom have expressed vaccine-skeptical views or questioned pandemic restrictions. Kennedy himself has a long history of anti-vaccination activism. The American Academy of Pediatrics has called the new ACIP members a ' radical departure' from the committee's mission of protecting kids. ACIP holds a significant amount of influence over vaccinations in the U.S.; the panel is responsible for setting the childhood vaccination schedule and determining what vaccines are given free of charge under the Vaccines for Children Program. Its recommendations guide what vaccinations are required for attending public school and what shots insurance covers. 'The real risk is that families and patients may not have access to vaccines' if the panel makes changes to their recommendations, said Dr. Molly O'Shea, a pediatrician in Michigan. 'The ramifications are deep,' said Dr. Michelle Taylor, a pediatrician and the director of the Shelby County Health Department in Memphis, Tennessee. 'Any school system that is requiring immunizations for school entry is looking for those ACIP recommendations, either directly from the CDC, from the Department of Education, if they are filtered there, or from their local or state health departments.' CIDRAP is now consulting with multiple medical organizations and public health groups — including the AAP, the American Academy of Family Physicians, the American College of Physicians, the American Pharmacists Association, the National Foundation for Infectious Diseases, as well as insurance providers — to discuss vaccine recommendations. Insurance companies rely on ACIP's guidance on which vaccines to cover. But if enough reputable public health groups come up with recommendations different from ACIP's, Osterholm said those groups could sway insurance companies on which shots to cover. Although vaccination rates have been slipping in recent years, the vast majority of American families do vaccinate their kids. The CDC reported that 92.7% of kindergartners in the 2023-24 school year had received their routine childhood vaccines. Parents depend on guidance from pediatricians on which shots to give and when. Those pediatricians rely on CDC guidance. 'Pediatricians have one goal, and that's to keep every child healthy and safe in every community. That is what we wake up every morning thinking about. That is what we go to sleep thinking about at night,' said Dr. Susan Kressly, the president of the AAP. 'If pediatricians are not standing up for what children and families deserve and need, then who?' Some major medical organizations are voicing their concerns about Kennedy's anti-vaccine actions. The American Medical Association has asked Congress to investigate Kennedy's handling of ACIP. States are also taking action. The Wisconsin Department of Health Services defied the HHS declaration that the federal government would no longer recommend Covid shots for healthy children and pregnant women. 'The recent changes in CDC guidance were not made based on new data, evidence, or scientific or medical studies, nor was the guidance issued following normal processes,' the state's department of health wrote in a press release. The Illinois Department of Public Health criticized Kennedy's gutting of ACIP, saying on X that the secretary had a 'misunderstanding of how vaccine trials work.' ACIP's approach ACIP was formed in 1972 as an independent panel of experts to educate the federal government on vaccines. The committee —composed of experts including pediatricians, geriatricians, infectious disease doctors, immunologists and vaccinologists — has three regular meetings a year to pore over the evidence for new or updated vaccines. All meetings are open to the public and are streamed online. The panel may also be convened outside of those regular meetings. During the Covid pandemic, for example, the committee reviewed rare reports of a heart problem called myocarditis in some young men who'd had the Covid shot. The committee also recommended against the Johnson & Johnson Covid vaccine after it was linked to rare but potentially deadly blood clots. Recommendations from ACIP are usually adopted by the director of the CDC. But there isn't any CDC director at the moment. President Donald Trump's pick for the job, Susan Monarez, has a scheduled confirmation hearing in the Senate on June 25 — the same day Kennedy's new ACIP members will meet for the first time. As head of the Department of Health and Human Services, Kennedy is the ultimate authority and has the ability to override ACIP recommendations. He flexed this rarely used muscle in May by announcing — without any input from ACIP — that the Covid vaccine would no longer be recommended for healthy children and pregnant women. ACIP members have historically gone through an extensive vetting process to ensure their expertise. If members have conflicts of interest, they recuse themselves from votes. An HHS spokesman said its eight new ACIP members were thoroughly vetted, but not did not offer specifics. Two members, Dr. Martin Kulldorff and Dr. Robert Malone, were previously paid experts in trials involving Merck vaccines. Another, Vicky Pebsworth, served as an expert witness in a federal lawsuit brought by activists who sought to outlaw childhood vaccination mandates. The case was dismissed in 2021. Vaccine skepticism isn't necessarily a bad thing. 'True scientists ask critical questions in a way that doesn't presume the answer,' the AAP's O'Shea said. 'What has made America great, however, is our medical and scientific innovation. To undermine that is gravely concerning to me.'
CNBC
11-06-2025
- Health
- CNBC
Why a Covid-19 vaccine could soon cost as much as $150—even if you're insured
If you're planning on getting a Covid-19 booster this fall, you could be faced with a hefty bill — even if you have insurance. Health and Human Services Secretary Robert F. Kennedy Jr. announced in May that the Centers for Disease Control and Prevention no longer recommends a Covid-19 vaccine for healthy children and pregnant people. Kennedy shared the announcement on the social media platform, X, in a video alongside Dr. Jay Bhattacharya, director of the National Institutes of Health, and Dr. Marty Makary, the commissioner of the Food and Drug Administration. "Last year, the Biden administration urged healthy children to get yet another Covid shot, despite the lack of any clinical data to support the repeat booster strategy in children," Kennedy said in the video. He did not share scientific evidence to support the need for changes to Covid vaccine recommendations. A representative from the CDC was noticeably missing from the announcement. The agency currently has no acting director, and late last week, RFK Jr. dismissed all 17 members of the CDC's Advisory Committee for Immunization Practices. Typically, changes to the federal immunization recommendations and schedule only occur after the CDC's vaccine advisory panel discusses and votes on them. The committee did not meet or vote on the changes announced by Kennedy last month. For those who still want to get their Covid vaccines, these changes could affect how much insurance will cover — if anything at all. The national Covid emergency ended in 2020, which meant Covid-19 vaccines and boosters were no longer free and the uninsured would have to pay out of pocket. The CDC's vaccine guidance is what private insurers rely on to determine whether or not they will cover the costs of immunizations. Medicaid will only cover the full price of recommended vaccines, and children who are insured can receive free vaccinations through the Vaccines for Children Program only if those immunizations are recommended by the CDC. Without insurance, Pfizer and Moderna shots for Covid-19 can cost as much as $150, according to the CDC's site. This is troubling for health experts who see the positive effects of Covid vaccines on vulnerable populations up close. "As ob-gyns who treat patients every day, we have seen firsthand how dangerous COVID-19 infection can be during pregnancy and for newborns who depend on maternal antibodies from the vaccine for protection," Steven Fleischman, president of the American College of Obstetricians and Gynecologists, said in a statement. Research supports Fleischman's claim. "This decision could make it significantly harder for millions of Americans to access vaccines they want for themselves and their families," Tina Tan, president of the Infectious Diseases Society of America, said in a statement.
