Latest news with #Vaccines
CNN
6 hours ago
- Health
- CNN
Vaccinating young children against Covid-19 may be more challenging this respiratory virus season
Vaccines Respiratory viruses Children's health Federal agenciesFacebookTweetLink Follow Parents in the United States who want to vaccinate their young children against Covid-19 may face a growing set of challenges this fall. The US Food and Drug Administration might not renew authorization for Pfizer's Covid-19 vaccine for children younger than 5, the US Centers for Disease Control and Prevention told state and local health officials on Friday. 'This decision would affect Pfizer's pediatric COVID-19 vaccine for children aged 6m–4y for the 2025–2026 season,' the CDC's National Center for Immunization and Respiratory Diseases said in an email that was obtained by CNN. In May, US Health and Human Services Secretary Robert F. Kennedy Jr. announced that the CDC would no longer recommend Covid-19 vaccines for healthy children or pregnant women. The CDC's immunization schedule was updated to reflect that children would be able to get the vaccines after consulting with a health care provider — what's known as 'shared decision-making.' But without FDA authorization, Pfizer's Covid-19 vaccine would no longer be available to any children younger than 5 and the other option available for healthy children with no underlying conditions in this age group, Moderna's Covid-19 vaccine, would have to be given 'off label' by a willing pharmacist or physician. This contradicts the intent of shared clinical decision-making, said Dr. Paul Offit, a pediatrician and director of the Vaccine Education Center at Children's Hospital of Philadelphia. 'Shared clinical decision-making assumes that you're making a decision for that child whether they're healthy or not healthy. So now it's confusing,' he said. Covid-19 vaccines first became available to the American public during the pandemic under emergency use authorization, known as EUA — special permissions used by the FDA during an emergency that are short of full approval. Pfizer has had full FDA approval for its Covid-19 vaccine for individuals age 12 and older since 2022. The company anticipates that this approval will expand to children ages 5 to 11 for the upcoming respiratory virus season, according to the email that the CDC's National Center for Immunization and Respiratory Diseases sent to state and local health officials on Friday. But vaccine access for the youngest children, who are most vulnerable to severe illness from a Covid-19 infection, would be significantly more limited if the FDA does not renew emergency authorization for the Pfizer vaccine for children under 5. Pfizer confirmed to CNN that the FDA has said that it may not renew the emergency use authorization or the Pfizer-BioNTech Covid-19 vaccine for children ages 6 months to 4 years. 'We are currently in discussions with the agency on potential paths forward and have requested that the EUA for this age group remain in place for the 2025-2026 season,' Pfizer said in a statement. 'It is important to note that these deliberations are not related to the safety and efficacy of the vaccine which continues to demonstrate a favorable profile.' Fatima Khan, co-founder of the nonprofit grassroots group Protect Their Future, which advocates for vaccine access for kids, told CNN in a statement, that 'taking a proven, safe and effective vaccine away from vulnerable children is unconscionable.' 'The science is clear: Infants face Covid-19 hospitalization rates comparable to those over 65. Refusing to authorize it for children under 5 doesn't protect them–it abandons them,' she said. 'Parents have already struggled to safeguard their youngest because of limited vaccine access. Now that protection may disappear entirely this fall just as schools reopen. If this stands, it will be a lasting stain on our public health system and on every leader who left our children behind.' Moderna also has a Covid-19 vaccine available for children age 11 and younger. It was granted full approval by the FDA in July but only for those who are at 'increased risk for COVID-19 disease.' Moderna plans to increase vaccine supply for children to 'help mitigate any potential supply gap,' according to the CDC email sent on Friday, but Moderna is still determining the specific volume and timing. Like flu vaccines, Covid-19 vaccines have typically been updated with formulations that best target the virus strains that are in circulation each season. But the FDA has not yet approved the formulation for the 2025-2026 season. 'I think the bottom line is that children are going to be less likely to get this vaccine, which goes against the data,' Offit said. At a meeting in April, the CDC's vaccine advisory committee heard evidence that children accounted for about 4% of all Covid-19 hospitalizations over last fall and winter's respiratory virus season. Rates of Covid-19 hospitalizations among children are highest for the youngest age groups, CDC data shows. Last respiratory virus season, there were 48 Covid-19 hospitalizations for every 100,000 children under 5 – nearly seven times the rate for older children and more than twice the rate for adults under 50. 'It's a war on mRNA vaccines. Why? Because mRNA vaccines are now political,' Offit said. 'It's just a war against the science, war against the data, and we will suffer this. And the thing that I fear the most is: Will we know we're suffering this? Will we have the surveillance capacity to know who's getting hospitalized with Covid, who's dying from Covid?' Covid-19 levels are on the rise in the US, with transmission increasing in at least 45 states, according to the CDC. In a statement to CNN, the US Department of Health and Human Services said that the agency does not comment on potential regulatory changes. 'The COVID-19 pandemic ended with the expiration of the federal public health emergency in May 2023,' spokesperson Andrew Nixon said in an email. 'Unless officially announced by HHS, discussion about future agency action should be regarded as pure speculation.'
CNN
6 hours ago
- Health
- CNN
Vaccinating young children against Covid-19 may be more challenging this respiratory virus season
Vaccines Respiratory viruses Children's health Federal agenciesFacebookTweetLink Follow Parents in the United States who want to vaccinate their young children against Covid-19 may face a growing set of challenges this fall. The US Food and Drug Administration might not renew authorization for Pfizer's Covid-19 vaccine for children younger than 5, the US Centers for Disease Control and Prevention told state and local health officials on Friday. 'This decision would affect Pfizer's pediatric COVID-19 vaccine for children aged 6m–4y for the 2025–2026 season,' the CDC's National Center for Immunization and Respiratory Diseases said in an email that was obtained by CNN. In May, US Health and Human Services Secretary Robert F. Kennedy Jr. announced that the CDC would no longer recommend Covid-19 vaccines for healthy children or pregnant women. The CDC's immunization schedule was updated to reflect that children would be able to get the vaccines after consulting with a health care provider — what's known as 'shared decision-making.' But without FDA authorization, Pfizer's Covid-19 vaccine would no longer be available to any children younger than 5 and the other option available for healthy children with no underlying conditions in this age group, Moderna's Covid-19 vaccine, would have to be given 'off label' by a willing pharmacist or physician. This contradicts the intent of shared clinical decision-making, said Dr. Paul Offit, a pediatrician and director of the Vaccine Education Center at Children's Hospital of Philadelphia. 'Shared clinical decision-making assumes that you're making a decision for that child whether they're healthy or not healthy. So now it's confusing,' he said. Covid-19 vaccines first became available to the American public during the pandemic under emergency use authorization, known as EUA — special permissions used by the FDA during an emergency that are short of full approval. Pfizer has had full FDA approval for its Covid-19 vaccine for individuals age 12 and older since 2022. The company anticipates that this approval will expand to children ages 5 to 11 for the upcoming respiratory virus season, according to the email that the CDC's National Center for Immunization and Respiratory Diseases sent to state and local health officials on Friday. But vaccine access for the youngest children, who are most vulnerable to severe illness from a Covid-19 infection, would be significantly more limited if the FDA does not renew emergency authorization for the Pfizer vaccine for children under 5. Pfizer confirmed to CNN that the FDA has said that it may not renew the emergency use authorization or the Pfizer-BioNTech Covid-19 vaccine for children ages 6 months to 4 years. 'We are currently in discussions with the agency on potential paths forward and have requested that the EUA for this age group remain in place for the 2025-2026 season,' Pfizer said in a statement. 'It is important to note that these deliberations are not related to the safety and efficacy of the vaccine which continues to demonstrate a favorable profile.' Fatima Khan, co-founder of the nonprofit grassroots group Protect Their Future, which advocates for vaccine access for kids, told CNN in a statement, that 'taking a proven, safe and effective vaccine away from vulnerable children is unconscionable.' 'The science is clear: Infants face Covid-19 hospitalization rates comparable to those over 65. Refusing to authorize it for children under 5 doesn't protect them–it abandons them,' she said. 'Parents have already struggled to safeguard their youngest because of limited vaccine access. Now that protection may disappear entirely this fall just as schools reopen. If this stands, it will be a lasting stain on our public health system and on every leader who left our children behind.' Moderna also has a Covid-19 vaccine available for children age 11 and younger. It was granted full approval by the FDA in July but only for those who are at 'increased risk for COVID-19 disease.' Moderna plans to increase vaccine supply for children to 'help mitigate any potential supply gap,' according to the CDC email sent on Friday, but Moderna is still determining the specific volume and timing. Like flu vaccines, Covid-19 vaccines have typically been updated with formulations that best target the virus strains that are in circulation each season. But the FDA has not yet approved the formulation for the 2025-2026 season. 'I think the bottom line is that children are going to be less likely to get this vaccine, which goes against the data,' Offit said. At a meeting in April, the CDC's vaccine advisory committee heard evidence that children accounted for about 4% of all Covid-19 hospitalizations over last fall and winter's respiratory virus season. Rates of Covid-19 hospitalizations among children are highest for the youngest age groups, CDC data shows. Last respiratory virus season, there were 48 Covid-19 hospitalizations for every 100,000 children under 5 – nearly seven times the rate for older children and more than twice the rate for adults under 50. 'It's a war on mRNA vaccines. Why? Because mRNA vaccines are now political,' Offit said. 'It's just a war against the science, war against the data, and we will suffer this. And the thing that I fear the most is: Will we know we're suffering this? Will we have the surveillance capacity to know who's getting hospitalized with Covid, who's dying from Covid?' Covid-19 levels are on the rise in the US, with transmission increasing in at least 45 states, according to the CDC. In a statement to CNN, the US Department of Health and Human Services said that the agency does not comment on potential regulatory changes. 'The COVID-19 pandemic ended with the expiration of the federal public health emergency in May 2023,' spokesperson Andrew Nixon said in an email. 'Unless officially announced by HHS, discussion about future agency action should be regarded as pure speculation.'
CNN
02-08-2025
- Health
- CNN
HHS further constrains certain vaccine advisers to the CDC, limiting their input in evidence reviews
Vaccines Federal agenciesFacebookTweetLink Follow In a further jolt to the process of reviewing and recommending vaccines at the US Centers for Disease Control and Prevention, another group of outside advisers to the agency was abruptly sidelined this week. In an email sent late Thursday evening, which was obtained by CNN, members of roughly 30 medical and public health organizations who serve as liaison members of the CDC's Advisory Committee on Immunization Practices, or ACIP, were told they could no longer participate in the committee's crucial workgroups. Liaison members don't vote at ACIP's public meetings on vaccine recommendations, but they can participate by asking questions and commenting on presentations. Behind the scenes, they have also historically done important work undertaking detailed evidence reviews of the safety and effectiveness of vaccines that helps to inform the group's votes. Those reviews happen in subcommittees called workgroups. As of late last year, ACIP had 11 active workgroups. In addition to studying scientific research, workgroups consider issues of public health importance like what age groups might get the most benefit from a vaccine, what an immunization costs and whether it will be accessible to people who should get it. Workgroups also help craft the language of the recommendations that are voted on by the full committee. Votes are typically held during ACIP's three public meetings each year. If ACIP approves a recommendation, it's forwarded to the CDC director for consideration. The director isn't bound by the committee's recommendation but usually follows it. Liaisons include groups like the American Medical Association, the American Academy of Pediatrics and the American Pharmacists Association. Members also represent nurses and public health officials, typically groups that play a significant role in delivering vaccinations. The latest move comes more than a month after US Health and Human Services Secretary Robert F. Kennedy Jr. removed all 17 voting members of ACIP, replacing them days later with eight of his own picks, many of whom have cast doubt on the safety of vaccines and public policy around vaccination. One member later dropped out during the required financial review. The email sent Thursday called the liaison members 'special interest groups' that are 'expected to have a 'bias' based on their constituency and/or population they represent.' 'It is important that the ACIP workgroup activities remain free of any influence from any special interest groups so ACIP workgroups will no longer include Liaison organizations,' the email said. Andrew Nixon, director of communications for HHS, said in a statement Friday that 'Under the old ACIP, outside pressure to align with vaccine orthodoxy limited asking the hard questions. The old ACIP members were plagued by conflicts of interest, influence and bias. We are fulfilling our promise to the American people to never again allow those conflicts to taint vaccine recommendations.' Dr. William Schaffner, an infectious disease expert at Vanderbilt University who has been participating in ACIP for 40 years as both a voting member and a liaison member, said the move to exclude professional organizations from the process of making vaccine recommendations was shortsighted. 'The organizations have a certain ownership in the recommendations because they participate,' Schaffner said. That participation increases buy-in from different stakeholder groups, which helps ACIP recommendations become the accepted standards of medical practice. Without that participation, Schaffner said, there's a risk that groups will make their own vaccine recommendations, which could lead to conflicting and confusing advice. In fact, some outside organizations, including the Vaccine Integrity Project, have already started the process of making independent vaccination recommendations. Shaffner said he also takes issue with the idea that liaison representatives are biased, which he says implies a conflict of interest. 'Every work group member, no matter who they are, is vetted for a conflict of interest,' he said, and that vetting process has only become more stringent over time as society has become more attuned to the problem. 'I have to turn down opportunities because they would interfere with my being on a work group, and that's something I do, or did,' he said. ACIP's charter spells out that some 30 specific groups should hold non-voting seats on the committee. It also allows the HHS secretary to appoint other liaison members as necessary to carry out the functions of the committee. On Friday, eight organizations that are liaisons to the committee said in a joint statement that they were 'deeply disappointed' and 'alarmed' to be barred from reviewing scientific data and informing the development of vaccine recommendations. 'To remove our deep medical expertise from this vital and once transparent process is irresponsible, dangerous to our nation's health, and will further undermine public and clinician trust in vaccines,' said the statement, which was sent by the American Medical Association. New outside experts may be invited to participate in the workgroups as needed based on their expertise, according to an HHS official who spoke on the condition that they not be named because they had not been authorized to share the information, but such inclusion will no longer be based on organizational affiliation. 'Many of these groups don't like us,' the official said. 'They've publicly attacked us.'
CNN
01-08-2025
- Health
- CNN
Covid-19 vaccine policy changes raise questions and concerns for US adults as summer wave ramps up
Vaccines Respiratory viruses Children's healthFacebookTweetLink Follow As Covid-19 transmission ramps up in the United States, recent changes to federal vaccine guidance have left many Americans confused about the latest policies and concerned about access to shots this fall. The US has had a summer surge in Covid-19 cases each year since the pandemic began. This year, however, experts say that the seasonal wave is starting later than anticipated and is relatively subdued. Surveillance data from WastewaterSCAN shows that median Covid-19 concentrations ticked up from June to July, with high levels in some parts of the country, but overall, it's far below this time last year. 'My hypothesis was that the weak winter wave would set the stage for a bigger summer, because many people would not have recent immunity. So far, activity has been more sedate than I anticipated,' epidemiologist Caitlin Rivers wrote in her newsletter Sunday. 'I remain open-minded about what August will bring. My best guess is continued increases until early September, but I am uncertain.' Although it's too early to know how big the current uptick will be or how long it will last, Dr. Jennifer Nuzzo, an epidemiologist and director of the Pandemic Center at the Brown University School of Public Health, says her key concern is whether Covid-19 vaccines will be available 'in time to protect people, especially those at high risk, against severe illness.' 'My biggest worry at this point is the uncertainty about when updated Covid vaccines will become available and who will be able to get them,' Nuzzo said. New survey data from KFF published Friday shows that most adults in the US don't plan to get a Covid-19 vaccine this fall, but most who do plan to get the shot share concerns that the vaccine won't be available to them and that their insurance won't cover the cost. In the past few months, US Department of Health and Human Services Secretary Robert F. Kennedy Jr. has said that the Covid-19 shot will no longer be recommended for healthy children and pregnant women, replaced a federal vaccine advisory panel and announced plans to examine the well-established federal childhood vaccine schedule. For the latest survey, KFF polled a nationally representative sample of nearly 1,300 adults between July 8 and 14 – at least two weeks after each of these events. About a quarter of US adults say Kennedy has made 'major' changes to vaccine policy in the US, but another 40% 'don't know enough to say,' the KFF poll found. Of those who do plan to get a Covid-19 vaccine this fall – more likely to be older adults and Democrats – about two-thirds say they are concerned that it might not be available to them. And more than 60% of insured adults who plan to get the shot are worried that their insurance won't cover it. About half of parents are not sure whether federal health agencies are currently recommending that healthy children receive a Covid-19 vaccine this fall, according to the new KFF data. Kennedy announced that the US Centers for Disease Control and Prevention will not formally recommend the Covid-19 vaccine for healthy children, leaving decisions to be made between parents and their health care provider. KFF found that personal doctors or health care providers remain the most trusted source for information about vaccines, with 8 in 10 adults saying they trust their own doctor at least 'a fair amount.' Trust in local health departments and the CDC has been eroding over the past two years, but most adults still say they trust these sources for vaccine information. But far fewer – only 37% of adults – say they trust Kennedy at least 'a fair amount' to provide information on vaccines, according to KFF. When asked about the impact of the changes to federal vaccine policy, more than a third of adults said they are making people less safe. Only 1 in 5 said the changes are making people safer. Rivers says she recommends that people who want their annual Covid-19 get it sooner rather than later. 'The big drawback is, it is not updated yet; the new formulation will be released closer to autumn,' she said, but getting a shot now will offer protection against the unpredictable summer wave and get ahead of access concerns that may arise in the future.
CNN
31-07-2025
- Health
- CNN
Questions and expectations swirl as Monarez steps into director's role at CDC
Federal agencies Vaccines Chronic diseases Disability issuesFacebookTweetLink Follow Dr. Susan Monarez will be sworn in as director of the US Centers for Disease Control and Prevention on Thursday, and she's taking the reins at a perilous time for the agency. The CDC has lost nearly a quarter of its staff since January, thanks to massive workforce cuts at federal health agencies. The Trump administration's proposed budget for the fiscal year 2026 would slash the agency's funding by more than half. And under a proposed reorganization, the agency stands to lose more of its programs: Some are set to be moved to a new Administration for a Healthy America while others, such as the National Center for Chronic Disease and Health Promotion, would be eliminated altogether. All this is playing out as US Health and Human Services Secretary Robert F. Kennedy Jr., who has long promoted misinformation about vaccines, has moved to undermine longstanding federal policies and processes that support vaccination in the United States. Kennedy has also throttled communications coming out of federal health agencies, including the CDC, all but silencing its scientists amid the worst measles outbreak in the US in three decades. Many at the agency and in the wider public health world are wondering whether Monarez will prove to be a savior or a sycophant. Morale among agency staff is bleak, according to one CDC official who spoke on the condition that they not be named for fear of reprisals. Staffers are feeling unsure about what Monarez's confirmation means, the official said. Many see her as a good scientist and someone with experience in leadership positions at federal agencies. But they also wonder whether she'll be constrained by Kennedy, the official said. Monarez's tenure in government spans Republican and Democratic administrations. Before coming to the CDC in January, she was deputy director for the Advance Research Projects Agency for Health, or ARPA-H, and was founding director of the Center for Innovation at the Health Resources and Services Administration. She held other leadership positions at the Department of Homeland Security and the Biomedical Advanced Research and Development Authority. In her confirmation hearing, Monarez described herself as the daughter of a dairy farmer from rural Wisconsin who attended state schools and paid her own way through college, eventually earning a Ph.D. in microbiology and immunology. She said that her research was focused on two diseases, African sleeping sickness and toxoplasmosis, and that she was drawn to public health because treatments for those diseases remain limited but public health interventions have reduced the impact of the diseases. Under questioning by senators, Monarez seemed to distance herself from Kennedy on two issues: vaccines and fluoride. In response to questions from Sen. Bernie Sanders, an independent from Vermont, about the US ending its support for the Global Alliance for Vaccines and Immunization, Monarez said, 'I think vaccines save lives. I think that we need to continue to support the promotion and utilization of vaccines.' When Sanders asked whether she agrees that there is no scientific proven link between vaccines and autism, Monarez said, 'I have not seen a causal link between vaccines and autism.' Regarding fluoride, Monarez told Sen. Angela Alsobrooks that she considered it 'an important component to oral health. … The direct application can be very valuable.' Alsobrooks asked about fluoridation of public drinking water, including in Monarez's own town. 'They have fluoridation there. Is it safe for families, the water in Potomac, Maryland?' 'I believe the water in Potomac, Maryland, is safe,' Monarez answered. One staffer who worked under Monarez at ARPA-H described her as a quiet presence. She wasn't the type of manager who is an active presence on Slack or email, they said. 'We all respected her. She's been in government a long time,' said the staffer, who spoke on the condition that they not be named for fear of retaliation. Dr. Jennifer Nuzzo, who directs the Pandemic Center at Brown University's School of Public Health, has known Monarez for at least a decade. 'She's a lifelong government scientist who has risen through the ranks to become a very senior leader,' Nuzzo said. 'She's loyal to serving the American people.' They worked together when Monarez was detailed to the White House, where she worked on the US National Action Plan for Combating Antibiotic-Resistant Bacteria. 'She got into the nitty-gritty of a complex policy issue, but she was also able to bring together a really diverse set of stakeholders to provide input into that strategy,' Nuzzo said. 'I think that's a great example of what Susan does.' Monarez has said she has three priorities for the CDC. First, she said, she wants to improve trust in the agency and its recommendations. Next, she will focus on strengthening public health infrastructure by investing in tools to prevent, detect and respond to threats in near real-time. She pledged to collaborate with state and local public health departments to build a nationwide public health network. Finally, she said, she will work to create rapid, evidence-based responses to public health emergencies, with timely communication that is consistent and grounded in facts. While these are worthy goals, Nuzzo said, her biggest worry is whether Monarez will be able to act independently, without political interference. 'You can't run an organization as important and large as the CDC if you need to get permission for everything that needs to be done,' Nuzzo added. Dr. Richard Besser, a former acting director of the CDC, said in a statement that he looked forward to meeting Monarez to better understand her plans to lead the agency. Besser is now president and CEO of the Robert Wood Johnson Foundation. 'Dr. Monarez must not only lead the CDC – she must fight for it. Our nation's entire public health system depends on CDC having the tools it needs to respond to pandemics, reduce chronic disease, and address health inequities that continue to leave too many communities behind. That starts with a director willing to speak the truth, defend science, and stand up for the health of every American,' Besser said.
