US Secretary of Health and Human Services Robert F Kennedy JrTasos Katopodis/Getty One of the top vaccine experts at the US Centers for Disease Control and Prevention (CDC), Lakshmi Panagiotakopoulos, resigned on 4 June – a week after Robert F Kennedy Jr announced that covid-19 vaccines would no longer be recommended for most children and pregnancies. The announcement set off several days of confusion around who will have access to covid-19 vaccines in the US going forward. In practice, there hasn’t been a drastic change to access, though there will probably be new obstacles for parents hoping to vaccinate their children. Still, Kennedy’s announcement signals a troubling circumvention of public health norms. “My career in public health and vaccinology started with a deep-seated desire to help the most vulnerable members of our population, and that is not something I am able to continue doing in this role,” said Panagiotakopoulos in an email to colleagues obtained by Reuters. Panagiotakopoulos supported the Advisory Committee on Immunization Practices (ACIP), which has advised the CDC on vaccine recommendations since 1964. But last week, Kennedy – the country’s highest-ranking public health official – upended this decades-long precedent. “I couldn’t be more pleased to announce that, as of today, the covid vaccine for healthy children and healthy pregnant woman has been removed from the CDC recommended immunisation schedule,” he said in a video posted to the social media platform X on 27 May. Despite his directive, the CDC has, so far, only made minor changes to its guidance on covid-19 vaccines. Instead of recommending them for children outright, it now recommends vaccination “based on shared clinical decision-making”. In other words, parents should talk with a doctor before deciding. It isn’t clear how this will affect access to these vaccines in every scenario, but it could make it more difficult for children to get a shot at pharmacies. Get the most essential health and fitness news in your inbox every Saturday. Sign up to newsletter The CDC’s guidance on vaccination in pregnancy is also ambiguous. While its website still recommends a covid-19 shot during pregnancy, a note at the top says, “this page will be updated to align with the updated immunization schedule.” Kennedy’s announcement contradicts the stances of major public health organisations, too. Both the American College of Obstetricians and Gynecologists (ACOG) and the American Academy of Pediatrics (APP) have come out opposing it. “The CDC and HHS encourage individuals to talk with their healthcare provider about any personal medical decision,” an HHS spokesperson told New Scientist. “Under the leadership of Secretary Kennedy, HHS is restoring the doctor-patient relationship.” However, Linda Eckert at the University of Washington in Seattle says the conflicting messages are confusing for people. “It opens up disinformation opportunities. It undermines confidence in vaccination in general,” she says. “I can’t imagine it won’t decrease immunisation rates overall.” Research has repeatedly shown covid-19 vaccination in adolescence and pregnancy is safe and effective. In fact, Martin Makary, the head of the US Food and Drug Administration (FDA), listed pregnancy as a risk factor for severe covid-19 a week before Kennedy’s announcement, further convoluting the government’s public health messaging. Kennedy’s announcement is in line with some other countries’ covid policies. For example, Australia and the UK don’t recommend covid-19 vaccines for children unless they are at risk of severe illness. They also don’t recommend covid-19 vaccination during pregnancy if someone is already vaccinated. Asma Khalil, a member of the UK Joint Committee on Vaccination and Immunisation, says the UK’s decision was based on the reduced risk of the omicron variant, the cost-effectiveness of vaccination and high population immunity. However, these factors can vary across countries. The UK population also tends to have better access to healthcare than the US, says Eckert. “These decisions need to carefully consider the risks and benefits relative to the national population,” says Khalil. The HHS didn’t answer New Scientist’s questions about whether a similar analysis guided Kennedy’s decision-making. What is maybe most troubling, however, is the precedent Kennedy’s announcement sets. The ACIP – an independent group of public health experts – was expected to vote on proposed changes to covid-19 vaccine recommendations later this month. But Kennedy’s decision has bypassed this process. “This style of decision-making – by individuals versus going through experts who are carefully vetted for conflicts of interest, who carefully look at the data – this has never happened in our country,” says Eckert. “We’re in uncharted territory.” She worries the move could pave the way for Kennedy to chip away at other vaccine recommendations. “I know there are a lot of vaccines he has been actively against in his career,” she says. Kennedy has previously blamed vaccines for autism and falsely claimed that the polio vaccine caused more deaths than it averted. “What it speaks to is the fact that [Kennedy] does not see value in these vaccines and is going to do everything he can to try and devalue them in the minds of the public and make them harder to receive,” says Amesh Adalja at Johns Hopkins University. Topics:

On May 20, 2025, the Food and Drug Administration announced a new stance on who should receive the COVID-19 vaccine. The agency said it would approve new versions of the vaccine only for adults 65 years of age and older as well as for people with one or more risk factors for severe COVID-19 outcomes. These risk factors include medical conditions such as asthma, cancer, chronic kidney disease, heart disease and diabetes. However, healthy younger adults and children who fall outside of these groups may not be eligible to receive the COVID-19 shot this fall. Vaccine manufacturers will have to conduct clinical trials to demonstrate that the vaccine benefits low-risk groups. FDA Commissioner Martin Makary and the agency’s head of vaccines, Vinay Prasad, described the new framework in an article published in the New England Journal of Medicine and in a public webcast. The Conversation U.S. asked Libby Richards, a nursing professor involved in public health promotion, to explain why the changes were made and what they mean for the general public. Why did the FDA diverge from past practice? Until the May 20 announcement, getting a yearly COVID-19 vaccine was recommended for everyone ages 6 months and older, regardless of their health risk. According to Makary and Prasad, the Food and Drug Administration is moving away from these universal recommendations and instead taking a risk-based approach based on its interpretation of public health trends – specifically, the declining COVID-19 booster uptake, a lack of strong evidence that repeated boosters improve health outcomes for healthy people and the fact that natural immunity from past COVID-19 infections is widespread. The FDA states it wants to ensure the vaccine is backed by solid clinical trial data, especially for low-risk groups. Was this a controversial decision or a clear consensus? The FDA’s decision to adopt a risk-based framework for the COVID-19 vaccine aligns with the expected recommendations from the Advisory Committee on Immunization Practices, an advisory group of vaccine experts offering expert guidance to the Centers for Disease Control and Prevention on vaccine policy, which is scheduled to meet in June 2025. But while this advisory committee was also expected to recommend allowing low-risk people to get annual COVID-19 vaccines if they want to, the FDA’s policy will likely make that difficult. Although the FDA states that its new policy aims to promote greater transparency and evidenced-based decision-making, the change is controversial – in part because it circumvents the usual process for evaluating vaccine recommendations. The FDA is enacting this policy change by limiting its approval of the vaccine to high-risk groups, and it is doing so without any new data supporting its decision. Usually, however, the FDA broadly approves a vaccine based on whether it is safe and effective, and decisions on who should be eligible to receive it are left to the CDC, which receives research-based guidance from the Advisory Committee on Immunization Practices. Additionally, FDA officials point to Canada, Australia and some European countries that limit vaccine recommendations to older adults and other high-risk people as a model for its revised framework. But vaccine strategies vary widely, and this more conservative approach has not necessarily proven superior. Also, those countries have universal health care systems and have a track record of more equitable access to COVID-19 care and better COVID-19 outcomes. Another question is how health officials’ positions on COVID-19 vaccines affect public perception. Makary and Prasad noted that COVID-19 vaccination campaigns may have actually eroded public trust in vaccination. But some vaccine experts have expressed concerns that limiting COVID-19 vaccine access might further fuel vaccine hesitancy because any barrier to vaccine access can reduce uptake and hinder efforts to achieve widespread immunity. What conditions count as risk factors? The New England Journal of Medicine article includes a lengthy list of conditions that increase the risk of severe COVID-19 and notes that about 100 million to 200 million people will fall into this category and will thus be eligible to get the vaccine. Pregnancy is included. Some items on the list, however, are unclear. For example, the list includes asthma, but the data that asthma is a risk factor for severe COVID-19 is scant. Also on the list is physical inactivity, which likely applies to a vast swath of Americans and is difficult to define. Studies have found links between regular physical activity and reduced risk of severe COVID-19 infection, but it’s unclear how health care providers will define and measure physical inactivity when assessing a patient’s eligibility for COVID-19 vaccines. Most importantly, the list leaves out an important group – caregivers and household members of people at high risk of severe illness from COVID-19 infection. This omission leaves high-risk people more vulnerable to exposure to COVID-19 from healthy people they regularly interact with. Multiple countries the new framework refers to do include this group. Why is the FDA requiring new clinical trials? According to the FDA, the benefits of multiple doses of COVID-19 vaccines for healthy adults are currently unproven. It’s true that studies beyond the fourth vaccine dose are scarce. However, multiple studies have demonstrated that the vaccine is effective at preventing the risk of severe COVID-19 infection, hospitalization and death in low-risk adults and children. Receiving multiple doses of COVID-19 vaccines has also been shown to reduce the risk of long COVID. The FDA is requiring vaccine manufactures to conduct additional large randomized clinical trials to further evaluate the safety and effectiveness of COVID-19 boosters for healthy adults and children. These trials will primarily test whether the vaccines prevent symptomatic infections, and secondarily whether they prevent hospitalization and death. Such trials are more complex, costly and time-consuming than the more common approach of testing for immunological response. This requirement will likely delay both the timeliness and the availability of COVID-19 vaccine boosters and slow public health decision-making. Will low-risk people be able to get a COVID-19 shot? Not automatically. Under the new FDA framework, healthy adults who wish to receive the fall COVID-19 vaccine will face obstacles. Health care providers can administer vaccines “off-label”, but insurance coverage is widely based on FDA recommendations. The new, narrower FDA approval will likely reduce both access to COVID-19 vaccines for the general public and insurance coverage for COVID-19 vaccines. The FDA’s focus on individual risks and benefits may overlook broader public health benefits. Communities with higher vaccination rates have fewer opportunities to spread the virus. What about vaccines for children? High-risk children age 6 months and older who have conditions that increase the risk of severe COVID-19 are still eligible for the vaccine under the new framework. As of now, healthy children age 6 months and older without underlying medical conditions will not have routine access to COVID-19 vaccines until further clinical trial data is available. Existing vaccines already on the market will remain available, but it is unclear how long they will stay authorized and how the change will affect childhood vaccination overall. Libby Richards is a professor of nursing at Purdue University. This article is republished from The Conversation under a Creative Commons license. Read the original article.

News Health & Medicine FDA significantly limits access to COVID-19 vaccines The agency is restricting new shots to people ages 65 and up or with underlying conditions FDA is restricting access to new COVID-19 vaccines, limiting options for younger people who want to get the shots. South_agency/Getty Images By McKenzie Prillaman 7 seconds ago The U.S. Food and Drug Administration is changing its policy on who should get COVID-19 shots, potentially limiting access to new vaccine formulations as they enter the market. New and updated jabs will be approved only for people ages 65 and up, as well as those between 6 months and 64 years with at least one medical condition that heightens their risk for severe outcomes, according to the new FDA framework unveiled May 20 in the New England Journal of Medicine. Between 100 million and 200 million Americans would still be covered through this approval method, the framework authors say. Sign up for our newsletter We summarize the week's scientific breakthroughs every Thursday.

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