\n<\/p>\n
Several shots lost their recommendation from the US Centers for Disease Control and Prevention (CDC) after a judge\u2019s stay against changes made by the Trump administration \u2013 which may affect access to the shots in some states. And no new vaccine recommendations may be made as long as the vaccines committee is halted.<\/p>\n
Access to existing vaccines \u2013 and the future development of new vaccines \u2013 has been increasingly called into question under the second Trump administration, as the now-halted Advisory Committee on Immunization Practices (ACIP) made controversial recommendations and health officials made unilateral changes to routine vaccines, with long-term and global implications.<\/p>\n
Recommendations for the current annual flu and Covid shots no longer exist, and the recommendation for a new shot to protect babies against RSV (respiratory syncytial virus) is also on hold. It\u2019s not clear if new shots will be recommended in coming months, even in anticipation of respiratory virus spikes.<\/p>\n
\u201cWe could see delays in updates of vaccines,\u201d said Jen Kates, senior vice-president and director of the Global and Public Health Policy Program at KFF, a health policy non-profit. \u201cWe\u2019re going into some pretty uncharted territory.\u201d<\/p>\n
America\u2019s vaccines landscape has been thrown into greater tumult after a judge essentially overturned all decisions made by the vaccine advisers, who were hand-picked by Robert F Kennedy Jr, the secretary of the US Department of Health and Human Services (HHS) and a longtime vaccine opponent.<\/p>\n
Brian Murphy, a US district court judge, issued a stay on vaccine changes after a lawsuit brought by the American Academy of Pediatrics (AAP) against decisions made both by ACIP and directly by health officials. Although the lawsuit didn\u2019t challenge recommendations for new shots, the stay appears to have included them.<\/p>\n
\u201cThe whole thing got thrown out,\u201d said Sarah DesPres, a former counselor to the HHS secretary for public health and science during the Biden administration and a consultant to nonprofits on vaccines.<\/p>\n
In addition to recommendations for the most recent season\u2019s flu and Covid shots, the recommendation for Merck\u2019s RSV monoclonal antibodies also ended, in the midst of RSV season \u2013 though another RSV shot for babies, Beyfortus, is still recommended.<\/p>\n
Some insurance providers said they would continue to cover all vaccines recommended as of September 2025, \u201cbut this is a new recommendation\u201d, DesPres pointed out, so it\u2019s not clear if insurers will cover it.<\/p>\n
The tumult also has implications for vaccines in the pipeline, like Moderna\u2019s new flu shot and Pfizer\u2019s new Lyme vaccination, which has shown promising results in trials.<\/p>\n
Although the US Food and Drug Administration (FDA) has not made a decision on Moderna\u2019s new flu shot \u2013 after initially rejecting the application outright \u2013 vaccine advisers usually review the data before approval in case they need to make a recommendation quickly. Typically, the ACIP working group on flu vaccination would already be reviewing the confidential data from Moderna, for example, DesPres said.<\/p>\n
If the new flu shot is approved by the FDA but not recommended by the CDC or ACIP, it\u2019s not clear if insurers (also known as payers) will cover it.<\/p>\n
\u201cI don\u2019t know how the payers will respond to that,\u201d DesPres said.<\/p>\n
Professional organizations have stepped into the gap to make vaccination recommendations based on publicly available data \u2013 but data on vaccines not yet on the market is often shared with ACIP confidentially.<\/p>\n
\u201cWhen you\u2019re talking about a new vaccine, it just becomes a little more challenging, because you\u2019re not going to have as much data about it,\u201d DesPres said.<\/p>\n
There are also questions about whether pharmacists may administer Covid and flu vaccines without existing recommendations. Pharmacists and providers are protected against liability in administering Covid shots under the Prep Act \u2013 but the shots must be recommended by ACIP, so they may not be able to continue administering Covid shots with Prep Act protections.<\/p>\n
Flu shots don\u2019t have the same obstacle.<\/p>\n
\u201cAs long as the payers are prepared to pay for it, and the professional societies can make recommendations, I think that the public will be able to have access to flu vaccines\u201d \u2013 at least, to existing flu shots, DesPres said.<\/p>\n
About 29 states and Washington DC have moved to decouple their vaccination processes from the ACIP following the committee\u2019s controversial decisions to end recommendations for certain routine childhood vaccines.<\/p>\n
But other states still have laws tied to CDC or ACIP recommendations, which means providers and pharmacists may be unable to administer flu or Covid shots. Residents of those states could face challenges accessing them \u2013 both now and when the formulations are updated in the fall.<\/p>\n
\u201cThere\u2019s a lot of uncertainty on this,\u201d Kates said. \u201cWe just don\u2019t have the answers right now.\u201d<\/p>\n
With no functioning ACIP, new recommendations \u2013 for shots that are updated each year or for new vaccines coming out of the pipeline \u2013 can\u2019t be made.<\/p>\n
There is no confirmed or acting director of the CDC who could make recommendations without the committee\u2019s input. Kennedy, as HHS secretary, has the legal authority to sign off on recommendations, but the AAP lawsuit challenged officials\u2019 abilities to make unilateral decisions on vaccines.<\/p>\n
\u201cPotentially Kennedy could make the recommendation, but it would have to meet the satisfaction of what\u2019s laid out in the court ruling,\u201d Kates said.<\/p>\n
Health officials could also simply ignore the stay. \u201cThis administration has certainly done that in other cases where a judge has ruled one way and they\u2019ve continued to do the behavior. So there\u2019s a lot of different ways this could go,\u201d Kates added.<\/p>\n
Last week, the CDC released a new charter for ACIP, elevating the committee\u2019s existing focus on potential vaccine side-effects and adding new expertise areas for members. It also brought in liaison groups that have challenged scientific evidence, especially around vaccines, such as the Association of American Physicians and Surgeons, Physicians for Informed Consent and Independent Medical Alliance.<\/p>\n
The new charter seems unlikely to address the judge\u2019s concerns about the way advisers were selected and onboarded. And even if the administration brings on new advisers in a way that isn\u2019t subjected to legal challenges, that process can take months.<\/p>\n
For annual respiratory vaccines like the flu and Covid, ACIP usually meets in June to make recommendations that are published by August.<\/p>\n
In some ways, the damage is already done, Kates said. Polling already indicates decreased trust in the CDC, and confusion abounds over which vaccines are safe and recommended.<\/p>\n
\u201cThe increased level of mistrust among the public, among parents, the increased level of confusion \u2013 that\u2019s happened. The genie is not going to go back in the bottle,\u201d Kates said. \u201cIn a way, it\u2019s partially too late because what has happened in the last year has contributed to this increasing context of confusion and mistrust.\u201d<\/p>\n
The loss of trust amid continued misinformation from officials could have serious long-term consequences, Kates added. \u201cIf there\u2019s going to be some kind of public health emergency at any point, it would be pretty challenging if more and more people are not trusting the federal government to provide advice about what to do.\u201d<\/p>\n
It was clear that the administration is \u201cundermining confidence in vaccines and creating confusion\u201d, DesPres said. \u201cThe confusion is really part of the overarching strategy of undermining confidence.\u201d These moves also make it harder for vaccine developers to bring new shots to the public by \u201ccreating an uncertain climate\u201d, she said.<\/p>\n
The role played by trusted independent advisers in assessing vaccine safety and effectiveness is integral to the process, DesPres said: \u201cWe need a functioning ACIP to put out recommendations that providers and patients and the public can trust.\u201d Yet it was not clear when ACIP would function correctly again, she said.<\/p>\n","protected":false},"excerpt":{"rendered":"
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