By\u00a0Peter Lurie, MD, MPH,\u00a0Sarah Despres,\u00a0Josh Rising, MD, MPH,\u00a0Joshua M. Sharfstein, MD<\/p>\n\n\n\n
The first half of 2025 has seen many changes in federal vaccine policy and programs. This list\u2014published June 3, 2025, and drawn from news reports and other information\u2014ranks the most significant changes to vaccination policy, with brief commentary from the editors.<\/p>\n\n\n\n
As of May 30, 2025, there have been 1,088 confirmed cases<\/a> of the disease, including 127 hospitalizations and three deaths; this is the largest outbreak in the US in 25 years<\/a>. Among the challenges in the response are Sec. Kennedy making misstatements<\/a> about the safety<\/a> of the measles vaccine, endorsing<\/a> unproven treatments<\/a>, and preventing experts from briefing<\/a> the public. HHS also cut grant funds<\/a> for the states’ measles response.<\/p>\n\n\n\n On May 27, without consultation<\/a> with the CDC, Secretary Kennedy announced<\/a> in a 1-minute video on X that the administration had decided to remove the Covid vaccine for healthy children and healthy pregnant people from the CDC\u2019s recommended immunization schedule. Two days later, the CDC updated the immunization schedules to change the Covid recommendations<\/a>, leaving routine childhood vaccination in the category of “shared decision-making,” but not recommending vaccination during pregnancy. This is despite the CDC listing pregnancy<\/a> as a \u201cconclusive\u201d risk factor for adverse outcomes from Covid.<\/p>\n\n\n\n Editors’ notes: A recommendation is the basis for protecting clinicians administering the vaccine from lawsuits under the\u00a0<\/em>PREP Act<\/em><\/a>. Without clarity from HHS, clinicians may be reluctant to provide the vaccine to <\/em><\/p>\n\n\n\n The shared decision-making recommendation for children preserves essential access to vaccines through the Vaccines for Children’s Program and makes it more likely that private insurers will cover the shot. That sound you hear is a lot of pediatricians breathing a sigh of relief, because this decision\u2013while causing confusion\u2013could have been much worse. \u2013 <\/em>JS<\/em><\/a> All the confusion about these changing recommendations is unnecessary. Had HHS followed a normal process, recommendations could have been made clearly and with all the implications spelled out in advance. \u2013 <\/em>JR<\/em><\/a><\/p>\n\n\n\n As detailed in the previous issue of the Straight Shot, FDA Commissioner Makary and new FDA biologics center Director Prasad recently announced<\/a> a new FDA approach to Covid vaccine approvals that will limit access to these vaccines. Two weeks later, there are still no official FDA documents or explanations for how this will actually be implemented in order to answer the many <\/a>questions<\/a> that have been raised.<\/p>\n\n\n\n On May 31, the FDA approved a new version<\/a> of the Moderna mRNA Covid vaccine, with a lower dose than previous versions. Consistent with the new framework for Covid vaccines, the approval was limited to people 65 and older and those aged 12 to 64 years with at least one risk factor for Covid as defined by the CDC.<\/p>\n\n\n\n Previously, Moderna had submitted an application to the FDA for approval of a combined Covid and flu shot that uses mRNA technology for both viruses, a product that would likely increase uptake in advance of the respiratory virus season. According to results<\/a> published in the Journal of the American Medical Association<\/em>, this vaccine outperformed stand-alone vaccines for both flu and Covid. On May 21, however, Moderna announced<\/a>, without explanation, that they were pulling their application for this vaccine and would wait for the results from its standalone flu vaccine to resubmit. <\/p>\n\n\n\n Editor’s note: I’d like to know whether Moderna’s decision to pull their application for this combination product is related to a real issue with the application or is part of a larger pattern of arbitrary decision-making on mRNA technology and on respiratory vaccines, including influenza, RSV, and Covid vaccines. \u2013 <\/em>JR<\/em><\/a><\/p>\n\n\n\n HHS announced that it was canceling<\/a> $766 million in contracts with Moderna to develop mRNA vaccines for various strains of flu, including the H5N1 strain<\/a> currently circulating in birds that could develop into new pandemics. Early data around safety and immune response showed<\/a> promise.<\/p>\n\n\n\n Editor’s note: Having these vaccines developed before a pandemic begins would save critical time should another virus make the leap from animals to humans. <\/em><\/p>\n\n\n\n HHS abruptly pulled $500 million from contracts for next-generation vaccines and is using the funds<\/a> to study a type of “whole-virus” vaccine technology developed and championed by two political appointees. “Whole-virus” vaccines are 70 years old and thought by many scientists<\/a> to be less effective and cause more adverse effects than newer technologies.<\/p>\n\n\n\n Numerous HIV vaccine research projects were abruptly ended by HHS this past week. Additionally, NIH was instructed not to fund new research efforts in this area.<\/p>\n\n\n\n Editor’s note: In 2023,\u00a0<\/em>630,000 people<\/em><\/a>\u00a0died of HIV worldwide.<\/em><\/p>\n\n\n\n On March 24, President Trump nominated<\/a> the Acting CDC Director, Dr. Susan Monarez, to lead the agency, forcing her to step aside from this position. On May 14, Sec. Kennedy testified<\/a> that CDC Chief of Staff, Matt Buzzelli, is the acting CDC director. But the CDC website lists him as the Chief of Staff<\/a>, and he may not meet the necessary legal qualifications<\/a> to serve as the acting director, which appear to include having worked at the agency for 90 days in the prior year. While Sec. Kennedy referred to Buzzelli as a \u201cpublic health expert,\u201d he is a former trial attorney<\/a> with no discernible public health experience. <\/p>\n\n\n\n Editor’s note: The CDC Director is responsible for overseeing the agency’s work on vaccines, including updating the immunization schedule. <\/em><\/p>\n\n\n\n At the April 16 meeting of the ACIP, the committee made recommendations for the use of a new chikungunya vaccine, RSV vaccines for older adults, and a new pentavalent meningococcal vaccine. While Secretary Kennedy, acting in the absence of a CDC director, has adopted the ACIP recommendation<\/a> for a new chikungunya vaccine, he has not yet acted on the two other ACIP recommendations. (No change from last update.) <\/p>\n\n\n\n HHS has hired<\/a> David Geier, a leading source of misinformation about vaccines, to investigate questions related to vaccine safety.<\/p>\n\n\n\n A federal judge has ruled<\/a> that the Administration cannot proceed with the $11 billion in cuts<\/a> to state public health funds. Some of these funds were used to fund vaccination clinics; others were used for outbreak monitoring and response.<\/p>\n\n\n\n On May 22, the White House issued the Make Our Children Healthy Again Assessment<\/a>. One section of the report was dedicated to concerns regarding vaccines, questioning the expansion of the childhood immunization schedule, the adequacy of clinical trials, the effectiveness of safety monitoring, the integrity of the Vaccine Injury Compensation program, and the role of vaccine mandates. The report has come under fire for inaccuracy of data as well as errors in citations as a result of the use of generative AI.<\/a><\/p>\n","protected":false},"excerpt":{"rendered":" By\u00a0Peter Lurie, MD, MPH,\u00a0Sarah Despres,\u00a0Josh Rising, MD, MPH,\u00a0Joshua M. Sharfstein, MD The first half of 2025 has seen many changes in federal vaccine policy and programs. 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\n\n\n\n2. HHS changes the status of Covid vaccines for healthy children and pregnant women on the immunization schedule<\/h2>\n\n\n\n
<\/em>
HHS has made these consequential changes without making public the scientific evidence underpinning its decisions. \u2013 <\/em>PL<\/em><\/a><\/p>\n\n\n\n
\n\n\n\n3. FDA adds new restrictions and requirements on Covid vaccines<\/h2>\n\n\n\n
\n\n\n\n4. Moderna withdraws a vaccine application<\/h2>\n\n\n\n
\n\n\n\n5. HHS pulls funding from Moderna<\/h2>\n\n\n\n
\n\n\n\n6. HHS moves $500 million to study older vaccine technology favored by two appointees<\/h2>\n\n\n\n
7. HHS ends HIV vaccine research<\/h2>\n\n\n\n
\n\n\n\n8. Confusion over leadership at the CDC<\/h2>\n\n\n\n
\n\n\n\n9. HHS Secretary delays action on ACIP recommendations<\/h2>\n\n\n\n
\n\n\n\n10. HHS hires anti-vaccine activist to review vaccine safety data<\/h2>\n\n\n\n
\n\n\n\n11. HHS cuts funds for vaccination in states and its own vaccine staff<\/h2>\n\n\n\n
\n\n\n\n12. White House issues an initial MAHA report<\/h2>\n\n\n\n