COVID-19 Vaccine Booster Receives Approval With Limits on Patient Access

The FDA approved the latest iteration of COVID-19 vaccines with new limits on recipient eligibility, clearing them only for individuals at higher risk of severe illness.¹ This move was announced in a statement from HHS Secretary Robert F. Kennedy Jr on X, where he highlighted the rescission of emergency use authorizations (EUAs) for COVID-19 vaccines.²

The decision represents a significant departure from past US vaccine policy, which had recommended annual COVID-19 shots for all Americans aged 6 months and up.¹ The shift occurs amid several controversial actions by Kennedy, a vocal vaccine skeptic, to reconfigure the nation's health department and its immunization strategies.

Details on the FDA Approval and RFK Jr's Announcement

The FDA ceased its broader authorization for COVID-19 vaccines, designating the updated shots solely for those at elevated risk of severe illness from the virus. This group includes individuals aged 65 years and older, as well as younger adults with at least 1 underlying condition predisposing them to higher risk, such as immunocompromised status, cancer, obesity, diabetes, chronic kidney disease, or heart disease, as defined by the CDC. Specific approvals covered Moderna's, Pfizer's, and Novavax's updated shots, all restricted to these higher-risk populations.

In his post on X, Kennedy declared, “The emergency use authorizations for Covid vaccines, once used to justify broad mandates on the general public during the Biden administration, are now rescinded.”² He added, “The American people demanded science, safety, and common sense. This framework delivers all three.”

Kennedy noted that the shots were “available for all patients who choose them after consulting with their doctors,” though it remained unclear how easily patients without high-risk factors would be able to obtain a COVID-19 vaccine and whether insurance plans would continue to cover these shots for healthy Americans. This ambiguity presented potential challenges for managed care organizations regarding coverage policies and patient access.

Other Vaccine Efforts Pushed by RFK Jr

Since taking office earlier this year, Kennedy has initiated several significant policy changes impacting immunization. Earlier this month, Kennedy dismantled the CDC's Advisory Committee for Immunization Practices (ACIP) by dismissing all 17 members on June 9, 2025.³

He subsequently appointed new members, some of whom were recognized vaccine critics and lacked apparent expertise in infectious diseases, vaccines, or clinical trials.⁴ Yonatan Grad, MD, PhD, a professor at Harvard T.H. Chan School of Public Health, voiced concerns that policies emerging from this reconstituted ACIP would be influenced by an antivaccine stance. Kennedy's justification, citing “persistent conflicts of interest” among former ACIP members, was characterized as “deliberately misleading” by experts.

Prior to the ACIP overhaul, HHS, under Kennedy's leadership, issued guidance no longer recommending COVID-19 vaccines for children and pregnant individuals.⁵ This change was implemented without formal review, prompting objections from numerous medical organizations that cited data on COVID-19's severe consequences and vaccination safety during pregnancy.

In early August 2025, Kennedy announced the cancellation of $500 million in funding for mRNA vaccine development targeting diseases like influenza and COVID-19, affecting 22 projects by major pharmaceutical companies. Kennedy asserted that “mRNA technology poses more risks than benefits for these respiratory viruses” and that “these vaccines fail to protect effectively against upper respiratory infections,” further claiming mRNA vaccines could “encourage new mutations and can actually prolong pandemics.”

Experts have expressed apprehension that Kennedy's actions could lead to reduced vaccination rates, potentially resulting in preventable illness and suffering.⁴ A significant concern for managed care organizations involves the potential for exacerbated health disparities if insurance coverage for non-ACIP recommended vaccines became restricted, disproportionately affecting those unable to afford them. These policy shifts were viewed by some as undermining public confidence in vaccines and scientific consensus, including launching a government study on autism led by an individual promoting debunked links between vaccines and autism.

The recent FDA approval, coupled with Kennedy's broader policy redirections, represented a pivotal transformation in US public health strategy.¹ Lingering questions regarding access to vaccines for healthy adults, insurance coverage parameters, and the overall impact on national vaccination rates will undoubtedly continue to shape the managed care landscape and public health discourse.

References

1. Kim A. FDA approves new Covid shots with limits on who can get them under RFK Jr. CNBC. August 27, 2025. Accessed August 27, 2025. https://www.cnbc.com/2025/08/27/fda-covid-vaccine-authorization--rfk.html

2. @SecKennedy. I promised 4 things: 1. to end covid vaccine mandates. 2. to keep vaccines available to people who want them, especially the vulnerable. 3. to demand placebo-controlled trials from companies. 4. to end the emergency. In a series of FDA actions today we accomplished all four goals. The emergency use authorizations for Covid vaccines, once used to justify broad mandates on the general public during the Biden administration, are now rescinded. FDA has now issued marketing authorization for those at higher risk: Moderna (6+ months), Pfizer (5+), and Novavax (12+). These vaccines are available for all patients who choose them after consulting with their doctors. The American people demanded science, safety, and common sense. This framework delivers all three. Thank you @DrMakaryFDA for your leadership. August 27, 2025. Accessed August 27, 2025. https://x.com/SecKennedy/status/1960742897201872969

3. McCormick B. Conflicts of interest in federal vaccine advisory committees at historic lows despite RFK Jr claims. AJMC^®. August 19, 2025. Accessed August 27, 2025. https://www.ajmc.com/view/conflicts-of-interest-in-federal-vaccine-advisory-committees-at-historic-lows-despite-rfk-jr-claims

4. Feldscher K. RFK Jr. moves on vaccines could have broad ramifications for public health, says expert. Harvard T.H. Chan School of Public Health. June 18, 2025. Accessed August 27, 2025. https://hsph.harvard.edu/news/rfk-jr-moves-on-vaccines-could-have-broad-ramifications-for-public-health-says-expert/

5. Halpert M. RFK Jr cancels $500m in funding for mRNA vaccines for diseases like Covid. BBC. August 5, 2025. Accessed August 27, 2025. https://www.bbc.com/news/articles/c74dzdddvmjo