Is the US Quietly Ending COVID-19 Vaccination for the Young and Healthy

This year, we are seeing a severe narrowing of COVID-19 vaccine recommendations, with an apparent objective of effectively eliminating vaccinations in healthy young adults and children.Already, the vaccine has lost its recommendation for pregnant women and healthy children, being replaced by “shared decision making,” a concept that should be present in all medical decisions, not just COVID-19 vaccinations.

The updated 2025 formulation of the COVID-19 vaccines, as determined by the FDA’s VRBPAC Committee, “should be monovalent JN.1-lineage-based COVID-19 vaccines (2025-2026 Formula), preferentially using the LP.8.1 strain.”

So far, Moderna and Novavax have been approved for those over the age of 65 years, and high-risk adults and children. But adults without significant health problems and pregnant women (who are known to be at high risk) did not receive approval.

Unlike other treatment recommendation processes, COVID-19 vaccination approvals have undergone a myopic approach, mainly focusing on preventing COVID-19 deaths and avoiding the vaccine complication of myocarditis. Although the latter occurs most frequently in teenage and young males, it is usually mild and, with the possible exception of the second dose of the Moderna vaccine, has a lower incidence than after COVID-19.

The European Commission (EC) appears to be taking a different approach with the European Medicines Agency’s (EMA) recommendation of marketing Pfizer’s LP.8.1 formulation for those 6 months of age or older.

The FDA’s elimination of COVID-19 vaccine approvals for healthy adults has significant real-world implications. Even if replaced by “shared decision making”, insurance coverage may be lost, costing patients hundreds of dollars and creating a significant barrier for vaccine utilization. All payers, except Medicare Part B, are required to provide no-cost coverage of vaccinations recommended by the CDC’s Advisory Committee on Immunization Practices (ACIP).

The restricted approval of the COVID-19 vaccines appears to be based on exaggerated and irrational statements regarding their risks, as illustrated by Florida Surgeon Joseph Lapado's statement that mRNA vaccines are “…not fit for human use.”

In actuality, billions of doses of COVID-19 vaccines have been administered, and they are credited with saving 2.5 million lives globally.

Justifying the recommendations by focusing on the perceived low death rates in young adults is not consistent with advisements given for other vaccines. For example, COVID-19 has a higher death rate than the 0.05 to 0.005% death rate in polio and has a 2 to 3 times higher incidence rate ratio of hospitalization and death than seasonal influenza. Fewer than 100 people die each year from shingles, but this vaccine is still recommended.

However, the prevention of death is only one benefit to consider when making COVID-19 vaccination recommendations. COVID-19 all too often causes long-term damage in a myriad of other organ systems, and the prevention of long COVID should be a primary goal of vaccine recommendations.

Vaccination of children is of utmost importance. Children have a lower incidence of long COVID than adults, but lower does not mean low. One study found that overall, 4% of children developed long COVID after an infection. A May 2025 research study by Gross and colleagues observed that 14% to 15% of children developed long COVID after an acute infection. Another study found that during the Omicron phase, vaccinations were 60% effective in preventing long COVID in children and 75% effective in adolescents, primarily by preventing infections.

mRNA vaccines are just first generation COVID-19 vaccines. Many have pointed to their drawbacks, from frequent local reactions to the uncertainty of the delivered dosage of the spike protein. In actuality, the spike protein is not delivered but is produced by the injected mRNA, which creates another variable in dosage administration. The COVID-19 vaccine, Novavax, avoids this problem since it is protein-based, not mRNA-based. Novavax also has milder short-term side effects. But neither vaccine produces the desired durability in immunity or stops the spread of the virus.

No one knows the long-term effects of vaccinating every 5 to 6 months in high-risk individuals. But one can argue it is much preferable to getting COVID-19 once or twice a year, with a much higher exposure to the spike protein, along with the massive cellular destruction produced by the viral infection.

Vaccines with greater durability and ones that can elicit an IgA immunological response to help stop viral spread are desperately needed. Although funding for vaccine development was halted earlier this year, most of it has been restored. The United States Biomedical Advanced Research and Development Authority (BARDA) has initiated a $5 billion NextGen project devoted to developing the next generation of COVID-19 vaccines. One such vaccine is Vaxart. A vaccine in tablet form that increases IgA, and has shown potential to reduce spread and increase the durability of the immune response. The company has received $460.7 million in federal grants and is currently conducting Phase 2b double-anonymized clinical trials.

The continued accumulation of data regarding the societal toll of long COVID, along with the massive second-generation COVID-19 vaccine development initiative by BARDA, are testaments to the seriousness of COVID-19 infections. But this contrasts with our current underwhelming approach in vaccine recommendations, which appears not to take COVID-19 seriously.

Until second-generation vaccines become available, we need to use the tools that we have. I, for one, will continue to recommend COVID-19 vaccinations for all healthy adults, but the loss of FDA approval will make vaccines unaffordable for many, creating an insurmountable barrier. Until this changes, the US is placing the health of its population along with the long-term viability of its workforce at risk.