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Saturday, December 13, 2025

Conflicting Covid Vaccine Guidelines by FDA and CDC for healthy people under the age of 65

The Covid vaccine guidelines for this upcoming year (2025-2026) are in total disarray.

On August 27, the FDA under political pressure from the Trump administration effectively removed the approval for the Covid vaccine for healthy adults under 65. First, the FDA officially ended the Emergency Use Authorizations (EUAs) that had previously covered the broad population (including healthy adults), and was issued during the early stages of the Covid pandemic in December, 2020. They then replaced the EUAs with full marketing approval, but restricted this approval specifically to adults 65 years and older, and individuals (6 months to 64 years) with high-risk medical conditions. Healthy people under 65 were no longer authorized to receive the vaccine.

Two months later on November 4, the CDC formally updated their Covid vaccine age eligibility guidance for this season. They stated that the 2025–2026 COVID-19 vaccine is recommended for all people ages 6 months and older, using "individual-based (shared clinical) decision-making." In other words, the decision to vaccinate should be made on a case-by-case basis through a conversation between you and your healthcare provider. This is a significant departure from the "universal" recommendation of previous years, but it leaves room for healthy people to get vaccinated for reasons including the following:
  • Health History: Do you have conditions like diabetes, asthma, or obesity?
  • Living Situation: Do you live with elderly parents or immunocompromised family members?
  • Risk Tolerance: Are you personally worried about Long COVID or missing work/school, even if you aren't likely to be hospitalized?
Thus there are conflicting messages/guidelines/rulings from the FDA and CDC. Unfortunately the FDA ruling takes precedence not because it legally bans you from getting the vaccine, but because it controls the liability protections, insurance coverage, and pharmacy rules that make the vaccine accessible. In particular, the FDA removes legal protection for the provider. For example, corporate pharmacies (CVS, Walgreens, etc.) may refuse to give you the shot because, without FDA approval, they could be sued if you have a bad reaction. They are likely to follow the stricter FDA rule to protect themselves from liability.

Despite this politicized climate, the medical community has remained steadfast in their support of the Covid vaccine. Every major U.S. medical organizations recommends the 2025–2026 COVID-19 vaccine for all people above a certain age (e.g. 6 months), and they often use stronger language than the "shared clinical decision-making" framework adopted by the CDC. For example, the American Medical Association (AMA) advocates for broad access to the vaccine for all eligible patients. They emphasize the safety and efficacy of the vaccines in preventing severe disease and death, viewing it as a standard part of preventative care.

Despite this confusion and poorly thought out policy at the national level, there is a glimmer of hope at the state level if you live in a Blue state. In particular California has led the charge to reinstate the right of the healthy to receive the Covid vaccine. A new state bill (Assembly Bill 144) was signed into law on September 17 (after the FDA ruling). The law grants the California Department of Public Health (CDPH) the sole authority to determine vaccine recommendations for the state. More importantly, the law allows pharmacists to independently initiate and administer vaccines recommended by the CDPH to people 3 years and older. AB 144 includes a specific provision that grants legal immunity to healthcare providers—including pharmacists—who administer vaccines in accordance with California Department of Public Health (CDPH) guidelines. As a result, you do not need a prescription from your own doctor; a healthy person under 65 can walk into the neighborhood CVS pharmacy, and the pharmacist can administer you the shot under state-granted authority. In addition, the law mandates that all state-regulated health insurance plans must cover any vaccine recommended by the CDPH, regardless of whether the FDA has fully approved it for that specific group.

According to Gemini, other states have followed California's example. The following state health departments have issued standing orders or executive actions allowing pharmacists to vaccinate anyone who wants it, regardless of the narrower FDA approval:
  • New York: Executive order signed Sept. 2025 allows pharmacists to vaccinate anyone 3+ without a prescription.
  • Massachusetts: Standing order allows pharmacists to vaccinate all residents; CVS and Walgreens have resumed service here after a brief pause.
  • New Jersey: State guidance explicitly allows pharmacies to vaccinate everyone.
  • North Carolina: Updated rules allow pharmacists to vaccinate adults under "shared clinical decision-making" without a prescription.
  • New Mexico: Public health order issued to ensure universal access.
  • Colorado: State order allows universal access.
In addition, Connecticut, Illinois, Maryland, Minnesota, Vermont, Washington follow broader CDC guidance allowing pharmacy access for all adults. More generally, states with Democratic leadership have moved to keep the vaccine available to everyone at pharmacies (e.g., Oregon, Rhode Island, Delaware).

This issue has flown under the radar because Covid does not pose much threat to a healthy person under 65. However, there are a number of good reasons to get vaccinated. For one to prevent spread to those who may be at risk. The vaccine protects an elderly person but not perfectly. A healthy person who catches Covid can spread the virus to elderly relatives potentially endangering their health and even their lives. Vaccination lowers your chances of being infected, and the severity of your infection (i.e. length of infection). As listed above, health history, living situation, and risk tolerance are all important factors why a healthy person would want to get vaccinated.

Another good reason to be vaccinated this year is that the vaccines are targeting a new variant that is the most prevalent these days. In particular, the mRNA vaccines specifically target the LP.8.1 lineage which is significantly different from the KP.2 lineage, which was the antigen target of last year's (2024-2025) Covid vaccine. As people become immunized to the dominant virus strain, new variants will pop up that can at least partially evade the new immunity, and so it is important to update the Covid vaccines to track the virus (just as we do with the flu vaccine).

So despite the conflicting guidelines and the muddled recommendations of the FDA and CDC, one should follow the advice of the medical professionals who advise all eligible people, both at risk and healthy alike, to be vaccinated against COVID-19. 
Figure 1. Governor Gavin Newsom signed AB 144 into law making the Covid vaccine available to all California residents, including those who are healthy and under 65.

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