When the FDA announced new limits on COVID-19 vaccines, the headlines all sounded the same: “access restricted,” “eligibility reduced.” That framing is backward. The FDA didn’t take away something valuable; it finally aligned its recommendations with the evidence.
The confusion is understandable. In May, the CDC issued updated guidance narrowing eligibility. Just last month, the American Academy of Pediatrics and the American College of Obstetricians and Gynecologists called for much broader use, insisting it was “evidence-based.” Now the FDA has spoken, and its policy is not universal at all. Families are left wondering what to believe.
The truth is actually straightforward: COVID-19 vaccines have a place, but not as a universal vaccine.
Who does not need the vaccine?
The clearest group is infants and healthy children. Most pediatric trials have had too few cases to make any conclusions as to whether COVID-19 vaccines provide a consistent clinical benefit. Whatever signal once existed with early variants dropped dramatically in 2022. There is no durable evidence that COVID-19 vaccination protects healthy infants or children from serious disease.
The same is true for healthy adults younger than 65. Early randomized trials in 2020 showed short-term protection against infection with the original strain, but not against severe outcomes in healthy populations. As with children, the evidence for effectiveness in adults in preventing infection had collapsed by 2022 (and there had never been enough hospitalizations in either group to determine whether it conferred a benefit for that outcome). The evidence does not justify routine vaccination of healthy adults in their 20s, 30s, 40s, or 50s.
Who can benefit?
The FDA’s new guidance is consistent on this point: the people who should still receive COVID-19 vaccines are older adults and those with genuine medical risk factors. For people older than age 65, especially those with multiple chronic medical conditions, there is evidence for some short-term benefit. For younger people with chronic conditions – immunosuppression, diabetes, lung or heart disease – the risk of severe illness is elevated enough that vaccination may help, and so vaccines remain available for these groups as well, regardless of age.
This is what evidence-based policy looks like. COVID-19 vaccines do not offer herd immunity or universal protection. The FDA has properly recategorized them: important for some, not for all.
Pregnancy clarified
Pregnancy deserves its own section, because there have been multiple different recommendations. As with all other groups, the evidence for a benefit in pregnant women is limited and uncertain, and largely faded with Omicron. But this lack of evidence must be balanced out by immune system changes in pregnancy.
The FDA landed on a decision that reconciled both these factors, keeping pregnant women eligible, even without another risk factor. The CDC’s May guidance emphasized shared decision-making. While each statement looks at the choice from a different angle, their approaches are consistent. The FDA sets the bounds of who can receive the vaccine; the CDC advises that the decision about whether or not to be vaccinated should be a decision between a patient and her healthcare provider.
What the FDA got right
The real story is not that the FDA “restricted access.” It is that the agency is finally taking an evidence-based approach. COVID-19 vaccines reliably show an immune response in lab tests. For most people, regardless of age group, there is no evidence that they offer a clinically significant benefit. The COVID-19 vaccine is an individual protection tool that is best considered for specific groups: older people, people with high-risk medical conditions, and, in some instances, for pregnant women who decide it’s right for them.
The U.S. has taken a step that should restore public confidence: policy is finally aligned with the evidence. For years, universal COVID-19 vaccination was presented as settled science. It never was. Families deserve clarity, not confusion, about what vaccines can and cannot do.
Bottom line
Healthy children and healthy adults under 65 do not need COVID-19 vaccination. Older adults and those with risk factors do. Pregnant women may consider it, but only through genuine shared decision-making. That isn’t restrictive for patients – it’s what evidence-based medicine is supposed to look like.