An article titled » An Evidence-Based Approach to Covid-19 Vaccination , » published on May 20, 2025, in the New England Journal of Medicine by Vinay Prasad and Martin A. Makary, proposes a reform of the Food and Drug Administration’s (FDA) regulatory framework for Covid-19 vaccination in the United States . This approach, which aims to balance rapid access to vaccines for high-risk populations with rigorous scientific evidence requirements for low-risk populations, could influence vaccine policies globally, including in France . While addressing public pressures for greater transparency and the growing role of patients in public health decisions, the consequences of this proposal for vaccine policy in the United States will likely have implications for France.
The FDA’s proposal
The regulatory framework proposed by the FDA is based on two key principles:
- Fast track approval for high-risk populations : Covid-19 vaccines will be approved for adults over 65 years of age and people over 6 months of age with risk factors (such as obesity, diabetes, or chronic diseases) based on immunogenicity (antibody production).
- Clinical trial requirement for healthy populations : For healthy individuals aged 6 months to 64 years, randomized controlled trials (RCTs) evaluating clinical outcomes (incidence of symptomatic Covid-19, hospitalizations, mortality) will be required prior to authorization. These trials must demonstrate at least a 30% reduction in the incidence of symptomatic Covid-19, with at least 6 months of follow-up, and may include a saline placebo to assess the full adverse effect profile.
This proposal responds to low uptake of booster vaccinations in the United States (less than 25% of the population, with less than 10% among children under 12) and growing vaccine distrust, which is affecting even critical programs like the measles-mumps-rubella (MMR) program.
Real consequences for vaccination policy
First, a revision of universal recommendations : the current strategy of annual boosters for everyone in the United States could be replaced by a targeted approach, aligned with the practices of other high-income countries such as Canada, Europe, and Australia, which limit boosters to the elderly or at-risk individuals.
This development could reduce the perception of an overly aggressive vaccination policy and restore public confidence by demonstrating that recommendations are evidence-based.
The third consequence relates to strengthening scientific requirements : requiring RCTs for healthy populations will ensure rigorous evaluation of vaccine efficacy, but could delay access for these groups if manufacturers are reluctant to invest in costly trials. Post-marketing trials for high-risk populations will generate valuable data on long-term efficacy, influencing future vaccine policies.
Second, it aims to restore public trust: by responding to skepticism with robust data, the FDA could mitigate vaccine mistrust. However, clear communication will be crucial to prevent healthy populations from perceiving their exclusion from recommendations as a sign of vaccine uselessness. The decline in trust observed in the United States, with repercussions for programs such as the measles program, is a warning for other countries.
Finally, on logistical and economic challenges : Implementing large-scale RCTs will require significant resources, which could hinder manufacturers, especially for populations where the benefits are uncertain. The broad definition of high-risk groups (including conditions such as obesity or depression) could complicate the prioritization of vaccination campaigns and lead to overuse of vaccines.
Implications for France
France, as a member of the European Union, follows the recommendations of the European Medicines Agency (EMA) and the French National Authority for Health (HAS), which differ from the United States’ universal approach. Here’s how the FDA’s proposal could influence French vaccination policy:
- Alignment with European practices : France already limits its recommendations for booster vaccinations to the elderly (>65 years) and at-risk groups (immunocompromised, chronic diseases). The FDA proposal reinforces this targeted approach, suggesting that France is already aligned with a risk-based strategy.
However, France could draw inspiration from the RCT requirement to assess the effectiveness of boosters in populations such as healthy 50-64 year-olds, where data remain limited.
- Building public trust : Vaccine hesitancy in France, which was marked during the initial Covid-19 campaigns, could be mitigated by robust data, such as that proposed by the FDA. Transparent communication about the benefits and risks of vaccines for target groups is essential to counter skepticism. Educational campaigns co-developed with communities could strengthen support by addressing citizens’ concerns.
- Adapting vaccination campaigns : France could clarify its criteria for high-risk groups, as the CDC’s broad list (including obesity or depression) could apply to a large part of the population, making campaigns less targeted. Data from the RCTs proposed by the FDA could guide the HAS in adapting recommendations, for example by assessing whether annual boosters are necessary or whether longer intervals are sufficient depending on the SARS-CoV-2 variants.
- Economic and logistical considerations : France could benefit from international collaboration to share RCT costs and data, avoiding duplication of efforts. Vaccine manufacturers operating in Europe, such as Pfizer or Moderna, could be incentivized by the FDA to conduct similar trials, influencing vaccine availability in France.
- Pediatric specifics : The FDA proposal notes a higher risk in young children (<4 years) compared to older children, but lower than that in adults >65 years. In France, where vaccination of young children remains limited, additional data from clinical trials could clarify the usefulness of boosters for this group.
Taking into account public pressures and the growing role of patients
The FDA’s proposal comes amid calls for greater transparency, notably from Robert F. Kennedy Jr., who advocates for randomized, placebo-controlled clinical trials to rigorously assess vaccine safety and efficacy. Moreover, low vaccine adherence and growing distrust signal a demand for greater patient autonomy in public health decisions. In France, involving citizens in decision-making processes, through public consultations or committees that include patient representatives, could strengthen trust and align vaccine policies with public expectations. Such an approach will require a delicate balance between scientific rigor and the inclusion of citizen concerns to ensure the effectiveness of vaccination campaigns.
The FDA’s proposal marks a shift toward a more nuanced, evidence-based vaccine policy, addressing low adherence and public mistrust in the United States. For France, this approach reinforces the relevance of current European strategies, which prioritize at-risk populations, while highlighting the need for robust data to justify boosters in groups where the benefits are uncertain. By incorporating patient concerns and responding to calls for greater transparency, such as those made by influential figures, France could optimize its vaccination campaigns and restore public trust.
Collaboration with the EMA and other international agencies to share RCT results would be essential to harmonize approaches and maximize the effectiveness of vaccine policies globally.
In the United States, patient interests are gradually returning to the forefront, to the detriment of those of industry.