The US Food and Drug Administration (FDA) has introduced a new framework to approve COVID-19 vaccines, aiming to balance access with the need for evidence on their effectiveness in younger populations. Under this plan, vaccine makers must conduct trials to assess benefits in healthy adults and children. While some see it as a compromise that allows millions of Americans to access vaccines, others express concerns about the lack of clarity and potential delays. The FDA’s new framework may provide answers, but its impact on COVID-19 vaccination efforts remains uncertain.
Source: https://www.statnews.com/2025/05/21/fda-covid-vaccine-guidelines-analysis-questions-raised-on-access-trials-transparency