The US Department of Health and Human Services (HHS) has announced plans to require all new vaccines be tested in placebo-controlled trials before they’re licensed for use, raising concerns about the safety and efficacy of updated COVID-19 boosters. This change would significantly alter the current system used for flu-like vaccines, which only requires post-marketing surveillance. The move aims to ensure better safety and efficacy, particularly for vulnerable populations such as the elderly. Experts warn that this new requirement could delay availability of updated shots by months, putting high-risk individuals at risk.
Source: https://edition.cnn.com/2025/04/30/health/hhs-vaccine-placebo-testing