In a New England Journal of Medicine editorial, FDA commissioners Makary and Prasad announced a major policy shift: COVID-19 vaccines would be recommended only for adults aged 65 and older or those at high risk, with new clinical trials required before authorizing vaccines for healthy adults under 65. While the policy itself has drawn debate, many concerns center on how the decision is being made. The FDA bypassed its standard advisory process by not consulting the Vaccines and Related Biological Products Advisory Committee (VRBPAC), breaking with long-standing protocol. This move comes despite COVID-19 vaccines having saved an estimated 19.8 million lives globally and reducing the risk of complications like long COVID that can impact those at low risk. The commissioners justified the change by pointing to declining booster uptake (now below 25%) and argued that broad recommendations may have eroded trust in vaccination overall. The CDC's Advisory Committee on Immunization Practices (ACIP) is expected to vote in June on its own recommendations, potentially creating conflicting federal guidance. ACIP had previously discussed a hybrid model that would preserve vaccine access for anyone seeking protection. Requiring large randomized controlled trials for each updated vaccine strain marks a sharp departure from the process used for flu vaccines, which typically rely on smaller immunogenicity studies to ensure vaccines are available in time for seasonal use. Ultimately, this shift—both in policy and process—raises concerns about reduced access to protection, the potential erosion of public trust, and the lack of transparency in how decisions that impact public health are being made. 🔗https://www.nejm.org/doi/full/10.1056/NEJMsb2506929 (fb)

Low-quality and non-credible studies are everywhere online, presented as proven science to bolster false claims. Sometimes, they masquerade as “analyses” published on authors’ websites. Others publish papers in unreliable journals that lack editorial integrity and a strict review process. It can be difficult to catch red flags if you don’t frequently read scientific or medical studies. Many researchers have formal training and years of practice to help them understand these papers. But you don’t need to be an expert to identify a flawed study. This post is part of a collaboration between Unbiased Science Podcast and Public Good News! 🔗https://publicgoodnews.com/2025/04/16/how-to-spot-fake-scientific-studies-fact-checking/ (fb)