The rollout of updated Covid vaccines this fall faces potential delays due to a policy change instituted by Health and Human Services Secretary Robert F. Kennedy Jr. According to experts, all new vaccines must undergo placebo-controlled trials, meaning some participants would receive a saline shot instead of the vaccine. While this practice is standard for most vaccine trials, the original Covid vaccines were approved after similar trials. Since then, updates to the vaccines were managed more like flu shots, employing smaller studies to test immune responses against new variants without being treated as entirely new products.
However, if the FDA classifies the updated Pfizer and Moderna vaccines as “new” products needing new trials, it could significantly delay their availability. Experts predict that this could extend the timeline by months, as the drugmakers would need to design the trials, enroll participants, and analyze the results, a process which previously took about six months for the initial Phase 3 trials.
The HHS defended the new requirement by stating that trials from four years ago might not reflect current immunity levels and safety concerns. Experts criticized this move as “unethical,” arguing it risks exposing participants to illness when existing vaccines offer protection. There are broader concerns that these regulatory hurdles may sow distrust in vaccines and limit access.
Concerns arise not only for Covid vaccines but also for others that may require updates, as extensive placebo trials can lead to increased hospitalizations and deaths. Experts warn that this approach could impede the development of vaccines for other serious diseases, such as HIV.
Note: The image is for illustrative purposes only and is not the original image associated with the presented article. Due to copyright reasons, we are unable to use the original images. However, you can still enjoy the accurate and up-to-date content and information provided.
