The US Department of Health and Human Services plans to require placebo testing for all new vaccines before they are licensed for public use. The move aims to provide “straightforward” information about vaccine safety, but experts warn that it could limit availability and raise ethical concerns.
According to the department, all new vaccines will undergo safety testing in placebo-controlled trials prior to licensure. However, officials have not specified which vaccines will be included or when the testing will take place.
Some experts believe that updated COVID-19 shots may be part of this new requirement, which could slow down vaccine access. Peter Lurie, a former FDA official, said that requiring modification-based placebo trials could be “ethically dubious” and potentially deny Americans life-saving vaccines.
The plan is based on Robert F. Kennedy Jr.’s goal of “radical transparency,” aiming to provide clear information about medical products, including vaccines. However, public health experts argue that this approach misrepresents the fact that many childhood vaccinations have already undergone placebo testing.
Kennedy’s office claims that since childhood vaccinations were initially tested against a placebo, there is little known about their actual risk profiles. However, vaccine experts point out that all new immunizations undergo random testing where one group receives the immunization and the other gets a placebo.
The FDA has acknowledged a “void of data” for updated COVID-19 shots, but Commissioner Marty Makary said that he was taking a closer look at potential updates. The HHS spokesperson stated that significant updates to existing vaccines may be considered new products requiring additional clinical evaluation.
Requiring companies to conduct placebo tests for minor vaccine upgrades would be costly and could lead to the development of newer, more effective versions being abandoned due to lack of data. Experts fear that Kennedy’s approach will hinder vaccine access and put public health at risk.
Source: https://www.bbc.com/news/articles/crkx3egk3ygo