US Health Secretary Robert F. Kennedy Jr. has announced plans to require placebo testing for all new vaccine approvals, sparking concern among experts. The move is seen as a significant shift from current practices, where some vaccines are tested against existing shots.
However, experts argue that placebos have already been used in many phase 3 vaccine trials and may not be considered ethical when effective vaccines exist. Testing new vaccines against a placebo could slow down the development of new vaccines, like those needed for annual updates such as flu and COVID-19.
The FDA’s proposed policy change raises questions about what constitutes a “new” vaccine under this requirement. The agency will release guidelines for manufacturers in the coming days.
Kennedy stated that some vaccines may not have been tested against placebos, but this isn’t entirely accurate. Experts say that placebos become standard in most phase 3 trials and may increase costs and complexity due to larger sample sizes, sophisticated analysis, and ongoing monitoring.
The industry must wait for official guidance from the FDA on its new policy. Upcoming events, including an advisory committee meeting in May and a PDUFA date for Moderna’s next-gen COVID jab, may provide clues into the agency’s thinking.
Source: https://www.pharmavoice.com/news/placebo-vaccine-fda-rfk-trump-novavax/748524