July 11, 2023
In August 2022, ICAN’s attorneys filed a formal petition demanding that FDA suspend or withdraw approval of IPOL, Sanofi Pasteur’s inactivated polio vaccine for babies and children, until appropriate clinical trials are undertaken.
The petition is simple and straightforward, and requests that, until the safety of IPOL is demonstrated with a properly powered, double blind, placebo-controlled study (that lasts beyond three days), the vaccine should be withdrawn or suspended from the market and, if reintroduced, its label amended to note that IPOL does not prevent infection or transmission.
Despite this simple request, it was not until six months later that ICAN finally received a response – required by law – from Dr. Peter Marks, Director of FDA’s Center for Biologics Evaluation and Research, who oversees vaccine approval. Like his previous responses to ICAN’s citizen petitions, this one was as inane as ever. He wrote simply to state that FDA had “not yet reached a resolution because [the petition] raises issues requiring further review and analysis by agency officials.”
Further review and analysis! Effectively, what the FDA is really saying is that despite the passage of six months, it cannot yet figure out how to rebut ICAN’s claim that three days of safety review in the clinical trial was insufficient.