The Informed Consent Action Network (ICAN) has filed a formal petition with the FDA to withdraw or suspend the approval for Engerix-B and Recombivax HB for infants and toddlers “until a properly controlled and adequately powered double-blind trial of sufficient duration is conducted to assess the safety of these products as required pursuant to applicable federal statutes and regulations for licensing these products. . . .The clinical trials relied upon to license these products only assessed safety for up to five days after injection. Therefore, these trials did not comply with the applicable federal statutory and regulatory requirements necessary to prove they were “safe” prior to licensure.”
Informed Choice WA full supports this petition and has filed the below comment with the Federal Register.