WHEREAS, there are two Hepatitis B vaccines licensed for injection into newborns, Engerix-B sold by GSK and Recombivax HB sold by Merck (the “Hep B vaccines”), and the Centers for Disease Control and Prevention (CDC) recommends all infants receive a Hep B vaccine at birth, 1-month of age, and 6-months of age.

WHEREAS, the Informed Consent Action Network (ICAN) is a non-profit organization that advocates for informed consent with regard to all medical interventions.

WHEREAS, in 2017, a supporter of ICAN advised that the Food and Drug Administration (FDA) licensed the Hep B vaccines based on clinical trials that reviewed safety for a few days after injection.

WHEREAS, ICAN found this claim incredible and assumed it was false because (i) even drugs for adults, such as Enbrel, Lipitor, and Botox, had safety review periods of 6.6 years, 4.8 years and 51 weeks respectively, each with a placebo control group; (ii) the FDA explains that clinical trials for licensure are typically “1 to 4 years” and should be even longer for infants since disorders are often not diagnosed until babies are at least a few years old; and (iii) Congress mandated that the FDA only license a vaccine if its clinical trials have proven it to be “safe and effective,” and five days of post-administration safety data is patently insufficient to demonstrate safety.

WHEREAS, based on the foregoing, the claim that the Hep B vaccines were licensed based on only a few days of safety data after injection sounded like science fiction; that was, until ICAN reviewed the package insert for these products, which indicated that they were licensed for babies based on clinical trials that only reviewed safety for a few days after injection.

WHEREAS, by approving, recommending and aggressively promoting use of the Hep B vaccine for all infants, the FDA created a liability-free captive market for Merck and GSK which has generated over $10 billion in sales for these companies by ensuring that millions of babies every year will be injected with these companies’ products.

WHEREAS, ICAN has over the last three years repeatedly demanded that HHS and FDA produce clinical trials reflecting that the Hep B vaccines were licensed based on clinical trials that reviewed safety for more than one week after injection and no such studies have been produced.

WHEREAS, it now appears clear that 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.

THEREFORE, ICAN demands that the FDA withdraw or suspend the approval for Engerix-B and Recombivax HB for infants and toddlers until a double-blind properly controlled trial of sufficient duration is conducted to assess the safety of these products.