ICAN, through its attorneys, has provided the U.S. Department of Health & Human Services (HHS) and the Food and Drug Administration (FDA) numerous opportunities over the past three years to provide proof it licensed the vaccines for Hepatitis B based on clinical trials that reviewed safety for more than five days after injection.  All that HHS and FDA have provided in response are a litany of excuses — not science.  ICAN’s attorneys have therefore filed a petition to revoke or suspend the license for these vaccines until a proper clinical trial is conducted.

The Centers for Disease Control and Prevention (CDC) childhood vaccine schedule recommends universal vaccination of all infants with a Hepatitis B vaccine at birth, 1-month of age, and 6-months of age.  There are only two Hepatitis B vaccines licensed for administration to newborns: Engerix-B and Recombivax HB.  

In 2017, a supporter of ICAN told us that the clinical trials the FDA relied upon to license these vaccines only reviewed safety for a few days after injection.  ICAN found this claim incredible.  It assumed the claim was likely false.

It seemed improbable because Congress mandated that the FDA only license drugs which have been proven to be “safe and effective” in a clinical trial, and five days of post-injection safety data would be patently insufficient to demonstrate safety.  This is why drugs, such as Enbrel, Lipitor, Belviq, and Botox, typically given to adults, had safety review periods of 6.6 years, 4.8 years, 2 years, and 51 weeks respectively, and each was tested against a placebo control group.  The FDA even states that the clinical trial relied upon for licensure is typically “1 to 4 years” in duration.

If anything, the safety review period in a clinical trial for a vaccine given to babies and toddlers should be longer since autoimmune, neurological, and developmental disorders will often not be diagnosed until after babies are at least a few years old.  Indeed, a 2019 review of 306 pediatric studies, authored by researchers at the FDA and Duke University, explained that, compared to licensing a drug for adults, “data on drug efficacy and safety in children may require an additional 6 years.”

Putting this all together, it seemed like science fiction to claim the Hepatitis B vaccines were licensed by the FDA based on only a few days of post-injection safety data.  That was, until ICAN reviewed the package inserts for Engerix-B and Recombivax HB issued by their manufacturers and approved by the FDA.  To ICAN’s amazement, the package inserts stated that safety in these clinical trials was only reviewed for a few days post-injection into babies. 

Therefore, on October 12, 2017, ICAN sent a letter to HHS demanding that it “list and provide the safety data relied upon when recommending babies receive the Hepatitis B vaccine on the first day of life.”  On January 18, 2018, HHS (in a response reviewed and approved by the FDA) responded by letter in which it failed to provide any clinical trial supporting the safety of either Hepatitis B vaccine that reviewed safety for more than a week post-injection.  

After careful review of every single study HHS cited, ICAN responded on December 31, 2018 in a letter which pummeled HHS for failing to provide a single clinical trial reviewing safety of the Hepatitis B vaccines for more than a week post-injection to babies.  ICAN even provided HHS and the FDA another opportunity to provide any such data, including sending a follow-up letter repeating this demand on March 12, 2020.  HHS and FDA still have not provided any such data. 

ICAN’s legal team also formally submitted a Freedom of Information Act request to the FDA demanding a copy of the clinical trials relied upon to license Recombivax HB and received a 1,264 page production of clinical trial reports for this vaccine which confirmed it only reviewed safety for a few days post-injection into babies.  ICAN’s legal team made a similar request to the FDA for Engerix-B, but this time only requested clinical trials that reviewed safety for more than a week post-injection.  The FDA has refused to respond to this request and ICAN’s legal team has filed a federal lawsuit against the FDA demanding it respond to this request – more on that lawsuit in a future legal update.

Given the foregoing, it has come time to take formal action.  ICAN’s legal team therefore, on September 4, 2020, formally filed a petition to the FDA demanding that the licensure of the Hepatitis B vaccines be revoked or suspended until their safety, as required by law, is determined in a properly designed clinical trial of sufficient duration. 

Please submit a comment to the FDA today in support of the petition!

There may be some uncertainty as to what is required under federal law to determine that a product is “safe” prior to licensure, but what is clear is that five days cannot possibly be sufficient to meet that requirement.  Hence, if the FDA refuses to grant or timely respond to ICAN’s petition, we intend to sue the FDA in federal court to demand that the license for these vaccines be revoke or suspend until a proper clinical trial is conducted.