On Friday, December 5th, the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) will face arguably its most important vote in recent times – the fate of the hepatitis B vaccine given on day one of life.

In September, ACIP members voted 11 to 1 to delay further discussions on the vote to alter current Hep B shot recommendations.

The upcoming vote on December 5th represents the first major opportunity to apply both growing scientific courage and an evolving ACIP apparatus towards one of the clearer targets on the CDC’s recommended schedule, which has rested upon questionable science.

The vote is symbolic against a backdrop of lost trust in the CDC, redlined during the failed pandemic response, alongside a critical mass of the public demanding common sense change to an American vaccine paradigm based more on faith than science and reality.

With each major inflection point offered for change, wrong moves by public health agencies in the current environment have the potential to exclude lifetimes of hearts and minds. The stakes couldn’t be higher.

In 2020, the Informed Consent Action Network (ICAN) submitted a petition to the commissioner of the FDA to withdraw or suspend the approval of two Hep B shots on the market – Engerix-B and Recombivax HB for infants and toddlers.

The petition demanded that the above actions be taken until a properly controlled and adequately powered double-blind trial of sufficient duration is conducted to assess the safety of the injectable products as required by federal statutes and regulations for licensing these products.

The Hep B shot suspension request was submitted because, when formally asked, HHS couldn’t produce evidence to support the safety of the shots. In fact, the evidence they provided wouldn’t even be sufficient to license these products for veterinary use in farm animals.

ICAN received an ACIP report that HHS asserted it relied upon for its “recommendation for all children to receive these vaccines.” Aaron Siri, along with ICAN’s legal team, broke down the government’s failed attempt at ‘The Science’ writing:

The ACIP report cites seven studies to support its recommendation that every baby in this country receive Hepatitis B vaccine injections at 1-day, 1-month, and 6-months of life.

Two of the cited studies only included adult[s]…and therefore provide no useful data to evaluate the safety of injecting newborns. The third was a retrospective study that did not use either of the Hepatitis B vaccines licensed for infants in the United States, excluded children that did not complete the vaccine series and lacked a placebo control.

The fourth was a retrospective study of potential neurological events from the Hepatitis B vaccine based on reports submitted to a passive surveillance system…“[in which] underreporting is a well recognized problem”…[and which] involved “virtually all” adults and did not provide any separate results for infants or children.

The three remaining studies…were clinical trials. But none…are useful for understanding the safety of injecting Hepatitis B vaccine into babies. First, none of them had a placebo control. Second, none…assessed safety for longer than seven days after vaccination.

Indeed, one study had 122 infants and monitored safety for only 7 days. Another study had 79 children monitored for 5 days. Remarkably, in this study 18 percent of the children experienced a systemic or serious adverse reaction…but, absent a placebo.

Meanwhile, Sen. Bill Cassidy has been making the rounds on CNN to drum the tired talking points into a growingly sparse audience that anything that undermines the message that vaccines are ‘safe and effective’ is a problem. A problem for whom?

Jefferey Jaxen

Jefferey Jaxen is an investigative journalist and researcher, best known for his weekly segment The Jaxen Report on The HighWire. With a sharp eye for detail and a talent for clear, compelling storytelling, he has exposed major issues in medicine, science, and public health policy, earning recognition as a trusted voice in independent journalism.