1962 – Eli Lilly Warns of Hepatitis Transmission Via Jet Injection

Jet Injectors = Jet Infectors

May 21, 2016

In 2005, Dr. Martin Friede led the Initiative for Vaccine Research at the World Health Organization. In this same year, during a FDA panel discussion evaluating the safety of jet injectors, Dr. Friede presented a review of the scientific literature. Most shockingly was a slide he presented capturing a 1962 influenza vaccine product insert by Eli Lilly & Company. From the minutes of the meeting comes a startling revelation about what researchers knew but more importantly when the knew it. Dr. Friede stated,

In 1962, though, Eli Lilly & Company, I’ll show you this in a moment, but on their inference of product insert, [sic] that bleeding could occur and that this would carry a risk of hepatitis, and that it recommended to the doctor that if blood was observed, then resterilization should be done (FDA, 2005).

Moreover, for all the skeptics, Dr. Friede stated a second time,

This is the product insert from the 1962 package from Eli Lilly and it states somewhere there under red lined that if bleeding does occur, and bleeding does occur sometimes with jet injection, then the nozzle should be resterilized. So there was recognition then that hepatitis B transmission could take place (FDA, 2005).

1962 Eli Lilly Product insert Jet injection

Eli Lilly stated special precautions should be taken for jet injectors. “Epidermal wheals and mild bleeding may occur occasionally after jet injection” (emphasis added). The product insert does not state bleeding occurred rarely or seldom but occurred occasionally. The word occasionally means infrequently, irregularly and occurs now and then and is distinguished separately on the frequency spectrum from the words rarely and seldom. Moreover, the product insert stated, “If the nozzle becomes contaminated with blood or serum, it should be replaced or resterilized before further use to prevent the transmission of serum hepatitis virus or other infectious agents from one person to another” (Eli Lilly & Co., 1962).
References:

  • (Eli Lilly & Co., 1962) Eli Lilly and Company. Influenza Virus Vaccine Polyvalent (Types A and B) [vaccine product insert; 03516, 80:12, PA 1787 AMP]. Indianapolis, IN: Eli Lilly and Company; December 28, 1962;102.
  • (FDA, 2005) FDA. General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee. August 9, 2005. 35th Conference. Washington, D.C.

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