February 9, 2017
NIH’s discussion on the risk of transmitting hepatitis via jet injectors in 1971 was completely forgotten and almost forever lost within the pages of an archaic book. Jet Infectors discovery casts new light on this old issue. What was once lost and forgotten is now rediscovered.
Tuesday, October 26, 1971
U.S. Surgeon General, Dr. Jesse Steinfield, convenes a conference to discuss the status and efficacy of tuberculosis vaccinations. Prominent health officials, physicians, and professors arrive at the John E. Fogarty International Center for Advanced Study in the Health Sciences, within the National Institute of Health complex, for the three-day conference.
Amongst the thirty-eight attendees are such prominent officials as the—
- Surgeon General of the U.S. Public Health Service for the Department of Health, Education and Welfare, Dr. Jesse Steinfield
- Director of the Armed Forces Epidemiological Board Commission on Immunization and co-inventor of the Ped-O-Jet, Dr. Abram Benenson
- Assistant Director of Research Service for the Veterans Administration [Department of Veterans Affairs], Dr. James Matthews
- Assistant Executive Vice President of the American Medical Association, Dr. William Barclay
- Director of the National Institute of Allergy and Infectious Diseases, National Institute of Health, Dr. Dorland Davis
- Special Assistant to the Office of the Director of the National Institute of Allergy and Infectious Diseases, Dr. Earl Chamberlayne
- Director of State and Community Services Division for the Center for Disease Control, Dr. J. Donald Millar
Dr. Sol Roy Rosenthal, the Director of the Institution for Tuberculosis Research at the University of Illinois takes the podium to present his findings upon the mass BCG vaccinations of British schoolchildren. Several minutes into his presentation, he appropriately raises concern about the presence of blood during these mass vaccinations with jet injectors.
“During the high pressure injection, traces of blood may cover the inside of the bell adjacent to the skin and the possibility of transfer of infectious hepatitis must be considered,” said Dr. Rosenthal.
Rosenthal saw what so many other health officials failed to see during the 1960s. The mass skin-testing and vaccination programs, along the introduction and implementation of multi-dose jet injectors, and the increased incidence of viral hepatitis all during this era prompted Rosenthal to assess the safety of vaccination devices. He questioned if jet injectors were jet infectors.
Not only did Rosenthal witness and participate in the mass BCG vaccinations of schoolchildren but he also evaluated a multi-dose jet injector, the Hypospray Model K-3, for blood contamination during the immunizations. His findings are reported in his 1967 article, Transference of Blood By Various Inoculation Devices.
Rosenthal’s observation of bloody jet injectors and the risk this posed compelled him to present his findings within this NIH conference in 1971.
With a room of captivated health officials and peers, Rosenthal expounded upon his findings.
Sampling the inside of the bell and testing for hemoglobin by the benzidine method, it was found that with one apparatus 22 of 248 samples gave positive benzidine tests (8.9 percent) and with another similar apparatus and a different operator 46 of the 139 samples gave positive tests (34 percent)…Visible bleeding from the site of inoculation was noted in 50 percent of the tests and may have been responsible for the variations in the size of the wheals (DHEW, 1972).
A benzidine test detects for the presence of blood. The test is conducted by swabbing a sample and then placing the swab into a test tube. A benzidine solution is mixed and then poured into the test tube. When benzidine oxidizes with hemoglobin a chemical reaction causes the sample to turn a blue-green color; thus indicating the sample is positive for blood.
Based upon Rosenthal’s findings, 8.9 % and 34% of the samples from the jet injector nozzle were contaminated with blood. In all, 68 out of 387 (17.6%) of the samples were positive for blood contamination.
Before continuing several clarifying points need to be made. The “bell,” aforementioned by Rosenthal, refers to the spherical shape of the nozzle. This is explained in greater detail within his article, in which he wrote, “The principle involved in this instrument is to depress the skin by a central post [referring to the nozzle]; the depth of the depression is governed by the free margin of a bell that surrounds the post” (Rosenthal, 1967).
Second, Rosenthal’s statement that “blood may cover the inside of the bell” does not refer to the internal components of the nozzle. The procedural methods of the study never mentioned any disassembling of devices for testing. His statement is, however, referring to the central point of the nozzle. This skin-contacting portion of the nozzle was swabbed and tested for blood.
Lastly, the mention of the word “infectious hepatitis” can be of great confusion. Infectious hepatitis is an outdated medical term referring to what is now identified as the Hepatitis A virus, which is primarily acquired from ingestion of contaminated food and water. Rosenthal’s use of the word at the 1971 conference is incorrect by todays standards. However, within his 1967 article, he appropriately used the terms viral hepatitis and parenteral hepatitis. Viral hepatitis is an inclusive term which acknowledges all forms of hepatitis (A, B, C, D, E). Parenteral hepatitis refers to hepatitis that is acquired through means other than the mouth such as through blood and bodily fluids and is primarily associated with Hepatitis B, C, and D.
It is important to note these terms were used before the identification of Hepatitis A in 1973. Hepatitis B, identified in 1967, was still a new discovery. It is likely the word infectious hepatitis was incorrectly used as a synonym for parenteral hepatitis. The fact that Rosenthal’s study tested jet injectors for blood contamination affirms this point.
Following Rosenthal’s presentation a discussion ensued amongst the attendees and a consensus was reached. The written account of the consensus stated,
The jet method of vaccination would save time as compared to the intradermal method. The possibility of transfer of infectious hepatitis, however, is not excluded. When compared to using disposable units of the multiple-puncture method, the time for vaccination is about the same for both. By the latter method, transference of infectious hepatitis is entirely ruled out; no expensive apparatus is needed, and it can be applied for mass vaccination as well as for individual vaccinations (DHEW, 1972).
Lets put this into perspective. Amongst the attendees of the conference were top health officials, elite scientists, and top-notch doctors and all concurred on the following points:
- Blood contamination upon jet injectors during mass vaccinations occurs.
- The risk of transmitting hepatitis via mass jet injections is not excluded. In other words the risk exists.
- When compared to other vaccination methods, the jet injector is too risky and too expensive, and thus should not be used when more viable options are available.
- The Multiple-puncture method for BCG vaccination is a safer, more versatile, and more economical approach.
In 1972, the Department of Health, Education and Welfare (DHEW) published an overview of the conference, in a publication titled, Status of Immunizations in Tuberculosis in 1971. The book included synopses to all presentations and outlined the ensuing discussions. Overtime numerous copies of the publication survived but were rarely ever referenced.
- (DHEW, 1972) Department of Health, Education and Welfare, Public Health Service, National Institutes of Health. Status of Immunization in Tuberculosis in 1971; DHEW Publication No. (NIH) 72-68, pp. 185-187. Washington, D.C., 1972.
- (Rosenthal, 1967) Rosenthal SR. Transference of blood by various inoculation devices. Am Rev Respir Dis. October 1967; 96(4):815-819.