Part 2 – CDC Retests the Safety of Jet Injectors in 1986

June 19, 2017

“Hepatitis Outbreak Laid to Contaminated Jet Injection Gun,” read the headline of the June 13th, 1986 edition of the LA Times (Maugh, 1986).  Between 1985 and 1986, the CDC thoroughly investigated a Hepatitis B outbreak caused by a jet injector at a LA weight reduction clinic.

Assessing the Outbreak
The weight reduction clinic in Long Beach was administering regular injections of human chorionic gonadotropin (HCG) to its patients via a Med-E-Jet injector and by syringe and needle at the time the outbreak was identified by local health officials.

Analyses by CDC found twenty-one percent (60/287) of those attending the clinic had an acute infection of Hepatitis B.  Twenty-seven individuals were infected with Hepatitis B and another thirty-three individuals were IgM positive meaning each had the antibody to hepatitis B core antigen (Canter et al., 1990; CDC,1986).  For a person to test IgM positive is indicative that he or she was infected with the hepatitis B virus within the last 6-months.  Two individuals identified with Hepatitis B were found to have other risk factors for acquiring Hepatitis B virus within the previous six-months (CDC, 1986).  Therefore, two individuals already infected with Hepatitis B were identified amongst the cohort receiving jet injections and were likely the culprits who unknowingly infected the others.

Amongst those individuals who exclusively received HCG by jet injection, twenty-four percent (57/239) had developed an acute Hepatitis B virus infection.  Interestingly, the 22 patients who received injections exclusively by a syringe never acquired the hepatitis B virus (CDC, 1986; Canter et al., 1990).  This data indicates that a total of 57 individuals had evidence of acute infection with hepatitis B virus as the result of receiving injections with a multi-use nozzle jet injector.

“Everyone always assumed that jet guns were safe,” said Dr. Steve Hadler, Chief of Epidemiology Activity within CDC’s Hepatitis Branch, in a newspaper article (Hendrick, 1986).

CDC’s assessment of the outbreak found 57 individuals had been infected from receiving injections with a jet injector.  Throughout the years, the Department of Veterans Affairs (VA) has grossly minimized this outbreak. VA states, “there is at least one case report of hepatitis B being transmitted by an airgun injection” (VBA Fast Letter 211 (04-13)).  A case report is defined as a detailed report listing the signs, symptoms, diagnosis and treatment of an individual patient.  Therefore, contrary to VA’s reporting, there are in actuality 57 documented cases, or rather 57 cases reports, of Hepatitis B being transmitted by jet injection.

The outbreak prompted CDC to retest the safety of jet injectors.

 

CDC’s Laboratory Investigations
“Five Med-E-Jet injectors used in these weight reduction clinics were sent to the Centers for Disease Control, Atlanta, Ga, for further evaluation,” stated a report by the researchers (Canter et al., 1990).

CDC’s 1986 investigations evaluated the threat of cross-contamination of blood-borne pathogens when using a Med-E-Jet injector.  The researchers explained their 1986 investigations within a medical journal.  “A series of in vitro and in vivo laboratory experiments were carried out to assess the potential for a contaminated Med-E-Jet to transmit HBV from patient to patient and to assess the potential for HBsAg contamination of this jet injector during actual use,” stated the article (Canter et al., 1990).  Within these experiments detection of the Hepatitis B surface antigen (HBsAg) would be presumptive evidence of Hepatitis B contamination.

Analysis of the outbreak and investigations of the Med-E-Jet were published twice; once within a 1986 CDC report and again in a 1990 medical journal.  It is interesting to also note that CDC microbiologist Walter Bond, who was a part of the 1977 investigations of the Ped-O-Jet, was also a part of the 1986 laboratory investigations of the Med-E-Jet in Atlanta.

 

Firing Into Vials – In Vitro Experiments
Several in vitro tests were implemented to assess the frequency of contamination when using the Med-E-Jet.  Within the first experiment, the Med-E-Jet nozzle was artificially contaminated with Hepatitis B surface antigen (HBsAg) to see if the antigen would be sucked back into the nozzle head and contaminate the next dosage to be fired.
Results found, after the nozzle was contaminated, the ejected fluid of the next shot fired was positive for HBsAg in 40 out of 50 (80%) of the samples.  Med-E-Jet surfaces were also tested for contamination.  Results showed HBsAg contamination upon the exterior of the nozzle in 9 out of 10 (90%) of the samples.  Samples from within the nozzle interior were HBsAg-positive in 8 out of 10 (80%) occurrences.  The nozzle tip was HBsAg-positive in 9 out of 10 (90%) of the samples (Weniger, 2003).  This data demonstrated gross contamination of the Med-E-Jet due to fluid suck-back.

In a second set of experiments, researchers assessed if wiping the nozzle between consecutive patients would remove any contamination from the nozzle surface.  Using a cotton ball moistened in acetone researchers wiped the contaminated Med-E-Jet nozzle to see if the HBsAg would be reduced or eliminated.

The results after wiping the nozzle found the ejected fluid of the next shot fired was positive for HBsAg in 29 out of 45 (64%) of the samples.  Results of Med-E-Jet surfaces were positive for HBsAg in 7 out of 9 (78%) of the samples from the nozzle exterior, 5 out of 9 (56%) of the samples from the nozzle interior, and 6 out of 9 (67%) of the samples from the nozzle tip.  This data indicated wiping the Med-E-Jet with acetone after each injection did not significantly reduce the frequency of HBsAg contamination (Weniger, 2003).

 

Jet Injecting Chimpanzees – In Vivo Experiments
In this in vivo experiment the CDC assessed if the Med-E-Jet would become contaminated with Hepatitis B surface antigen after injecting a chimpanzee infected with the pathogen.  Immediately following the injection the next shot to be delivered was fired into a vial and tested for blood and HBsAg.  This test was repeated five times.

Results could not detect HBsAg in the ejected fluid in any of the five injections with the Med-E-Jet.  The researchers, however, did state, “Bleeding did occur at the four of the five injection sites, even though injections were carefully done according to the manufacturer’s recommendation” (Canter et al., 1990).

Despite these findings it is duly noted that the exact Med-E-Jet injectors documented in the 1985 Hepatitis B outbreak of 57 individuals did not demonstrate such cross-contamination when tested upon a chimpanzee.  This finding calls into question the validity of relying upon chimpanzee studies to assess the safety of jet injectors.  It appears, in this regard, comparing humans to chimpanzees is like comparing apples to oranges.

Possibly the assay used by CDC within their laboratory investigations was not able to detect HBsAg.  The report did not specifically mention which assay product was used within the laboratory investigations.  Although it was noted that within the investigation of the outbreak serum specimens of those attending the Long Beach clinic were evaluated using Auszyme by Abbott Laboratories (Canter et al., 1990).  Assuming the assays were the same for both procedures would call into question the validity of the animal model used.  If the assays were different it would call into question the capability of the assay used within the laboratories investigation to detect low levels of HBsAg.

 

Summary of Findings
In 1986, the CDC investigated the Med-E-Jet in a laboratory setting to assess the degree of contamination caused by this particular model of device.  The official 1986 report stated,

the estimated volume of contaminating material transferred in downstream injections was 0.53 micro liters (0.53 x 10–3ml).  Therefore, it can be estimated that viruses that circulate in high titers in blood, such as HBV (10-8/ml) and LDH virus (10-7/ml), could be transferred during a procedure if gun contamination occurred.  The probability of transferring microorganisms present in lower concentration ( < 10-3/ml) would be correspondingly lower (CDC, 1986).

Herein the CDC recognizes highly infectious viruses can be transferred via jet injection.

Canter and colleagues (1990) concluded, “This epidemiologic and laboratory investigation suggests that when this model of jet injector [Med-E-Jet] becomes contaminated with blood, transmission of HBV can occur” (Canter et al., 1990).

 

References:

  • (Canter et al., 1990) Canter J, Mackey K, Good LS, Roberto RR, Chin J, Bond WW, Alter MJ, Horan JM. An outbreak of hepatitis B associated with jet injections in a weight reduction clinic. Arch Intern Med. 1990 Sep; 150(9):1923-7. 
  • (CDC, 1986) Centers of Disease Control. Epidemiologic Notes and Reports Hepatitis B Associated with Jet Gun Injection — California. MMWR 1986;35(23):373-376.
  • (Hendrick, 1986) Hendrick O. Jet gun injector causes hepatitis outbreak. United Press International 12 June 1986. Accessed at: http://www.upi.com/Archives/1986/06/12/Jet-gun-injector-causes-hepatitis-outbreak/5885518932800/.
  • (Maugh, 1986) Maugh TH. Hepatitis outbreak laid to contaminated jet injection gun. Los Angeles Times. 13 June 1986. Accessed at: http://articles.latimes.com/1986-06-13/news/mn-10799_1_jet-injector.
  • (VBA Fast Letter 211 (04-13)) VBA Fast Letter 211 (04-13). Relationship Between Immunization with Jet Injectors and Hepatitis C Infection as it Relates to Service Connection, Veterans Benefit Admin. (VBA) Fast Letter No. 04-13, 211 (April 29, 2004).
  • (Weniger, 2003) Weniger BG. Jet Injection of Vaccines: Overview and challenges for mass vaccination with jet injectors. Innovative Administration Systems for Vaccines (conference). Rockville, Maryland, USA, 18-19 December 2003.

 

Copyright Notice
© Shaun Brown and Jet Infectors, 2017. Veterans are encouraged to use these documents as evidence within their VA claims. Any other use and/or duplication of this material without express and written permission from this site’s author and/or owner is strictly prohibited. Excerpts and links may be used, provided that full and clear credit is given to Shaun Brown and Jet Infectors with appropriate and specific direction to the original content.

Fair Use Notice
In accordance with the Fair Use Law (17 U.S.C. § 107), copyrighted sources cited within this website are distributed without profit and are presented for educational, research, and in some cases critical analysis purposes. For these reasons authorization from the copyrighted holders has not been obtained. If you wish to use the copyrighted material for purposes that go beyond the Fair Use Law 17 U.S.C. § 107, you must obtain permission from the copyright owner.

 

 

December of 1977 Summary

June 13, 2017

The Special Investigations Section summarized it’s findings of the Ped-O-Jet by stating,

Although there is a lack of epidemiologic data implicating jet injector guns in the transmission of viral hepatitis B, we feel that the remote possibility of transmission would be increased by improper use of the gun.  For example, our in vitro studies showed that a massively contaminated nozzle was capable of contaminating the injected fluid for at least two subsequent shots; if the gun was not properly pressed on a patient’s arm during injection and the skin was torn, it is conceivable that such massive contamination may occur in an in-use situation.  We did not demonstrate such carry-over of HBsAg in our in vivo studies, but these experiments were not designed to simulate a worst-case condition as described.  A more definitive statement regarding the safety of jet injector guns with regard to hepatitis B transmission is dependent upon specifically designed prospective seroepidemiologic studies.

The irony of the situation is befitting—the location where the CDC secretly requested epidemiological evidence to further assess the risk of jet injectors was thirty-years later turned over to a government agency that serves precisely the population who was most impacted by jet injectors—military veterans.

Veterans have long blamed jet injectors as one of the sources for the high prevalence of Hepatitis C amongst the now older veteran population.  Jet guns were widely used within the military to deliver numerous immunizations until being banned in 1998.  The VA acknowledges the nexus as “biologically plausible” but to date refuses to recognize jet guns as an official risk factor.

In light of this report, the true historical account of jet injectors demonstrates the Ped-O-Jet came under investigation by the CDC in 1977 from the presence of blood during mass vaccination campaigns.  The full details of the report by the Hepatitis Laboratories Division demonstrated the possibility of transmission of blood and viral hepatitis.  The report signified concern, not relief, over the device.

The researchers did note the lack of epidemiological data implicating the devices.  That is to say there was a lack of any known outbreaks due to jet injectors.  However, this was an illogical point even for that time period.  Knowledge of the asymptomatic progression of serum hepatitis and the recognition of a new hepatitis virus, called non-A, non-B Hepatitis were known throughout the mid- to late-70s and should have brought heightened awareness and the exercising of precautionary measures.

Development of more precise Hepatitis B assays have made detection of low levels of Hepatitis B surface antigen possible.  DNA hybridization, for instance, can detect Hepatitis B surface antigen in solutions 1,000 times smaller than within the method used by the Special Investigations Section.  Therefore, based upon the methods used by the Special Investigations Section, it is highly possible that transmission could have occurred and gone undetected within their experiments.

The final conclusion by the Hepatitis Laboratories Division suggested further studies be implemented.

 

More Questions Than Answers
After reading this report more questions than answers arose.  For instance, what did Deputy Director of the Hepatitis Laboratories Division, Martin Favero, do upon receiving the report in December of 1977?  Did he pass the report along to CDC Headquarters in Atlanta?  Did he wish to implement another study?  Was he going to inform the manufacturer of the Ped-O-Jet of the test results?  Or did he assume the responsibility now befell upon others to create seroeopidemiological studies?

Attempts to reach out to Mr. Favero were made.  Although, he had asked Norman Petersen, the lead investigator of this study, to speak on his behalf.

Former Chief Norman Petersen explained in a recent communication,

The report you cite was a routine quarterly report that was submitted by the Special Investigations Section to Dr. Favero as a means of documenting the work done in the past quarter.  These reports were widely distributed to an established list of interested readers as well as to the CDC chain of command in Atlanta.

Petersen added, “While it has been 40 years since the writing of the report, I do not recall that the findings resulted in further investigations by our group.  At the time we, and CDC in general, were more interested in whether jet injectors were found to be a significant risk factor in the transmission of hepatitis B in seroepidemiologic studies involving real-life activities.”

The question arises, how does a lab inquire about the possibility of Hepatitis B transmission via jet injectors, discovers transmission is possible and then does nothing afterwards?  Secondly wouldn’t the possibility of transmission demonstrated within the in vitro experiments prompt the lab to inquire about the degree of transmission under worst case scenarios?

The CDC unequivocally acknowledged the jet gun risk in 1977 but viewed the benefits of these devices as a tool for mass immunizations outweighed the risk of transmission.

Mr. Petersen said so himself.  “Although the observed risk of contamination of jet injectors is recognized, the risk-benefit ratio of their use in mass immunization programs is an equally important public health factor.”

CDC’s decision in 1977 to disregard transmission via jet injectors is shocking and disheartening.  Although this report was disseminated within CDC and to a limited number of researchers, it was never made known to the general public.  Thus the public was never given informed consent on the risks of receiving immunizations with such devices or the option of whether or not to partake in this method of vaccination.  An agency solely established to protect the health of its citizenry should not have gambled on whether an outbreak would arise from jet injectors.

In 1985 an outbreak did arise and the CDC was called upon to retest the safety of jet injector devices.   Next Article – Part 2 – CDC Retests the Safety of Jet Injectors in 1986

 

Copyright Notice
© Shaun Brown and Jet Infectors, 2017. Unauthorized use and/or duplication of this material without express and written permission from this site’s author and/or owner is strictly prohibited. Excerpts and links may be used, provided that full and clear credit is given to Shaun Brown and Jet Infectors with appropriate and specific direction to the original content.

Fair Use Notice
In accordance with the Fair Use Law (17 U.S.C. § 107), copyrighted sources cited within this website are distributed without profit and are presented for educational, research, and in some cases critical analysis purposes. For these reasons authorization from the copyrighted holders has not been obtained. If you wish to use the copyrighted material for purposes that go beyond the Fair Use Law 17 U.S.C. § 107, you must obtain permission from the copyright owner.

Jake The Chimpanzee – In Vivo Expirements

June 9, 2017

Petersen, Bond and Carson then conducted a series of tests to assess if the Ped-O-Jet would become contaminated after injecting an animal already infected with hepatitis B surface antigen (HBsAg).  Two male chimpanzees were used: Jake an adult chimpanzee weighing 145 pounds and a juvenile chimpanzee (name unknown) weighing 44 pounds.  Both chimps were sedated with ketamine for the experiment.

In this in vivo experiment—an experiment taking place in a living organism—a 0.5 ml sterile saline injection was given with a sterile Ped-O-Jet to the HBsAg-positive chimpanzees.  The Ped-O-Jet was firmly held against the skin during the administration of the injection and for three-seconds after the injection.  Following the injection the Ped-O-Jet was fired into a vial and the ejected fluid tested.  If the fluid was HBsAg-positive it would implicate the jet injector as a vehicle in the cross-contamination of viral hepatitis.

Jet Infectors - Phoenix Field Station In Vivo study

Special Investigations Team testing a Ped-O-Jet injector on a chimp in 1977

Detection of blood and HBsAg were obtained using methods viable in 1977 and which are no longer relied upon.  Nonetheless, the results from the in vivo experiments were inconsistent.  For Jake, the adult chimpanzee, one sample from the injection site tested positive for occult blood by Hemastix (urine dipstick) and positive for HBsAg by radioimmunoassay (RIA) using Ausria II, while the remaining four injection site samples were negative.  For the juvenile chimp, 4 out of 5 injection sites were positive for occult blood but all five were negative for HBsAg.  The Ped-O-Jet was swabbed but all samples were negative for HBsAg.  Results of the ejected fluid, the most critical test within the experiment, were also all negative for HBsAg.

The researchers concluded, “from these in vivo experiments that jet injector nozzle surfaces and interior surfaces of the gun are apparently not easily contaminated during actual use.”  The researchers further stated, this experiment only tested conditions under normal use and did not represent a “worse-case condition.”

Although not part of the original report, it is interesting to note that trauma to the injection sites was observed.  Walter Bond recalled the experiment many years later in an email with a colleague-friend.  Bond stated upon visiting Jake in the animal quarters the following day that the injection sites looked “agggh!”

 

Results No Longer Valid
The Phoenix Labs’ radioimmunoassay method of HBsAg detection, albeit novel for 1977, quickly became outdated.  Advances in science ushered in more precise Hepatitis B assays capable of detecting extremely low levels of HBsAg.  These advances made the results of the Special Investigations Team no longer valid.

Imagine using a magnifying glass.  Several years later, a more powerful lens with a greater magnification emerges allowing things previously unseen to be observed.  Very similarly advances in medicine have allowed for low levels of Hepatitis B surface antigen previously unseen to be observed.

In 1984, Feinman and colleagues found DNA hybridization to be a far more accurate tool than radioimmunoassay in detecting low levels of HBsAg.  Precisely 1,000 times better.  Radioimmunoassay detects HBsAg in dilutions as small as 1/ 100,000 milliliters or rather 10-5 mL.  Whereas DNA hybridization detects as small as 1/ 100,000,000 milliliters or rather 10-8 mL within the same samples (Feinman et al., 1984). This is a huge difference!

“DNA hybridization is the most sensitive method for detecting hepatitis B virus (HBV) infection.  In situations with low virus levels it may be the only indicator of the presence of infectious hepatitis B virus,” wrote Feinman in 1984.

The discovery by Feinman and colleagues made HBsAg detectable in microscopic levels previously unheard of in the medical community.  With this method they found the minimum known volume of blood capable of transmitting Hepatitis B virus was 100 million chimpanzee-infectious doses per milliliter (Feinman et al., 1984).  Former Lead Researcher on Vaccine Technology within the CDC, Dr. Bruce Weniger stated, “This converts to 10 picoliters (10-8 mL) of HBV-infected blood transmitting infection, well below the sensitivity to detect blood by human vision, by common urine dipstick, and by non-PCR HBV assays” (Weniger, Jones & Chen).

Therefore, the radioimmunoassay used by the Phoenix Lab, a non-polymerase chain reaction Hepatitis B virus assay, could not detect positive samples within such low levels.  Neither would the Hemastix urine dipstick be able to detect such low levels.  These tests would give false-negative, or rather would falsely deem a positive sample to be negative.  Ultimately, low levels of infectious Hepatitis B surface antigen could have been transmitted within this study and could have gone undetected.

For any critics who would argue that such low levels of blood would not be infectious or carryover to the next vaccinee…think again.  As stated within the last article, subsequent research on jet injection has demonstrated cross-contamination of blood (Hoffman et al., 2001; Hoffman et. al., unpublished), infectious material (Brink et al., 1985), and the Hepatitis B virus (Kelly et al., 2008) in such low levels.  In fact, in several samples which demonstrated carryover there was no observable bleeding at the injection site.  This means that microscopic levels of blood and viruses were transmitted via jet injectors despite the absence of any visible bleeding.

From these experiments the team summarized it’s findings.

Next Article – December of 1977 Summary

 

References:

  • (Brink et al., 1985) Brink PRG, van Loon AM, Trommelen JCM, Gribnau FWJ, Smale-Novakova IRO. Virus transmission by subcutaneous jet injection. J Med Microbiol. December 1985; 20(3): 393-397.
  • (Feinman et al., 1984) Feinman SV, et al. DNA: DNA hybridization method for the diagnosis of hepatitis B infection. J Virol Methods 1984;8(3):199-206
  • (Hoffman et al., 2001) Hoffman PN, Abuknesha RA, Andrews NJ, Samuel D, Lloyd JS. A model to assess the infection potential of jet injectors used in mass immunization. Vaccine 19 (2001): 4020-4027.
  • (Hoffman et al., unpublished) Hoffman PN, Abuknesha RA, Andrews NJ, Brito GS, Carrasco P, Weckx LY, Moia LJMP, Silva AEB, Lloyd J. A field trial of jet injector safety in Brazil. (unpublished).
  • (Kelly et al., 2008) Kelly K, Loskutov A, Zehrung D, Puaa K, LaBarre P, Muller N, Guiqiang W, Ding H, Hu D, Blackwelder WC. Preventing contamination between injections with multi-use nozzle needle-free injectors: a safety trial. Vaccine (2008) 26, 1344-1352.
  • (Weniger, Jones & Chen) Weniger BC, Jones TS, & Chen RT. The Unintended Consequences of Vaccine Delivery Devices Used to Eradicate Smallpox: Lessons for Future Vaccination Methods. [Poster Presentation]

 

Copyright Notice
© Shaun Brown and Jet Infectors, 2017. Unauthorized use and/or duplication of this material without express and written permission from this site’s author and/or owner is strictly prohibited. Excerpts and links may be used, provided that full and clear credit is given to Shaun Brown and Jet Infectors with appropriate and specific direction to the original content.

Fair Use Notice
In accordance with the Fair Use Law (17 U.S.C. § 107), copyrighted sources cited within this website are distributed without profit and are presented for educational, research, and in some cases critical analysis purposes. For these reasons authorization from the copyrighted holders has not been obtained. If you wish to use the copyrighted material for purposes that go beyond the Fair Use Law 17 U.S.C. § 107, you must obtain permission from the copyright owner.

CDC Secretly Conducted Safety Testing of Jet Injectors in 1977

June 5, 2017

The Special Investigations Section within CDC’s Hepatitis Laboratories Division took a keen interest into jet injectors in the Fall of 1977.  Researchers—Petersen, Bond and Carson—noted widespread use of jet guns in mass immunization campaigns along with reports of bleeding at the injection site.  Although not mentioned within their report, the investigation was in the wake of the Swine Flu vaccination campaign of 1976 in which 75 million Americans were immunized.

The presence of blood during the jet gun vaccinations prompted the lab to inquire about the possible transmission of Hepatitis B virus.  It is important to note that the researchers only mention Hepatitis B because blood-borne pathogens like HIV and Hepatitis C would not be identified until 1983 and 1989, respectively.

“An extensive literature search has produced only three articles dealing with jet injection and its possible association with viral hepatitis B transmission,” wrote the researchers.  Although all three articles were editorials and not peer-reviewed studies.  Since a review of the literature failed to provide an adequate answer, the team conducted it’s own set of experiments upon the most widely known jet injector in the world—the Ped-O-Jet.

“We have conducted a series of in vitro and in vivo experiments in the laboratory to assess the degree of HBsAg [Hepatitis B surface antigen] contamination of jet injector guns during use (detection of HBsAg is presumptive evidence of HBV contamination),” stated the report.

1977 CDC - Unpublished Jet Injector Study
Snapshot of the 1977 Jet Injector Report

Firing Into Vials – In Vitro Experiments
Initial investigations unveiled a shocking phenomenon after firing the Ped-O-Jet.  “It was observed that when the device was held horizontally, a drop of fluid would remain on the injection nozzle port after firing,” stated the report.  When the gun was held vertically “the drop would disappear (back into the injection nozzle head) in 3 to 5 seconds.”  It was also noted that if the trigger was cocked while the jet gun was held in a horizontal position the drop of fluid would immediately disappear back into the nozzle head 3 to 5 seconds after firing.  The researchers concluded, “These manipulations causing disappearance of the fluid drop are common during clinical use of the jet injector.”

The researchers were observing the undesirable phenomenon known as fluid suck-back.  This means if blood were upon the nozzle it would be sucked-back into the orifice of the jet gun contaminating the drug reservoir and the next dosage to be fired.

Inventor of the Ped-O-Jet, Aaron Ismach, stated within his 1962 patent that his invention is “free from danger of sucking fluid back from a patient either during or after the firing cycle is completed so that the danger of cross-infection is almost completely avoided” (Ismach, 1962).  In light of the Phoenix Labs investigation, Ismach’s assertion appears to be no more than a puffing statement to promote the sale of his invention.

Next the lab investigated if the jet gun could cross-contaminate the Hepatitis B surface antigen (HBsAg).  In this in vitro experiment—an experiment conducted outside of a living organism such as in a test tube, vial, or culture dish—the jet gun nozzle was artificially contaminated with HBsAg to see if the antigen would be sucked back into the nozzle head and contaminate the next dosage to be fired.  If the ejected fluid of the next shot contained HBsAg the feasibility of cross-contamination of viral hepatitis by jet injection would be confirmed.

Results found, after the nozzle was contaminated, the ejected fluid of the next shot fired was positive for HBsAg in 4 out of 5 (80%) of the samples.  The second shot fired after the nozzle was contaminated was positive in 3 out of 5 (60%) of the samples.  The third, fourth and fifth shots fired were all negative.  These results indicated that once the Ped-O-Jet became contaminated it remained contaminated for the next two consecutive shots.  Putting this into perspective, for every bleeder in the vaccination line the two subsequent persons were potentially exposed to blood.

The researchers also observed “bleeding from injection sites does sometimes occur but only after the injection nozzle has been removed from the skin surface.”  They, like researchers before them (Elisberg, McCown & Smadel, 1956; Darlow, 1970), incorrectly assumed that since bleeding occurred after the nozzle was removed there was no risk in transferring viral hepatitis.  To alleviate this problem, the researchers recommended, “Proper pressure of the nozzle surface against the skin during and after injection should effectively prevent heavily contaminated nozzle surfaces as simulated in our in vitro experiments.”

Today we know that proper pressure of the nozzle surface against the skin would not eliminate the inherent risks of the jet guns.  Even when the devices worked properly they were inherently dangerous.  Subsequent research on jet injection has also shown the occurrence of pathogen transfer without any visible bleeding at the injection site (Brink et al, 1985; Kelly et al., 2008).  Even when the Ped-O-Jet was used correctly, and incorrectly, in an unpublished Brazilian study, the device transferred enough blood to contain blood-borne pathogens despite delayed bleeding or the absence of visible bleeding at the injection site (Hoffman et al., unpublished).

In 1977, Petersen, Bond and Carson correctly concluded, “a massively contaminated jet injector nozzle could potentially transmit hepatitis B” (emphasis added).

Next the Special Investigations Section assessed if the devices would cause cross-contamination when used upon animals.

Next Article – Jake The Chimpanzee – In Vivo Experiment

References:

  • (Brink et al., 1985) Brink PRG, van Loon AM, Trommelen JCM, Gribnau FWJ, Smale-Novakova IRO. Virus transmission by subcutaneous jet injection. J Med Microbiol. December 1985; 20(3): 393-397.
  • (Darlow, 1970) Darlow HM. Jet vaccination. British Medical Journal 4(734):554, 1970.
  • (Elisberg, McCown, & Smadel, 1956) Elisberg BL, McCown JM, Smadel JE. Vaccination against smallpox. Jet injection of chorio-allantoic membrane vaccine. J Immunol 1956;77(5):340-351.
  • (Hoffman et al., unpublished) Hoffman PN, Abuknesha RA, Andrews NJ, Brito GS, Carrasco P, Weckx LY, Moia LJMP, Silva AEB, Lloyd J. A field trial of jet injector safety in Brazil. (unpublished).
  • (Ismach, 1962) Ismach, Aaron. “Multi-dose jet injection device.” United States Patent 3,057,349. 9 October 1962.
  • (Kelly et al., 2008) Kelly K, Loskutov A, Zehrung D, Puaa K, LaBarre P, Muller N, Guiqiang W, Ding H, Hu D, Blackwelder WC. Preventing contamination between injections with multi-use nozzle needle-free injectors: a safety trial. Vaccine (2008) 26, 1344-1352.

Copyright Notice
© Shaun Brown and Jet Infectors, 2017. Unauthorized use and/or duplication of this material without express and written permission from this site’s author and/or owner is strictly prohibited. Excerpts and links may be used, provided that full and clear credit is given to Shaun Brown and Jet Infectors with appropriate and specific direction to the original content.

Fair Use Notice
In accordance with the Fair Use Law (17 U.S.C. § 107), copyrighted sources cited within this website are distributed without profit and are presented for educational, research, and in some cases critical analysis purposes. For these reasons authorization from the copyrighted holders has not been obtained. If you wish to use the copyrighted material for purposes that go beyond the Fair Use Law 17 U.S.C. § 107, you must obtain permission from the copyright owner.

CDC’s Unpublished Jet Injector Studies – Part 1

June 1, 2017

Jet Infectors

Not so long ago, hundreds of millions of people from across the United States and around the globe were given immunizations with a needleless vaccination gun known as a jet injector.  The device offered speedy and efficient immunizations to children, civilians and military personnel.  Although in 1985 after a jet gun was implicated in spreading the Hepatitis B virus at a Los Angeles clinic, the devices fell under scrutiny.  Jet guns were found to act as vehicles in the spread of contagions and viruses due to their reusable parts and lack of sterilization.  However, this 1985 incident did not prompt the first investigation into jet injectors.  Unbeknownst to the public, the Center for Disease Control (CDC) had secretly conducted safety testing upon the devices almost ten-years prior.

No longer does 4402 North 7th Street in Phoenix, Arizona hold the mystery of research conducted by the CDC.  The property, now a part of the Phoenix VA Hospital, was in a bygone era the CDC’s Phoenix Field Station and the location where in the Fall of 1977 the Hepatitis Laboratories Division assessed the possibility of serum hepatitis being transmitted by jet injectors.

Phoenix Field Station - Copyrighted Google 2017

A present day image of what was once the Phoenix Field Station. © 2017 Google

The Special Investigations Section, the team overseeing the project, was made-up of Chief, Norman Petersen, and two research microbiologists, Walter Bond and Loretta Carson.  They reported their findings to Martin Favero, the Deputy Director of the Hepatitis Laboratories Division, in an Informal Quarterly Report dated Oct-Dec 1977.

Although never classified, the report was never published nor made known to the public.

For the past forty-years the document has been almost non-existent.  This author’s attempt to obtain the document through the Freedom of Information Act was delayed for a year before being denied on the grounds that the CDC did not possess any such documents.  The only known copy surfaced after retired CDC researcher, Walter Bond, unboxed the paperwork from his basement and shared it with a colleague-friend.

Many have wondered the contents held within the CDC’s unpublished jet injector studies.  Now there will no longer be any mystery or secrecy.

Next article – CDC Secretly Conducted Safety Testing of Jet Injectors in 1977

Copyright Notice
© Shaun Brown and Jet Infectors, 2017. Unauthorized use and/or duplication of this material without express and written permission from this site’s author and/or owner is strictly prohibited. Excerpts and links may be used, provided that full and clear credit is given to Shaun Brown and Jet Infectors with appropriate and specific direction to the original content.

Fair Use Notice
In accordance with the Fair Use Law (17 U.S.C. § 107), copyrighted sources cited within this website are distributed without profit and are presented for educational, research, and in some cases critical analysis purposes. For these reasons authorization from the copyrighted holders has not been obtained. If you wish to use the copyrighted material for purposes that go beyond the Fair Use Law 17 U.S.C. § 107, you must obtain permission from the copyright owner.

Nigeria Forced to Use Ped-O-Jet Injectors in 1996 Despite Fears of Spreading Hepatitis and AIDS

May 1, 2017

In 1996, during one of the most severe meningococcal meningitis outbreaks in the history of Nigeria, health officials were forced to use Ped-O-Jet injectors due to a shortage of syringes and needles.

The official report of the mass vaccination campaign by Mohammed and colleagues (2000) stated,

“There was a dearth of supplies, particularly of syringes and needles, which made it necessary to use ‘Ped-O-Jet’ injectors (Vernitron, Carlstatdt, NY, USA) for vaccinating most of the people. These are manually operated jet injectors which deliver 0.5 mL of the vaccine into the deltoid muscle of the arm. The nozzle is placed about 1 cm from the skin surface (no contact is allowed), but inaccurate application often results in physical contact and bleeding, raising concerns about transmission of infectious agents such as hepatitis viruses and HIV.”

The jet injectors vaccinated “most” of the 13.4 million Nigerians immunized in the campaign.

Furthermore, the report openly admitted the risk of spreading infectious diseases via the Ped-O-Jet injector to prevent the further spread of meningitis.

“An important problem of mass vaccination in Africa is the inadequate supply of syringes and needles, necessitating the use of ‘Ped-O-Jet’ injectors for vaccination, as happened during this epidemic. We may never know how many infectious agents (including hepatitis B and C viruses and HIV) were transmitted as a result of using these injectors, but clearly their use must be stopped as soon as practicable.”

The fear generated during this mass vaccination campaign caused the World Health Organization to change its official stance advising “against the use of jet injectors under any circumstances” (Fields, 1996). The risk of spreading Hepatitis B, Hepatitis C and HIV with the Ped-O-Jet was realized beyond just being biologically plausible. The risk is, in fact, real.

Moreover, the report by Mohammed and colleagues demonstrates a demographic other than veterans of the United States military arguing the risks and hazards of Ped-O-Jets.

2000 Mohammed- A severe epidemic of meningococcal meningitis in Nigeria, 1996

Due to proprietary reasons this study can be accessed here.

References:

  • (Fields, 1996) Fields R. Participation in Meeting: Jet injectors for immunization; current practice and safety; improving designs for the future. WHO/CDC Meeting. Atlanta, GA. 2-3 October, 1996.
  • (Mohammed et al., 2000) Mohammed I, Abdussalam N, Alkali AS, Garbati MA, Ajayi-Obe EK, Audu KA, Usman A, Abdullahi S. A Severe Epidemic of Meningococcal Meningitis in Nigeria, 1996. Royal Society of Tropical Medicine and Hygiene, 2000 (94): 265-270.

Copyright Notice
© Shaun Brown and Jet Infectors, 2017. Veterans are encouraged to use these documents as evidence within their VA claims. Any other use and/or duplication of this material without express and written permission from this site’s author and/or owner is strictly prohibited. Excerpts and links may be used, provided that full and clear credit is given to Shaun Brown and Jet Infectors with appropriate and specific direction to the original content.

Fair Use Notice
In accordance with the Fair Use Law (17 U.S.C. § 107), copyrighted sources cited within this website are distributed without profit and are presented for educational, research, and in some cases critical analysis purposes. For these reasons authorization from the copyrighted holders has not been obtained. If you wish to use the copyrighted material for purposes that go beyond the Fair Use Law 17 U.S.C. § 107, you must obtain permission from the copyright owner.

Nigerians Recall Mass Jet Injector Vaccinations As Children

April 20, 2017

Nigeria 1969

During the 1960s and 1970s, mass vaccination campaigns sought to eradicate diseases such as polio, measles, and smallpox from the face of the earth. Vaccination teams from the US Public Health Service, the World Health Organization, and the non-profit Christian organization, Brother’s Brother Foundation, trekked the globe to educate foreign governments and medical personnel, isolate infectious pathogens, and to immunize all.

These medical expeditions have been well documented within government reports and photographs. Autobiographies by several health officials have also recorded the journeys. Yet never have these events been told by those who received the vaccinations. For the first time ever, those who received mass jet injector vaccinations in Nigeria as children tell what they remember.
What do you remember most of about the mass jet injector vaccinations?

“I remember getting my inoculation in 1968/69 in elementary school in Ibadan!! Gosh, I still remember it so vividly because it was so painful, and it left that unique mark,” reminisced a gentleman.

“Yes, I’m looking at the scar on my left arm,” said another gentleman.

“We called it ‘numba’ in primary school,” said a lady.

Another lady said, “Numba…like a bite mark on your arm!”

“The injections were quite painful then,” another gentleman recalled. “I still remember the horror on our faces when the health workers arrived at our school in 1975 and our headmaster delivered us unto their hands. I have never seen so many crying children in such close proximity—we were all united in terror.”

Another gentleman said, “Still on my left arm. Everyone collected ‘numba.’”

“Frightful,” declared yet another man. “The health workers hold that thing like it’s a pistol. The searing pain and the sure abscess that follows, who can forget!… some of the pupils running away and refusing to be vaccinated, chiefly as a result of the pains. We were vaccinated—this was in the late 1970s—against such diseases like polio, measles, and yellow fever.”

Nigerian child is receiving a smallpox vaccination

Was the whole village and community vaccinated all at once? I asked.

“The vaccination was done at the village level and it usually took 1 to 2 days to complete before they moved onto the next village within the community. The event took place at the village primary school, hence the pupils were first vaccinated before adults,” said the first gentleman.

Were there any fears with use of the jet injector?

“To the best of my knowledge, there was none, aside from the pains associated with the vaccination and the attendant abscess the most often (would say up to 80% developed into abscess).”

Another gentleman wittily reflected, “ A man was receiving what he will never understand.”

Many photographs captured looks of concern and apprehension and rightfully so. What were they to think as unknown foreigners arrived in their village with an unheard of device that resembled a pistol to prevent them from an unheard of disease? Success of the vaccination campaign was only the result of local officials who ensured the injections were safe.

Nigerian children were photographed as they received vaccination

Are these devices still used in your childhood village today? If not, when was the last time you remember jet injectors being used?

“The last time I remembered it being used was around 1981 and I can’t remember it still being used afterwards. Reason would be that the community’s clinic was ‘upgraded’ to a cottage hospital and most of the immunizations for kids took place there.”

Although vaccinated as young children, the experiences were so unique and fearful that they were forever imprinted within their memories. In fact, almost all who have been inoculated with these devices have not forgotten the experience.

* Names were withheld for privacy.

© Shaun Brown and Jet Infectors, 2017.

Babies and Breadwinners: 1961 Mass Polio Vaccination Campaign

April 4, 2017

Paralytic poliomyelitis, most commonly referred to as polio, once immobilized a nation in fear as the disease paralyzed children with no known cause. In the early 1950s, there were roughly 20,000 cases of polio diagnosed per year. In 1952, at the height of the epidemic, the disease took more than 3,000 lives (Sokol, 1997). Thankfully within the same year, Jonas Salk created an effective vaccine. In 1955, after almost three years of testing, the Salk polio vaccine was announced to the world. Salk’s vaccine was a medical relief to the nerves of many.

Babies and Breadwinners

Babies and Breadwinners was a government film documenting the mass Polio Vaccination Campaign of 1961. “This title referred, of course, to those two poorly immunized groups, the children five years and under and the young adults,” wrote Dr. Maynard Mires in the Delaware Medical Journal (Mires, 1961).

The film, produced by the Communicable Disease Center (more presently known as the Center for Disease Control and Prevention), was to be informative and encouraging in the implementation of mass vaccination campaigns across the nation.

Set in the city of Columbus, Georgia, the film documented the first of three phases of a vaccination campaign. Thirty-eight locations were set-up across the city over eight days. Vaccinations were free. People walked up, were vaccinated with the Hypospray Multidose Jet Injector, and then continued on their merry way. “A simple injection means polio protection.”

Babies and Breadwinners- 1961

The film also documented the lack of sterilization between jet gun inoculations. In the photo above, taken from the event in downtown Columbus, the vaccinator held the Hypospray Jet Injector in one hand and appropriately held the patient’s arm with his other hand. The jet injector was attached to a motor enclosed in a carrying-case on the table. Also placed upon the table, near the center, is a vaccine vial and a red protective cap to cover the jet injector nozzle when not in use. Upon the far right side of the table is a microphone belonging to the cameraman in the black suit. There appears to be a material object on the bench below the table, although this object remains unclear. As the video demonstrates, a nurse standing to the right side wipes the patient’s arm with cotton dipped in acetone. The jet injector, however, was used consecutively person after person. The nozzle was never wiped in between vaccinations.

1961 Babies and Breadwinners- turning of the lever

Video footage also captured vaccinators reaching toward the nozzle following injections. A snapshot of the video, above, demonstrates this action. A 1966 self-instructional lesson by the CDC, titled “Jet Injector Operation, Model K3,” pictured below, informs vaccinators how to use the Hypospray Multidose Jet Injector and explains this behavior. Before administering an injection the vaccinator must turn the cocking lever from the “Fill” position to the “Injection” position. Then immediately following the injection, the cocking lever must be turned-back to the “Fill” position to allow the vaccine vial to fill the drug reservoir with the next dosage.

1966 CDC- Hypospray Multidose Jet Injector Instructions

The video footage also captured a disregard for protocol. The CDC’s operating instructions stated, “Squeeze trigger for full THREE SECONDS (count: ‘One thousand one, one thousand two, one thousand three’).” Yet the film repeatedly documented vaccinators holding the jet injector for only one second, as shown in the clip below. Also note the nozzle was never wiped or cleansed in between injections.

In two instances the video captured the wiping of the injection site immediately following the jet injection. The incidents were unique as the video demonstrates the majority of the vaccinees did not have their arm wiped. In the following clip, a nurse cleansed a girl’s arm with cotton dipped in acetone whereupon a vaccinator administered an injection. Afterwards the nurse immediately wiped the girl’s arm, in a downward motion, with the same cotton. (You may need to watch twice to capture the motion). The girl then clutched her arm as her mother carried her away. The nurse discarded the dirty cotton which accidentally landed on the table. Then the next child stepped forward to receive a vaccination. The jet injector nozzle was never wiped or cleansed.

In another clip, a boy, appearing in the foreground, had just received a vaccination. Holding a piece of cotton within his left hand he wiped the injection site on the deltoid area of his right arm.

So why was the post-injection wiping important?

If the jet gun was held firmly against the vaccinee’s skin, and immediately following the injection there was a need to wipe the injection site of the vaccinee, then whatever was on the vaccinee’s arm was also on the nozzle of the jet injector. Despite the fact that we do not know what was being wiped, whether the substance was blood, splash-back of vaccine after after penetrating the outer layer of skin or a combination thereof, this footage demonstrates at that time the jet injector was contaminated and no longer sterile.

In our series, Faulty Design Created Inherent Risk, Mitragotri (2006) demonstrates through microcinematography the nozzle becomes contaminated through a phenomenon known as splash-back.

The complete video can be accessed here.
References:

  • (Mitragotri, 2006) Mitragotri S. Current status and future prospects of needle-free liquid jet injectors. Nature Reviews Drug Discovery 5:543–548, 2006.
  • (Mires, 1961) MH Mires. Babies and Breadwinners. Delaware Medical Journal. September 1961. pp. 270-272.
  • (Sokol, 1997) Sokol B. Fear of Polio in the 1950s. [Online Article] Available at: http://www.plosin.com/beatbegins/projects/sokol.html.

Copyright Notice
© Shaun Brown and Jet Infectors, 2017. Veterans are encouraged to use these documents as evidence within their VA claims. Any other use and/or duplication of this material without express and written permission from this site’s author and/or owner is strictly prohibited. Excerpts and links may be used, provided that full and clear credit is given to Shaun Brown and Jet Infectors with appropriate and specific direction to the original content.

Fair Use Notice
In accordance with the Fair Use Law (17 U.S.C. § 107), copyrighted sources cited within this website are distributed without profit and are presented for educational, research, and in some cases critical analysis purposes. For these reasons authorization from the copyrighted holders has not been obtained. If you wish to use the copyrighted material for purposes that go beyond the Fair Use Law 17 U.S.C. § 107, you must obtain permission from the copyright owner.

1971 NIH Conference Recognizes Bloody Jet Injectors Pose Risk For Hepatitis

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.

Jet Infectors strives to publish accurate, intriguing, and worthy content. Countless hours are poured into research, networking, writing and editing. As always Jet Infectors encourages the sharing of its posted content as long as credit is given to Jet Infectors. Plagiarism will not be tolerated.

Tuesday, October 26, 1971
Bethesda, Maryland

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.

status-of-immunization-in-tuberculosis-in-1971
References:

  • (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.

Copyright Notice
© Shaun Brown and Jet Infectors, 2017. Veterans are encouraged to use these documents as evidence within their VA claims. Any other use and/or duplication of this material without express and written permission from this site’s author and/or owner is strictly prohibited. Excerpts and links may be used, provided that full and clear credit is given to Shaun Brown and Jet Infectors with appropriate and specific direction to the original content.

Fair Use Notice
In accordance with the Fair Use Law (17 U.S.C. § 107), copyrighted sources cited within this website are distributed without profit and are presented for educational, research, and in some cases critical analysis purposes. For these reasons authorization from the copyrighted holders has not been obtained. If you wish to use the copyrighted material for purposes that go beyond the Fair Use Law 17 U.S.C. § 107, you must obtain permission from the copyright owner.

Seeing is believing: A Close-up of the Bifurcated Needle

January 2, 2017

Jet injectors were once used to administer smallpox vaccinations. Although with the invention of the bifurcated needle, administration of smallpox vaccine became simpler, faster, and more practical than with jet injectors.

Fenner and colleagues (1988) wrote,

A few disadvantages of jet injectors emerged during the campaigns in which they were used. In contrast to the simplicity of bifurcated needles, the jet injector required meticulous care and maintenance and considerable repair skills, which could not always be provided despite all the efforts to prepare a detailed, profusely illustrated manual.

As shown in the diagram below, bifurcated needles consisted of a forked-end. In between the forks, or prongs, held a droplet of smallpox vaccine. The vaccinator would perform the multi-puncture technique by pricking the skin with the ends of the prong. The technique consisted of pricking the skin 15 times within a small circular area.

bifurcated-needle

(WHO, 1968)

During the smallpox eradication campaign of the 1960s and 1970s bifurcated needles were reused. Sterilization of the needles were performed by placing 100 needles into a specialized plastic container which would then be submerged into boiling water. Holes in the bottom of the container would let-out the water (Fenner et al., 1988).

Both the jet injector and bifurcated needle have been implicated in spreading the hepatitis C virus amongst those who received smallpox vaccinations in Pakistan. “These results suggest that the widespread prevalence of hepatitis C infection in Pakistan may be an unintended consequence of the country’s smallpox vaccination program” (Aslam, 2005).

Weniger, Jones and Chen (2008) concluded, “Some iatrogenic infections with HBV likely occurred in countries where unsafe MUNJIs [Multiple-use Nozzle Jet Injectors] and unsterile BNs [Bifurcated Needles] were used.”
Statistical analyses and professional opinions by leading experts carry a lot of evidentiary weight. Although photographic evidence creates a new perspective to understanding.

Seeing is believing! These close-up images of the bifurcated needle magnify the reality that this instrument could have easily became infected with blood-borne pathogens.

Here is the Bifurcated Needle.
The tip of a bifurcated needle used to vaccinate individuals wit

Here is the Bifurcated Needle with smallpox vaccine between the prongs.
Close up of the tip of a bifurcated needle used to vaccinate ind

Here the image is magnified 41 times.

Roughened surface at the tip of a bifurcated smallpox vaccinatio
When magnified 187 times, striations in the metal emerge. Crevices appear within the prong area.
Oughened surface at the tip of one of the prongs of a bifurcated

When magnified 747 times, the bifurcated needle appears to be a completely foreign object. The metal appears porous. Ridges and valleys emerge within the prong area.
Roughened surface at the tip of one of the prongs of a bifurcate
Now is it so hard to imagine blood or viruses getting within these porous regions or getting attached upon the sharp microscopic ridges of the metal?

Today, bifurcated needles are still used in administering smallpox vaccine. Although now they are intended to be single-use, disposable needles. One needle, one patient.

Hmm…if only the jet injector nozzle was also photographed with a magnifying camera.

ped-o-jet-close-up

Acknowledgements:
Photos are courtesy of http://www.pixnio.com and are published under public domain.

References:

  • (Aslam et al., 2005) Aslam M, Aslam J, Mitchell BD, Munir KM. “Association Between Smallpox Vaccination and Hepatitis C Antibody Positive Serology in Pakistan Volunteers.” Journal of Clinical Gastroenterology. 2005 Mar;39(3):243-6.
  • (Fenner et al., 1988) Fenner F, Henderson DA, Arita I, Je〉ek Z, Ladnyi ID. Smallpox and its Eradication, Geneva: World Health Organization, 1988 (ISBN 92 4 156110 6).Available at: http://www.who.int/smallpox/9241561106.pdf.
  • (Weniger, Jones, & Chen, 2008) Weniger BC, Jones TS, & Chen RT. The Unintended Consequences of Vaccine Delivery Devices Used to Eradicate Smallpox: Lessons for Evaluating Future Vaccination Methods. 2008.
  • (WHO, 1968) World Health Organization. Instructions for smallpox vaccination with bifurcated needle. World Health Organization, Geneva. 1968. Available at: http://apps.who.int/iris/bitstream/10665/67962/1/SE_68.2.pdf.

Copyright Notice
© Shaun Brown and Jet Infectors, 2017. Veterans are encouraged to use these documents as evidence within their VA claims. Any other use and/or duplication of this material without express and written permission from this site’s author and/or owner is strictly prohibited. Excerpts and links may be used, provided that full and clear credit is given to Shaun Brown and Jet Infectors with appropriate and specific direction to the original content.

Fair Use Notice
In accordance with the Fair Use Law (17 U.S.C. § 107), copyrighted sources cited within this website are distributed without profit and are presented for educational, research, and in some cases critical analysis purposes. For these reasons authorization from the copyrighted holders has not been obtained. If you wish to use the copyrighted material for purposes that go beyond the Fair Use Law 17 U.S.C. § 107, you must obtain permission from the copyright owner.