Guillain-Barre Syndrome Following Vaccination in the National Influenza Immunization Program, United States, 1976–19771

Abstract

Because of an increase in the number of reports of Guillian-Barre syndrome (GBS) following A/New Jersey influenza vaccination, the National Influenza Immunization Program was suspended December 16, 1976 and nationwide surveillance for GBS was begun. This surveillance uncovered a total of 1098 patients with onset of GBS from October 1, 1976, to January 31, 1977, from all 50 states, District of Columbia, and Puerto Rico. A total of 532 patients had recently received an A/New Jersey influenza vaccination prior to their onset of GBS (vaccinated cases), and 15 patients received a vaccination after their onset of GBS. Five hundred forty-three patients had not been recently vaccinated with A/New Jersey influenza vaccine and the vaccination status for 8 was unknown. Epidemiologic evidence indicated that many cases of GBS were related to vaccination. When compared to the unvaccinated population, the vaccinated population had a significantly elevated attack rate in every adult age group. The estimated attributable risk of vaccine-related GBS in the adult population was just under one case per 100,000 vaccinations. The period of increased risk was concentrated primarily within the 5-week period after vaccination, although it lasted for approximately 9 or 10 weeks.

Causality assessment of serious neurologic adverse events following 2009 H1N1 vaccination

“…A total of 105,211,620 doses of inactivated H1N1 vaccine and 21,755,200 doses of live attenuated H1N1 vaccine were distributed in the U.S. as of April 28, 2010 [5]. Because of the GBS association seen previously with swine-origin influenza vaccine [9], we conducted a critical examination of serious non-fatal neurological AEFI reported to VAERS following immunization with 2009 H1N1 vaccine. Of several vaccine safety monitoring systems in place, VAERS is the spontaneous reporting system used by manufacturers, providers and the general public in the U.S. to report any event following vaccination whether or not the reporter believes the vaccine caused the event.…”

“…Further, the event should occur within a defined window of risk following vaccine administration and for many AEFIs this defined risk window is not established. The CCCR working group assigned a risk interval for onset of GBS symptoms, and all demyelinating disorders, of 8 weeks following receipt of vaccine based on the available evidence [9,18]. Also, the pathophysiologic mechanism by which the vaccine causes disease must make biological sense.…”

“…Because of the reported increase in Guillain-Barré Syndrome (GBS) case reports following immunization with the 1976 swine flu vaccine [9], assessing any possible relationship between the 2009 H1N1 vaccine and GBS was a key focus. In consultation with neurological experts, CISA investigators assigned every GBS case report a level of diagnostic certainty defined by the Brighton Collaboration [10] (Table 1), an international scientifically independent network of researchers dedicated to providing high quality vaccine safety information.…”

Vaccination and autoimmune diseases: is prevention of adverse health effects on the horizon?

“…Approximately 20-30% of the cases of GBS is positive to Campylobacter jejuni serologic markers [39,40]. More rarely Haemophilus influenzae type b (Hib) and respiratory or other microbic infections show an incidence rate of 0.6-4/100,000 person/year worldwide; GBS has been also time related with different vaccines administration, such as rabies, polio, tetanus, Bacillus Calmette-Guerin (BCG), smallpox, mumps, rubella, hepatitis B, and diphtheria [25]. However, the association of GBS and the influenza vaccine is more striking.…”

“…Nachamkin and coworkers using Bswine flu-influenza A (H1N1)^vaccine on 20 mice supposed the responsibility of contaminants, such as sialic acid-hemagglutinin (HA) complexes, or C. jejuni antigens mimicking GM1 ganglioside, leading to the high-titer-specific antibodies after inoculation. In 1976, indeed, the H1N1 vaccination campaign suddenly dropped in the USA due to an increase, within 6 weeks, of 500 cases of GBS (including 25 deaths) over 45 million vaccinated [41]. Laski et al [27] recorded a 2% of increase of GBS cases per million vaccinated persons and also in the influenza vaccination program (1992)(1993).…”