antibodies to PRP in plasma were high 15 days after immunization. The child responded to intravenous immunoglobulin therapy.

The other three reports of GBS following the administration of Hib conjugate vaccines were detected by VAERS (submitted between November 1990 and July 1992). Two of the three children developed an infection between the time of immunization and the onset of the neurologic symptoms. These two children developed GBS (within the time frame described by the committee as plausible) following immunization with HbOC vaccine. One of these children also had received MMR, and the other child had received DPT and OPV at the time of the HbOC immunization. The former developed GBS 12 days following immunization and 6 days following the onset of otitis media and bronchospasm. The latter developed GBS 6 days after immunization and was noted to be on amoxicillin, but the indication for antibiotic therapy was not specified.

The third VAERS report described a child who was immunized as part of a PRP-OMP vaccine safety trial and was not noted to have received any other vaccine. This child developed an unsteady gait and decreased deep tendon reflexes 44 days after immunization and had otitis media, an upper respiratory tract infection, and a rash about 1 month following receipt of Hib vaccine and 2 weeks prior to the onset of neurologic symptoms. The child's discharge diagnosis was GBS. Although the latency is close to the window specified by the committee as reasonable (see Chapter 2), the other antecedent events (infection and rash) also suggest that if this child had GBS, it was far more likely related to these antecedent events.

In one of the PRP-D vaccine recipients (D'Cruz et al., 1989) and one of the HbOC vaccine recipients reported by VAERS, OPV was given concurrently. An increased incidence of GBS was reported to have coincided with a national OPV immunization campaign in Finland, as discussed in Chapter 8 (Farkkila et al., 1991; Kinnunen et al., 1989; Uhari et al., 1989).

The time of onset of symptoms following Hib vaccine administration ranged from 1 day (D'Cruz et al., 1989) to 44 days (a report from VAERS) in seven patients, with the onset of symptoms in five of the patients beginning 6 to 12 days after vaccination. The cases beginning 1 and 44 days after vaccination are not considered likely to be related to vaccination (see Chapter 3). The ages of the patients whose GBS began 6 to 12 days after vaccination were 15, 19, 20, and 33 months and 4 years. The symptoms of GBS resolved in three of these patients, and the outcomes for the others were not reported.

There have been no cases of GBS reported in any case series or uncontrolled observational studies of Hib vaccines (Ahonkhai et al., 1990, 1991; Black et al., 1987; Claesson et al., 1991; Fritzell and Plotkin, 1992; Milstien et al., 1987; Parke et al., 1991; Popejoy et al., 1989; Rowe et al., 1990; Santosham et al., 1991a; Vadheim et al., 1990).

The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement