Causality Conclusion

Conclusion 8.4: The evidence is inadequate to accept or reject a causal relationship between hepatitis B vaccine and ADEM.


Epidemiologic Evidence

No studies were identified in the literature for the committee to evaluate the risk of transverse myelitis after the administration of hepatitis B vaccine.

Weight of Epidemiologic Evidence

The epidemiologic evidence is insufficient or absent to assess an association between hepatitis B vaccine and transverse myelitis.

Mechanistic Evidence

The committee identified seven publications reporting transverse myelitis after the administration of hepatitis B vaccine. Six publications did not provide evidence beyond temporality, some too long or too short based on the possible mechanisms involved (Fonseca et al., 2003; Iniguez et al., 2000; Karaali-Savrun et al., 2001; Mahassin et al., 1993; Renard et al., 1999; Senejoux et al., 1996). Long latencies between vaccine administration and development of symptoms make it impossible to rule out other possible causes. These publications did not contribute to the weight of mechanistic evidence.

Described below is one publication that reported clinical, diagnostic, or experimental evidence that contributed to the weight of mechanistic evidence.

Tartaglino and colleagues (1995) described a 40-year-old man presenting with lower extremity numbness and difficulty walking 2 weeks after receiving the first dose of hepatitis B vaccine. One month after receiving the second dose of hepatitis B vaccine the patient had difficulty walking, and the sensory disturbance ascended to the nipple level. A swollen edematous cord extending from C-3 to T-9 was revealed via T1-weighted and T2-weighted spin-echo pulse sequences.

Weight of Mechanistic Evidence

The publication described above did not present evidence sufficient for the committee to conclude the vaccine may be a contributing cause of

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