The evidence favors acceptance of a causal relation between DT, Td, and tetanus toxoid and GBS. The evidence establishes a causal relation between DT, Td, and tetanus toxoid and anaphylaxis (see Chapter 5). Both GBS and anaphylaxis can be fatal. The only well-documented cases of death causally related to immunization with tetanus toxoid, DT, or Td are attributable to anaphylaxis; the evidence regarding death as a consequence of GBS that temporally followed administration of one of these toxoids is limited (one case report). In the committee's judgment DT, Td, or tetanus toxoid may rarely cause fatal GBS or anaphylaxis. There is no evidence or reason to believe that the case fatality rate from vaccine-associated GBS or anaphylaxis would differ from the case fatality rate for these adverse events associated with any other cause.

Reports of death from all other causes are not clearly linked to the preceding immunization. No cases of death were reported by Christensen (1972) in Denmark between 1952 and 1970, a time during which 2.5 million doses of monovalent tetanus toxoid, 2.67 million doses of DT, and 1.1 million doses of Td were given. No cases of death associated with tetanus toxoid, DT, or Td were reported through MSAEFI between 1979 and 1990. During that time, approximately 1.3 million doses of DT and 29 million doses of Td were distributed.

Conclusion

The evidence establishes a causal relation between DT, Td, and tetanus toxoid and death from anaphylaxis. Although this conclusion is based on direct evidence, it is not based on controlled studies and no relative risk can be calculated. However, the risk of death from anaphylaxis following receipt of DT, Td, or tetanus toxoid would appear to be extraordinarily low.

The evidence favors acceptance of a causal relation between DT, Td, and tetanus toxoid and death from GBS. This conclusion is not based on controlled studies and no relative risk can be calculated. However, the risk of death from GBS following receipt of DT, Td, or tetanus toxoid would seem to be extraordinarily low.

The evidence favors rejection of a causal relation between DT and SIDS.

The evidence is inadequate to accept or reject a causal relation between tetanus toxoid, DT, or Td and death from causes other than those listed above.



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