Category C
Animal reproduction studies have not been conducted with Typhoid Vaccine Live Oral Ty21a. It is not known whether Typhoid Vaccine Live Oral Ty21a can cause fetal harm when administered to pregnant women or can affect reproduction capacity. Typhoid Vaccine Live Oral Ty21a should be given to a pregnant woman only if clearly needed.
There is no data to warrant the use of this product in nursing mothers. It is not known if Typhoid Vaccine Live Oral Ty21a is excreted in human milk.
Long-term studies in animals with Typhoid Vaccine Live Oral Ty21a have not been performed to evaluate carcinogenic potential, mutagenic potential or impairment of fertility.
More than 1.4 million doses of Ty21a have been administered in controlled clinical trials and more than 150 million doses of Typhoid Vaccine Live Oral Ty21a have been marketed world-wide. Active surveillance for adverse reactions of enteric-coated capsules was performed in a pilot study and in a subgroup of a large field trial involving a total of 483 individuals receiving 3 vaccine doses. The overall symptom rates from both studies when vaccinated with capsules were combined and shown to be: abdominal pain (6.4%), nausea (5.8%), headache (4.8%), fever (3.3%), diarrhea (2.9%), vomiting (1.5%) and skin rash (1.0%). Only the incidence of nausea occurred at a statistically higher frequency in the vaccinated group as compared to the placebo group. Administration of vaccine doses more than 5-fold higher than the currently recommended dose caused only mild reactions in an open study involving 155 healthy adult males.
Post-marketing surveillance has revealed that adverse reactions are infrequent and mild. Adverse reactions reported to the manufacturer during 1991–1995, during which time over 60 million doses (capsules) were administered, included: diarrhea (N=45), abdominal pain (N=42), nausea (N=35), fever (N=34), headache (N=26), skin rash (N=26), vomiting (N=18), or urticaria in the trunk and/or extremities (N=13). One isolated, non-fatal anaphylactic shock considered to be an allergic reaction to the vaccine was reported.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
