Postmarketing Safety Surveillance for Typhoid Fever Vaccines from the Vaccine Adverse Event Reporting System, July 1990 through June 2002

Vaccine Safety Branch, Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20852-1448, USA.
Clinical Infectious Diseases (Impact Factor: 8.89). 04/2004; 38(6):771-9. DOI: 10.1086/381548
Source: PubMed


Vaccines against Salmonella enterica serotype Typhi are used for prophylaxis of international travelers and have potential use as counterbioterrorism agents.
The Vaccine Adverse Event Reporting System (VAERS) cannot usually establish causal relationships between vaccines and reported
adverse events without further research but has successfully detected unrecognized side effects of vaccine. We reviewed reports
to VAERS for US-licensed typhoid fever vaccines for the period of July 1990 through June 2002. We received 321 reports for
parenteral Vi capsular polysaccharide vaccine and 345 reports for live, oral, attenuated Ty21a vaccine, with 7.5% and 5.5%,
respectively, describing death, hospitalization, permanent disability, or life-threatening illness. Unexpected frequently
reported symptoms included dizziness and pruritus for Vi vaccine and fatigue and myalgia for Ty21a vaccine. Gastroenteritis-like
illness after receipt of Ty21a vaccine and abdominal pain after receipt of Vi vaccine, which are previously recognized events,
occasionally required hospitalization. Nonfatal anaphylaxis was reported after both vaccines. VAERS reports do not indicate
any unexpected serious side effects that compromise these vaccines' use for travelers' prophylaxis.

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    • "Efficacy seems to be higher using the new vaccine (<75 % seroconversion) compared with the two others (~50 %) [101, 102]. The oral vaccine rarely has side effects that mainly consist of abdominal discomfort, nausea and vomiting, whereas with the parenteral vaccines the local reactions at the site of injection dominate [103]. Theoretically, the live vaccine’s effect can be diminished by the use of antibiotics. "
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    ABSTRACT: Public health vaccination guidelines cannot be easily transferred to elite athletes. An enhanced benefit from preventing even mild diseases is obvious but stronger interference from otherwise minor side effects has to be considered as well. Thus, special vaccination guidelines for adult elite athletes are required. In most of them, protection should be strived for against tetanus, diphtheria, pertussis, influenza, hepatitis A, hepatitis B, measles, mumps and varicella. When living or traveling to endemic areas, the athletes should be immune against tick-borne encephalitis, yellow fever, Japanese encephalitis, poliomyelitis, typhoid fever, and meningococcal disease. Vaccination against pneumococci and Haemophilus influenzae type b is only relevant in athletes with certain underlying disorders. Rubella and papillomavirus vaccination might be considered after an individual risk-benefit analysis. Other vaccinations such as cholera, rabies, herpes zoster, and Bacille Calmette-Guérin (BCG) cannot be universally recommended for athletes at present. Only for a very few diseases, a determination of antibody titers is reasonable to avoid unnecessary vaccinations or to control efficacy of an individual's vaccination (especially for measles, mumps, rubella, varicella, hepatitis B and, partly, hepatitis A). Vaccinations should be scheduled in a way that possible side effects are least likely to occur in periods of competition. Typically, vaccinations are well tolerated by elite athletes, and resulting antibody titers are not different from the general population. Side effects might be reduced by an optimal selection of vaccines and an appropriate technique of administration. Very few discipline-specific considerations apply to an athlete's vaccination schedule mainly from the competition and training pattern as well as from the typical geographical distribution of competitive sites.
    Full-text · Article · Jul 2014 · Sports Medicine
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    • "The typhoid–paratyphoid triple vaccine is made from the whole killed bacteria of Salmonella typhi, S. paratyphi A and Salmonella schottmuelleri (S. paratyphi B). But low immunoprotection and strong side effects of the triple vaccine have often been reported [1] [2] [3]. S. typhi, S. schottmuelleri and S. hirschfeldii, the causative agents of human typhoid fever, are known to possess a capsule composed of polysaccharide, called the virulent antigen (Vi-Ag). "
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    ABSTRACT: The Vi capsular polysaccharide vaccine is one of two vaccines against typhoid recommended worldwide and is the vaccine generally used in China. However, in recent years a Salmonella paratyphi A strain that is naturally devoid of capsule has caused frequent outbreaks of typhoid fever in Southern China, leading to the need for identification of additional antigens that could be incorporated into new vaccines. SpaO acts as a major invasion factor of Salmonella enterica spp. and H1a is the unique flagellin subunit ofS. paratyphi A. In this study, the two prokaryotic recombinant antigens, rSpaO and rH1a, were expressed and their immunogenicity was demonstrated by the slide agglutination test and Western blot assays. Using PCR and sequencing analysis as well as ELISA, we find that the spaO and h1a genes are widely distributed in 196 S. paratyphi A isolates (97.5 and 100%, respectively), with high expression frequencies for the SpaO (98.0%) and H1a (100%) antigens. The two genes also show high sequence conservation (similarities from 99.31 to 99.88% for both genes). In sera from 172 paratyphoid A patients, anti-SpaO and anti-H1a IgGs were detectable by ELISA, in 94.8 and 98.8% of patients, respectively. Furthermore, 41.7-66.7% of mice immunized with rSpaO or rH1a alone were protected against subsequent infection, and the protection rate rose to 75.0-91.7% in mice co-immunized with the two antigens. As the spaO and h1a genes of S. paratyphi A are sequence conserved, extensively distributed and highly expressed, the rSpaO and rH1a immunogens should be considered in the development of novel vaccines to prevent S. paratyphi A-caused typhoid fever.
    Full-text · Article · Oct 2008 · Vaccine
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    ABSTRACT: To clarify indications for typhoid vaccination, we reviewed laboratory-confirmed cases of typhoid fever reported to the United States Centers for Disease Control and Prevention between 1994 and 1999. To estimate the risk of adverse events associated with typhoid vaccination, we reviewed reports to the Vaccine Adverse Event Reporting System for the same period. Acute Salmonella enterica serotype Typhi infection was reported for 1393 patients. Of these patients, recent travel was reported by 1027 (74%), only 36 (4%) of whom reported having received a vaccination. Six countries accounted for 76% of travel-associated cases (India [30%], Pakistan [13%], Mexico [12%], Bangladesh [8%], The Philippines [8%], and Haiti [5%]). For 626 travelers who traveled to a single country, the length of stay was <or=1 week for 31 (5%), <or=2 weeks for 100 (16%), <or=3 weeks for 169 (27%), <or=4 weeks for 232 (37%), <or=5 weeks for 338 (54%), and <or=6 weeks for 376 (60%). Reports of serious adverse events due to typhoid vaccination were very rare. Vaccination should be considered even for persons planning short-term travel to high-risk areas.
    No preview · Article · Aug 2004 · Clinical Infectious Diseases
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