Safety experience with heptavalent pneumococcal CRM197-conjugate vaccine (Prevenar®) since vaccine introduction

Vaccine

Volumn 27, Issue 25-26, 2009, Pages 3281-3284

  Center, Kimberly J ^a   Strauss, Ann ^a  

^a PFIZER INC   (United States)

Author keywords

Benefit risk profile; Pneumococcal conjugate vaccine; Postmarketing data; Prevenar and Prevnar; Safety in vaccine development; Vaccine risk management; Vaccine safety; Vaccine safety profile; Vaccine tolerability profile

Indexed keywords

DIPHTHERIA TOXOID CRM197; PNEUMOCOCCUS VACCINE;

ARTICLE; CHILDHOOD; CLINICAL TRIAL; CONJUGATE; DECREASED APPETITE; DIARRHEA; DROWSINESS; DRUG EFFICACY; DRUG MANUFACTURE; DRUG MARKETING; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; ERYTHEMA; FEVER; GROUPS BY AGE; HUMAN; IMMUNIZATION; IRRITABILITY; LICENSING; PREVENTIVE HEALTH SERVICE; PRIORITY JOURNAL; RASH; RESTLESSNESS; RISK BENEFIT ANALYSIS; SEROTYPE; SIDE EFFECT; SKIN INDURATION; SLEEP DISORDER; UNITED STATES; VACCINATION; VOMITING; WORLD HEALTH ORGANIZATION;

HUMANS; PNEUMOCOCCAL VACCINES; PRODUCT SURVEILLANCE, POSTMARKETING; RISK MANAGEMENT; SAFETY; VACCINES, CONJUGATE;

EID: 67349096385     PISSN: 0264410X     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.vaccine.2009.01.060     Document Type: Article

References (17)

1. Centers for Disease Control and Prevention. Direct and indirect effects of routine vaccination of children with 7-valent pneumococcal conjugate vaccine on incidence of invasive pneumococcal disease-United States, 1998-2003. MMWR 54 (2005) 893-897
2. Talbot T.R., Poehling K.A., Hartert T.V., Arbogast P.G., Halasa N.B., Mitchel E., et al. Elimination of racial differences in invasive pneumococcal disease in young children after introduction of the conjugate pneumococcal vaccine. Pediatr Infect Dis J 23 (2004) 726-731
3. Black S., Shinefield H., Baxter R., Austrian R., Bracken L., Hansen J., et al. Postlicensure surveillance for pneumococcal invasive disease after use of heptavalent pneumococcal conjugate vaccine in Northern California Kaiser Permanente. Pediatr Infect Dis J 23 (2004) 485-489
4. Kaplan S.L., Mason Jr. E.O., Wald E.R., Schutze G.E., Bradley J.S., Tan T.Q., et al. Decrease of invasive pneumococcal infections in children among 8 children's hospitals in the United States after the introduction of the 7-valent pneumococcal conjugate vaccine. Pediatrics 113 (2004) 443-449
5. Poehling K.A., Talbot T.R., Griffin M.R., Craig A.S., Whitney C.G., Zell E., et al. Invasive pneumococcal disease among infants before and after introduction of pneumococcal conjugate vaccine. JAMA 295 (2006) 1668-1674
6. Flannery B., Heffernan R.T., Harrison L.H., Ray S.M., Reingold A.L., Hadler J., et al. Changes in invasive pneumococcal disease among HIV-infected adults living in the era of childhood pneumococcal immunization. Ann Intern Med 144 (2006) 1-9
7. Lexau C.A., Lynfield R., Danila R., Pilishvili T., Facklam R., Farley M.M., et al. Changing epidemiology of invasive pneumococcal disease among older adults in the era of pediatric pneumococcal conjugate vaccine. JAMA 294 (2005) 2043-2051
8. Flannery B., Schrag S., Bennett N.M., Lynfield R., Harrison L.H., Reingold A., et al. Impact of childhood vaccination on racial disparities in invasive Streptococcus pneumoniae infections. JAMA 291 (2004) 2197-2203
9. Hammitt L.L., Bruden D.L., Butler J.C., Baggett H.C., Hurlburt D.A., Reasonover A., et al. Indirect effect of conjugate vaccine on adult carriage of Streptococcus pneumoniae: an explanation of trends in invasive pneumococcal disease. J Infect Dis 193 (2006) 1487-1494
10. Grijalva C.G., Nuorti J.P., Arbogast P.G., Martin S.W., Edwards K.M., and Griffin M.R. Decline in pneumonia admissions after routine childhood immunisation with pneumococcal conjugate vaccine in the USA: a time-series analysis. Lancet 369 (2007) 1179-1186
11. Zhou F., Shefer A., Kong Y., and Nuorti J.P. Trends in acute otitis media-related health care utilization by privately insured young children in the United States, 1997-2004. Pediatrics 121 (2008) 253-260
12. Black S., Shinefield H., Fireman B., Lewis E., Ray P., Hansen J.R., et al. Efficacy, safety and immunogenicity of heptavalent pneumococcal conjugate vaccine in children. Pediatr Infect Dis J 19 (2000) 187-195
13. ®, 7-valent pneumococcal conjugate vaccine (PNCV7) [Poster 181]. Presented at Annual Meeting of the Pediatric Academic Societies, San Francisco, CA; April 30, 2006.
14. Wise R.P., Iskander J., Pratt R.D., Campbell S., Ball R., Pless R.P., et al. Postlicensure safety surveillance for 7-valent pneumococcal conjugate vaccine. JAMA 292 14 (2004) 1702-1710
15. deStefano F., Pfeifer D., and Nohynek H. Safety profile of pneumococcal conjugate vaccines: systematic review of pre- and post-licensure data. Bull WHO 86 (2008) 373-380
16. Weber J.C.P. Epidemiology of adverse reactions to nonsteroidal antiinflammatory drugs. Adv Inflamm Res 6 (1984) 1-7
17. WHO. Pneumococcal conjugate vaccine for childhood immunization-WHO position paper. WER 82 12 (2007) 93-104