Postlicensure safety surveillance for 7-valent pneumococcal conjugate vaccine
- PMID: 15479935
- DOI: 10.1001/jama.292.14.1702
Postlicensure safety surveillance for 7-valent pneumococcal conjugate vaccine
Abstract
Context: Clinical trials evaluate a vaccine's safety before approval, but some risks may escape detection or adequate characterization until larger population exposures occur after licensure.
Objective: To summarize reports of events occurring after vaccination with 7-valent pneumococcal conjugate vaccine (PCV), including those that may warrant further investigation to assess possible causation by PCV.
Design: Descriptive epidemiology of reports submitted to the Vaccine Adverse Event Reporting System (VAERS), a national passive surveillance database.
Setting and patients: United States during first 2 years after licensure of PCV (February 2000 through February 2002). Reports studied were for children younger than 18 years and vaccinated with PCV.
Main outcome measures: Numbers and proportional distributions of reports.
Results: A total of 4154 reports of events following PCV were submitted to VAERS, for a rate of 13.2 reports per 100,000 doses distributed. Multiple vaccines were given in 74.3% of reports. The most frequently reported symptoms and signs included fever, injection site reactions, fussiness, rashes, and urticaria. Serious events were described in 14.6% of reports. There were 117 deaths, 23 reports of positive rechallenges, and 34 cases of invasive pneumococcal infections possibly representing vaccine failure. Immune-mediated events occurred in 31.3% of reports. All 14 patients with anaphylactic or anaphylactoid reactions survived. Thrombocytopenia developed in 14 patients and serum sickness in 6 others. Neurologic symptoms occurred in 38% of reports. Seizures described in 393 reports included 94 febrile seizures.
Conclusions: The majority of reports to VAERS in the first 2 years after licensure of PCV described generally minor adverse events previously identified in clinical trials. The proportion of reports portraying serious events was similar to that for other vaccines. Although there are important limitations in passive surveillance data, and caution in their interpretation is necessary, symptoms experienced by a few children more than once after successive PCV doses, including allergic reactions, prolonged or abnormal crying, fussiness, dyspnea, and gastrointestinal distress, warrant continued surveillance, as do reports of rare but potentially serious events, such as seizures, anaphylactic or anaphylactoid reactions, serum sickness, and thrombocytopenia.
Similar articles
-
Post-licensure safety surveillance of 23-valent pneumococcal polysaccharide vaccine in the Vaccine Adverse Event Reporting System (VAERS), 1990-2013.Vaccine. 2016 May 27;34(25):2841-6. doi: 10.1016/j.vaccine.2016.04.021. Epub 2016 Apr 15. Vaccine. 2016. PMID: 27087150 Free PMC article.
-
The costs and effectiveness of large Phase III pre-licensure vaccine clinical trials.Expert Rev Vaccines. 2015;14(12):1543-8. doi: 10.1586/14760584.2015.1091733. Epub 2015 Sep 28. Expert Rev Vaccines. 2015. PMID: 26414015 Review.
-
Postlicensure surveillance for pre-specified adverse events following the 13-valent pneumococcal conjugate vaccine in children.Vaccine. 2013 May 24;31(22):2578-83. doi: 10.1016/j.vaccine.2013.03.040. Epub 2013 Apr 8. Vaccine. 2013. PMID: 23579258
-
The safety of 7-valent pneumococcal conjugate vaccine.Expert Opin Drug Saf. 2005 Jul;4(4):631-6. doi: 10.1517/14740338.4.4.631. Expert Opin Drug Saf. 2005. PMID: 16011442 Review.
-
Surveillance for safety after immunization: Vaccine Adverse Event Reporting System (VAERS)--United States, 1991-2001.MMWR Surveill Summ. 2003 Jan 24;52(1):1-24. MMWR Surveill Summ. 2003. PMID: 12825543
Cited by
-
Serum Sickness-Like Reactions After Pneumococcal Vaccination.Cureus. 2021 Sep 10;13(9):e17877. doi: 10.7759/cureus.17877. eCollection 2021 Sep. Cureus. 2021. PMID: 34660076 Free PMC article.
-
Vaccinations and Autoimmune Diseases.Vaccines (Basel). 2021 Jul 22;9(8):815. doi: 10.3390/vaccines9080815. Vaccines (Basel). 2021. PMID: 34451940 Free PMC article. Review.
-
Pneumococcal Vaccines - How Many Serotypes are Enough?Indian J Pediatr. 2018 Jan;85(1):47-52. doi: 10.1007/s12098-017-2449-3. Epub 2017 Sep 9. Indian J Pediatr. 2018. PMID: 28887787 Review.
-
Injection Site Lichenoid Dermatitis Following Pneumococcal Vaccination: Report and Review of Cutaneous Conditions Occurring at Vaccination Sites.Dermatol Ther (Heidelb). 2016 Jun;6(2):287-98. doi: 10.1007/s13555-016-0105-x. Epub 2016 Mar 17. Dermatol Ther (Heidelb). 2016. PMID: 26988991 Free PMC article.
-
The Clinical Effectiveness of Pneumococcal Conjugate Vaccines: A Systematic Review and Meta-analysis of Randomized Controlled Trials.Dtsch Arztebl Int. 2016 Mar 4;113(9):139-46. doi: 10.3238/arztebl.2016.0139. Dtsch Arztebl Int. 2016. PMID: 26987462 Free PMC article. Review.
MeSH terms
Substances
LinkOut - more resources
Full Text Sources