Tags

Type your tag names separated by a space and hit enter

Post licensure surveillance of influenza vaccines in the Vaccine Safety Datalink in the 2013-2014 and 2014-2015 seasons.
Pharmacoepidemiol Drug Saf. 2016 08; 25(8):928-34.PD

Abstract

PURPOSE

The changes in each year in influenza vaccine antigenic components as well as vaccine administration patterns may pose new risks of adverse events following immunization (AEs). To evaluate the safety of influenza vaccines annually administered to people ≥ 6 months, we conducted weekly post licensure surveillance for seven pre-specified adverse events following receipt of influenza vaccines during the 2013-2014 and 2014-2015 seasons in the Vaccine Safety Datalink (VSD).

METHODS

We used both a historically-controlled cohort design with the Poisson-based maximized sequential probability ratio test (maxSPRT) and a self-controlled risk interval (SCRI) design with the binomial-based maxSPRT. For each adverse event outcome, we defined the risk interval on the basis of biologic plausibility and prior literature. For the historical cohort design, numbers of expected adverse events were calculated from the prior seven seasons, adjusted for age and site. For the SCRI design, a comparison window was defined either before vaccination or after vaccination, depending on each specific outcome.

RESULTS

An elevated risk of febrile seizures 0-1 days following trivalent inactivated influenza vaccine (IIV3) was identified in children aged 6-23 months during the 2014-2015 season using the SCRI design. We found the relative risk (RR) of febrile seizures following concomitant administration of IIV3 and PCV13 was 5.3 with a 95% CI 1.87-14.75. Without concomitant PCV 13 administration, the estimated risk decreased and was no longer statistically significant (RR: 1.4; CI: 0.54 - 3.61).

CONCLUSION

No increased risks, other than for febrile seizures, were identified in influenza vaccine safety surveillance during 2013-2014 and 2014-2015 seasons in the VSD. Copyright © 2016 John Wiley & Sons, Ltd.

Authors+Show Affiliations

Immunization Safety Office, Centers for Disease Control and Prevention, Atlanta, GA, USA.Division of Tuberculosis Elimination, Centers for Disease Control and Prevention, Atlanta, GA, USA.Immunization Safety Office, Centers for Disease Control and Prevention, Atlanta, GA, USA.Immunization Safety Office, Centers for Disease Control and Prevention, Atlanta, GA, USA.Group Health Research Institute, Seattle, WA, USA.Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA.Kaiser Permanente Vaccine Study Center, Oakland, CA, USA.Marshfield Clinic Research Foundation, Marshfield, WI, USA.Immunization Safety Office, Centers for Disease Control and Prevention, Atlanta, GA, USA.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

27037540

Citation

Li, Rongxia, et al. "Post Licensure Surveillance of Influenza Vaccines in the Vaccine Safety Datalink in the 2013-2014 and 2014-2015 Seasons." Pharmacoepidemiology and Drug Safety, vol. 25, no. 8, 2016, pp. 928-34.
Li R, Stewart B, McNeil MM, et al. Post licensure surveillance of influenza vaccines in the Vaccine Safety Datalink in the 2013-2014 and 2014-2015 seasons. Pharmacoepidemiol Drug Saf. 2016;25(8):928-34.
Li, R., Stewart, B., McNeil, M. M., Duffy, J., Nelson, J., Kawai, A. T., Baxter, R., Belongia, E. A., & Weintraub, E. (2016). Post licensure surveillance of influenza vaccines in the Vaccine Safety Datalink in the 2013-2014 and 2014-2015 seasons. Pharmacoepidemiology and Drug Safety, 25(8), 928-34. https://doi.org/10.1002/pds.3996
Li R, et al. Post Licensure Surveillance of Influenza Vaccines in the Vaccine Safety Datalink in the 2013-2014 and 2014-2015 Seasons. Pharmacoepidemiol Drug Saf. 2016;25(8):928-34. PubMed PMID: 27037540.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Post licensure surveillance of influenza vaccines in the Vaccine Safety Datalink in the 2013-2014 and 2014-2015 seasons. AU - Li,Rongxia, AU - Stewart,Brock, AU - McNeil,Michael M, AU - Duffy,Jonathan, AU - Nelson,Jennifer, AU - Kawai,Alison Tse, AU - Baxter,Roger, AU - Belongia,Edward A, AU - Weintraub,Eric, Y1 - 2016/04/01/ PY - 2015/09/09/received PY - 2016/01/29/revised PY - 2016/02/14/accepted PY - 2016/4/3/entrez PY - 2016/4/3/pubmed PY - 2017/9/29/medline KW - PCV13 KW - febrile seizures KW - pharmacoepidemiology KW - vaccine safety SP - 928 EP - 34 JF - Pharmacoepidemiology and drug safety JO - Pharmacoepidemiol Drug Saf VL - 25 IS - 8 N2 - PURPOSE: The changes in each year in influenza vaccine antigenic components as well as vaccine administration patterns may pose new risks of adverse events following immunization (AEs). To evaluate the safety of influenza vaccines annually administered to people ≥ 6 months, we conducted weekly post licensure surveillance for seven pre-specified adverse events following receipt of influenza vaccines during the 2013-2014 and 2014-2015 seasons in the Vaccine Safety Datalink (VSD). METHODS: We used both a historically-controlled cohort design with the Poisson-based maximized sequential probability ratio test (maxSPRT) and a self-controlled risk interval (SCRI) design with the binomial-based maxSPRT. For each adverse event outcome, we defined the risk interval on the basis of biologic plausibility and prior literature. For the historical cohort design, numbers of expected adverse events were calculated from the prior seven seasons, adjusted for age and site. For the SCRI design, a comparison window was defined either before vaccination or after vaccination, depending on each specific outcome. RESULTS: An elevated risk of febrile seizures 0-1 days following trivalent inactivated influenza vaccine (IIV3) was identified in children aged 6-23 months during the 2014-2015 season using the SCRI design. We found the relative risk (RR) of febrile seizures following concomitant administration of IIV3 and PCV13 was 5.3 with a 95% CI 1.87-14.75. Without concomitant PCV 13 administration, the estimated risk decreased and was no longer statistically significant (RR: 1.4; CI: 0.54 - 3.61). CONCLUSION: No increased risks, other than for febrile seizures, were identified in influenza vaccine safety surveillance during 2013-2014 and 2014-2015 seasons in the VSD. Copyright © 2016 John Wiley & Sons, Ltd. SN - 1099-1557 UR - https://www.unboundmedicine.com/medline/citation/27037540/Post_licensure_surveillance_of_influenza_vaccines_in_the_Vaccine_Safety_Datalink_in_the_2013_2014_and_2014_2015_seasons_ L2 - https://doi.org/10.1002/pds.3996 DB - PRIME DP - Unbound Medicine ER -