Issue: February 2014
January 09, 2014
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Simultaneous TIV, PCV13 increased fever risk in young children

Issue: February 2014
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Simultaneous administration of the trivalent inactivated influenza vaccine and 13-valent pneumococcal conjugate vaccine in young children increased their risk of fever, according to recent study findings published in Pediatrics.

“While we observed an increase in fever with co-administration of [trivalent inactivated influenza vaccine] and [13-valent pneumococcal conjugate vaccine], this increased risk was short-lived and very few parents sought medical care for their child’s fever, supporting the recommendation to administer these vaccines according to the immunization schedule, including simultaneously,” Melissa S. Stockwell, MD, MPH, Florence Irving assistant professor of pediatrics, division of child and adolescent health, Columbia University, told Infectious Diseases in Children. “Health care providers can use this information to provide anticipatory guidance to families regarding fever. Additionally, this information regarding increased risk of fever may be helpful to health care providers caring for patients for whom fever should be avoided for medical reasons.”

Stockwell and colleagues evaluated 530 children aged 6 to 23 months who received trivalent inactivated influenza vaccine and 13-valent pneumococcal conjugate vaccine (PCV13 (Prevnar 13, Pfizer) either simultaneously or at separate visits to determine rates of fever.

Forty percent of children in the study received both vaccines on the same day, 39% received TIV without PCV13 and 21% received PCV13 without TIV. Text messages were sent to parents on the night of vaccination and the 7 subsequent nights, asking them to report the highest temperature recorded for their child each day.

“Before our study, text messaging had not been used to address a specific vaccine-safety question,” Stockwell said in a press release. “Unlike conventional surveillance methods, such as paper or phone, in which reporting may be delayed, text messaging appears to enable rapid, large-scale data collection.”

After adjusting for age, history of prior influenza vaccination, and co-administration of common childhood inactivated vaccines, patients who received TIV and PCV13 together were 2.7 times more likely to have a temperature of 38°C or higher on days 0 to 1. For every 100 patients vaccinated, there were an additional 20 to 23 cases of temperatures of 38°C or higher for those who received TIV and PCV13 together compared with those who received either vaccine without the other. Fifteen additional cases of temperatures of 39°C or higher were found in patients who received both vaccines together compared with the TIV without PCV13 but not PCV13 without TIV.

Ninety-five percent of parents who received text messages replied on day 0, but rates declined to 79.6% by day 7.

“Simultaneous TIV and PCV13 administration was associated with a higher transient increased fever risk than administration of either vaccine without the other product,” the researchers wrote. “Future studies could address the potential benefits and risks of administering TIV and PCV13 on different days or the effect of prophylactic antipyretics on vaccine-specific immune responses in patients for whom fever should be avoided for medical reasons. In addition, the use of text messaging to prospectively assess a specific vaccine adverse event has potential for enhancing pre-licensure and post-licensure monitoring of adverse events after immunization and deserves further study.” — by Amber Cox

Melissa S. Stockwell, MD, MPH, can be reached at Division of child and Adolescent Health, Columbia University, 622 W 168th St., VC 417, New York, NY 10032; email: mss2112@columbia.edu.

Disclosure: The study was funded by the Clinical Immunization Safety Assessment Network through a subcontract with America’s Health Insurance Plans under a contract from the CDC.