PLoS ONE (Jan 2022)

The safety of co-administration of Bacille Calmette-Guérin (BCG) and influenza vaccines.

  • Paola Villanueva,
  • Ushma Wadia,
  • Nigel W Crawford,
  • Nicole L Messina,
  • Tobias R Kollmann,
  • Michaela Lucas,
  • Laurens Manning,
  • Peter Richmond,
  • Laure F Pittet,
  • Nigel Curtis

DOI
https://doi.org/10.1371/journal.pone.0268042
Journal volume & issue
Vol. 17, no. 6
p. e0268042

Abstract

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BackgroundWith the emergence of novel vaccines and new applications for older vaccines, co-administration is increasingly likely. The immunomodulatory effects of BCG could theoretically alter the reactogenicity of co-administered vaccines. Using active surveillance in a randomised controlled trial, we aimed to determine whether co-administration of BCG vaccination changes the safety profile of influenza vaccination.MethodsParticipants who received influenza vaccine alone (Influenza group) were compared with those who also received BCG-Denmark vaccine in the contralateral arm (Influenza+BCG group). Data on the influenza vaccination site were collected using serial questionnaires and active follow-up for 3 months post vaccination.ResultsOf 1351 participants in the Influenza+BCG group and 1418 participants in the Influenza group, 2615 (94%) provided influenza vaccine safety data. There was no significant difference in the proportion of participants with any local adverse reaction between the Influenza+BCG group and the Influenza group (918/1293 [71.0%] versus (906/1322 [68.5%], p = 0.17). The proportion of participants reporting any pain, erythema and tenderness at the influenza vaccination site were similar in both groups. Swelling was less frequent (81/1293 [6.3%] versus 119/1322 (9.0%), p = 0.01) and the maximal diameter of erythema was smaller (mean 1.8 cm [SD 2.0] versus 3.0 cm [SD 2.5], pConclusionsAdverse events following influenza vaccination are not increased when BCG is co-administered.