Scientific article
Open access

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

Published inPloS one, vol. 17, no. 6, e0268042
Publication date2022-06-03
First online date2022-06-03

Background: With 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.

Methods: Participants 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.

Results: Of 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], p<0.001) in the Influenza+BCG group. Sixteen participants reported serious adverse events: 9 participants in the Influenza+BCG group and 7 in the Influenza group.

Conclusions: Adverse events following influenza vaccination are not increased when BCG is co-administered.

  • BCG Vaccine / adverse effects
  • Humans
  • Influenza Vaccines / adverse effects
  • Influenza, Human / prevention & control
  • Vaccination / adverse effects
Affiliation Not a UNIGE publication
Citation (ISO format)
VILLANUEVA, Paola et al. The safety of co-administration of Bacille Calmette-Guérin (BCG) and influenza vaccines. In: PloS one, 2022, vol. 17, n° 6, p. e0268042. doi: 10.1371/journal.pone.0268042
Main files (1)
Article (Published version)
Secondary files (4)
ISSN of the journal1932-6203

Technical informations

Creation03/31/2023 3:46:03 PM
First validation05/23/2023 10:42:52 AM
Update time05/23/2023 10:42:52 AM
Status update05/23/2023 10:42:52 AM
Last indexation05/06/2024 3:57:10 PM
All rights reserved by Archive ouverte UNIGE and the University of GenevaunigeBlack