AS03.e. Vaccine safety (post licensure)

EP083 - SAFETY AND IMMUNOGENICITY OF CO-ADMINISTERED MENINGOCOCCAL SEROGROUP B VACCINE (4CMENB) AND USE OF PROPHYLACTIC PARACETAMOL IN INFANTS AND TODDLERS: A LITERATURE REVIEW (ID 621)

Abstract

Backgrounds:

Co-administering 4CMenB with other childhood vaccines may improve vaccine uptake. We conducted a literature review of published immunogenicity and reactogenicity data related to 4CMenB vaccine co-administration in infants and toddlers, as well as published data on prophylactic paracetamol since 4CMenB licensure.

Methods

The non-systematic literature review was conducted in October 2021 (no specified timeframe) using PubMed. Search terms were 4CMenB, co-administration and associated terms.

Results:

Available evidence suggests that co-administration of 4CMenB with recommended routine childhood vaccines has no clinically significant effects on immunogenicity. In two phase 3 studies (N=3,630), 4CMenB (primary schedule or booster dose) did not impair immune responses when co-administered with DTaP-IPV-HBV/Hib vaccines in infants aged 2, 4 and 6 months, or the MMRV vaccine in toddlers aged 12 months (Vesikari, 2013). The safety profile of 4CMenB co-administration with other childhood vaccines was demonstrated by a real-world study of 107,231 infants and toddlers aged 1–18 months within the routine UK immunisation programme (93% of 4CMenB immunisations co-administered with other childhood vaccines [5-in-1, PCV13, rotavirus, Hib, MenC and MMR vaccines]; Hall, 2021). Five studies reported higher rates of fever in infants and toddlers when 4CMenB was co-administered with other childhood vaccines compared with administration of other vaccines alone. Two studies demonstrated the effectiveness of prophylactic paracetamol for reducing the rate of fever in infants without affecting the immune response; prophylactic paracetamol is recommended by the UK Joint Committee on Vaccination and Immunisation.

Conclusions/Learning Points:

Available real-world evidence supports the continuation of co-administration of 4CMenB with other childhood vaccines. The evidence suggests that there are no clinically significant effects on immunogenicity of 4CMenB or the co-administered vaccines and transient reactogenicity (fever) that can be managed with prophylactic paracetamol.

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