MenACWY-CRM, a quadrivalent meningococcal conjugate vaccination, is licenced for use in individuals as young as 2 months old in the Republic of Korea. This single-arm, open-label, observational, multicenter post-marketing research evaluated the safety of the MenACWY-CRM vaccination when administered according to local clinical practise. A total of 3939 people between the ages of 2 months and 55 years old supplied safety data after immunisation. Solicited and unsolicited adverse events (AEs) were collected 7 days after immunisation, and medically-attended AEs (MAAEs) and severe AEs (SAEs) were collected 29 days after vaccination. Injection site AEs were reported by 21.38 percent of participants, with tenderness/pain being the most common across age groups; systemic AEs were reported by 13.95 percent of individuals, with irritability, headache, and myalgia being the most commonly reported. The number of individuals reporting unsolicited AEs varied across the research group, with 12.56 percent of those aged 2–23 months reporting them and 3.18 percent of those aged 2 years reporting them. In all, less than 22% of unsolicited AEs were thought to be linked to vaccination.
The majority of MAAEs were minor, with only 2.82 percent being linked to vaccination. Participants aged 2–23 months and 2–55 years experienced three and five SAEs, respectively. There were no fatalities. MenACWY-safety CRM’s profile in this post-marketing surveillance was consistent with findings made during the vaccine’s clinical development, with no additional adverse concerns.
Reference: https://www.tandfonline.com/doi/full/10.1080/21645515.2019.1670125
