The following is a summary of “Safety of a 4-Dose 20-Valent Pneumococcal Conjugate Vaccine Series in Infants: A Randomized Trial,” published in the October 2024 issue of Pediatrics by Hajdu et al.
The 20-valent pneumococcal conjugate vaccine (PCV20) was designed to expand protection against pneumococcal disease and includes serotypes from the PCV13 plus 7 additional serotypes.
Researchers conducted a prospective study to evaluate infants’ tolerability and safety with PCV20.
They involved healthy infants (born at ≥34 weeks’ gestation), who were randomly assigned 2:1 to receive either the 20-valent pneumococcal conjugate vaccine (PCV20; n = 1000) or the 13-valent pneumococcal conjugate vaccine (PCV13; n = 504) at 2, 4, 6, and 12 to 15 months of age. Safety checks had local reactions and systemic events within 7 days after each vaccination, AEs from dose 1 to 1 month after dose 3 and from dose 4 to 1 month after dose 4, and severe AEs and newly diagnosed chronic medical conditions through 6 months after the final dose.
The results showed that in 91.7% of participants receiving all 4 doses, frequencies of local reactions and systemic events were similar between the PCV20 and PCV13 groups, with most events reported as mild or moderate. Most familiar local response was injection site pain (PCV20: 24.7%–40.5%; PCV13: 26.8%–42.0%), while irritability was a common systemic event (PCV20: 54.8%–68.2%; PCV13: 54.7%–68.5%). Few newly diagnosed chronic medical conditions (2.8% in both groups) and no SAEs related to the vaccines were reported, PCV20 was safe across multiple countries, in late preterm infants, and when co-administered with other vaccines.
They concluded that a 4-dose series of PCV20 has a safety and tolerability profile like that of PCV13.
