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Examining the Safety and Tolerability of a New 15-valent Pneumococcal Vaccine

June 13, 2023

The 13-valent pneumococcal vaccine (PCV13) has made major inroads in reducing serious invasive bacterial infections due to pneumococcus by as much as 90%.Yet there are still important serotypes not included in this vaccine, including serotypes 22F and 33F that make up a large proportion of breakthrough cases in children including those immunized against pneumococcus with PCV13. A new 15-valent pneumococcal vaccine called V114 has arrived, which adds serotypes 22F and 33F to PCV13. How safe is this new vaccine? Banniettis et al (10.1542/peds.2022-060428) share with us the results of a phase 3 study of the V114 pneumococcal vaccine looking at its safety and tolerability.

The authors analyzed data from a double-blind trial involving 2409 infants randomized to receive V114 (PCV15) in 2,000 children or PCV13 in 400 children at 2,4,6, and 12-15 months of age.  Adverse events were monitored for 14 days after each study vaccine was given and serious adverse events were monitored up to 6 months following administration. 

The results of this phase 3 trial demonstrated no difference in rates of systemic or injection site adverse events between the PCV13 and PCV15. Most adverse events were found to be mild to moderate in both groups and lasted less than or equal to 3 days. There were 2 non-vaccine related deaths, 1 in each group, and the PCV15 group had 2 episodes of higher fevers considered serious without discontinuing administration of the full vaccine series.

If the PCV15 vaccine is well-tolerated with a comparable safety profile, should we say good-bye to PCV13 and welcome this new 15 valent vaccine as the routine pneumococcal vaccine for our young patients? While the authors of the study suggest the answer to this question is yes, we also solicited a commentary from Drs. James Campbell and E. Adrianne Hamershaimb from the University of Maryland Center for Vaccine Development and Global Health (10.1542/peds.2022-060843). They remind us that there are serotypes still not in this PCV15 vaccine so protection from the PCV15 vaccine is not perfect; however, more serotypes is better so they encourage use of this vaccine if it becomes available in your area. Lest you feel this story has ended, there are currently trials ongoing in adults who are receiving a 20-valent conjugate vaccine (PCV20), and it is only a matter of time until children enter these trials. The more we can drive down deaths or serious injury due to pneumococcal variants not included in our PCV-13 vaccine, the better. Give this study and commentary your best shot and then check to see if your vaccine supplier will be providing you with PCV15.

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