Received Mar 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PPV | PNEUMO (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
pneumococcal infection; 5 cases of invasive pneumococcal disease in children that have been vaccinated with PCV13 (I am unsure if every child received every dose in the series)/pneumococcal infection; This is a spontaneous report received from a Physician. A patient (age and gender not provided) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PNEUMOCOCCAL INFECTION (medically significant), outcome "unknown", described as "5 cases of invasive pneumococcal disease in children that have been vaccinated with PCV13 (I am unsure if every child received every dose in the series)/pneumococcal infection"; DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "pneumococcal infection". It was stated that the reporter was hoping to submit an adverse reporting through this route as he/she believes this to be a unique situation. He/she had a clinical meeting with a pediatric infectious disease physician. She is the Director of the newly established Vaccine Center of Excellence and recently has come back in the last year and a half after practicing for 18 years. During their introductory discussion, she elaborated that upon returning, she has witnessed 5 cases of invasive pneumococcal disease in children that have been vaccinated with PCV13 (unsure if every child received every dose in the series). She said she had not seen this many cases during her entire tenure, so she had sought to get serotyping and see if anyone is following these cases. She stated she is having trouble with anyone showing interest in this and finds no one researching this area (ie- are we following pediatrics who received PCV13 and then get IPD or PNA? Should pediatric patients who received PCV13 get a booster of PCV20?). She said most research is in pediatrics age < 5 years and is struggling with serotyping and follow up given these patients are over the age of 5 years. The local departments of health utilize a lab in (name) and these cases do not fit their criteria as the patients are over 5 years of age. The adverse event here is the high number of potential breakthrough cases of invasive pneumococcal disease in (name) (she stated one was serotype 3) OR potentially cases of pneumococcal infection that could be covered with PCV20 in patients who received PCV13. The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.; Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded. Further information like confirmative serotype results, vaccination schedule, patient age, medical history and concomitant medications are needed for full medical assessment.,Linked Report(s) : US-PFIZER INC-PV202500026859 same reporter/drug/event, different patient;