Received May 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | 1 | — | — |
They thought Capvaxive was the same as Prevnar 20 so they gave the Capvaxive; Caller reported that they have copies of internal emails that they sent to the providers and they have been labeling another Merck product, Capvaxive, was being labeled as Prevnar 21.; They administered the product PCV-21/capvaxive to a baby.; This spontaneous report was received from a reporter and refers to a baby patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (dose, route of administration, vaccination site, lot # and expiration date were not reported) administered for prophylaxis. It was reported that the providers were labeling PCV-15 and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (reported as PCV-21/Capvaxive) as pneumococcal vaccine conj 20v (CRM197) (PREVNAR 20) (reported as Prevnar), and now there has been an administration error (product label on wrong product). The product of PCV-21/capvaxive was administered to a baby and the PCV-21/Capvaxive was not indicated for use in babies (product administered to patient of inappropriate age). They thought Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was the same as pneumococcal vaccine conj 20v (CRM197) (PREVNAR 20) so they gave the Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (wrong product administered). The office thought it was Prevnar with an extra serotype, but that was not what happened. There could be more mistakes because of the misrepresentation of other 2 products. It was concerning.