Received May 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLUR4 | INFLUENZA (SEASONAL) (FLUBLOK QUADRIVALENT) | PROTEIN SCIENCES CORPORATION | UNK | — | OT |
During the market research interview participant mentioned that Flublok was seen to not to be as efficacious as it was before; Initial information received on 22-Apr-2025 regarding an unsolicited valid serious case received from a other health professional. This case involves market research interview participant mentioned that Influenza quadrivalent recombinant vaccine [Flublok QIV] was seen to not to be as efficacious as it was before. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect Influenza quadrivalent recombinant vaccine (lot number, formulation and strength-unknown) via intramuscular route in unknown administration site for Prophylactic vaccination (Immunisation) and was seen to not to be as efficacious as it was before (Suspected clinical vaccine failure). Action taken was not applicable. Seriousness Criteria-The event is assessed as medically significant.; Sender's Comments: Sanofi company comment dated 29-APR-2025: This case involves market research interview participant mentioned that Influenza quadrivalent recombinant vaccine [Flublok QIV] was seen to not to be as efficacious as it was before. Further information regarding regarding allergic history, medical history, concomitant medication and tolerance, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.