Influenza

Afluria by Seqirus (Quadrivalent Influenza)

Captured 2022-12-09

Document Highlights

Initial U.S. Approval (AFLURIA QUADRIVALENT): 2016

AFLURIA QUADRIVALENT is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.

CONTRAINDICATIONS
Severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine including egg protein…

One subject, 8 years of age, experienced a cellulitis-like reaction at the injection site after vaccination with AFLURIA…

Study 3*. In the 180 days following vaccinations, AFLURIA QUADRIVALENT and comparator vaccine recipients experienced similar rates of serious adverse events (SAEs)…

Study 4**. In the 180 days following vaccinations, AFLURIA QUADRIVALENT and comparator vaccine recipients experienced similar rates of serious adverse events (SAEs)…

Postmarketing Experience
The adverse events described have been included in this section because they: 1) represent reactions that are known to occur following immunizations generally or influenza immunizations specifically; 2) are potentially serious; or 3) have been reported frequently. The adverse events listed below reflect experience in both children and adults and include those identified during post-approval…
– Thrombocytopenia
– Allergic or immediate hypersensitivity reactions including anaphylactic shock and serum sickness
– Neuralgia, paresthesia, convulsions (including febrile seizures), dizziness, encephalomyelitis, encephalopathy, neuritis or neuropathy, transverse myelitis, and GBS
– Vasculitis which may be associated with renal involvement
– Musculoskeletal pain and pain in the extremity
– Pruritus, urticaria, and rash
– Cellulitis and large injection site swelling
– Influenza-like illness, injected limb mobility decreased, pyrexia, injection site erythema and injection site reaction

AFLURIA QUADRIVALENT is prepared from influenza virus propagated in the allantoic fluid of embryonated chicken eggs.

The multi-dose presentation contains thimerosal added as a preservative; each 0.5 mL dose contains 24.5 mcg of mercury and each 0.25 mL dose contains 12.25 mcg of mercury.

From the manufacturing process, each 0.5 mL dose may also contain residual amounts of… ovalbumin… neomycin sulfate… polymyxin B… hydrocortisone…

AFLURIA QUADRIVALENT has not been evaluated for carcinogenic or mutagenic potential, or male infertility in animals.

Comments

Afluria was not tested for safety in a placebo-controlled clinical trial.

Why this is important.

*From the published study for Alfluria clinical trial "Study 3":

"In the overall safety population (n = 2252), 63.5% of participants reported at least one AE [adverse event] (combined solicited and unsolicited AEs)."

"Both study vaccines were well tolerated; most participants experienced AEs with a maximum of mild (36.9%) or moderate (20.8%) intensity."

36.9% + 20.8% = 57.7%.
This leaves 42.3% of participants who experienced AEs with a higher intensity than "moderate".

"Overall, 13 SAEs were reported in 10 participants. One SAE of influenza (presumed due to vaccination failure) was assessed as related to IIV4 by the Sponsor but not by the Investigator. This SAE occurred in a 5-year-old participant, 5 months postvaccination, and a respiratory swab was positive for influenza B..."

There are no other details on serious adverse events for this study.

Reference, here.

**From the published study for Afluria clinical trial "Study 4":

"Overall, 15 SAEs were reported in 14 participants; all were assessed as unrelated to the study vaccine. The nature of the SAEs reported was consistent with illnesses (such as respiratory tract infections) and injuries commonly occurring in this age group."

This is the extent of the detail provided regarding serious adverse events which occured in children 6 months through 35 months of age.

Reference, here.

Vaccine.Guide

Afluria by Seqirus (Quadrivalent Influenza)