Company:

CSL Biotherapies

Influenza vaccine

Trivalent, inactivated, "split virus" influenza vaccine (Types A and B); formulation changes annually; susp for IM inj; may contain trace amounts of neomycin sulfate, polymyxin B.

Influenza immunization.

Influenza is a highly contagious and potentially fatal viral disease that can reach epidemic levels and pose a significant threat to public health. Influenza immunization may help in preventing the flu and its severe complications. Because the virus is capable of changing frequently, protection is limited to those strains of virus from which the vaccine is prepared and possibly to closely-related strains.

Afluria is an inactivated influenza vaccine that contains the hemagglutinins of three virus strains representing those flu viruses considered likely to circulate in the upcoming winter. Annual vaccination with the current vaccine is necessary because immunity declines during the year after vaccination. Vaccine prepared for a previous flu season should not be given to provide protection for the current season. As for any vaccine, this product may not protect 100% of susceptible individuals.

The multi-dose formulation contains the preservative thimerosal, a mercury derivative. Each dose contains 24.5mcg of mercury.

Three randomized, controlled studies have evaluated the immune responses of over 2,000 subjects (HI antibody titers) to each virus strain in the vaccine. Study 1 conducted in the US, was a double-blind placebo controlled study. Studies 2 and 3 were conducted in the UK, comparing Afluria with a European-licensed trivalent inactivated influenza vaccine as an active control. Post-vaccination immunogenicity was evaluated on sera obtained 21 days after administration of Afluria. Antibody titers 1:40 or greater have been shown to protect against influenza illness in up to 50% of subjects in some human studies. Therefore, each of the three studies for Afluria evaluated for 1) seroconversion rate (4-fold increase in post-vaccination HI antibody titer from pre-vaccination titer); and 2) HI titer ≥ 1:40 for each of the three vaccine strains. The proportion of subjects with a minimum post-vaccination HI antibody titer of 1:40 had to meet a lower bound 95% CI of >70% in the US study and >60% and >70%, in the UK studies respectively. Each of the three studies met co-primary endpoints of immunogenicity. Post-hoc analysis of one UK study found that serum HI antibody responses were lower in subjects age 65 years and older after administration of Afluria. Serum HI antibody responses to the active control were similar to those for Afluria. No studies were performed demonstrating a decrease in influenza illness after vaccination with Afluria.

≥18yrs: 0.5mL by IM inj once in deltoid.

<18yrs: not recommended.

Allergy to egg or chicken proteins, neomycin, polymyxin. Life-threatening reaction to any previous flu vaccine.

Use current formulation only. Have epinephrine inj (1:1000) available. Guillain-Barre syndrome within 6 weeks of previous flu vaccine. Immunosuppressed. Pregnancy (Cat.C). Nursing mothers.

Concomitant vaccines: insufficient data (see literature). Immunosuppressants (eg, corticosteroids): may get suboptimal response.

Local reactions (eg, tenderness, redness, swelling, pain), headache, malaise, muscle aches.

To report adverse events to VAERS call (800) 822-7967.

Single-dose prefilled syringe 0.5mL (preservative-free)—10 (without needles)
Multi-dose vial 5mL (contains thimerosal)—1

11/21/07