What are the usage guidelines for Afluria quadrivalent (influenza vaccine) with preservative?

Afluria Quadrivalent with Preservative: Usage Guidelines

Afluria Quadrivalent with preservative (multi-dose vial format) is FDA-approved for persons aged ≥6 months, with age-specific dosing of 0.25 mL for children 6-35 months and 0.5 mL for persons ≥36 months, administered intramuscularly. 1

Age Indications and Licensing

• Afluria Quadrivalent received FDA approval expansion from ≥18 years to ≥6 months in October 2018, making it available for pediatric populations 1
• The vaccine was initially licensed for adults ≥18 years in August 2016, then expanded to ≥5 years in August 2017, and finally to ≥6 months in 2018 1

Dosing by Age Group

Children 6-35 Months

• Administer 0.25 mL per dose (containing 7.5 μg of hemagglutinin per vaccine virus) 1, 2
• Important caveat: 0.25-mL prefilled syringes are not expected to be available for recent seasons, requiring the 0.25-mL dose to be obtained from a multi-dose vial 1
• The multi-dose vial format contains thiomersal (thimerosal) as a preservative to prevent microbial contamination 3

Persons ≥36 Months (≥3 Years)

• Administer 0.5 mL per dose (containing 15 μg of hemagglutinin per vaccine virus) for all ages ≥3 years 1
• This includes children, adolescents, and adults of all ages 1

Route of Administration

• Administer intramuscularly via needle and syringe for all age groups 1
• For adults aged 18-64 years only, the multi-dose vial presentation may alternatively be administered using the PharmaJet Stratis jet injector device 1
• Children aged 6 months through 17 years and adults ≥65 years must receive the vaccine by needle and syringe only, not jet injector 1

Injection Site Selection

• Adults and older children: deltoid muscle (preferred site) 1
• Infants and young children: anterolateral thigh (preferred site) 1

Number of Doses Required

Children 6 Months Through 8 Years

• Two doses administered ≥4 weeks apart if the child has not previously received ≥2 total doses of influenza vaccine ≥4 weeks apart before July 1 of the current season 2, 4
• One dose if the child has previously received ≥2 total doses of influenza vaccine ≥4 weeks apart 2, 4

Persons ≥9 Years

• One dose per season, regardless of vaccination history 2

Immunogenicity and Safety Profile

• Afluria Quadrivalent met FDA prespecified criteria for immunologic noninferiority versus comparator vaccines for all four vaccine viruses in children aged 6-59 months 1, 5
• Fever rates were 5.8% with Afluria Quadrivalent versus 8.4% with comparator vaccine in pediatric studies, with no febrile seizures reported within 7 days of vaccination 1, 5
• Local injection site reactions (including Grade 3 induration/swelling at 0.3%) were slightly more common than with trivalent formulations (0.06%), but overall rates remained low 1
• The multi-dose vial format with thiomersal preservative demonstrated comparable immunogenicity and safety to thiomersal-free prefilled syringe formats 3

Storage and Handling

• Store refrigerated at 2°C to 8°C (36°F to 46°F) at all times 1
• Protect from light and maintain cold chain during transport 1
• Do not freeze; discard vaccine that has been frozen 1
• Multi-dose vials must be returned to recommended storage conditions between uses and should not be kept beyond the recommended period after first access 1
• Do not use after the expiration date on the label 1

Contraindications and Precautions

Contraindications

• History of severe allergic reaction to any component of the vaccine or to a previous dose of any influenza vaccine 1
• Note: Egg allergy is a labeled contraindication, but ACIP recommends that persons with egg allergy of any severity may receive any licensed, age-appropriate influenza vaccine 1

Precautions

• Moderate or severe acute illness with or without fever (defer vaccination until recovery) 1
• History of Guillain-Barré syndrome within 6 weeks of receipt of influenza vaccine 1

Multi-Dose Vial Specific Considerations

• Single-dose vials should not be accessed for more than one dose 1
• Multi-dose vials should be used only for the maximum number of doses specified in the package insert 1
• Any vaccine remaining after the maximum number of doses has been removed should be discarded, regardless of remaining volume 1
• The thiomersal preservative in multi-dose vials prevents microbial contamination and facilitates vaccination of large populations by reducing per-dose costs and cold storage requirements 3

Common Pitfalls to Avoid

• Do not administer 0.5 mL to children 6-35 months—the correct dose is 0.25 mL for this age group 1, 2
• Do not use jet injector for children or adults ≥65 years—only adults 18-64 years may receive via jet injector 1
• Do not confuse dose volume with number of doses—children requiring 2 doses need 2 separate administrations ≥4 weeks apart, regardless of volume per dose 1
• If a 0.5-mL single-dose vial is inadvertently used for a 0.25-mL pediatric dose, only half the volume should be administered and the other half discarded 1