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FLUVIRIN® (Influenza Virus Vaccine) is an inactivated subunit influenza virus vaccine indicated for active immunization of persons aged 4 years and older against influenza disease caused by influenza virus subtypes A and B included in the vaccine.

FLUVIRIN® Important Safety Information

FLUVIRIN® (Influenza Vaccine) should not be administered to anyone with known systemic hypersensitivity reactions to egg proteins (egg or egg products), or to any component of FLUVIRIN®, or who has had a life-threatening reaction to previous influenza vaccinations.

If Guillain-Barré syndrome has occurred within 6 weeks of receipt of prior influenza vaccine, the decision to give FLUVIRIN®  should be based on careful consideration of the potential benefits and risks.

If FLUVIRIN® is administered to immunocompromised persons, including individuals receiving immunosuppressive therapy, the expected immune response may not be obtained. Prior to administration of any dose of FLUVIRIN®, the healthcare provider should review the patient’s prior immunization history for possible adverse events, to determine the existence of any contraindication to immunization with FLUVIRIN® and to allow an assessment of benefits and risks. Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.

The tip caps of the FLUVIRIN® prefilled syringes may contain natural rubber latex which may cause allergic reactions in latex sensitive individuals.

Vaccination with FLUVIRIN® may not protect all individuals. In clinical trials, the most common adverse events in adults were headache, fatigue, injection site reaction (pain, mass, redness, and induration), and malaise.

Please see accompanying US Full Prescribing Information for FLUVIRIN®

FLUAD is the first U.S. FDA approved adjuvanted flu vaccine for use in the elderly population aged 65 and older. FLUAD contains the MF59® adjuvant and provides a strong immune response to help protect against the flu.1

FLUAD Important Safety Information1

Indications and Usage
FLUAD is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. FLUAD is approved for use in persons 65 years of age and older. Approval is based on the immune response elicited by FLUAD. Data demonstrating a decrease in influenza disease after vaccination with FLUAD are not available.

Contraindications
Severe allergic reaction to any component of the vaccine, including egg protein, or after a previous dose of any influenza vaccine.

Warnings and Precautions

  • If Guillain-Barré Syndrome (GBS) has occurred within six weeks of previous influenza vaccination, the decision to give FLUAD should be based on careful consideration of the potential benefits and risks.
  • The tip caps of the prefilled syringes contain natural rubber latex which may cause allergic reactions in latex sensitive individuals.

Adverse Reactions

  • The most common (≥ 10%) local (injection site) adverse reactions observed in clinical studies were injection site pain (25%) and tenderness (21%).
  • The most common (≥ 10%) systemic adverse reactions observed in clinical studies were myalgia (15%), headache (13%) and fatigue (13%).

To report Suspected Adverse Reactions, contact Seqirus Vaccines and Diagnostics, Inc. at 1- 855-358-8966 or VAERS at 1-800-822-7967 and www.vaers.hhs.gov.

Please see accompanying US Full Prescribing Information for FLUAD.

Reference:
1. FLUAD (package insert). Cambridge, MA.

AFLURIA® is an inactivated influenza vaccine used for immunization against influenza disease caused by influenza virus subtypes A and B present in the vaccine. It is the only flu vaccine with needle-free delivery option.

AFLURIA® Important Safety Information1

Indications and Usage

Afluria® Influenza Vaccine is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes A and type B present in the vaccine. Administration of Afluria with a needle and syringe is approved for use in persons 5 years of age and older. Administration of Afluria with the PharmaJet® Stratis® Needle-Free Injection System is approved for use in persons 18 through 64 years of age only.

Contraindications

Afluria is contraindicated in individuals with known severe allergic reactions (eg, anaphylaxis) to any component of the vaccine including egg protein, or to a previous dose of any influenza vaccine.

Warnings & Precautions

Administration of CSL’s 2010 Southern Hemisphere influenza vaccine was associated with postmarketing reports of increased rates of fever and febrile seizures in children predominantly below the age of 5 years as compared to previous years; these increased rates were confirmed by postmarketing studies. Febrile events were also observed in children 5 to less than 9 years of age.

If Guillain-Barré Syndrome (GBS) has occurred within 6 weeks of previous influenza vaccination, the decision to give Afluria should be based on careful consideration of the potential benefits and risks.

If Afluria is administered to immunocompromised persons, including those receiving immunosuppressive therapy, the immune response may be diminished.

Afluria should be given to a pregnant woman only if clearly needed.

Afluria has not been evaluated in nursing mothers. It is not known whether Afluria is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Afluria is administered to a nursing woman.

Antibody responses in persons 65 years of age and older were lower after administration of Afluria as compared to younger adult subjects.

In children 5 through 17 years of age, most common injection-site adverse reactions observed in clinical studies of Afluria when administered by needle and syringe were pain, redness, and swelling. The most common systemic adverse events were headache, myalgia, irritability, malaise, and fever.

In adults 18 through 64 years of age, the most common injection-site adverse reactions observed in clinical studies of Afluria when administered by needle and syringe were tenderness, pain, swelling, redness, and itching. The most common systemic adverse reactions observed were muscle aches, headache, and malaise.

In adults 18 through 64 years of age, the most common injection-site adverse reactions observed in clinical studies of Afluria when administered by the PharmaJet Stratis Needle-Free Injection System up to 7 days post-vaccination were tenderness, swelling, pain, redness, itching, and bruising. The most common systemic adverse events within this period were myalgia, malaise, and headache.

In adults 65 years of age and older, the most common injection-site adverse reactions observed in clinical studies of Afluria when administered by needle and syringe were tenderness and pain.

Vaccination with Afluria may not protect all individuals.

Please see full prescribing information for Afluria.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.