Flucelvax Vaccine

Flucelvax is a cell-based flu vaccine that is made in dog kidney cells rather than chicken eggs. There are Trivalent and Quadrivalent versions of Flucelvax and both are approved for children over 4 years old.

What is Flucelvax?

Flucelvax® is an immunization against influenza (“the flu”). It is the first antibiotic-free flu shot that is not made in chicken eggs, which means it can be used by people who are allergic to eggs and antibiotics.

Seqirus Inc. manufactures two versions: Flucelvax Trivalent, a three-strain flu vaccine that was approved 2012, and Flucelvax Quadrivalent, a four-strain flu vaccine that was approved in 2016.

Flucelvax was originally approved for adults over 18 years old, but in 2016, the FDA expanded approval to include anyone over 4 years old.

Flucelvax is also sold under the name Optaflu in the European Union, where it was approved in 2007.

What is cell-culture technology?

Cell-culture technology is a way to make flu shots in cells instead of fertilized chicken eggs, which is the traditional way flu shots are made. This eliminates the need for antibiotics in the vaccine. It also allows for quick production of large quantities of flu shots in an emergency.

Flucelvax is the first flu shot to be manufactured with cell-culture technology, but this process has been previously used to make vaccines for polio, smallpox, rubella, and chickenpox.

How is Flucelvax made?

Flucelvax is made from a flu virus that is grown in kidney cells from a dog, specifically Madin-Darby canine kidney epithelial cells (MDCK), a well-known cell line that was harvested from a female Cocker Spaniel in 1958 and grown in the lab ever since. The cells are grown in Holly Spring, North Carolina at a $1 billion manufacturing facility paid for in part by the U.S. Department of Health and Human Services (HHS).

How is Flucelvax given?

Flucelvax is given in a single 0.5-mL injection in the upper arm.

Can Flucelvax give you the flu?

No. Flucelvax is an inactivated virus vaccine. The virus can’t cause the flu. Many people develop flu-like symptoms as their body develops immunity to the viruses, but this is not the flu.

How many shots do I need?

Children between the ages of 4 and 8 years old who have never had a flu shot before can get two doses of Flucelvax, 0.5-mL each, spaced at least 4 weeks apart. Only one dose of Flucelvax is recommended for children who have had a flu shot before and people over 9 years old.

Who should NOT get Flucelvax?

Flucelvax is not for children under 4 years old or anyone who has had a severe allergic reaction to any ingredient (see below for a list).

Tell your doctor if you had Guillain-Barrè Syndrome (severe muscle weakness) after a flu shot, latex allergies, or fainted after an injection.

What are the most common side effects of Flucelvax?

• Pain or redness where you got the shot
• Headache
• Tiredness
• Muscle aches
• Feeling unwell (malaise)

What is the risk of side effects?

The following rates of side effects were observed in clinical trials of children and adults who received Flucelvax Quadrivalent:

• Children 4-6 years old, 1st dose: Injection-site tenderness (46%), redness (18%), sleepiness (19%), irritability (16%), lump (13%), and change in eating habits (10%).
• Children 6-8 years old, 1st dose: Injection-site pain (54%), redness (22%), lump (16%), headache (14%), fatigue (13%), muscle pain (12%).
• Adolescents 9-17 years old: Injection-site pain (58%), headache (22%), redness (19%), fatigue (18%), muscle pain (16%), lump (15%).
• Adults 18-64 years old: Injection-site pain (45%), headache (19%), fatigue (18%), muscle pain (15%), injection-site redness (13%) and lump (12%).
• Adults over 65 years old: Injection-site pain (22%) and redness (12%)

What are severe side effects of Flucelvax?

In clinical trials of Flucelvax, a 5 year-old child developed a skin rash called erythema multiforme, which is a serious type of hypersensitivity reaction that can be life-threatening or deadly.

Flucelvax has been linked to the following severe side effects:

• Allergic reaction
• Anaphylactic reaction
• Angioedema
• Erythema Multiforme
• Fainting and fall injury
• Guillain-Barrè Syndrome
• Paresthesia
• Pre-syncope (nearly fainting)
• Rash
• Shoulder Injury Related to Vaccine Administration (SIRVA)
• SIRVA
• Skin reactions
• Swelling of the entire arm
• Tonic-clonic limb movements
• Visual disturbance

What ingredients are in Flucelvax Trivalent?

Flucelvax Trivalent has 45 mcg of hemagglutinin (HA) per 0.5 mL-dose, or 15 mcg HA for each of the 3 flu viruses in the vaccine This is the flu virus protein that triggers an immune response.

Each dose of Flucelvax Trivalent may contain residual amounts of dog cell protein (≤8.4 mcg), protein other than HA (≤ 120 mcg), dog cell DNA (≤ 10 ng), polysorbate 80 (≤ 1125 mcg), cetyltrimethlyammonium bromide (≤ 13.5 mcg), and β-propiolactone (<0.5 mcg), which are used in the manufacturing process.

What ingredients are in Flucelvax Quadrivalent?

Flucelvax Quadrivalent contains 60 mcg of hemagglutinin per 0.5-mL dose, or 15 mcg HA for each of the 4 flu viruses in the vaccine. This is the flu virus protein that triggers an immune response.

Each dose of Flucelvax Quadrivalent may contain residual amounts of dog cell protein (≤8.4 mcg), protein other than HA (≤160 mcg), dog cell DNA (≤ 10 ng), polysorbate 80 (≤1500 mcg), cetyltrimethlyammonium bromide (≤18 mcg), and β-propiolactone (<0.5 mcg), which are used in the manufacturing process.

Does Flucelvax Trivalent have thimerosal?

Flucelvax Trivalent does NOT contain thimerosal, a mercury-based preservative, or any other preservatives or antibiotics.

Does Flucelvax Quadrivalent have thimerosal?

Thimerosal is added to the 5-mL multi-dose vials of Flucelvax Quadrivalent, with 25 mcg of mercury per 0.5-mL dose.

Thimerosal is NOT added to the 0.5-mL pre-filled dose of Flucelvax Quadrivalent.

Can Flucelvax cause a Shoulder Injury Related to Vaccine Administration (SIRVA)?

Yes. Like all injection vaccines, Flucelvax can cause a Shoulder Injury Related to Vaccine Administration (SIRVA) if the needle is injected improperly into the shoulder.

Can Flucelvax cause Guillain-Barre Syndrome (GBS)?

Yes. Like all flu shots, Flucelvax is associated with a rare but devastating side effect called Guillain-Barré Syndrome (GBS), which can cause nerve damage and paralysis.

Can I file a Flucelvax lawsuit?

Anyone who developed SIRVA or GBS after Flucelvax should contact our law firm about filing a lawsuit. You may be eligible for up to $250,000 from the Vaccine Injury Compensation Program (VICP).

Where can I get more information?

• Flucelvax Lawsuit & Vaccine Injury Compensation Program
• Flucelvax Quadrivalent Package Insert 2016-2017 Formula
• Flucelvax Trivalent Package Insert 2015-2016 Formula
• Flucelvax FDA Product Information
• Cell-Based Flu Vaccines | Seasonal Influenza (Flu) – CDC

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