Fluad High-Dose Vaccine for Influenza

Fluad Vaccine

Fluad is a flu shot for adults over 65. It contains an adjuvant called MF59, which triggers a stronger immune response to the vaccine. Fluad caused a health scare in Italy after 19 people died, but there is no evidence that Fluad caused the deaths.

What is Fluad?

Fluad™ is an trivalent immunization against three strains of the influenza (flu) virus. It is made with an egg-based process. Unlike most flu shots, Fluad contains an adjuvant called MF59 and it is only for adults over 65. Fluad was approved in Italy in 1997 and in the United States in November 2015. It is manufactured by Seqirus Inc.

What is MF59?

MF59 is the adjuvant in Fluad. MF59 is an oil-in-water mixture of squalene and surfactants (soap-like chemicals). Squalene is naturally found in humans, plants, and animals.

The surfactants in MF59 are Tween 80 (Polysorbate 80) and Span 85. Both of these chemicals cause slight irritation inside the human body.

Squalene alone does not work as an adjuvant, but mixtures of squalene with surfactant chemicals do enhance the body’s immune response to vaccines. Fluad has about 10-mg of squalene per dose.

MF59 was fast-tracked through the FDA approval process, which means it did not go through placebo-controlled clinical trials. It was tested in about 1,000 healthy adults in the United States over age 65. This study showed that Fluad did not work better than a non-adjuvant flu shot (Agriflu), but it did show Fluad caused more side effects.

Why are adjuvants added to flu shots?

An adjuvant is an ingredient that is added to a vaccine to help create a stronger immune response to vaccination. They also reduce the amount of virus needed to make a vaccine, which allows for greater supplies of vaccines to be manufactured more quickly.

Did Fluad cause 19 deaths in Italy?

In November 2014, Italy suspended and recalled Fluad after 4 people died and one person had severe side effects soon after being injected with Fluad. By December 2014, at least 19 deaths were reported. However, investigators found no evidence that Fluad caused the deaths and it was declared safe.

How is Fluad given?

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

Can Fluad give you the flu?

No. Fluad contains inactivated (dead) influenza viruses that can’t cause the flu. However, many people do develop mild flu-like symptoms as their body develops immunity to the virus.

Can anyone get Fluad?

No. Fluad is only for people over 65 years old.

Who should NOT get Fluad?

Fluad is contraindicated in people who have had severe allergic reaction to egg protein, any ingredient in Fluad (see below for a list), or a previous flu shot. The tip caps of the pre-filled syringes contain latex that could cause allergic reactions in hypersensitive individuals.

Carefully consider the risks and benefits of Fluad in anyone who had Guillain-Barré syndrome (GBS) within 6 weeks of a previous flu shot. The 1976 swine flu vaccine was associated with a higher risk of GBS.

What are the most common side effects of Fluad?

The most common side effects of Fluad were pain (25%), tenderness (21%), swelling (1%), and a hard lump (1%) where the shot was given, muscle pain (15%), fatigue (13%), headache (13%), joint pain (9%), chills (7%), diarrhea (5%), fever (4%), nausea (3%), and vomiting (1%). Adults who received Agriflu had lower rates of many side effects.

What is the risk of fever from Fluad?

In clinical trials, fevers occurred in 3.6% of patients who were given Fluad. The risk of fever was as follows:

  • 100°-101°F fever risk was 1.8%
  • 100°-102°F fever risk was 1.3%
  • 102°-104°F fever risk was 0.4%
  • Over 104°F fever risk was 0.1%

What are severe side effects of Fluad?

  • Allergic reaction
  • Anaphylaxis
  • Anaphylactic shock
  • Angioedema
  • Convulsions
  • Death
  • Encephalomyelitis
  • Enlarged lymph nodes
  • Erythema multiforme
  • Fever over 104°F
  • Guillain-Barré Syndrome (GBS)
  • Muscular weakness
  • Nerve damage
  • Neuralgia
  • Neuritis
  • Pain
  • Paraesthesia
  • Rash with hives and severe itching
  • Seizures
  • Shoulder injury
  • SIRVA
  • Skin reactions
  • Swelling of entire limb lasting more than 1 week
  • Thrombocytopenia (very severe cases reported)
  • Vasculitis with transient renal involvement

What ingredients are in Fluad?

Each 0.5 mL dose of Fluad contains 15 mcg of hemagglutinin (HA) from each of the three recommended influenza strains.

Fluad contains about 10-mg of MF59. The ingredients in MF59 include 9.75-mg squalene, 1.175 mg of Tween 80 (Polysorbate 80), 1.175 mg of Span 85 (sorbitan trioleate), 0.66 mg of sodium citrate dihydrate, and 0.04 mg of citric acid monohydrate at pH 6.9-7.7.

Fluad may contain trace amounts of neomycin (< 0.02 mcg), kanamycin (< 0.02 mcg), kanamycin (<0.03 mcg) and barium (<0.5  mcg), which are used during the initial stages of manufacture, as well as residual egg proteins (<0.4 mcg), formaldehyde (<10 mcg), or CTAB (<12 mcg).

Does Fluad have thimerosal?

No. Fluad is a preservative-free vaccine. It doesn’t contain thimerosal, a mercury-based preservative.

Where can I get more information?

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