FluGuard® vaccine, a quadrivalent recombinant vaccine that stimulates immune
system against diseases caused by influenza type A virus (subtype H1N1 and H3N2) and influenza
type B virus (lineage Victoria and Yamagata) for adults 18 years of age and older.
FluGuard® is a sterile, transparent and colorless suspension.
Each dose contains 0.5 mL (45 micrograms from each serotype of influenza virus):
Excipients: Sodium chloride (4.4 mg), sodium dihydrogen phosphate (0.23 mg), disodium dihydrogen phosphate (1.6 mg), and polysorbate 20 (27.5 µg).
FluGuard® does not contain any protein of egg origin, antibiotic, or preservative ingredients.
Active Immunization against disease caused by Influenza viruses (2021-2022 formula recommended by WHO).
FluGuard® contains pure proteins of recombinant hemagglutinin (HA) from four serotypes of influenza virus which is announced yearly for seasonal vaccination against influenza by WHO.
The proteins are produced in insect cell culture using the baculovirus expression system that is not able to replicate in human cells. Each one of four HA in cell line is being expressed by a baculovirus vector and then being extracted and purified by linear chromatography.
These proteins act as an antigen to induce humoral immune response hemagglutinin inhibitors antibodies.
Before using the vaccine, consult with your health care provider or pharmacist.
Management of hypersensitivity reactions:
Appropriate medical treatment and supervision must be available to manage possible hypersensitivity reactions following administration of FluGuard® Quadrivalent.
Guillain Barré Syndrome (GBS):
Evidence for a causal relation of GBS with other influenza vaccines is
inconclusive; if an excess risk exists, it is probably slightly more than one additional case
per 1 million persons vaccinated.
If GBS has occurred within 6 weeks of receipt of a prior influenza vaccine, the decision to give FluGuard® should be based on careful considerations of the potential benefits and risks.
If you have a weak or altered immune system (due to disease, taking medicines such as corticosteroids, or chemotherapy), inform your health care provider.
Like any other vaccine, this vaccine may not cause immunization in all individuals.
There is no available information about interaction of this vaccine with other vaccines.
If you have to inject another vaccine at the same time, the vaccine should be given in a different site of injection.
This parenteral product should not be mixed with any other medicines.
FluGuard® administration during pregnancy is under investigation.
There is no available information about FluGuard® excretion into human breast milk.
The decision to give the FluGuard® during pregnancy should be based on careful consideration of the potential benefits and risks
There is insufficient information about vaccine effect on human fertility.
Animal clinical trials did not prove adverse effects on female fertility.
Efficacy and safety of FluGuard® have not been established in children 6 months to 18 years.
Due to insufficient information of efficacy studies for adults over 65 years old, difference of response in this population in comparison to younger population is unclear.
Very common (≥10%)
Very common (≥10%)
Very common (≥10%)
Rare ( < 1%):
Frequency of complication according to the percentage of prevalence is Very minor, not predictable.
If you feel any adverse event, even cases that is not mentioned in this brochure, be sure to tell a doctor or a pharmacist.
You can directly report the adverse effects to Iran Food and Drug Administration’s website (www.fda.gov.ir) or with number +98-21-8609-2503.