Avian Influenza A H5N1 Virus Vaccine

What is Avian Influenza A H5N1 Virus Vaccine

Avian influenza A H5N1 virus vaccine is an inactivated monovalent vaccine indicated for active immunization of persons at increased risk of exposure to the H5N1 influenza virus subtype contained in the vaccine.

Two vaccines have received approval from the FDA, with each containing a different viral stains.

The first vaccine, influenza A virus vaccine (H5N1), contains the virus strain A/Vietnam/1203/2004 (H5N1, clad 1) and is indicated for use in persons 18—64 years of age.

The second vaccine is the AS03 adjuvanted influenza A (H5N1) virus monovalent vaccine which contains the virus strain A/Indonesia/05/2005 (H5N1) and is approved for use in patients >= 18 years of age.

Avian influenza A is an infectious disease of birds, with some viruses (such as H5N1) causing illness/death in humans.

As of October 8, 2013, there have been 641 laboratory-confirmed cases of and 380 deaths from H5N1 infection in humans reported to the World Health Organization (WHO).

To date, most cases of avian influenza infection in humans have resulted from contact with infected poultry or surfaces contaminated with secretions or excretions from infected birds.

Human to human transmission of the H5N1 virus may have occurred in a small number of cases, but the strain could mutate into a form that spreads easily from person to person.

If viral mutation occurs and a pandemic ensues, the immediate availability of an effective vaccine is essential to minimize human morbidity and mortality. Natural immunity is low to none, as the influenza strain does not commonly infect humans.

Additionally, the H5N1 virus that has caused human illness and death in Asia is resistant to amantadine and rimantadine.

Unfortunately, the first FDA-approved vaccine had limited efficacy with only 43% of patients (n = 99) achieving both a >= 4-fold increase over baseline in hemagglutination inhibition and a >= 1:40 titer 28 days after the second dose.

The second vaccine, which contains an AS03 adjuvant, appears to have improved efficacy with 90.8% of patients age 18—64 years and 74.5% of patients >= 65 years achieving a >= 1:40 titer 21 days after the second dose.

The US government intends to stockpile the FDA-approved vaccines for inclusion within the US Strategic National Stockpile for distribution by public health officials, if needed; the vaccine will not be available commercially.

The influenza A (H5N1) virus vaccine was approved by the FDA in April 2007; the AS03 adjuvanted influenza A (H5N1) virus monovalent vaccine was FDA approved in November 2013.


  • avian influenza prophylaxis

NOTE: The FDA-approved indication is based on immune response and not on demonstration of decreased influenza disease after vaccination.

For avian influenza prophylaxis of persons at increased risk of exposure to the H5N1 influenza virus subtype contained in the vaccine

Side Effects

  1. pain (73.8—83%)
  2. tenderness (69.9%)
  3. erythema (9—20.4%)
  4. induration or swelling (10—14.6%)
  5. pruritus (1.8%)
  6. warmth (1.3%)
  7. myalgia (15.5—45%)
  8. headache (2.9—35.9%)
  9. fatigue (34%)
  10. arthralgia (25%)
  11. malaise (22.3%)
  12. shivering (17%)
  13. sweating (11%)
  14. nausea (9.7%)
  15. fever (5—6.8%)
  16. diarrhea (5.8%)
  17. pharyngolaryngeal pain (4.9%)
  18. upper respiratory tract infection (1.9%)
  19. nasopharyngitis (1.9%)
  20. dizziness (1.4%)
  21. nasal congestion (1%)
  22. rash (unspecified) (0.6%)

Monitoring Parameters

  • laboratory monitoring not necessary


  • anticoagulant therapy
  • breast-feeding
  • children
  • coagulopathy
  • egg hypersensitivity
  • geriatric
  • Guillain-Barre syndrome
  • hemophilia
  • immunosuppression
  • infants
  • intravenous administration
  • neonates
  • pregnancy
  • syncope
  • thimerosal hypersensitivity
  • thrombocytopenia


No information is available regarding drug interactions associated with Avian Influenza A (H5N1) Virus Vaccine


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