Afluria
SIDE EFFECTS
Overall Adverse Reactions
Serious allergic reactions, including anaphylactic shock, have been observed during postmarketing surveillance in individuals receiving AFLURIA®.
The most common local (injection-site) adverse reactions observed in clinical studies with AFLURIA® were tenderness, pain, redness, and swelling. The most common systemic adverse reactions observed were headache, malaise, and muscle aches.
Safety Experience from Clinical Studies
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a vaccine cannot be directly compared to rates in the clinical studies of another vaccine and may not reflect the rates observed in clinical practice.
Clinical safety data for AFLURIA® have been obtained in two clinical studies (see randomized to receive AFLURIA® (1,089 subjects) or placebo (268 subjects) (see Clinical Studies for study demographics). There were no deaths or serious adverse events reported in this study.
A UK study (Study 2) included 275 subjects, ages 65 years and older, randomized to receive preservative-free AFLURIA® (206 subjects) or a European-licensed trivalent inactivated influenza vaccine as an active control (69 subjects) (see Clinical Studies). There were no deaths or serious adverse events reported in this study.
The safety assessment was identical for the two studies. Local (injection-site) and systemic adverse events were solicited by completion of a symptom diary card for 5 days post-vaccination (Table 1). Unsolicited local and systemic adverse events were collected for 21 days post-vaccination (Table 2). These unsolicited adverse events were reported either spontaneously or when subjects were questioned about any changes in their health post-vaccination. All adverse events are presented regardless of any treatment causality assigned by study investigators.
Table 1: Proportion of Subjects With Solicited Local or Systemic Adverse Events* Within 5 days After Administration of AFLURIA® or Placebo, Irrespective of Causality†
| Study 1 Subjects ≥ 18 to < 65 Years |
Study 2 Subjects ≥ 65 Years |
||
| Solicited dverse event |
AFLURIA®‡ n=1089 |
Placebo§ n=268 |
AFLURIA® n=206 |
| Local | |||
| Tenderness|| | 60% | 18% | 34% |
| Pain¶ | 40% | 9% | 9% |
| Redness | 16% | 8% | 23% |
| Swelling | 9% | 1% | 11% |
| Bruising | 5% | 1% | 4% |
| Systemic | |||
| Headache | 26% | 26% | 15% |
| Malaise | 20% | 19% | 10% |
| Muscle aches | 13% | 9% | 14% |
| Nausea | 6% | 9% | 3% |
| Chills/ Shivering | 3% | 2% | 7% |
| Fever ≥ 37.7°C (99.86°F) | 1% | 1% | 1% |
| Vomiting | 1% | 1% | 0% |
| * In Study 1, 87% of solicited local and systemic adverse
events were mild, 12% were moderate, and 1% were severe. In Study 2, 76.5%
were mild, 20.5% were moderate, and 3% were severe. In both studies, most
solicited local and systemic adverse events lasted no longer than 2 days.
† Values rounded to the nearest whole percent. ‡ Includes subjects who received either the single-dose (preservative-free) or multi-dose formulation of AFLURIA®. § Thimerosal-containing placebo. || Tenderness defined as pain on touching. ¶ Pain defined as spontaneously painful without touch. |
|||
Table 2: Adverse Events* Reported Spontaneously by ≥ 1% of Subjects Within 21 Days After Administration of AFLURIA® or Placebo, Irrespective of Causality†
| Study 1 Subjects ≥ 18 to < 65 years |
Study 2 Subjects ≥ 65 years |
||
| Adverse Event | AFLURIA®‡ n=1089 |
Placebo§ n=268 |
AFLURIA® n=206 |
| Headache | 8% | 6% | 8% |
| Nasal Congestion | 1% | 1% | 7% |
| Cough | 1% | 0.4% | 5% |
| Rhinorrhea | 1% | 1% | 5% |
| Pharyngolaryngeal Pain | 3% | 1% | 5% |
| Reactogenicity Event | 3% | 3% | 0% |
| Diarrhea | 2% | 3% | 1% |
| Back Pain | 2% | 0.4% | 2% |
| Upper Respiratory Tract Infection | 2% | 1% | 0.5% |
| Viral Infection | 0.4% | 1% | 0% |
| Lower Respiratory Tract Infection | 0% | 0% | 1% |
| Myalgia | 1% | 1% | 1% |
| Muscle Spasms | 0.4% | 1% | 0% |
| * In Study 1, 63% of unsolicited adverse events were mild,
35% were moderate, and 2% were severe. In Study 2, 47% weremild, 51% were
moderate, and 3% were severe. In both studies, most unsolicited adverse
events lasted no longer than 5 days. † Values greater than 0.5% rounded to the nearest whole percent. ‡Includes subjects who received either the single-dose (preservative-free) or multi-dose formulation of AFLURIA®. § Thimerosal-containing placebo. |
|||
Postmarketing Experience
Because postmarketing reporting of adverse reactions is voluntary and from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure. The adverse reactions described have been included in this section because they: 1) represent reactions that are known to occur following immunizations generally or influenza immunizations specifically; 2) are potentially serious; or 3) have been reported frequently. The following adverse reactions also include those identified during postapproval use of AFLURIA® outside the US since 1985.
Blood and lymphatic system disorders
Transient thrombocytopenia
Immune system disorders
Allergic reactions including anaphylactic shock and serum sickness
Nervous system disorders
Neuralgia, paresthesia, and convulsions; encephalopathy, neuritis or neuropathy, transverse myelitis, and GBS
Vascular disorders
Vasculitis with transient renal involvement
Skin and subcutaneous tissue disorders
General disorders and administration site conditions
Influenza-like illness (e.g., pyrexia, chills, headache, malaise, myalgia), injection-site inflammation (e.g., pain, erythema, swelling, warmth), and induration
Other Adverse Reactions Associated With Influenza Vaccination
Anaphylaxis has been reported after administration of AFLURIA®. Although AFLURIA® contains only a limited quantity of egg protein, this protein can induce immediate hypersensitivity reactions among persons who have severe egg allergy. Allergic reactions include hives, angioedema, allergic asthma, and systemic anaphylaxis (see CONTRAINDICATIONS).
The 1976 swine influenza vaccine was associated with an increased frequency of GBS. Evidence for a causal relation of GBS with subsequent vaccines prepared from other influenza viruses is unclear. If influenza vaccine does pose a risk, it is probably slightly more than one additional case per 1 million persons vaccinated.
Neurological disorders temporally associated with influenza vaccination, such as encephalopathy, optic neuritis/neuropathy, partial facial paralysis, and brachial plexus neuropathy, have been reported.
Microscopic polyangiitis (vasculitis) has been reported temporally associated with influenza vaccination.
DRUG INTERACTIONS
Concurrent Use With Other Vaccines
There are no data to assess the concomitant administration of AFLURIA® with other vaccines. If AFLURIA® is to be given at the same time as another injectable vaccine(s), the vaccine(s) should be administered at different injection sites.
AFLURIA® should not be mixed with any other vaccine in the same syringe or vial.
Concurrent Use With Immunosuppressive Therapies
The immunological response to AFLURIA® may be diminished in individuals receiving corticosteroid or immunosuppressive therapies.
Generic Name: Influenza Virus Vaccine
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