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BioThrax

"The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, today announced three new contracts to fund research on vaccines to protect against emerging infectious diseases and biological threats "...

BioThrax

BioThrax Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

BioThrax (anthrax) Vaccine Adsorbed is an immunization used to help prevent anthrax disease in people exposed to the bacteria through the skin or lungs. This vaccine works by exposing you to an antigen protein that causes your body to develop immunity to the disease. It does not contain live or killed forms of the bacteria that causes anthrax. BioThrax vaccine will not treat an active infection. Common side effects include pain/redness/swelling at the injection site, limited arm movement, muscle ache, headache, or tiredness.

Immunization with BioThrax consists of a series of 5 intramuscular doses administered at 0 and 4 weeks and 6, 12 and 18 months. Select a different injection site for each sequential injection of this vaccine. Individuals should not be considered protected until they have received the full series of vaccinations. BioThrax may interact with other vaccines, steroids, medicines to treat or prevent organ transplant rejection, or medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders. Tell your doctor all medications and supplements you use and all vaccines you recently received. BioThrax is not recommended for use during pregnancy. It may harm a fetus. It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Our BioThrax (anthrax) Vaccine Adsorbed Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

BioThrax in Detail - Patient Information: Side Effects

You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects you have after receiving this vaccine. When you receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with anthrax is much more dangerous to your health than receiving the vaccine to protect against it. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect (some are rare but serious) such as:

  • severe swelling or a hard lump where the shot was given;
  • severe swelling spreading to other parts of your arm;
  • fever, chills, body aches, nausea, flu symptoms;
  • pale skin, easy bruising or bleeding;
  • confusion, changes in mood or behavior;
  • seizure (convulsions);
  • blistering, redness, and swelling or warmth of the skin;
  • weakness, numbness or tingly feeling in your feet spreading upward;
  • problems with vision, hearing, speech, swallowing, or bladder and bowel functions;
  • severe lower back pain; or
  • slow heart rate, trouble breathing, weak pulse, or feeling like you might pass out.

Less serious side effects include:

  • mild redness, warmth, itching, or tenderness where the shot was given;
  • low fever;
  • feeling tired or weak;
  • headache, dizziness;
  • mild pain or stiffness in the injected arm;
  • joint or muscle pain;
  • swelling in your hands or feet; or
  • mild skin rash.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for BioThrax (Anthrax Vaccine Adsorbed Emergent BioSolutions) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

BioThrax Overview - Patient Information: Side Effects

SIDE EFFECTS: Pain/redness/swelling at the injection site, limited arm movement, muscle ache, headache, or tiredness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Infrequently, temporary symptoms such as fainting/dizziness/lightheadedness, vision changes, numbness/tingling, or seizure-like movements have happened after vaccine injections. Tell your health care provider right away if you have any of these symptoms soon after receiving an injection. Sitting or lying down may relieve symptoms.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US, you may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967. In Canada, you may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for BioThrax (Anthrax Vaccine Adsorbed Emergent BioSolutions)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

BioThrax FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The most common ( ≥ 10%) local (injection-site) adverse reactions observed in clinical studies were tenderness, pain, erythema and arm motion limitation. The most common ( ≥ 5%) systemic adverse reactions were muscle aches, headache, and fatigue.

Serious allergic reactions, including anaphylactic shock, have been observed during post-marketing surveillance in individuals receiving BioThrax (anthrax vaccine adsorbed emergent biosolutions) .

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a product cannot be directly compared to rates in the clinical trials of another product and may not reflect the rates observed in clinical practice.

Local and systemic reactions were monitored in an open-label safety study of 15,907 doses of BioThrax (anthrax vaccine adsorbed emergent biosolutions) administered by the subcutaneous route to approximately 7,000 textile employees, laboratory workers and other at risk individuals. Over the course of the 5-year study the following local reactions were reported: 24 (0.15% of doses administered) severe local reactions (defined as edema or induration measuring greater than 120 mm in diameter or accompanied by marked limitation of arm motion or marked axillary node tenderness), 150 (0.94% of doses administered) moderate local reactions (edema or induration greater than 30 mm but less than 120 mm in diameter), and 1,373 (8.63% of doses administered) mild local reactions (erythema only or induration measuring less than 30 mm in diameter). Four cases of systemic reactions were reported during the 5-year reporting period ( < 0.06% of doses administered). These reactions, which were reported to have been transient, included fever, chills, nausea and general body aches.

The CDC sponsored a randomized, double-blind, placebo-controlled, multi-center clinical study [NCT00119067] in which 1,564 healthy volunteers were enrolled [See Clinical Studies section]. The objective of this study was to evaluate the effect of (1) changing the route of vaccine administration from subcutaneous (SQ) to intramuscular (IM), and (2) of reducing the number of doses on the safety and immunogenicity of BioThrax (anthrax vaccine adsorbed emergent biosolutions) . A planned analysis of the first 1,005 subjects compared four treatment groups over a period of seven months in which subjects received a total of either three (3) or four (4) doses of BioThrax (anthrax vaccine adsorbed emergent biosolutions) . Subjects were instructed to complete a 14-day post-vaccination diary card after the first 2 doses and a 28-day diary card after the subsequent doses to capture solicited and unsolicited adverse events. Adverse reaction data were also collected from in-clinic exams, which were performed prior to, and 15 to 60 minutes post each injection, at 1 to 3 days after each injection, and at 28 days after injections 3 and 4. Demographic characteristics for each respective treatment group in the analysis are provided in Table 1.

Table 1: Demographic characteristics: CDC Study

Study Group
(Total vaccinated cohortn= 1,005)
Group A BioThrax SQ Weeks-0-2-4-26
n=165
Group B BioThrax IM Weeks-0-2-4-26
n=170
Group C BioThrax IM Weeks-0-4-26
n=501
Placebo Control
n=169
Characteristic Parameters or categories Value or n (%) Value or n (%) Value or n (%) Value or n (%)
Age < 30 yrs 58
(35.15%)
42
(24.71%)
149
(29.74%)
52
(30.77%)
30 to < 40 yrs 30
(18.18%)
44
(25.88%)
132
(26.35%)
35
(20.71%)
40 to < 50 yrs 50
(30.30%)
52
(30.59%)
128
(25.55%)
51
(30.18%)
≥ 50 yrs 27
(16.36%)
32
(18.82%)
92
(18.36%)
31
(18.34%)
Gender Female 81
(49%)
87
(51 %)
249
(50 %)
83
(49%)
Male 84
(51%)
83
(49 %)
252
(50%)
86
(51%)
Race Caucasian 129
(78%)
126
(74%)
383
(76%)
130
(79%)
African-American 28
(17%)
32
(19%)
96
(19%)
31
(18%)
Other 8
(5%)
12
(7%)
22
(4%)
8
(5%)

Shown in Table 2 and Table 3, respectively, are the rates (percentage) of prospectively defined local and systemic solicited adverse reactions observed in the in-clinic exams.

The analysis of injection site (local) reactions demonstrated that administration of the vaccine by the IM route, as compared to the SQ route, resulted in a statistically significant reduction in reactogenicity (i.e. cutaneous adverse reactions). Injection site adverse reactions, including warmth, tenderness, itching, erythema, induration, edema, and nodule, consistently occurred at lower frequencies and for shorter duration in participants given BioThrax (anthrax vaccine adsorbed emergent biosolutions) by the IM route. Route of administration did not statistically significantly influence the occurrence or duration of systemic adverse reactions, with the exception of muscle ache (increased occurrence only). Most local and systemic adverse reactions were mild or moderate in severity; the proportion of participants with severe adverse reactions reported was very low ( < 1%). It was observed in this study that women receiving BioThrax (anthrax vaccine adsorbed emergent biosolutions) reported significantly more injection-site adverse reactions than did men. This gender-related difference was seen regardless of the route of administration, but was more pronounced in those receiving the vaccine by the SQ route. Women also reported more systemic adverse reactions than men (in particular fatigue, muscle ache and headache), but these gender differences were not influenced by route of administration. A brief pain or burning sensation, felt immediately after vaccine injection, was reported by most study participants. The pain was rated on a visual analog scale as 0-10. It was described as significant ( > 3) more often following SQ administration (41%) than IM administration (26%). Female participants generally experienced a higher pain scale rating than male participants.

Serious adverse reactions were infrequently reported during this study but two (2) important serious adverse reactions that were noted to be possibly related to BioThrax (anthrax vaccine adsorbed emergent biosolutions) administration include: a case of anaphylaxis and a case of an ANA positive autoimmune disorder manifesting as a moderate bilateral arthralgia of the metacarpophalangeal (MCP) joints. The majority of serious adverse reactions reported were unrelated to vaccination. Out of a total of 44 pregnancies reported in this study, no distinct patterns of infant outcome were seen, with the majority of pregnancies uncomplicated and healthy term infants delivered. Of women who received vaccine approximately within the first trimester (n = 15), 2 reports of spontaneous abortion were reported, along with one report of a healthy term infant with mild right clubbed foot abnormality.

Table 2: Local Adverse Reactions: In-Clinic Solicited by Dose Number*

  TREATMENT ARM
Group B BioThrax IM Weeks-0-2-4-26 Group C BioThrax IM Weeks-0-4-26 Placebo SQ/IM Weeks-0-2-4-26 Group A BioThrax SQWeeks-0-2-4-26
Number of Subjects (N)** 170 501 169 165
Dose Dose Dose Dose
1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4
% % % % % % % % % % % % % % % %
Adverse Reactions
Warmth 4 8 6 11 3 1 10 9 2 0 0 0 28 37 29 36
Tenderness 51 61 37 42 47 10 52 51 5 6 6 9 67 72 45 60
Itching 1 3 4 9 0 1 3 6 0 0 0 0 4 15 21 19
Pain 23 23 11 17 18 4 23 15 2 2 3 3 18 24 8 16
Arm motion limitation 11 14 5 10 16 1 16 13 1 0 2 0 9 14 6 12
Erythema 13 22 21 31 10 8 20 25 12 10 8 13 52 60 57 63
Induration 5 9 8 11 4 3 9 14 1 2 4 3 26 32 30 43
Edema 4 12 13 16 3 1 13 11 1 4 3 2 14 28 27 29
Nodule 4 2 5 6 2 1 3 6 0 1 0 1 38 45 36 27
Bruise 6 4 3 3 4 3 5 4 4 6 2 4 5 5 5 3
Presence of any local adverse reaction 62 69 52 62 58 25 67 68 20 19 17 23 81 86 79 81
Presence of any moderate/severe localadverse reactions§ 6 9 5 8 5 1 9 5 1 0 0 0 6 16 8 10
Presence of any large local adverse reaction 0 1 3 1 0 0 1 2 0 0 0 0 1 1 5 3
*Per-dose, statistical assessment performed on Intent-to-Treat population data. Evaluations performed at 15-60 minutes and 1-3 days following each injection and prior to the next scheduled injection.
** N is the highest number per treatment arm; denominator (N) varied with dose number due to attrition over time.
Subjects received saline (instead of BioThrax (anthrax vaccine adsorbed emergent biosolutions) ) for the Week 2 dose.
The two saline groups (SQ and IM) were combined.
§Moderate = causes discomfort and interferes with normal daily activities; Severe = incapacitating and completely prevents performing normal daily activities.
Large = an occurrence of induration, erythema, edema, nodule and bruise with a largest diameter greater than 120 mm.

Table 3: Systemic Adverse Reactions: In-Clinic Solicited by Dose Number*

  TREATMENT ARM
Group B BioThrax IM Weeks-0-2-4-26 Group C BioThrax IM Weeks-0-4-26 Placebo SQ/IM Weeks-0-2-4-26 Group A BioThrax SQ Weeks-0-2-4-26
Number of Subjects (N)** 170 501 169 165
Dose Dose Dose Dose
1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4
% % % % % % % % % % % % % % % %
Systemic Adverse Reactions
Fatigue 7 10 12 8 8 5 12 8 5 5 6 5 8 9 7 8
Muscle ache 11 10 6 6 9 2 14 7 1 2 3 3 6 8 3 5
Headache 4 7 9 5 5 5 7 4 2 6 3 1 7 6 8 9
Fever > 100.4 oF 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Tender/painful axillary adenopathy 0 1 0 1 0 0 1 0 0 0 0 0 1 1 4 1
Presence of any systemic adverse reaction 20 22 21 15 18 10 26 15 8 10 12 8 17 17 17 17
Presence of any moderate/severe systemic adversereactions§ 1 3 3 4 2 1 6 4 1 1 3 2 1 4 3 3
*Per-dose, statistical assessment performed on Intent-to-Treat population data. Evaluations performed at 15-60 minutes and 1-3 days following each injection and prior to the next scheduled injection.
** N is the highest number per treatment arm; denominator (N) varied with dose number due to attrition over time.
Subjects received saline (instead of BioThrax (anthrax vaccine adsorbed emergent biosolutions) ) for the Week 2 dose.
The two saline groups (SQ and IM) were combined.
§Moderate = causes discomfort and interferes with normal daily activities; Severe = incapacitating and completely prevents performing normal daily activities.

Table 4 shows adverse events (excluding injection site reactions) that occurred in ≥ 2% of participants through Study Month 7, and excluding those that occurred at a lower rate than those observed in the placebo group.

Table 4: Solicited and Unsolicited Adverse Events Occurring in > 2% of Subjects*

MedDRA Preferred Term Group B BioThrax IM Weeks 0-2-4-26 Group C BioThrax IM Weeks 0-4-26 Placebo SQ/IM Weeks 0-2-4-26 Group A BioThrax SQWeeks 0-2-4-26
Number of Subjects 170 501 169 165
N (%) N (%) N (%) N (%)
Headache 108 (63.5) 312 (62.3) 82 (48.5) 111 (67.3)
Myalgia 105 (61.8) 360 (71.9) 63 (37.3) 101 (61.2)
Fatigue 104 (61.2) 311 (62.1) 82 (48.5) 101 (61.2)
Nasopharyngitis 26 (15.3) 61 (12.2) 13 (7.7) 18 (10.9)
Pharyngolaryngeal Pain 21 (12.4) 58 (11.6) 18 (10.7) 20 (12.1)
Back Pain 15 (8.8) 36 (7.2) 6 (3.6) 11 (6.7)
Diarrhea NOS 13 (7.7) 31 (6.2) 6 (3.6) 7 (4.2)
Dysmenorrhoea 12 (7.1) 36 (7.2) 11 (6.5) 7 (4.2)
Sinusitis NOS 12 (7.1) 24 (4.8) 8 (4.7) 7 (4.2)
Nausea 10 (5.9) 29 (5.8) 8 (4.7) 15 (9.1)
Hypersensitivity NOS 6 (3.5) 12 (2.4) 0 (0.0) 6 (3.6)
Neck Pain 5 (2.9) 16 (3.2) 3 (1.8) 1 (0.6)
Sinus Headache 5 (2.9) 7 (1.4) 0 (0.0) 3 (1.8)
Rigors 4 (2.3) 7 (1.4) 2 (1.2) 0 (0.0)
Upper Respiratory Tract Infection NOS 3 (1.8) 16 (3.2) 2 (1.2) 7 (4.2)
Influenza Like Illness 3 (1.8) 12 (2.4) 2 (1.2) 1 (0.6)
Lymphadenopathy 5 (2.9) 9 (1.8) 2 (1.2) 5 (3.0)
Rash NOS 0 (0.0) 12 (2.4) 1(0.6) 3 (1.8)
Joint Sprain 0 (0.0) 10 (2.0) 3 (1.8) 1 (0.6)
Pruritus 0 (0.0) 10 (2.0) 1 (0.6) 3 (1.8)
* Listed MedDRA terms (N) are limited to those for which the adverse reaction rate for BioThrax (anthrax vaccine adsorbed emergent biosolutions) (Weeks 0-2-4-26 or Weeks 0-4-26) exceeds the adverse reactions rate for placebo (Weeks 0-2-4-26) through month 7 irrespective of causality and severity; for each MedDRA Preferred Term in this table, an adverse event is only listed once per subject, even if the adverse event occurs more than once during the 7-month observation period; events already listed in Table 2 are not listed here. The denominator includes any subject who was randomized and received at least one dose of vaccine.
The two saline groups (SQ and IM) were combined

Postmarketing Experience

The following adverse events have been identified during postapproval use of BioThrax (anthrax vaccine adsorbed emergent biosolutions) . Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The reports included below are listed due to one or more of the following factors: (1) seriousness of the event, (2) number of reports, or (3) strength of causal relationship to the drug.

  • Blood and lymphatic system disorders

Lymphadenopathy

  • Immune system disorders

Allergic reactions (including anaphylaxis, angioedema, rash, urticaria, pruritus, erythema multiforme, anaphylactoid reaction and Stevens Johnson syndrome)

  • Nervous system disorders

Headache, paresthesia syncope, tremor, ulnar nerve neuropathy

  • Musculoskeletal, connective tissue and bone disorders

Arthralgia, arthropathy, myalgia, rhabdomyolysis, alopecia

  • General disorders and administration site conditions

Injection site reactions (including pain, nodule, edema, induration, erythema, warmth, pruritus, cellulitis), fatigue, pyrexia, flu-like symptoms

Infrequent reports were also received of multisystem disorders defined as chronic symptoms involving at least two of the following three categories: fatigue, mood-cognition and musculoskeletal system.

No fatalities have been determined to have been causally related to the administration of BioThrax (anthrax vaccine adsorbed emergent biosolutions) .

Read the entire FDA prescribing information for BioThrax (Anthrax Vaccine Adsorbed Emergent BioSolutions) »

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