Dryvax

In the U.S.

• ACAM2000
• Dryvax

Available Dosage Forms:

• Powder for Suspension
• Powder for Solution

Therapeutic Class: Vaccine

Smallpox vaccine is an active immunizing agent used to prevent smallpox infection. It works by causing your immune system to produce its own protection (antibodies) against the virus .

This vaccine should only be administered by or under the supervision of your doctor or another health care professional .

This medicine is available only with a doctor's prescription .

This section provides information on the proper use of a number of products that contain smallpox vaccine. It may not be specific to Dryvax. Please read with care.

A nurse or other trained health professional will give you this vaccine. This vaccine is given by using a needle to poke or jab the skin on your upper arm .

You may need a booster dose of this vaccine every three years to maintain protection against smallpox. Ask your doctor if you will need another dose of this vaccine .

This vaccine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions .

It is very important that your doctor check your progress at regular visits to make sure this vaccine is working properly and to check for unwanted effects .

This vaccine may cause serious heart problems in some patients. Check with your doctor right away if you are having chest pain or discomfort; dizziness; fast or irregular heartbeat; fever and chills; shortness of breath; sweating, weakness; or trouble breathing .

Tell your doctor if you smoke cigarettes or other tobacco products. The risk of heart problems is increased in people who smoke .

You should not receive this vaccine if you are using medicines that weaken your immune system, such as steroids, radiation, or cancer medicines .

You should not become pregnant for at least 3 months after receiving this vaccine without first checking with your doctor. There is a chance that this vaccine may cause problems during pregnancy. If you think you have become pregnant, tell your doctor right away .

This vaccine contains neomycin and polymyxin B. Make sure your doctor knows if you have had an allergic reaction to these medicines .

This vaccine contains a live virus. The virus can cause an infection in other parts of your body or in other people if you touch the vaccination site and then touch your body or other people. Always cover the vaccination site with a bandage. Wash your hands thoroughly after changing the bandage or after touching the vaccination site. Your doctor will tell you how to care for the vaccination site. Make sure you understand the directions and follow them carefully. Avoid contact with people who are sick or have infections until the scab falls off (usually 2 to 4 weeks after vaccination). Talk to your doctor about this if you have concerns .

You must wait at least 30 days before you can donate blood, use a hot tub or swim, handle a baby, or breastfeed .

Before you have any medical tests for syphilis or a tuberculin (TB) skin test, tell the medical doctor in charge that you have received this vaccine. The results of these tests may be affected by this vaccine .

Applies to smallpox vaccine: percutaneous powder for injection

General

Regional lymphadenopathy, myalgia, fever, nausea, and malaise occur at the height of the major reaction after vaccination, indicating the vaccination was successful. Fever commonly occurs in children after vaccination but is less common in adults. From 4 to 14 days after primary vaccination at least 70% of children have had 1 or more days of temperature greater than 100 degrees F. Fifteen to twenty percent have had temperatures greater than 102 degrees F.[Ref]

Other

The most frequent complication is inadvertent inoculation of other sites, usually due of autoinoculation of the virus transferred from the vaccination site to other parts of the body. The face, eyelids, nose, mouth, genitalia, and rectum are most commonly involved. Autoinoculation of the eyes may cause blindness.[Ref]

Postvaccinial encephalitis, encephalomyelitis, encephalopathy, progressive vaccinia (vaccinia necrosum) and eczema vaccinatum are more severe complications that may occur following primary vaccination or revaccination. Severe disability, permanent neurological sequelae, and/or death may occur. Approximately 1 death per million primary vaccinations and 1 death per 4 million revaccinations have been reported, most often due to encephalitis or progressive vaccinia. Death has also occurred in unvaccinated contacts of vaccinated persons. Vaccinia viremia has been rarely reported after vaccination.

Vaccinia Immune Globulin may be indicated for certain vaccine complications such as eczema vaccinatum, progressive vaccinia, severe generalized vaccinia, or severe ocular vaccinia and may be obtained from the Centers for Disease Control (CDC). Physicians may contact the CDC for assistance with diagnosis and treatment of smallpox vaccine complications. Telephone: (404) 639-3670 (Monday-Friday, 8 AM-4:30 PM EST) or (404) 639-2888 (at other times).[Ref]

Dermatologic

Healthy persons may develop generalized vaccinia with a generally self-limited vesicular or maculopapular rash within 6 to 9 days after vaccination. This condition is more serious in immunocompromised individuals.

Eczema vaccinatum appears shortly after the vaccinial lesion appears and is characterized by a high fever, malaise, generalized lymphadenopathy, and extensive vesicular and pustular eruptions. Patients with a history of atopic dermatitis have the highest risk of developing EV. The prognosis is poor and the mortality rate is high.

Progressive vaccinia (i.e., vaccinia necrosum, vaccinia gangrenosa, prolonged vaccinia, disseminated vaccinia), is characterized by a nonhealing vaccination site, painless progressive necrosis at the vaccination site, and occasionally metastasis to other parts of the skin, bones, and viscera. The distant lesions contain live vaccinia virus. Immunocompromised patients are at a greater risk. The prognosis is poor.

Vaccinia Immune Globulin (VIG) may be indicated for eczema vaccinatum or progressive vaccinia and may be obtained from the Centers for Disease Control (CDC). Physicians may contact the CDC for assistance with diagnosis and treatment of smallpox vaccine (the active ingredient contained in Dryvax) complications. Telephone: (404) 639-3670 (Monday-Friday, 8 AM-4:30 PM EST) or (404) 639-2888 (at other times).

Hypersensitivity reactions including Stevens-Johnson syndrome and erythema multiforme have rarely been reported. The onset of symptoms (bulls-eye lesions and pruritus) is generally 10 days after vaccination.

Dermatofibrosarcoma protuberans, malignant fibrous histiocytoma, malignant melanoma, squamous cell carcinoma, basal cell carcinoma, and benign dermatofibroma have been reported in smallpox vaccination scars.

Contact spread of vaccinia from recently vaccinated military personnel has been reported.[Ref]

Dermatologic side effects have included pruritus, rash, generalized vaccinia (GV), eczema vaccinatum (EV), progressive vaccinia (PV), erythema multiforme, folliculitis, Stevens-Johnson syndrome, bacterial infections, and contact spread. In addition, precipitation of erythema nodosum in patients with leprosy, malignant tumors at the vaccination scar, discoid lupus, and localized myxedema have been reported; however, causality has not been established.[Ref]

Local

Local side effects have included secondary pyogenic infections at the site of vaccine application. occurring approximately 5 days after vaccination. Swelling, warmth, and pain at the injection site, with peak symptoms occurring 8 to 10 days after vaccination and resolving within 24 to 72 hours, are indicative of a normal vaccination reaction.[Ref]

Hypersensitivity

Hypersensitivity reactions may include persistent allergic sensitization to viral proteins even after immunity has waned. The allergy is manifested by the appearance of a papule and a small area of redness appearing within the first 24 hours after revaccination. Vesicles may appear in 24 to 48 hours, followed by scabbing. Stevens-Johnson syndrome, and erythema multiforme have also been reported.[Ref]

Ocular

Ocular side effects have included mild to severe ocular vaccinia resulting from inadvertent autoinoculation and manifested by keratitis (epithelial and stromal), iritis, conjunctivitis (hyperemia, edema, membranes, focal lesions), and/or blepharitis (lid pustules, edema, hyperemia, cellulitis). Corneal scarring, disciform edema, and loss of vision have occurred in patients with vaccinial keratitis. Lymphadenopathy and fever have also been associated with ocular vaccinia. Ocular vaccinia has been reported in contacts of vaccinees.[Ref]

Trifluridine or vidarabine ophthalmic ointment have been recommended for conjunctival or corneal vaccinia infections. In addition, vaccinia immune globulin (VIG) may be considered for severe blepharitis, blepharoconjunctivitis, or keratitis (if there is a risk of vision loss). When using of VIG for keratitis, the possibility of an increased risk of corneal scar formation (associated with large doses over multiple days in animal models) should be taken into consideration. VIG is not recommended for isolated keratitis.

VIG may be obtained from the Centers for Disease Control (CDC). Physicians may contact the CDC for assistance with diagnosis and treatment of smallpox vaccine complications. Telephone: (404) 639-3670 (Monday-Friday, 8 AM-4:30 PM EST) or (404) 639-2888 (at other times).[Ref]

Nervous system

Nervous system side effects have rarely included headache, dizziness, paresthesia, vertigo, transient global amnesia, anoxic encephalopathy, polyneuropathy, cerebrovascular accident, CNS tumor, precipitation of neuritis in leprosy patients, transverse myelitis, seizures, paralysis, polyneuritis, brachial neuritis, and one case of ptosis, diplopia, slurred speech, and paresis, although causality has not been clearly established in all cases. The vaccine has also been associated with encephalitis (PVE) and encephalomyelitis (PVEM). PVE is has a sudden onset (6 to 10 days after vaccination) and is characterized by seizures, hemiplegia, aphasia, transient amnesia, generalized cerebral edema, mild lymphocytic meningeal infiltration, ganglion degenerative changes, and perivascular hemorrhages. Cerebrospinal fluid examination may demonstrate increased opening CSF pressure, monocytosis, lymphocytosis, or elevated CSF protein. PVEM is characterized by sudden onset (11 to 15 days after vaccination) of fever, headache, malaise, lethargy, vomiting, and anorexia. Symptoms may progress to unconsciousness, amnesia, confusion, disorientation, restlessness, delirium, drowsiness, seizures, urinary incontinence, urinary retention, constipation, meningismus and/or coma. Increased CSF pressure is present, but chemistry and cell count may be normal. Histopathological changes include perivenous demyelination, microglial proliferation in demyelinated areas with lymphocytic infiltration.[Ref]

PVE occurs more commonly in children less than 2 years old. The incidence in 1968 was reported as 2.9 cases per million vaccinees. The mortality rate is 25%, complete recovery occurs in 50%, and neurologic sequelae remain in 25%.[Ref]

Cardiovascular

Cardiovascular side effects have rarely included myocarditis, pericarditis, myocardial infarction, hypertension, atypical chest pain, angina, palpitations, supraventricular tachycardia, atrial dysrhythmias, symptomatic trigeminy, premature ventricular contractions, coronary artery disease, dilated cardiomyopathy, sudden death due to atherosclerotic coronary artery disease 60 days after vaccination, and chest tightness with ECG changes, although causality has not been clearly established in all cases.[Ref]

Symptoms of myopericarditis include chest pain, ECG changes, increased cardiac enzymes, and sometimes abnormal echocardiograms, and usually occur 4 to 30 days after vaccination.

Pulmonary edema and eosinophilic myopericarditis developed in a 29-year-old male 3 weeks after multiple vaccinations including smallpox vaccine.[Ref]

Musculoskeletal

Musculoskeletal side effects have included osteomyelitis, arthritis, shoulder pain, and noncardiac chest pain; however, causality has not been established in all cases.[Ref]

Respiratory

Respiratory side effects have rarely included asthma, pneumonia, respiratory distress, and pseudomediastinum associated with scuba diving, although causality has not been clearly established.[Ref]

Genitourinary

Genitourinary side effects have rarely included prostatitis, although causality has not been clearly established.[Ref]

Gastrointestinal

Gastrointestinal side effects have rarely included cholecystitis and gastroesophageal reflux disease, although causality has not been clearly established in all cases.[Ref]

Some side effects of Dryvax may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.