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November 25, 2025
Brand Name :
ACAM2000, Dryvax
Synonyms :
smallpox (vaccinia) vaccine live
Class :
Vaccines, Live and Viral
Dosage Forms & Strengths
lyophilized vaccine and vial containing diluent- Multiple-dose vial:
After reconstitution with the diluent:
0.0025 mL contains 2.5 x 105 to 12.5 x 105 plaque-forming units (PFU) of vaccinia virus
Smallpox Prophylaxis:
Administer one drop through scarification, the percutaneous route by multiple puncture technique in the upper arm over-insertion
Note:
At the vaccination site, a trace of blood should appear after 15-20 seconds; if not, three insertions need to be done with the same needle and avoid reinserting the needle in the vaccine bottle.
Booster dose:
For high-risk smallpox infection: revaccination is needed every three years.
Nonemergency revaccination: every 3 to 10 years, followed by the type of exposure
Renal Dose Adjustments
No data available
Liver Dose Adjustments
No data available
Administer one drop through scarification, the percutaneous route by multiple puncture technique in the upper arm over-insertion.
Note:
At the vaccination site, a trace of blood should appear after 15-20 seconds; if not, three insertions need to be done with the same needle and avoid reinserting the needle in the vaccine bottle.
Booster dose:
For high-risk smallpox infection: revaccination is needed every three years.
Nonemergency revaccination: every 3 to 10 years, followed by the type of exposure
Dose Adjustments
Renal Dose Adjustments:
No data available
Liver Dose Adjustments:
No data available
Dosage Forms & Strengths
lyophilized vaccine and vial containing diluent- Multiple-dose vial:
After reconstitution with the diluent:
0.0025 mL contains 2.5 x 105 to 12.5 x 105 plaque-forming units (PFU) of vaccinia virus
Smallpox Immunization:
Age: below 16 years (only in emergent conditions) and ≥16 years:
Administer one drop through scarification, the percutaneous route by multiple puncture technique in the upper arm over-insertion
Note:
At the vaccination site, a trace of blood should have appeared after 15-20 seconds. If not, more than three insertions must be done with the same needle, and avoid reinserting the same needle in the vaccine bottle.
Age: below 16 years (only in emergent conditions) and ≥16 years:
Administer one drop through scarification, the percutaneous route by multiple puncture technique in the upper arm over-insertion
Note:
At the vaccination site, a trace of blood should have appeared after 15-20 seconds. If not, more than three insertions must be done with the same needle, and avoid reinserting the same needle in the vaccine bottle.
measles, mumps, rubella, and varicella vaccine, live (Rx)
may diminish the therapeutic effect of other vaccines (live)
may decrease the therapeutic effect of immunosuppressants
may decrease the therapeutic effect of immunosuppressants
may decrease the therapeutic effect of immunosuppressants
may diminish the immunosuppressive effect of each other when combined
may diminish the immunosuppressive effect of each other when combined
may diminish the immunosuppressive effect of each other when combined
may diminish the immunosuppressive effect of each other when combined
may diminish the immunosuppressive effect of each other when combined
corticosteroids may diminish the therapeutic effect of vaccines
corticosteroids may diminish the therapeutic effect of vaccines
corticosteroids may diminish the therapeutic effect of vaccines
corticosteroids may diminish the therapeutic effect of vaccines
corticosteroids may diminish the therapeutic effect of vaccines
measles, mumps, rubella, and varicella vaccine, live (Rx)
may diminish the therapeutic effect of other vaccines (live)
may diminish the therapeutic effect of vaccines
may diminish the therapeutic effect of vaccines
may diminish the therapeutic effect of vaccines
may diminish the therapeutic effect of vaccines
may diminish the therapeutic effect of vaccines
may increase the toxic effect of COVID-19 vaccine
may decrease the therapeutic effect of immunosuppressants
it may increase the risk of adverse effects of vaccines
it may increase the risk of adverse effects of vaccines
it may increase the risk of adverse effects of vaccines
it may increase the risk of adverse effects of vaccines
it may increase the risk of adverse effects of vaccines
it may increase the risk of adverse effects of vaccines
it may increase the risk of adverse effects of vaccines
it may increase the risk of adverse effects of vaccines
it may reduce the therapeutic efficacy of vaccines
may reduce the therapeutic effect of vaccines
may reduce the therapeutic effect of vaccines
may reduce the therapeutic effect of vaccines
may reduce the therapeutic effect of vaccines
may reduce the therapeutic effect of vaccines
may reduce the therapeutic effect of vaccines
may diminish the therapeutic effect
amoxicillin and clavulanate potassium
may diminish the therapeutic effect
bismuth subcitrate, metronidazole and tetracycline
may diminish the therapeutic effect
may diminish the therapeutic effect
may diminish the therapeutic effect
lansoprazole, amoxicillin, and clarithromycin
may diminish the therapeutic effect
may diminish the therapeutic effect
may diminish the therapeutic effect
may diminish the therapeutic effect
may diminish the therapeutic effect
may diminish the therapeutic effect
may diminish the therapeutic effect
may diminish the therapeutic effect
may diminish the therapeutic effect
may diminish the therapeutic effect
may diminish the therapeutic effect
may diminish the therapeutic effect
may diminish the therapeutic effect
may diminish the therapeutic effect
may diminish the therapeutic effect
may diminish the therapeutic effect
may diminish the therapeutic effect
may diminish the therapeutic effect
may diminish the therapeutic effect
may diminish the therapeutic effect
immune globulins: it may decrease the therapeutic effect of vaccines (Live)
immune globulins: it may decrease the therapeutic effect of vaccines (Live)
immune globulins: it may decrease the therapeutic effect of vaccines (Live)
immune globulins: it may decrease the therapeutic effect of vaccines (Live)
immune globulins: it may decrease the therapeutic effect of vaccines (Live)
may reduce the therapeutic efficacy of the drug
cladribine: they may decrease the therapeutic effect of vaccines
corticosteroids: they may decrease the therapeutic effect of vaccines
corticosteroids: they may decrease the therapeutic effect of vaccines
corticosteroids: they may decrease the therapeutic effect of vaccines
corticosteroids: they may decrease the therapeutic effect of vaccines
corticosteroids: they may decrease the therapeutic effect of vaccines
methotrexate: they may decrease the therapeutic effect of vaccines
teplizumab: they may decrease the therapeutic effect of vaccines
fingolimod: they may decrease the therapeutic effect of vaccines
siponimod: they may decrease the therapeutic effect of vaccines
Immunosuppressants may enhance the adverse/toxic effect of Vaccines
Immunosuppressants may enhance the adverse/toxic effect of Vaccines
Immunosuppressants may enhance the adverse/toxic effect of Vaccines
Immunosuppressants may enhance the adverse/toxic effect of Vaccines
Immunosuppressants may enhance the adverse/toxic effect of Vaccines
may increase the adverse/toxic effect of immunosuppressants
may increase the adverse/toxic effect of immunosuppressants
may increase the adverse/toxic effect of immunosuppressants
may increase the adverse/toxic effect of immunosuppressants
may increase the adverse/toxic effect of immunosuppressants
may enhance the adverse/toxic effect
may enhance the adverse/toxic effect
may enhance the adverse/toxic effect
may diminish the pharmacodynamic antagonistic effect of each other when combined
may diminish the pharmacodynamic antagonistic effect of each other when combined
may diminish the pharmacodynamic antagonistic effect of each other when combined
may diminish the pharmacodynamic antagonistic effect of each other when combined
may diminish the pharmacodynamic antagonistic effect of each other when combined
Immunosuppressants may enhance the adverse/toxic effect of Vaccines
Immunosuppressants may enhance the adverse/toxic effect of Vaccines
Immunosuppressants may enhance the adverse/toxic effect of Vaccines
Immunosuppressants may enhance the adverse/toxic effect of Vaccines
Immunosuppressants may enhance the adverse/toxic effect of Vaccines
may decrease the effects of each other
it increases the toxicity of live vaccines
it increases the toxicity of live vaccines
it increases the toxicity of live vaccines
it increases the toxicity of live vaccines
may increase the toxic effect of salicylates
may increase the adverse effect of Immunosuppressants
famciclovir: they may increase the toxic effect of vaccines
ozanimod: they may increase the toxic effect of vaccines
tezepelumab: they may increase the toxic effect of vaccines
may diminish the therapeutic effect of other vaccines
vaccinia immune globulin intravenous (Rx)
may diminish the therapeutic effect of other vaccines
may diminish the therapeutic effect of other vaccines
may diminish the therapeutic effect of other vaccines
may diminish the therapeutic effect of other vaccines
measles mumps and rubella vaccine, live
they decrease the efficacy of other vaccines
they decrease the efficacy of other vaccines
smallpox (vaccinia) vaccine, live
they decrease the efficacy of other vaccines
they decrease the efficacy of other vaccines
they decrease the efficacy of other vaccines
immune globulins decrease the efficacy of live vaccines
immune globulins decrease the efficacy of live vaccines
immune globulins decrease the efficacy of live vaccines
immune globulins decrease the efficacy of live vaccines
immune globulins decrease the efficacy of live vaccines
may diminish the therapeutic effect of vaccines
may diminish the therapeutic effect of vaccines
may diminish the therapeutic effect of vaccines
may diminish the therapeutic effect of vaccines
may diminish the therapeutic effect of vaccines
measles, mumps, rubella and varicella vaccine, live
may decrease the therapeutic effects of vaccine(live)
measles mumps and rubella vaccine, live
they decrease the efficacy of other vaccines
they decrease the efficacy of other vaccines
smallpox (vaccinia) vaccine, live
they decrease the efficacy of other vaccines
they decrease the efficacy of other vaccines
they decrease the efficacy of other vaccines
may diminish the immunosuppressive effect of each other when combined
may diminish the pharmacodynamic antagonistic effect of each other when combined
may diminish the pharmacodynamic antagonistic effect of each other when combined
may diminish the pharmacodynamic antagonistic effect of each other when combined
may diminish the immunosuppressive effect of each other when combined
may diminish the immunosuppressive effect of each other when combined
may diminish the pharmacodynamic antagonistic effect of each other when combined
may diminish the pharmacodynamic antagonistic effect of each other when combined
may decrease the therapeutic effect of immunosuppressive Agents
may decrease the therapeutic effect of immunosuppressive Agents
may decrease the therapeutic effect of immunosuppressive Agents
may decrease the therapeutic effect of immunosuppressive Agents
may decrease the therapeutic effect of immunosuppressive Agents
leniolisib: they may increase the toxic effect of vaccines
it decreases the efficacy of live vaccines
Percutaneous scarification is the method used to give smallpox vaccinations.
A small region of skin is punctured multiple times using a bifurcated needle loaded with live antigen.
The successful development of protective immunity is proven by the production of a pustule, which is the outcome of a local reaction.
Adverse drug reactions:
Frequency defined:
>10%
Diarrhea
Decreased exercise tolerance
Injection site pruritus
Feeling hot
GI disorders
Erythema
Injection site erythema
Rigors
Injection site pain
Blood and lymphatic system disorders
Lymph node pain
Headache
Nausea
Rash
1-10%
Dyspnea
Constipation
Lymphadenopathy
Vomiting
Corneal scarring and dermatitis are two ocular consequences that can arise from an unintentional eye infection and cause blindness.
It contains live vaccinia virus, which can spread to people who are near to the person who received the vaccine.
Contacts are at the same risk as the person who received the vaccination.
The risks of contracting a potentially fatal smallpox infection must be balanced against the possibilities of experiencing major vaccine consequences.
Contraindication:
Severe immune deficiency
Caution:
Serious complications
Cardiac disease
Ocular complications
History or presence of eczema
Congenital or acquired immune deficiency
Pregnancy warnings:
US FDA pregnancy category: D
Breastfeeding warnings:
The release of the drug into the human breastmilk is unknown
Pregnancy Categories:
Category A: Satisfactory and well-controlled studies show no risk to the fetus in the first or later trimester.
Category B: No evidence shown of risk to the fetus found in animal reproduction studies, and there are not enough studies on pregnant women
Category C: Adverse effects on the fetus found with evidence in animal reproduction studies and no adequate evidence for a result in humans must take care of potential risks in pregnant women
Category D: There is adequate data available with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits
Category X: Drugs listed in this category outweigh risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.
Category N: There is no data available for the drug under this category
The variola virus, which causes smallpox and mpox, is a member of the same taxonomic group as the vaccine virus.
The vaccinia virus can cross-protect against the mpox and variola viruses.
A pustule also known as a “pock” or “take” forming at the site of inoculation is proof of protective immunity.
Vaccine Preparation:
Before reconstitution, the vial was taken out of cold storage and allowed to come to room temperature.
Using an isopropyl alcohol swab, wipe each rubber stopper and let it dry completely after removing the flip cap seals from the vaccine and diluent vials. Use a sterile 1 mL syringe and aseptic method.
Percutaneous (Scarification) Administration:
Skin preparation is not necessary unless the skin at the desired vaccination site is visibly unclean, in which case an alcohol swab or swabs may be used to clean the region. To avoid alcohol inactivating the live vaccine virus, let the skin completely dry.
Apply a droplet of the vaccine to the dry, clean arm skin that is ready for the shot.
Perpendicular to the skin, hold the needle between your thumb and first finger.
Place the wrist of the needle-holding hand against the patient’s arm and quickly insert 15 needle jabs through the vaccine droplet, perpendicular to the skin, to puncture the skin within a 5 mm diameter.
Patient information leaflet
Generic Name: smallpox (vaccinia) vaccine live
Why do we use smallpox (vaccinia) vaccine live?
The ACAM2000 formulation contains the live antigen of the New York City Board of Health strain of Vaccinia, which is recommended for active smallpox vaccination.
It is used for active immunization for prevention of smallpox disease in individuals determined to be at high risk for infection.