Dosing & Uses
Dosage Forms & Strengths
lyophilized powder for reconstitution
- Following reconstitution: 2.5-12.5 x 10^5 plaque forming units/0.0025mL
- Both the vaccine and provided diluent vial stoppers do not contain latex material
Smallpox Immunization
Indicated for active immunization against smallpox disease for persons determined to be at high risk for smallpox infection
A droplet is administered by the percutaneous route (scarification) using 15 jabs of a bifurcated needle (see Administration for complete preparation and scarification instructions)
Immunization Schedules
Up-to-date vaccination schedules available at http://www.cdc.gov/vaccines/schedules/hcp/index.html
Dosage Forms & Strengths
lyophilized powder for reconstitution
- Following reconstitution: 2.5-12.5 x 10^5 plaque forming units/0.0025mL
- Both the vaccine and provided diluent vial stoppers do not contain latex material
Smallpox Immunization
<16 years: Safety and efficacy not established; use of the vaccine in all pediatric age groups is supported by evidence from the adequate and well-controlled studies in adults and with additional historical data with use of live vaccinia virus smallpox vaccine in pediatrics
No longer recommended for routine immunization since smallpox disease has been eradicated
Indicated for active immunization against smallpox disease for persons determined to be at high risk for smallpox infection
A droplet is administered by the percutaneous route (scarification) using 15 jabs of a bifurcated needle (see Administration for complete preparation and scarification instructions)
Dosing Considerations
Before the eradication of smallpox disease, live vaccinia virus smallpox vaccine was administered routinely in all pediatric age groups, including neonates and infants, and was effective in preventing smallpox disease
During that time, live vaccinia virus was occasionally associated with serious complications in children, the highest risk being in infants aged ≤1 yr
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (13)
- belimumab
belimumab decreases effects of smallpox (vaccinia) vaccine, live by immunosuppressive effects; risk of infection. Contraindicated. Do not administer live vaccines 30 days before or concurrently with belimumab.
- certolizumab pegol
certolizumab pegol decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Do not give live vaccines concurrently with certolizumab.
- ibrutinib
ibrutinib decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection). Live-attenuated vaccines should be avoided for at least 3 mo after cessation of immunosuppressive therapy.
- ifosfamide
ifosfamide decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection). Live-attenuated vaccines should be avoided for at least 3 mo. after cessation of immunosuppressive therapy.
- ixekizumab
ixekizumab decreases effects of smallpox (vaccinia) vaccine, live by immunosuppressive effects; risk of infection. Contraindicated. Ixekizumab may interfere with immune response of live vaccines and increase risk for vaccine adverse effects; prior to initiating ixekizumab, complete all age appropriate immunizations.
- mechlorethamine
mechlorethamine decreases effects of smallpox (vaccinia) vaccine, live by immunosuppressive effects; risk of infection. Contraindicated. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection). Live-attenuated vaccines should be avoided for at least 3 mo after cessation of immunosuppressive therapy.
- melphalan
melphalan decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection). Live-attenuated vaccines should be avoided for at least 3 mo. after cessation of immunosuppressive therapy.
- methotrexate
methotrexate decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunization with live virus vaccines is generally not recommended.
- onasemnogene abeparvovec
onasemnogene abeparvovec decreases effects of smallpox (vaccinia) vaccine, live by immunosuppressive effects; risk of infection. Contraindicated. Adjust vaccinations to accommodate concomitant corticosteroid administration prior to and following onasemnogene abeparvovec infusion. Avoid live vaccines for at least 1 month when initiating or after high-dose systemic corticosteroid therapy administered for =2 weeks.
- oxaliplatin
oxaliplatin decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection). Live-attenuated vaccines should be avoided for at least 3 mo. after cessation of immunosuppressive therapy.
- procarbazine
procarbazine decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection). Live-attenuated vaccines should be avoided for at least 3 mo after cessation of immunosuppressive therapy.
- secukinumab
secukinumab decreases effects of smallpox (vaccinia) vaccine, live by immunosuppressive effects; risk of infection. Contraindicated. Secukinumab may interfere with immune response of live vaccines and increase risk for vaccine adverse effects; prior to initiating secukinumab, complete all age appropriate immunizations.
- ustekinumab
ustekinumab decreases effects of smallpox (vaccinia) vaccine, live by Mechanism: pharmacodynamic antagonism. Contraindicated. Prior initiating therapy, patients should receive all age-appropriate immunizations as recommended by current guidelines. Immunosuppressants also increase risk of infection with concomitant live vaccines.
Serious - Use Alternative (67)
- abrocitinib
abrocitinib decreases effects of smallpox (vaccinia) vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Administration of live vaccines is not recommended during abrocitinib treatment and immediately before or after treatment.
- adalimumab
adalimumab decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- alefacept
alefacept decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- anakinra
anakinra decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- anifrolumab
anifrolumab decreases effects of smallpox (vaccinia) vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Before initiation, update immunization according to current guidelines.
- antithymocyte globulin equine
antithymocyte globulin equine decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- antithymocyte globulin rabbit
antithymocyte globulin rabbit decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- atoltivimab/maftivimab/odesivimab
atoltivimab/maftivimab/odesivimab decreases effects of smallpox (vaccinia) vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Ebola monoclonal antibodies may interfere with immune response of live vaccines. Refer to vaccine guidelines for vaccination timing during and following treatment. .
- axicabtagene ciloleucel
axicabtagene ciloleucel decreases effects of smallpox (vaccinia) vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid live virus vaccines for at least 6 weeks before initiating lymphodepleting therapy, during axicabtagene ciloleucel treatment, and after treatment until full immune recovery is achieved.
- azathioprine
azathioprine decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- baricitinib
baricitinib decreases effects of smallpox (vaccinia) vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live vaccines with baricitinib. Update immunizations in agreement with current immunization guidelines before initiating baricitinib.
- basiliximab
basiliximab decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- brexucabtagene autoleucel
brexucabtagene autoleucel decreases effects of smallpox (vaccinia) vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid live virus vaccines for at least 6 weeks before initiating lymphodepleting therapy, during brexucabtagene autoleucel treatment, and after treatment until full immune recovery is achieved.
- budesonide
budesonide decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.
- cabazitaxel
cabazitaxel decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Live attenuated vaccines should not be used in patients receiving immunosuppressive therapy. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects.
- canakinumab
canakinumab decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- ciltacabtagene autoleucel
ciltacabtagene autoleucel decreases effects of smallpox (vaccinia) vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live virus vaccines is not recommended for at least 6 weeks before starting lymphodepleting chemotherapy, during CAR-T cell treatment, and until immune recovery following treatment. .
- cortisone
cortisone decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.
- cyclosporine
cyclosporine decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Avoid live vaccines in immunocompromised patients due to the risk of developing a clinical infection from the live vaccine. Inadequate immune response to the vaccine may also occur in the presence of immunosuppressants. Avoid live vaccines for at least 3 months after cessation of immunosuppressant therapy unless the benefit of vaccine administration outweighs the potential risk.
- deflazacort
deflazacort decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.
deflazacort decreases effects of smallpox (vaccinia) vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Do not administer live or live attenuated vaccines to patients receiving immunosuppressive doses of corticosteroids. - dexamethasone
dexamethasone decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.
- dupilumab
dupilumab, smallpox (vaccinia) vaccine, live. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating dupilumab, complete all age appropriate immunizations. Avoid use of live vaccines in patients treated with dupilumab.
- elivaldogene autotemcel
elivaldogene autotemcel, smallpox (vaccinia) vaccine, live. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .
- etanercept
etanercept decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- everolimus
everolimus decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- fingolimod
fingolimod decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Avoid live attenuated vaccines during and for 2 months after stopping fingolimod.
- fludrocortisone
fludrocortisone decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.
- glatiramer
glatiramer decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- golimumab
golimumab decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- guselkumab
guselkumab, smallpox (vaccinia) vaccine, live. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating guselkumab, complete all age appropriate immunizations. No data available on the ability of live or inactive vaccine to elicit an immune response in patients treated with guselkumab.
- hydrocortisone
hydrocortisone decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.
- hydroxychloroquine sulfate
hydroxychloroquine sulfate decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- hydroxyurea
hydroxyurea decreases effects of smallpox (vaccinia) vaccine, live by Other (see comment). Avoid or Use Alternate Drug. Comment: Vaccination with live vaccines in a patient receiving hydroxyurea may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection).
- idecabtagene vicleucel
idecabtagene vicleucel decreases effects of smallpox (vaccinia) vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live virus vaccines is not recommended for at least 6 weeks before starting lymphodepleting chemotherapy, during CAR-T cell treatment, and until immune recovery following treatment. .
- infliximab
infliximab decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- leflunomide
leflunomide decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- lomustine
lomustine decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection). Live-attenuated vaccines should be avoided for at least 3mo after cessation of immunosuppressive therapy.
- mercaptopurine
mercaptopurine decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- methylprednisolone
methylprednisolone decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.
- muromonab CD3
muromonab CD3 decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- mycophenolate
mycophenolate decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- ocrelizumab
ocrelizumab decreases effects of smallpox (vaccinia) vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live-attenuated or live vaccines is not recommended during ocrelizumab treatment and until B-cell repletion.
- ofatumumab SC
ofatumumab SC decreases effects of smallpox (vaccinia) vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Administer all immunizations according to immunization guidelines at least 4 weeks prior to initiation of ofatumumab SC for live or live-attenuated vaccines, and whenever possible.
- ozanimod
ozanimod decreases effects of smallpox (vaccinia) vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live-attenuated vaccines with ozanimod during treatment and for up to 3 months after discontinuing ozanimod. .
- ponesimod
ponesimod decreases effects of smallpox (vaccinia) vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live attenuated vaccines at least 1 month before initiating, during, and for 1-2 weeks after treatment. Coadministration with live attenuated vaccines may increase infection risk.
- prednisolone
prednisolone decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.
- prednisone
prednisone decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.
- rilonacept
rilonacept decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- risankizumab
risankizumab decreases effects of smallpox (vaccinia) vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live vaccines. Before starting risankizumab, complete age appropriate immunizations.
- rituximab
rituximab, smallpox (vaccinia) vaccine, live. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Safety of immunization with live viral vaccines following rituximab therapy has not been studied and vaccination with live virus vaccines is not recommended.
- rituximab-hyaluronidase
rituximab-hyaluronidase, smallpox (vaccinia) vaccine, live. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Safety of immunization with live viral vaccines following rituximab therapy has not been studied and vaccination with live virus vaccines is not recommended.
- sarilumab
sarilumab, smallpox (vaccinia) vaccine, live. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid concurrent use of live virus vaccines, owing to potentially increased risk of infections. The interval between live vaccinations and initiation of sarilumab therapy should be in accordance with current vaccination guidelines regarding immunosuppressive agents.
- satralizumab
satralizumab decreases effects of smallpox (vaccinia) vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. ive vaccines are not recommended during treatment. Administer all immunizations according to immunization guidelines. At least 4 weeks before initiating for live or live-attenuated vaccines.
- siponimod
siponimod decreases effects of smallpox (vaccinia) vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Pause vaccinations beginning 1 week before initiating siponimod and for 4 weeks after stopping treatment. Coadministration with live attenuated vaccines may increase infection risk.
- sirolimus
sirolimus decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- tacrolimus
tacrolimus decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- temsirolimus
temsirolimus decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- teplizumab
teplizumab decreases effects of smallpox (vaccinia) vaccine, live by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Live-attenuated vaccines are not recommended within 8 weeks before teplizumab treatment, during treatment, or up to 52 weeks after treatment.
- tildrakizumab
tildrakizumab decreases effects of smallpox (vaccinia) vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Before initiating tildrakizumab therapy, consider completion of all age appropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with tildrakizumab. No data are available on the response to live or inactive vaccines.
- tisagenlecleucel
tisagenlecleucel decreases effects of smallpox (vaccinia) vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live virus vaccines is not recommended for at least 6 weeks before starting lymphodepleting chemotherapy, during CAR-T cell treatment, and until immune recovery following treatment. .
- tocilizumab
tocilizumab decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- tralokinumab
tralokinumab decreases effects of smallpox (vaccinia) vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live vaccines. Before starting tralokinumab, complete age appropriate immunizations.
- triamcinolone acetonide injectable suspension
triamcinolone acetonide injectable suspension decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.
- upadacitinib
upadacitinib decreases effects of smallpox (vaccinia) vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- ustekinumab
ustekinumab decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Prior initiating therapy, patients should receive all age-appropriate immunizations as recommended by current guidelines. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- vedolizumab
vedolizumab decreases effects of smallpox (vaccinia) vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live virus vaccines while receiving vedolizumab; live vaccines may be administered concurrently with vedolizumab only if the benefits outweigh the risks.
- voclosporin
voclosporin decreases effects of smallpox (vaccinia) vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Immunosuppressants also increase risk of infection with concomitant live vaccines. Avoid live vaccines for at least 3 months after immunosuppressants.
Monitor Closely (14)
- anthrax immune globulin
anthrax immune globulin decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Immune globulin administration may impair the efficacy of live attenuated vaccines. Defer vaccination with live virus vaccines until ~3 months after administration of anthrax IG. Revaccinate people who received anthrax IG shortly after live virus vaccination following 3 months after the administration of anthrax IG.
- belatacept
belatacept decreases effects of smallpox (vaccinia) vaccine, live by Other (see comment). Use Caution/Monitor. Comment: The use of live vaccines should be avoided during treatment with belatacept. Inform patients that vaccinations may be less effective while they are being treated with belatacept.
- betibeglogene autotemcel
betibeglogene autotemcel, smallpox (vaccinia) vaccine, live. Other (see comment). Use Caution/Monitor. Comment: Follow institutional guidelines for vaccine administration. Safety of live vaccines during or following treatment not studied. .
- cytomegalovirus immune globulin (CMV IG)
cytomegalovirus immune globulin (CMV IG) decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Use Caution/Monitor. Separate by 3 months.
- hepatitis B immune globulin (HBIG)
hepatitis B immune globulin (HBIG) decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Use Caution/Monitor. Separate by 3 months.
- immune globulin IM (IGIM)
immune globulin IM (IGIM) decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Use Caution/Monitor. Separate by 3 months.
- immune globulin IV (IGIV)
immune globulin IV (IGIV) decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Use Caution/Monitor. Separate by 3 months.
- immune globulin SC
immune globulin SC decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Use Caution/Monitor.
- obinutuzumab
obinutuzumab decreases effects of smallpox (vaccinia) vaccine, live by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunization with live virus vaccines is not recommended during obinutuzumab treatment and until after B-cell recovery.
- rabies immune globulin, human (RIG)
rabies immune globulin, human (RIG) decreases effects of smallpox (vaccinia) vaccine, live by Other (see comment). Use Caution/Monitor. Comment: High dose rabies immunoglobulin may impair response to active immunization.
- tecovirimat
tecovirimat, smallpox (vaccinia) vaccine, live. Other (see comment). Use Caution/Monitor. Comment: No vaccine-drug interaction studies have been performed in humans. Some animal studies suggest a reduced immune response to smallpox vaccine if coadministered with tecovirimat. The clinical impact of this interaction on vaccine efficacy is unknown.
- tetanus immune globulin (TIG)
tetanus immune globulin (TIG) decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Use Caution/Monitor. Separate by 3 months.
- ublituximab
ublituximab decreases effects of smallpox (vaccinia) vaccine, live by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Administer all immunizations according to immunization guidelines at least 4 weeks before initiating ublituximab for live or live-attenuated vaccines and, whenever possible, at least 2 weeks before initiating for non-live vaccines. Vaccination with live virus vaccines is not recommended during treatment and until B-cell repletion. Do not administer live or live-attenuated vaccines to infants of mothers exposed to ublituximab during pregnancy, before confirming recovery of B-cell counts as measured by CD19+ B cells.
- vaccinia immune globulin intravenous
vaccinia immune globulin intravenous decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Use Caution/Monitor. Defer live vaccines for 3 months after immune globulin administration.
Minor (2)
- chloroquine
chloroquine decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Minor/Significance Unknown.
- Rho(D) immune globulin
Rho(D) immune globulin decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Minor/Significance Unknown. Separate by 3 months.
Adverse Effects
>10%
Injection site pruritus (82-92%)
Injection site erythema (61-74%)
Injection site pain (37-67%)
Blood and lymphatic system disorders (22-59%)
Lymph node pain (19-57%)
Headache (32-50%)
Injection site swelling (28-48%)
Fatigue (34-48%)
Myalgia (27-46%)
Malaise (28-37%)
Feeling hot (20-32%)
GI disorders (23-31%)
Erythema (22-24%)
Rigors (12-21%)
Nausea (10-19%)
Diarrhea (12-16%)
Decreased exercise tolerance (8-11%)
Rash (6-11%)
1-10%
Constipation (6%)
Vomiting (3-5%)
Dyspnea (3-4%)
Lymphadenopathy (6-8%)
Warnings
Black Box Warnings
Suspected cases of myocarditis and/or pericarditis have been observed in healthy adult primary vaccinees
Encephalitis, encephalomyelitis, encephalopathy, progressive vaccinia, generalized vaccinia, severe vaccinial skin infections, erythema multiforme major (including Stevens-Johnson syndrome), and eczema resulting in permanent sequelae or death, ocular complications, blindness, and fetal death have occurred following either primary vaccination or revaccination with smallpox vaccines
This is a live vaccinia virus that can be transmitted to persons who have close contact with the recipient of the vaccine, and the risks in contacts are the same as those for the vaccinated patient
The risk for experiencing serious vaccination complications must be weighed against the risks for experiencing a potentially fatal smallpox infection
Risks increased with the following conditions
These risks of severe adverse effects are increased with the following conditions and may result in severe disability, permanent neurologic sequelae, and/or death
- Cardiac disease or a history of cardiac disease
- Eye disease treated with topical steroids
- Congenital or acquired immune deficiency disorders, including those taking immunosuppressive medications
- Eczema and persons with a history of eczema or other acute or chronic exfoliative skin conditions
- Infants aged <1 yr
- Pregnancy
Contraindications
There are very few absolute contraindications to the vaccine for those who are at high risk for smallpox
The risk for experiencing serious vaccination complications must be weighed against the risks for experiencing a potentially fatal smallpox infection; see Cautions for persons who are at higher risk of experiencing serious vaccination complications
Severe immune deficiency
- Severe localized or systemic infection with vaccinia (progressive vaccinia) may occur in persons with weakened immune systems
- Individuals with severe immunodeficiency who are not expected to benefit from the vaccine should not receive ACAM2000
- These individuals may include those who are undergoing bone marrow transplantation or individuals with primary or acquired immunodeficiency who require isolation
Cautions
Serious complications may follow vaccination and may include myocarditis and/or pericarditis, encephalitis, encephalomyelitis, encephalopathy, progressive vaccinia (vaccinia necrosum), generalized vaccinia, severe vaccinial skin infections, erythema multiforme major (including Stevens-Johnson syndrome), eczema vaccinatum, blindness, and fetal death in pregnant women; these complications may rarely lead to severe disability, permanent neurological sequelae, and death
Ischemic cardiac events and nonischemic, dilated cardiomyopathy have been reported following smallpox vaccination; relationship to the vaccine is unknown
Accidental infection of the eye (ocular vaccinia) may result in ocular keratitis, corneal scarring, and blindness
Severe localized or systemic infection with vaccinia (progressive vaccinia) may occur in persons with weakened immune systems, including those with leukemia, lymphoma, organ transplantation, generalized malignancy, HIV/AIDS, cellular or humoral immune deficiency, radiation therapy, or treatment with antimetabolites, alkylating agents, high-dose corticosteroids (>10 mg prednisone/day or equivalent for ≥2 weeks), or other immunomodulatory drugs; contraindicated in individuals with severe immunodeficiency (see Contraindications)
Persons with eczema of any description such as, atopic dermatitis, neurodermatitis, and other eczematous conditions, regardless of severity of the condition, or persons who have a history of these conditions at any time in the past, are at higher risk of developing eczema vaccinatum
Not studied in infants or children; risk of serious adverse events is higher in infants; vaccinated persons who have close contact with infants (eg, breastfeeding women), must take precautions to avoid inadvertent transmission of live vaccinia virus to infants
Not studied in pregnant women; live vaccinia virus vaccines can cause fetal vaccinia and fetal death; if administered during pregnancy, the vaccinee should be apprised of the potential hazard to the fetus; pregnant women who are close contacts of vaccinees may be at increased risk because live vaccinia virus can shed and be transmitted to close contacts
Contains neomycin and polymyxin B; caution with history of allergy to these components on
Vaccinia immune globulin (VIG) is indicated for certain complications of vaccination live vaccinia virus smallpox vaccine; if VIG is needed or additional information is required, physicians should contact the CDC at (404) 639-3670 (M-F) or (404) 639-2888 evenings/weekends
The most important measure to prevent inadvertent auto-inoculation and contact transmission from vaccinia vaccination is thorough hand washing after changing the bandage or after any other contact with the vaccination site
Avoid blood and organ donation for at least 30 days following vaccination
Pregnancy & Lactation
Pregnancy
Pregnancy Category: D; has not been studied in pregnant women
The only setting in which vaccination of pregnant women should be considered is when exposure to smallpox is considered likely
Live vaccinia virus vaccines can cause fetal harm when administered to a pregnant woman; congenital infection, principally occurring during the first trimester, has been observed after vaccination with live vaccinia smallpox vaccines, although the risk may be low
Generalized vaccinia of the fetus, early delivery of a stillborn infant, or a high risk of perinatal death has been reported
If this vaccine is used during pregnancy, or if the vaccinee lives in the same household with or has close contact with a pregnant women, the vaccinee should be apprised of the potential hazard to the fetus
Lactation
Not known if excreted in breast milk, not recommended for nursing women in non-emergency situations
Live vaccinia virus can be inadvertently transmitted from a lactating mother to her infant
Infants are at high risk of developing serious complications from live vaccinia smallpox vaccination
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Lyophilized preparation of live vaccinia virus; vaccinia virus is similar to the variola (smallpox) virus; immunity to both virus achieved with induced vaccinia virus infection by stimulating the production of neutralizing antibodies
Conveys active immunity via stimulation of production of endogenously produced antibodies
Pharmacokinetics
Onset: Neutralizing antibodies appear 15-20 days after vaccination; appearance of neutralizing antibodies may occur 7 days following vaccination
Administration
Vaccine Preparation
Reconstitution
- Reconstitute only with diluent provided
- Removed vial from cold storage and bring to room temperature before reconstitution
- Remove the flip cap seals of the vaccine and diluent vials and wipe each rubber stopper with an isopropyl alcohol swab and allowed to dry thoroughly
- Using aseptic technique and a sterile 1 mL syringe fitted with a 25 gauge x 5/8” needle (provided), draw up 0.3 mL of diluent and transfer the entire content of the syringe to the vaccine vial
- Note: this 0.3 mL of diluent is not the entire content of the diluent vial
- Gently swirl to mix but try not to get product on the rubber stopper
- Reconstituted liquid should appear clear to slightly hazy, colorless to straw-colored, and free from extraneous matter
- Inspect visually for particulate matter and discoloration prior to administration; if particulate matter or discoloration is observed, the vaccine should not be used and the vial should be disposed of according to biocontaminant regulations
Handling precautions and disposal
- Personnel preparing and administering the vaccine should wear surgical or protective gloves and avoid contact of vaccine with skin, eyes or mucous membranes
- The vaccine vial, its stopper, the diluent syringe, the vented needle used for reconstitution, the bifurcated needle used for administration, and any gauze or cotton that came in contact with the vaccine should be discarded in leak-proof, puncture-proof biohazard containers
- These containers should then be disposed of appropriately
Percutaneous (Scarification) Administration
The site of vaccination is the upper arm over the insertion of the deltoid muscle
No skin preparation should be performed unless the skin at the intended site of vaccination is obviously dirty, in which case an alcohol swab(s) may be used to clean the area; the skin must be allowed to dry thoroughly to prevent inactivation of the live vaccine virus by the alcohol
Remove the vaccine vial cap and bifurcated needle from individual wrapping; submerge bifurcated end of needle in reconstituted vaccine solution; the needle will pick up a droplet of vaccine (0.0025 mL) within the fork of the bifurcation
Use aseptic technique; ie, do not insert the upper part of the needle that has been in contact with fingers into the vaccine vial, and never redip the needle into the vaccine vial if the needle has touched skin
Deposit the droplet of vaccine onto clean, dry skin of the arm prepared for vaccination; the needle is held between thumb and first finger perpendicular to the skin; the wrist of the hand holding the needle of the vaccinator rests against the patient’s arm; rapidly make 15 jabs of the needle perpendicular to the skin through the vaccine droplet to puncture the skin, within a diameter of about 5 mm; the jabs should be vigorous enough so that a drop of blood appears at the vaccination site
Any excess droplets of vaccine and blood should be wiped off the skin using a dry gauze pad and discarded in a biohazard container; discard the needle in a biohazard sharps container
Close the vaccine vial by reinserting the rubber cap and return to a refrigerator or place on ice unless it will be used immediately to vaccinate another subject (see Storage)
Cover the vaccination site loosely with a gauze bandage, using first aid adhesive tape to keep it in place; this bandage provides a barrier to protect against spread of the vaccinia virus
If the vaccinee is involved in direct patient care, the gauze should be covered with a semipermeable (semiocclusive) dressing as an additional barrier; a semipermeable dressing is one that allows for the passage of air but does not allow for the passage of fluids
Wash hands with soap and warm water or with alcohol-based hand rubs such as gels or foams after direct contact with the vaccination site, the bandage or clothes, towels or sheets that might be contaminated with virus from the vaccination site; this is vital in order to remove any virus from your hands and prevent contact spread
Put the contaminated bandages in a sealed plastic bag and throw them away in the trash
Wash separately clothing, towels, bedding, or other items that may have come in direct contact with the vaccination site or drainage from the site, using hot water with detergent and/or bleach; wash hands afterwards
Don’t use a bandage that blocks air from the vaccination site; this may cause the skin at the vaccination site to soften and wear away; use loose gauze secured with medical tape to cover the site
Don’t put salves or ointments on the vaccination site
See ACAM2000 prescribing information for visual photos on how to interpret vaccination response
Storage
Lyophilized powder
- Store in freezer with an average temperature of -15°C to -25°C (+5°F to -13°F)
- Prior to reconstitution, smallpox vaccine retains a potency of ≥1 x 10^8 PFU per dose for at least 18 months when stored at refrigerated temperatures of +2-8°C (36-46°F)
- During shipment: Maintain temperature of -10°C or colder
Reconstituted solution
- After reconstitution, vaccine may be administered within 6-8 hr if kept at room temperature (20-25°C, 68-77°F)
- Unused, reconstituted vaccine may be refrigerated (2-8°C, 36-46°F) for up to 30 days, after which it should be discarded as a biohazardous material
- Exposure of reconstituted vaccine to room temperature during vaccination sessions should be minimized by placing it in refrigerator or on ice between patient administrations
Images
Formulary
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