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Spikevax
COVID-19 vaccine, mRNA (1vCOV-mRNA)
Adult Dosing .
Dosage forms: INJ
COVID-19 prevention
- [immunocompetent or mildly immunocompromised patients, <65 yo]
- Dose: 0.5 mL IM x1 dose; Info: give at least 8wk after last COVID-19 vaccine dose if previously vaccinated; search 'immunization' for epocrates Adult Immunization decision tool
- [immunocompetent or mildly immunocompromised patients, 65 yo and older]
- Dose: 0.5 mL IM x2 doses at least 6mo apart; Info: give at least 8wk after last COVID-19 vaccine dose if previously vaccinated; search 'immunization' for epocrates Adult Immunization decision tool
- [moderately-severely immunocompromised patients, not previously vaccinated]
- Dose: 0.5 mL IM x2 doses 4wk apart, then 0.5 mL IM x1 dose at least 4wk later, then 0.5 mL IM x1 dose at least 6mo later; Info: may give additional dose at least 2mo after last dose and consider further doses based on shared clinical decision-making; search 'immunization' for epocrates Adult Immunization decision tool
- [moderately-severely immunocompromised patients, previously received 1 Moderna vaccine dose]
- Dose: 0.5 mL IM x2 doses at least 4wk apart, then 0.5 mL IM x1 dose at least 6mo later; Start: 4wk after last dose; Info: may give additional dose at least 2mo after last dose and consider further doses based on shared clinical decision-making; search 'immunization' for epocrates Adult Immunization decision tool
- [moderately-severely immunocompromised patients, previously received 2 Moderna vaccine doses]
- Dose: 0.5 mL IM x2 doses at least 6mo apart; Start: at least 4wk after last dose; Info: may give additional dose at least 2mo after last dose and consider further doses based on shared clinical decision-making; search 'immunization' for epocrates Adult Immunization decision tool
- [moderately-severely immunocompromised patients, previously received 3 or more mRNA vaccine doses]
- Dose: 0.5 mL IM x2 doses at least 6mo apart; Start: at least 8wk after last dose; Info: may give additional dose at least 2mo after last dose and consider further doses based on shared clinical decision-making; search 'immunization' for epocrates Adult Immunization decision tool
- [moderately-severely immunocompromised patients, previously received 2 or more Novavax vaccine doses]
- Dose: 0.5 mL IM x2 doses at least 6mo apart; Start: at least 8wk after last dose; Info: may give additional dose at least 2mo after last dose and consider further doses based on shared clinical decision-making; search 'immunization' for epocrates Adult Immunization decision tool
renal dosing
- [no adjustment]
- renal impairment: no adjustment
- HD/PD: no adjustment; no supplement
hepatic dosing
- [no adjustment]
Peds Dosing .
- Dosage forms: INJ
COVID-19 prevention
- [6-23 mo, immunocompetent or mildly immunocompromised patients, not previously vaccinated]
- Dose: 0.25 mL IM x2 doses 4-8wk apart; Info: ACIP recommends shared clinical decision-making; search 'immunization' for epocrates Child/Adolescent Immunization decision tool
- [6-23 mo, immunocompetent or mildly immunocompromised patients, previously received 1 Moderna vaccine dose]
- Dose: 0.25 mL IM x1 dose; Start: 4-8wk after last dose; Info: ACIP recommends shared clinical decision-making; search 'immunization' for epocrates Child/Adolescent Immunization decision tool
- [6-23 mo, immunocompetent or mildly immunocompromised patients, previously received 2 or more Moderna vaccine doses]
- Dose: 0.25 mL IM x1 dose; Start: at least 8wk after last dose; Info: ACIP recommends shared clinical decision-making; search 'immunization' for epocrates Child/Adolescent Immunization decision tool
- [6-23 mo, moderately-severely immunocompromised patients, not previously vaccinated]
- Dose: 0.25 mL IM x2 doses 4wk apart, then 0.25 mL IM x1 dose at least 4wk later, then 0.25 mL IM x1 dose at least 6mo later; Info: may give additional dose at least 2mo after last dose and consider further doses based on shared clinical decision-making; search 'immunization' for epocrates Child/Adolescent Immunization decision tool
- [6-23 mo, moderately-severely immunocompromised patients, previously received 1 Moderna vaccine dose]
- Dose: 0.25 mL IM x2 doses at least 4wk apart, then 0.25 mL IM x1 dose at least 6mo later; Start: 4wk after last dose; Info: may give additional dose at least 2mo after last dose and consider further doses based on shared clinical decision-making; search 'immunization' for epocrates Child/Adolescent Immunization decision tool
- [6-23 mo, moderately-severely immunocompromised patients, previously received 2 Moderna vaccine doses]
- Dose: 0.25 mL IM x2 doses at least 6mo apart; Start: at least 4wk after last dose; Info: may give additional dose at least 2mo after last dose and consider further doses based on shared clinical decision-making; search 'immunization' for epocrates Child/Adolescent Immunization decision tool
- [6-23 mo, moderately-severely immunocompromised patients, previously received 3 or more Moderna vaccine doses]
- Dose: 0.25 mL IM x2 doses at least 6mo apart; Start: at least 8wk after last dose; Info: may give additional dose at least 2mo after last dose and consider further doses based on shared clinical decision-making; search 'immunization' for epocrates Child/Adolescent Immunization decision tool
- [2-11 yo, immunocompetent or mildly immunocompromised patients]
- Dose: 0.25 mL IM x1 dose; Info: give at least 8wk after last COVID-19 vaccine dose if previously vaccinated; give based on shared clinical decision-making; search 'immunization' for epocrates Child/Adolescent Immunization decision tool
- [2-11 yo, moderately-severely immunocompromised patients, not previously vaccinated]
- Dose: 0.25 mL IM x2 doses 4wk apart, then 0.25 mL IM x1 dose at least 4wk later, then 0.25 mL IM x1 dose at least 6mo later; Info: may give additional dose at least 2mo after last dose and consider further doses based on shared clinical decision-making; search 'immunization' for epocrates Child/Adolescent Immunization decision tool
- [2-11 yo, moderately-severely immunocompromised patients, previously received 1 Moderna vaccine dose]
- Dose: 0.25 mL IM x2 doses at least 4wk apart, then 0.25 mL IM x1 dose at least 6mo later; Start: 4wk after last dose; Info: may give additional dose at least 2mo after last dose and consider further doses based on shared clinical decision-making; search 'immunization' for epocrates Child/Adolescent Immunization decision tool
- [2-11 yo, moderately-severely immunocompromised patients, previously received 2 Moderna vaccine doses]
- Dose: 0.25 mL IM x2 doses at least 6mo apart; Start: at least 4wk after last dose; Info: may give additional dose at least 2mo after last dose and consider further doses based on shared clinical decision-making; search 'immunization' for epocrates Child/Adolescent Immunization decision tool
- [2-11 yo, moderately-severely immunocompromised patients, previously received 3 or more mRNA vaccine doses]
- Dose: 0.25 mL IM x2 doses at least 6mo apart; Start: at least 8wk after last dose; Info: may give additional dose at least 2mo after last dose and consider further doses based on shared clinical decision-making; search 'immunization' for epocrates Child/Adolescent Immunization decision tool
- [2-11 yo, moderately-severely immunocompromised patients, previously received 2 or more Novavax vaccine doses]
- Dose: 0.25 mL IM x2 doses at least 6mo apart; Start: at least 8wk after last dose; Info: may give additional dose at least 2mo after last dose and consider further doses based on shared clinical decision-making; search 'immunization' for epocrates Child/Adolescent Immunization decision tool
- [12 yo and older, immunocompetent or mildly immunocompromised patients]
- Dose: 0.5 mL IM x1 dose; Info: give at least 8wk after last COVID-19 vaccine dose if previously vaccinated; give based on shared clinical decision-making; search 'immunization' for epocrates Child/Adolescent Immunization decision tool
- [12 yo and older, moderately-severely immunocompromised patients, not previously vaccinated]
- Dose: 0.5 mL IM x2 doses 4wk apart, then 0.5 mL IM x1 dose at least 4wk later, then 0.5 mL IM x1 dose at least 6mo later; Info: may give additional dose at least 2mo after last dose and consider further doses based on shared clinical decision-making; search 'immunization' for epocrates Child/Adolescent Immunization decision tool
- [12 yo and older, moderately-severely immunocompromised patients, previously received 1 Moderna vaccine dose]
- Dose: 0.5 mL IM x2 doses at least 4wk apart, then 0.5 mL IM x1 dose at least 6mo later; Start: 4wk after last dose; Info: may give additional dose at least 2mo after last dose and consider further doses based on shared clinical decision-making; search 'immunization' for epocrates Child/Adolescent Immunization decision tool
- [12 yo and older, moderately-severely immunocompromised patients, previously received 2 Moderna vaccine doses]
- Dose: 0.5 mL IM x2 doses at least 6mo apart; Start: at least 4wk after last dose; Info: may give additional dose at least 2mo after last dose and consider further doses based on shared clinical decision-making; search 'immunization' for epocrates Child/Adolescent Immunization decision tool
- [12 yo and older, moderately-severely immunocompromised patients, previously received 3 or more mRNA vaccine doses]
- Dose: 0.5 mL IM x2 doses at least 6mo apart; Start: at least 8wk after last dose; Info: may give additional dose at least 2mo after last dose and consider further doses based on shared clinical decision-making; search 'immunization' for epocrates Child/Adolescent Immunization decision tool
- [12 yo and older, moderately-severely immunocompromised patients, previously received 2 or more Novavax vaccine doses]
- Dose: 0.5 mL IM x2 doses at least 6mo apart; Start: at least 8wk after last dose; Info: may give additional dose at least 2mo after last dose and consider further doses based on shared clinical decision-making; search 'immunization' for epocrates Child/Adolescent Immunization decision tool
renal dosing
- [no adjustment]
- renal impairment: no adjustment
- HD/PD: no adjustment; no supplement
hepatic dosing
- [no adjustment]
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- hypersensitivity to other mRNA COVID-19 vaccines
- caution: non-severe hypersensitivity to prior mRNA COVID-19 vaccine dose
- caution: non-severe hypersensitivity to mRNA COVID-19 vaccine component
- caution: hypersensitivity to vector COVID-19 vaccine
- caution: hypersensitivity to protein subunit COVID-19 vaccine
- caution: immunocompromised patients
- caution: male patients <40 yo
- caution: multisystem inflammatory syndrome history
- caution: myocarditis within 3wk of prior COVID-19 vaccine
- caution: pericarditis within 3wk of prior COVID-19 vaccine
- caution: illness, acute moderate-severe
Drug Interactions .
Overview
COVID-19 vaccine
vaccine
- non-live vaccine
Avoid/Use Alternative
- interferon gamma 1b
Monitor/Modify Tx
- abatacept
- abemaciclib
- abrocitinib
- acalabrutinib
- adalimumab
- ado-trastuzumab emtansine
- afamitresgene autoleucel
- aldesleukin
- alemtuzumab
- amivantamab
- anakinra
- anifrolumab
- anti-thymocyte globulin
- asciminib
- atezolizumab
- atidarsagene autotemcel
- avelumab
- avutometinib
- axicabtagene ciloleucel
- azacitidine
- azathioprine
- baricitinib
- basiliximab
- belantamab mafodotin
- belatacept
- belimumab
- belinostat
- belzutifan
- bendamustine
- betamethasone
- bevacizumab
- bimekizumab
- blinatumomab
- bortezomib
- brentuximab vedotin
- brexucabtagene autoleucel
- brodalumab
- budesonide
- budesonide rectal
- busulfan
- cabazitaxel
- canakinumab
- capecitabine
- capmatinib
- carboplatin
- carfilzomib
- carmustine
- cemiplimab
- certolizumab pegol
- cetuximab
- chlorambucil
- ciltacabtagene autoleucel
- cisplatin
- cladribine injection
- cladribine oral
- clofarabine
- copanlisib
- corticotropin
- cortisone
- cosibelimab
- cyclophosphamide
- cyclosporine
- cytarabine
- dacarbazine
- dactinomycin
- daratumumab
- dasatinib
- daunorubicin
- decitabine
- defactinib
- deflazacort
- delgocitinib topical
- deucravacitinib
- deuruxolitinib
- dexamethasone
- dimethyl fumarate
- dinutuximab
- diroximel fumarate
- docetaxel
- dordaviprone
- dostarlimab
- doxorubicin
- dupilumab
- durvalumab
- duvelisib
- efgartigimod alfa
- elivaldogene autotemcel
- elotuzumab
- elranatamab
- emapalumab
- epcoritamab
- epirubicin
- erdafitinib
- eribulin
- etanercept
- etoposide
- etrasimod
- etuvetidigene autotemcel
- everolimus
- fam-trastuzumab deruxtecan
- fingolimod
- floxuridine
- fludarabine
- fludrocortisone
- fluorouracil
- fruquintinib
- futibatinib
- gemcitabine
- gemtuzumab ozogamicin
- glofitamab
- golimumab
- guselkumab
- hydrocortisone
- hydroxyurea
- ibritumomab tiuxetan
- ibrutinib
- icotrokinra
- idarubicin
- idecabtagene vicleucel
- idelalisib
- ifosfamide
- imatinib
- inebilizumab
- infliximab
- inotuzumab ozogamicin
- ipilimumab
- irinotecan
- isatuximab
- ixabepilone
- ixekizumab
- lazertinib
- lebrikizumab
- leflunomide
- lenalidomide
- lifileucel
- linvoseltamab
- lisocabtagene maraleucel
- lomustine
- loncastuximab tesirine
- lurbinectedin
- lymphocyte immune globulin, anti-thymocyte globulin
- margetuximab
- marnetegragene autotemcel
- melphalan
- mercaptopurine
- methotrexate
- methylprednisolone
- midostaurin
- mirikizumab
- mitomycin
- mitoxantrone
- mogamulizumab
- momelotinib
- monomethyl fumarate
- mosunetuzumab
- mycophenolate mofetil
- mycophenolic acid
- natalizumab
- nelarabine
- nemolizumab
- nilotinib
- nipocalimab
- nivolumab
- nogapendekin alfa inbakicept intravesical
- obecabtagene autoleucel
- obinutuzumab
- ocrelizumab
- ofatumumab
- olaparib
- oxaliplatin
- ozanimod
- paclitaxel
- pacritinib
- palbociclib
- panitumumab
- peginterferon alfa 2a
- pembrolizumab
- pemetrexed
- pemivibart
- penpulimab
- pentostatin
- pertuzumab
- pirtobrutinib
- polatuzumab vedotin
- pomalidomide
- ponatinib
- ponesimod
- pralatrexate
- prednisolone
- prednisone
- procarbazine
- quizartinib
- regorafenib
- relacorilant
- relatlimab
- retifanlimab
- revumenib
- rilonacept
- rilzabrutinib
- ripretinib
- risankizumab
- ritlecitinib
- rituximab
- romidepsin
- ropeginterferon alfa-2b
- rozanolixizumab
- rucaparib
- ruxolitinib
- sarilumab
- satralizumab
- secukinumab
- selinexor
- selumetinib
- sevabertinib
- sibeprenlimab
- siltuximab
- siponimod
- sipuleucel-T
- sirolimus
- sirolimus albumin-bound
- sirolimus topical
- smallpox vaccine, live
- smallpox/mpox vaccine, live
- sorafenib
- spesolimab
- sunitinib
- sunvozertinib
- tacrolimus
- tafasitamab
- taletrectinib
- talquetamab
- tarlatamab
- teclistamab
- telisotuzumab vedotin
- temozolomide
- temsirolimus
- teplizumab
- teriflunomide
- thalidomide
- thioguanine
- thiotepa
- tildrakizumab
- tisagenlecleucel
- tislelizumab
- tocilizumab
- tofacitinib
- topotecan
- toripalimab
- trabectedin
- tralokinumab
- trastuzumab
- tremelimumab
- triamcinolone
- ublituximab
- upadacitinib
- ustekinumab
- vamorolone
- vandetanib
- vedolizumab
- venetoclax
- vinblastine
- vincristine
- vinorelbine
- voclosporin
- zanidatamab
- zanubrutinib
- zenocutuzumab
- ziftomenib
- zongertinib
Adverse Reactions .
Serious Reactions
- hypersensitivity reaction
- anaphylaxis
- Bell palsy
- myocarditis
- pericarditis
Common Reactions
- injection site reaction
- fatigue
- headache
- myalgia
- arthralgia
- chills
- nausea
- vomiting
- fever
- lymphadenopathy
- urticaria
Safety/Monitoring .
Monitoring Parameters
no routine tests recommended
Pregnancy/Lactation .
Pregnancy
Clinical Summary
may use during pregnancy; no known risk of fetal harm based on limited human data
Pregnancy Registry
encourage patients to enroll in COVID-19 Vaccines International Pregnancy Exposure Registry at https://cviper.pregistry.com; encourage patients to enroll in v-safe COVID-19 Vaccine Pregnancy Registry at https://vsafe.cdc.gov; encourage patients to enroll in COVID-19 Vaccines Pregnancy Registry at https://mothertobaby.org/ongoing-study/covid19-vaccines/
Lactation
Clinical Summary
may use while breastfeeding; no human data available, though risk of infant harm not expected based on vaccine properties; no human data available to assess effects on milk production
Pharmacology .
Metabolism: for COVID-19 vaccine: other; CYP450: unknown
Excretion: for COVID-19 vaccine: other; Half-life: unknown
Subclass: Coronavirus Vaccines ; Routine Adult Vaccines ; Routine Pediatric Vaccines
Mechanism of Action
for COVID-19 vaccine: elicits humoral and cellular immune response to the SARS-CoV-2 virus
Formulary .
No Formulary Selected
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