COVID-19 adenovirus vector vaccines (United States: Not available): Drug information

(For additional information see "COVID-19 adenovirus vector vaccines (United States: Not available): Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)

Brand Names: US

Janssen COVID-19 Vaccine [DSC]

Brand Names: Canada

AstraZeneca COVID-19 Vaccine [DSC];
Covishield [DSC];
Jcovden [DSC];
Vaxzevria [DSC]

Pharmacologic Category

Vaccine;
Vaccine, Adenovirus Vector;
Vaccine, COVID-19

Dosing: Adult

COVID-19 prevention

COVID-19 prevention:

Janssen COVID-19 Vaccine [Canadian product]:

Note: The Janssen COVID-19 Vaccine emergency use authorization (EUA) for active immunization to prevent COVID-19 in the United States has been revoked as of June 1, 2023.

The National Advisory Committee on Immunization (NACI) prefers mRNA and subunit COVID-19 vaccines; adenovirus vector vaccines may be offered only when all other COVID-19 vaccines are contraindicated (Ref).

Primary dose: IM: 0.5 mL as a single dose (Ref).

For patients who are moderately to severely immunocompromised:

• If received a single dose of Janssen for the primary series, administer a second (additional) dose using an mRNA COVID-19 vaccine (eg, Pfizer or Moderna) ≥4 weeks after the Janssen dose.

Booster dose: Bivalent Omicron-containing mRNA COVID-19 vaccines are recommended for booster doses; see NACI guidelines for more information (Ref).

AstraZeneca COVID-19 Vaccine [Canadian product]:

Note: mRNA and subunit COVID-19 vaccines are preferred; adenovirus vector vaccines may be offered only when all other COVID-19 vaccines are contraindicated (Ref).

Primary series: IM: 0.5 mL per dose for 2 doses administered 28 to 84 days (4 to 12 weeks) apart. Note: The Canadian National Advisory Committee on Immunization (NACI) recommends an mRNA COVID-19 vaccine as the preferred second dose (≥28 days after the first dose) of a series initiated with AstraZeneca COVID-19 Vaccine (Ref). For primary series consisting of 2 doses of AstraZeneca COVID-19 Vaccine, the WHO recommends an interval of 56 to 84 days (8 to 12 weeks) between doses due to increased efficacy and immunogenicity observed with a longer dose interval (Ref).

Additional primary series dose: An additional (third) primary series dose may be offered to moderately to severely immunocompromised individuals ≥28 days after the second dose ONLY when other authorized COVID-19 vaccines (ie, mRNA vaccines) are contraindicated or inaccessible (Ref).

Booster dose: Bivalent Omicron-containing mRNA COVID-19 vaccines are recommended for booster doses; see NACI guidelines for more information (Ref).

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions (Significant): Considerations

Janssen: Note: The Janssen COVID-19 Vaccine has been discontinued in the United States.

JCovden (Canadian product):

Capillary leak syndrome

Cases (including fatal cases) of capillary leak syndrome (CLS) have been reported rarely. Some cases have occurred in patients with a history of CLS; patients with a known history of CLS should not receive the vaccine. CLS symptoms include acute episodes of limb edema, hypotension, hemoconcentration, and hypoalbuminemia and require prompt medical attention and treatment.

Onset: Rapid; within the first days after vaccination.

Hypersensitivity reactions

Hypersensitivity reactions, including anaphylaxis, have been reported with the JCovden COVID-19 Vaccine (Ref). Immediate treatment (including epinephrine 1 mg/mL) for anaphylactoid and/or hypersensitivity reactions should be available during vaccine use (Ref).

Immune thrombocytopenia

Immune thrombocytopenia with very low platelet levels <20,000 per µL (including bleeding and fatal outcomes in some cases), has been reported very rarely with the JCovden COVID-19 Vaccine. Patients with neurological symptoms (including severe or persistent headaches, blurred vision, confusion, or seizure), persistent abdominal pain, chest pain, leg pain or swelling, shortness of breath, spontaneous bleeding, unusual skin bruising, or petechiae beyond the site of vaccination should seek immediate medical care (Ref).

Onset: Intermediate: most cases occur within 4 weeks after vaccination (Ref).

Risk factors:

• History of immune thrombocytopenia (Ref)

Neurologic events

Demyelinating disorders, including Guillain-Barre syndrome and transverse myelitis, have been reported with the JCovden COVID-19 Vaccine (Ref).

Thrombosis with thrombocytopenia syndrome

Thrombosis with thrombocytopenia syndrome (TTS) (including bleeding and fatal outcomes in some cases), which clinically mimics autoimmune heparin-induced thrombocytopenia, has been reported very rarely with the JCovden COVID-19 Vaccine (Ref). Thrombotic events included cerebral sinus thrombosis, thrombosis of the splanchnic-vein, and arterial thrombosis (Ref). Most cases have occurred in females between the ages of 30 to 49 years (Ref). Patients with neurological symptoms (including severe or persistent headaches or blurred vision), persistent abdominal pain, chest pain, leg swelling, shortness of breath, spontaneous bleeding, unusual skin bruising, or petechiae beyond the site of vaccination should seek immediate medical care.

Mechanism: Not clearly established; may be immune-mediated. Vaccine-induced platelet-activating antibodies against platelet factor 4 (PF4) may be present (Ref).

Onset: Intermediate; most cases occur within 3 weeks after vaccination (Ref).

Risk factors:

• Females between the ages of 30 and 49 years (Ref)

Vaxzevria (Canadian product):

Capillary leak syndrome

Onset: Rapid; within the first days after vaccination.

Local reactions

Local reactions have been reported and include erythema at injection site, induration at injection site, injection site pruritus, pain at injection site, swelling at injection site, tenderness at injection site, and warm sensation at injection site. Local reactions were reported more frequently in younger patients (18 to 64 years of age) compared to patients ≥65 years of age with the Vaxzevria COVID-19 Vaccine (adenovirus vector) [Canadian product]; frequency of local reactions was also higher after the first dose compared to the second dose (Ref).

Onset: Varied; within 7 days after either injection (Ref).

Systemic reactions

Systemic reactions have been reported and include arthralgia, asthenia, chills, decreased appetite, fatigue, fever, headache, malaise, myalgia, nausea, and vomiting. Systemic reactions were reported more frequently in younger patients (18 to 64 years of age) compared to patients ≥65 years of age with the Vaxzevria COVID-19 Vaccine (adenovirus vector) [Canadian product]; frequency of systemic reactions was also higher after the first dose compared to the second dose. One case of severe fever (40.5°C) (possibly related to vaccine) was reported (Ref).

Onset: Varied; within 7 days after either injection. Severe fever: In the single case reported, onset was 2 days after the first dose (Ref).

Thrombosis with thrombocytopenia syndrome

Thrombosis with new onset thrombocytopenia syndrome (TTS), which clinically mimics autoimmune heparin-induced thrombocytopenia, has been reported rarely with the Vaxzevria COVID-19 Vaccine (adenovirus vector) (Ref). Thrombotic events (including fatal cases) included cerebral sinus thrombosis (in some cases accompanied by cerebral hemorrhage), portal vein thrombosis, pulmonary embolism, thrombosis of the splanchnic-vein, and arterial thrombosis (Ref). Disseminated intravascular coagulation has also been reported (Ref). In one review, the median age was 36 (range: 22 to 49 years) and most reported cases occurred in females (Ref). In another study, the median age was 48 (range: 18 to 79 years) with no sex predominance or medical risk factors identified (Ref). More cases of TTS were reported after the first dose compared to the second dose. Patients with neurological symptoms (including severe or persistent headaches, blurred vision, confusion, or seizures), persistent abdominal pain, chest pain, leg swelling, shortness of breath, or petechiae or unusual bruising beyond the site of vaccination should seek immediate medical care. Patients who experience major arterial or venous thrombosis with thrombocytopenia with the Vaxzevria COVID-19 Vaccine should not receive a second dose of the Vaxzevria COVID-19 Vaccine. Treatment may differ from management of other thromboses; consult current guidance and hematology specialists (Ref).

Mechanism: Not clearly established; may be immune-mediated. Vaccine-induced platelet-activating antibodies against platelet factor 4 (PF4) may be present (Ref).

Onset: Varied; most cases occurred within the first 3 weeks after vaccination (Ref). In one review describing 11 patients, cases occurred 5 to 16 days after vaccination (Ref). In another study describing 170 definite and 50 probable cases of VITT, onset occurred 5 to 48 days (median 14) after vaccination (Ref).

Adverse Reactions

The following adverse reactions and incidences are derived from the product information for the JCovden and Vaxzevria COVID-19 Vaccines (adenovirus vector [Canadian products]), unless otherwise specified. Refer to Canadian product information for respective products for information regarding reporting adverse reactions (JCovden Canadian product monograph; Vaxzevria Canadian product monograph). Adverse reactions reported in adults.

JCovden (Canadian product):

>10%:

Gastrointestinal: Nausea (13% to 20%) (table 1)NauseaJCov

**COVID-19 Vaccine (Adenovirus Vector [JCovden]): Adverse Reaction: Nausea**
Drug (COVID-19 Vaccine [Adenovirus Vector])	Placebo	Population	Number of Patients (COVID-19 Vaccine [Adenovirus Vector])	Number of Patients (Placebo)	Comments
20%	10%	18 to 59 years of age	4,450	4,058	Primary series
13%	11%	≥60 years of age	2,860	2,696	Primary series

Local: Pain at injection site (38% to 65%) (table 2)PainJCov

**COVID-19 Vaccine (Adenovirus Vector [JCovden]): Adverse Reaction: Pain at Injection Site**
Drug (COVID-19 Vaccine [Adenovirus Vector])	Placebo	Population	Number of Patients (COVID-19 Vaccine [Adenovirus Vector])	Number of Patients (Placebo)	Comments
65%	19%	18 to 59 years of age	4,450	4,058	Primary series
38%	15%	≥60 years of age	2,860	2,696	Primary series

Nervous system: Fatigue (32% to 52%) (table 3)FatigueJCov, headache (32% to 50%) (table 4)HeadacheJCov

**COVID-19 Vaccine (Adenovirus Vector [JCovden]): Adverse Reaction: Fatigue**
Drug (COVID-19 Vaccine [Adenovirus Vector])	Placebo	Population	Number of Patients (COVID-19 Vaccine [Adenovirus Vector])	Number of Patients (Placebo)	Comments
52%	26%	18 to 59 years of age	4,450	4,058	Primary series
32%	22%	≥60 years of age	2,860	2,696	Primary series

**COVID-19 Vaccine (Adenovirus Vector [JCovden]): Adverse Reaction: Headache**
Drug (COVID-19 Vaccine [Adenovirus Vector])	Placebo	Population	Number of Patients (COVID-19 Vaccine [Adenovirus Vector])	Number of Patients (Placebo)	Comments
50%	27%	18 to 59 years of age	4,450	4,058	Primary series
32%	22%	≥60 years of age	2,860	2,696	Primary series

Neuromuscular & skeletal: Myalgia (26% to 46%) (table 5)MyalgiaJCov

**COVID-19 Vaccine (Adenovirus Vector [JCovden]): Adverse Reaction: Myalgia**
Drug (COVID-19 Vaccine [Adenovirus Vector])	Placebo	Population	Number of Patients (COVID-19 Vaccine [Adenovirus Vector])	Number of Patients (Placebo)	Comments
46%	15%	18 to 59 years of age	4,450	4,058	Primary series
26%	13%	≥60 years of age	2,860	2,696	Primary series

1% to 10%:

Local: Erythema at injection site (4% to 9%) (table 6)ErythemaJCov, swelling at injection site (3% to 7%) (table 7)SwellingJCov

**COVID-19 Vaccine (Adenovirus Vector [JCovden]): Adverse Reaction: Erythema at Injection Site**
Drug (COVID-19 Vaccine [Adenovirus Vector])	Placebo	Population	Number of Patients (COVID-19 Vaccine [Adenovirus Vector])	Number of Patients (Placebo)	Comments
9%	5%	18 to 59 years of age	4,450	4,058	Primary series
4%	3%	≥60 years of age	2,860	2,696	Primary series

**COVID-19 Vaccine (Adenovirus Vector [JCovden]): Adverse Reaction: Swelling at Injection Site**
Drug (COVID-19 Vaccine [Adenovirus Vector])	Placebo	Population	Number of Patients (COVID-19 Vaccine [Adenovirus Vector])	Number of Patients (Placebo)	Comments
7%	2%	18 to 59 years of age	4,450	4,058	Primary series
3%	1%	≥60 years of age	2,860	2,696	Primary series

Nervous system: Chills (2%)

Miscellaneous: Fever (2% to 10%) (table 8)FeverJCov

**COVID-19 Vaccine (Adenovirus Vector [JCovden]): Adverse Reaction: Fever**
Drug (COVID-19 Vaccine [Adenovirus Vector])	Placebo	Population	Number of Patients (COVID-19 Vaccine [Adenovirus Vector])	Number of Patients (Placebo)	Comments
10%	0.4%	18 to 59 years of age	4,450	4,058	Primary series
2%	0.3%	≥60 years of age	2,860	2,696	Primary series

<1%: Otic: Tinnitus

Frequency not defined:

Cardiovascular: Pericarditis

Hypersensitivity: Facial swelling, type IV hypersensitivity reaction

Nervous system: Asthenia, cerebrovascular accident, complex regional pain syndrome, facial paresis, hemiparesis, malaise, myasthenia

Neuromuscular & skeletal: Limb pain

Vaxzevria (Canadian product):

>10%:

Gastrointestinal: Nausea (8% to 22%) (table 9)NauseaVax

**COVID-19 Vaccine (Adenovirus Vector [Vaxzevria]): Adverse Reaction: Nausea**
Drug (COVID-19 Vaccine [Adenovirus Vector])	Comparator (MenACWY Vaccine, Placebo, or a Combination)	Population	Number of Patients (COVID-19 Vaccine [Adenovirus Vector])	Number of Patients (Comparator [MenACWY Vaccine, Placebo, or a Combination])	Comments
22%	N/A	≥18 years of age	12,282	N/A	N/A
11%	8%	≥18 years of age	2,037	1,013	Dose 1
8%	7%	≥18 years of age	1,962	968	Dose 2

Local: Injection-site pruritus (13%), pain at injection site (35% to 54%) (table 10)PainVax, tenderness at injection site (49% to 64%) (table 11)TendernessVax, warm sensation at injection site (18%)

**COVID-19 Vaccine (Adenovirus Vector [Vaxzevria]): Adverse Reaction: Pain at Injection Site**
Drug (COVID-19 Vaccine [Adenovirus Vector])	Comparator (MenACWY Vaccine, Placebo, or a Combination)	Population	Number of Patients (COVID-19 Vaccine [Adenovirus Vector])	Number of Patients (Comparator [MenACWY Vaccine, Placebo, or a Combination])	Comments
54%	N/A	≥18 years of age	12,282	N/A	N/A
52%	10%	≥18 years of age	2,037	1,013	Dose 1
35%	9%	≥18 years of age	1,962	968	Dose 2

**COVID-19 Vaccine (Adenovirus Vector [Vaxzevria]): Adverse Reaction: Tenderness at Injection Site**
Drug (COVID-19 Vaccine [Adenovirus Vector])	Comparator (MenACWY Vaccine, Placebo, or a Combination)	Population	Number of Patients (COVID-19 Vaccine [Adenovirus Vector])	Number of Patients (Comparator [MenACWY Vaccine, Placebo, or a Combination])	Comments
64%	N/A	≥18 years of age	12,282	N/A	N/A
62%	15%	≥18 years of age	2,037	1,013	Dose 1
49%	10%	≥18 years of age	1,962	968	Dose 2

Nervous system: Chills (9% to 32%) (table 12)ChillsVax, fatigue (27% to 53%) (table 13)FatigueVax, headache (29% to 53%) (table 14)HeadacheVax, malaise (16% to 44%) (table 15)MalaiseVax

**COVID-19 Vaccine (Adenovirus Vector [Vaxzevria]): Adverse Reaction: Chills**
Drug (COVID-19 Vaccine [Adenovirus Vector])	Comparator (MenACWY Vaccine, Placebo, or a Combination)	Population	Number of Patients (COVID-19 Vaccine [Adenovirus Vector])	Number of Patients (Comparator [MenACWY Vaccine, Placebo, or a Combination])	Comments
32%	N/A	≥18 years of age	12,282	N/A	N/A
25%	6%	≥18 years of age	2,037	1,013	Dose 1
9%	6%	≥18 years of age	1,962	968	Dose 2

**COVID-19 Vaccine (Adenovirus Vector [Vaxzevria]): Adverse Reaction: Fatigue**
Drug (COVID-19 Vaccine [Adenovirus Vector])	Comparator (MenACWY Vaccine, Placebo, or a Combination)	Population	Number of Patients (COVID-19 Vaccine [Adenovirus Vector])	Number of Patients (Comparator [MenACWY Vaccine, Placebo, or a Combination])	Comments
53%	N/A	≥18 years of age	12,282	N/A	N/A
44%	24%	≥18 years of age	2,037	1,013	Dose 1
27%	18%	≥18 years of age	1,962	968	Dose 2

**COVID-19 Vaccine (Adenovirus Vector [Vaxzevria]): Adverse Reaction: Headache**
Drug (COVID-19 Vaccine [Adenovirus Vector])	Comparator (MenACWY Vaccine, Placebo, or a Combination)	Population	Number of Patients (COVID-19 Vaccine [Adenovirus Vector])	Number of Patients (Comparator [MenACWY Vaccine, Placebo, or a Combination])	Comments
53%	N/A	≥18 years of age	12,282	N/A	N/A
42%	29%	≥18 years of age	2,037	1,013	Dose 1
29%	19%	≥18 years of age	1,962	968	Dose 2

**COVID-19 Vaccine (Adenovirus Vector [Vaxzevria]): Adverse Reaction: Malaise**
Drug (COVID-19 Vaccine [Adenovirus Vector])	Comparator (MenACWY Vaccine, Placebo, or a Combination)	Population	Number of Patients (COVID-19 Vaccine [Adenovirus Vector])	Number of Patients (Comparator [MenACWY Vaccine, Placebo, or a Combination])	Comments
44%	N/A	≥18 years of age	12,282	N/A	N/A
30%	12%	≥18 years of age	2,037	1,013	Dose 1
16%	9%	≥18 years of age	1,962	968	Dose 2

Neuromuscular & skeletal: Arthralgia (27%), myalgia (19% to 44%) (table 16)MyalgiaVax

**COVID-19 Vaccine (Adenovirus Vector [Vaxzevria]): Adverse Reaction: Myalgia**
Drug (COVID-19 Vaccine [Adenovirus Vector])	Comparator (MenACWY Vaccine, Placebo, or a Combination)	Population	Number of Patients (COVID-19 Vaccine [Adenovirus Vector])	Number of Patients (Comparator [MenACWY Vaccine, Placebo, or a Combination])	Comments
44%	N/A	≥18 years of age	12,282	N/A	N/A
37%	14%	≥18 years of age	2,037	1,013	Dose 1
19%	11%	≥18 years of age	1,962	968	Dose 2

1% to 10%:

Gastrointestinal: Diarrhea (2%), vomiting (≤2%) (table 17)VomitingVax

**COVID-19 Vaccine (Adenovirus Vector [Vaxzevria]): Adverse Reaction: Vomiting**
Drug (COVID-19 Vaccine [Adenovirus Vector])	Comparator (MenACWY Vaccine, Placebo, or a Combination)	Population	Number of Patients (COVID-19 Vaccine [Adenovirus Vector])	Number of Patients (Comparator [MenACWY Vaccine, Placebo, or a Combination])	Comments
2%	N/A	≥18 years of age	12,282	N/A	N/A
1%	1%	≥18 years of age	2,037	1,013	Dose 1
0.8%	0.8%	≥18 years of age	1,962	968	Dose 2

Local: Erythema at injection site (1% to 3%) (table 18)ErythemaVax, induration at injection site (≤3%) (table 19)IndurationVax, swelling at injection site (≤3%)

**COVID-19 Vaccine (Adenovirus Vector [Vaxzevria]): Adverse Reaction: Erythema at Injection Site**
Drug (COVID-19 Vaccine [Adenovirus Vector])	Comparator (MenACWY Vaccine, Placebo, or a Combination)	Population	Number of Patients (COVID-19 Vaccine [Adenovirus Vector])	Number of Patients (Comparator [MenACWY Vaccine, Placebo, or a Combination])	Comments
3%	N/A	≥18 years of age	12,282	N/A	N/A
2%	0.5%	≥18 years of age	2,037	1,013	Dose 1
1%	0.1%	≥18 years of age	1,962	968	Dose 2

**COVID-19 Vaccine (Adenovirus Vector [Vaxzevria]): Adverse Reaction: Induration at Injection Site**
Drug (COVID-19 Vaccine [Adenovirus Vector])	Comparator (MenACWY Vaccine, Placebo, or a Combination)	Population	Number of Patients (COVID-19 Vaccine [Adenovirus Vector])	Number of Patients (Comparator [MenACWY Vaccine, Placebo, or a Combination])	Comments
3%	0.1%	≥18 years of age	2,037	1,013	Dose 1
1%	0%	≥18 years of age	1,962	968	Dose 2

Nervous system: Asthenia (≥2%)

Neuromuscular & skeletal: Limb pain (1%)

Respiratory: Flu-like symptoms (≤1%), oropharyngeal pain (≥2%), rhinorrhea (≥2%)

Miscellaneous: Fever (≤8%; feverishness: 34%) (table 20)FeverVax

**COVID-19 Vaccine (Adenovirus Vector [Vaxzevria]): Adverse Reaction: Fever**
Drug (COVID-19 Vaccine [Adenovirus Vector])	Comparator (MenACWY Vaccine, Placebo, or a Combination)	Population	Number of Patients (COVID-19 Vaccine [Adenovirus Vector])	Number of Patients (Comparator [MenACWY Vaccine, Placebo, or a Combination])	Comments
8%	N/A	≥18 years of age	12,282	N/A	N/A
7%	0.7%	≥18 years of age	2,037	1,013	Dose 1
0.7%	0.1%	≥18 years of age	1,962	968	Dose 2

<1%:

Dermatologic: Hyperhidrosis, pruritus, skin rash, urticaria

Gastrointestinal: Abdominal pain, decreased appetite (table 21)DecreasedAppVax

**COVID-19 Vaccine (Adenovirus Vector [Vaxzevria]): Adverse Reaction: Decreased Appetite**
Drug (COVID-19 Vaccine [Adenovirus Vector])	Comparator (MenACWY Vaccine, Placebo, or a Combination)	Population	Number of Patients (COVID-19 Vaccine [Adenovirus Vector])	Number of Patients (Comparator [MenACWY Vaccine, Placebo, or a Combination])
0.2%	0.1%	≥18 years of age	12,282	11,962

Hematologic & oncologic: Lymphadenopathy

Nervous system: Dizziness, drowsiness, facial nerve paralysis (data insufficient to determine causal relationship), hypoesthesia, paresthesia

Post-authorization (any adenovirus vector COVID-19 vaccine):

Cardiovascular: Arterial thrombosis (including acute myocardial infarction and ischemic stroke) (Cari 2022), capillary leak syndrome, myocarditis, portal vein thrombosis (Greinacher 2021), pulmonary embolism (Greinacher 2021), thromboembolism (including deep vein thrombosis, pulmonary embolism, and transverse sinus thrombosis), thrombosis (splanchnic-vein and other) (Cari 2022, Greinacher 2021), vasculitis (small-vessel vasculitis with cutaneous manifestations)

Dermatologic: Alopecia (Washrawirul 2022), ecchymoses (Washrawirul 2022), maculopapular rash (Washrawirul 2022), pruritus (Washrawirul 2022), psoriasis (Washrawirul 2022), skin rash (Washrawirul 2022), Sweet syndrome (Washrawirul 2022), urticaria (Washrawirul 2022)

Gastrointestinal: Diarrhea, vomiting

Hematologic & oncologic: Disseminated intravascular coagulation (Greinacher 2021), immune thrombocytopenia (risk may be increased in the first 4 weeks after vaccination and in patients with a history of immune thrombocytopenia) (Cari 2022), lymphadenopathy, petechia (Washrawirul 2022), purpuric disease (Washrawirul 2022), thrombocytopenia (syndrome in combination with thrombosis [TTS]; also referred to as vaccine-induced [VITT]; or without thrombosis [risk may be increased in the first 4 weeks after vaccination]) (Cari 2022, CDC 2021d)

Hypersensitivity: Anaphylaxis (Washrawirul 2022), angioedema (Washrawirul 2022), hypersensitivity angiitis

Nervous system: Bell palsy, cerebral hemorrhage (Greinacher 2021; Schultz 2021), cerebral sinus thrombosis (with thrombocytopenia; or without thrombocytopenia [risk may be increased in the first 4 weeks after vaccination]) (Cari 2022), chronic inflammatory demyelinating polyneuropathy, dizziness, facial nerve paralysis, Guillain-Barre syndrome (Lee 2023), hypoesthesia, paresthesia, transverse myelitis

Otic: Tinnitus

Contraindications

History of a severe allergic reaction (eg, anaphylaxis) after a previous dose or to a component of the formulation (eg, polysorbate 80); history of thrombosis with thrombocytopenia syndrome (TTS) following previous dose of Janssen COVID-19 Vaccine or any other adenovirus vector COVID-19 vaccine (eg, AstraZeneca COVID-19 Vaccine) (FDA 2023).

Canadian labeling: Additional contraindications (not in US labeling): History of capillary leak syndrome.

Warnings/Precautions

Concerns related to adverse effects:

• Shoulder injury related to vaccine administration: Vaccine administration that is too high on the upper arm may cause shoulder injury (eg, shoulder bursitis or tendinopathy) resulting in shoulder pain and reduced range of motion following injection. Use proper injection technique for vaccines administered in the deltoid muscle (eg, injecting in the central, thickest part of the muscle) to reduce the risk of shoulder injury related to vaccine administration (Cross 2016; Foster 2013).

• Syncope: Syncope has been reported with use of injectable vaccines and may result in serious secondary injury (eg, skull fracture, cerebral hemorrhage); typically reported in adolescents and young adults and within 15 minutes after vaccination. Procedures should be in place to avoid injuries from falling and to restore cerebral perfusion if syncope occurs (ACIP [Kroger 2022]).

Disease-related concerns:

• Acute illness: The decision to administer or delay vaccination because of current or recent febrile illness depends on the severity of symptoms and the etiology of the disease. In general, it is recommended to defer vaccine administration in patients with moderate or severe acute illness (with or without fever) and to provide vaccination in patients with mild acute illness (with or without fever) (ACIP [Kroger 2022]). The Canadian product information for the AstraZeneca vaccine states to postpone vaccination in patients with acute severe febrile illness or acute infection.

• Bleeding disorders: Use with caution in patients with a history of bleeding disorders (including thrombocytopenia); bleeding or hematoma may occur from IM administration; if the patient receives antihemophilia or other similar therapy, IM injection can be scheduled shortly after such therapy is administered (ACIP [Kroger 2022]). For more information on administering the COVID-19 vaccine in patients with bleeding disorders, see society recommendations (eg, US National Hemophilia Foundation, World Federation of Hemophilia).

• Guillain-Barré syndrome: The Janssen COVID-19 Vaccine has been associated with an increased risk of Guillain-Barré Syndrome (GBS). Not recommended in patients who developed GBS within 6 weeks after a dose of Janssen COVID-19 Vaccine; an mRNA COVID-19 vaccine should be used for subsequent doses. In patients who develop GBS ≥6 weeks following a dose of the Janssen vaccine, a bivalent mRNA vaccine should be strongly considered for any subsequent doses (CDC 2023a).

• Immune-mediated syndrome/thrombosis with thrombocytopenia syndrome: For primary immunization, persons with a history of immune-mediated syndrome characterized by thrombosis and thrombocytopenia (eg, heparin-induced thrombocytopenia) should receive an mRNA COVID-19 vaccine. For patients who developed thrombosis with thrombocytopenia syndrome (TTS) following the Janssen COVID-19 Vaccine (or another adenovirus vector COVID-19 vaccine), do not administer the Janssen vaccine; a bivalent mRNA vaccine booster dose is recommended in these patients ≥2 months after the initial Janssen vaccine dose and after stabilization of the clinical condition (CDC 2023a).

• Multisystem inflammatory syndrome: In patients with a history of multisystem inflammatory syndrome (MIS), it is typically recommended to delay COVID-19 vaccination until clinical recovery from MIS. For pediatric patients with MIS in children (MIS-C), deferral until ≥90 days after diagnosis is typically recommended. Data on the safety of COVID-19 vaccination following MIS-C or MIS in adults (MIS-A) are limited; risks and benefits should be weighed with consideration given to patient-specific factors (eg, recovery from illness [including normal cardiac function], risk of COVID-19). In pediatric patients who developed MIS-C within 90 days following a dose of COVID-19 mRNA vaccine, subsequent doses should be deferred, but may be offered on a case-by-case basis per provider discretion. In pediatric patients who developed MIS-C ≥90 days after a previous dose of COVID-19 mRNA vaccine, subsequent doses should be considered ≥90 days after MIS-C diagnosis for patients who have clinically recovered (including return to normal cardiac function) and who are at increased risk of COVID-19 exposure. For adults with MIS-A, decisions to administer further doses should be made in collaboration with expert healthcare providers; see CDC recommendations for details (CDC 2023a).

• SARS-CoV-2 infection or exposure (CDC 2023a):

- Persons with history of COVID-19 or asymptomatic SARS-CoV-2 infection: Vaccination with an age-appropriate COVID-19 vaccine is recommended for everyone ≥6 months of age, regardless of history of symptomatic or asymptomatic SARS-CoV-2 infection. Persons who recently had SARS-CoV-2 infection may consider delaying vaccine doses by 3 months from symptom onset or positive test (if asymptomatic); increased time between infection and vaccination may improve vaccination immune response.

- Persons with current SARS-CoV-2 infection (including asymptomatic): In persons with known current SARS-CoV-2 infection, defer vaccination until the person has recovered from acute illness (if symptomatic) and no longer requires isolation. Persons who recently had SARS-CoV-2 infection may consider delaying vaccine doses by 3 months from symptom onset or positive test (if asymptomatic); increased time between infection and vaccination may improve vaccination immune response.

- Persons who received passive antibody COVID-19 therapy: Vaccination does not need to be delayed for persons who previously received COVID-19 monoclonal antibody therapy or convalescent plasma (postexposure prophylaxis or treatment).

- Persons with known SARS-CoV-2 exposure: Persons with recent known exposure may be vaccinated if they do not have symptoms consistent with SARS-CoV-2 infection; follow CDC’s postexposure guidance. Vaccination for postexposure prophylaxis is not recommended.

Concurrent drug therapy issues:

• Anticoagulant therapy: Clinicians administering vaccine should be aware of potential bleeding or hematoma that could occur due to IM administration (ACIP [Kroger 2022]).

• Medications for postvaccination adverse reactions: Antipyretic or analgesic medications (eg, acetaminophen, nonsteroidal anti-inflammatory drugs) may be taken for the treatment of postvaccination local/systemic symptoms (if medically appropriate) but should not be used prophylactically to prevent postvaccination symptoms (CDC 2023a).

• Vaccines: The CDC and AAP recommend simultaneous administration of the COVID-19 vaccine with other vaccines or administration in the days before and after receipt of other vaccines (AAP 2022; CDC 2023a). When administering multiple vaccines, consider risks and benefits of each vaccine; administer each vaccine at a different injection site (at least 1 inch apart), and administer COVID-19 vaccine in a different limb than other vaccines that are more likely to cause a local reaction (CDC 2023a).

Special populations:

• Altered immunocompetence: COVID-19 vaccines can be safely administered to immunocompromised persons (including those with HIV or receiving immunosuppressant therapy) if no contraindications exist; as with the general population, mRNA vaccines are preferred. Immunocompromised persons may have a diminished immune response to the vaccine, but the potential benefit of the vaccine outweighs the uncertainties. Booster doses should be administered as appropriate for age and medical conditions. If possible, complete COVID-19 vaccination ≥2 weeks prior to initiation of immunosuppressive therapy (CDC 2023a; NACI 2023). For more information on administering COVID-19 vaccine in specific disease states, see society recommendations (eg, American Cancer Society, National Multiple Sclerosis Society).

Dosage form specific issues:

• Polysorbate 80: Some COVID-19 vaccines may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). See manufacturer's labeling. Polysorbate and polyethylene glycol are structurally related; cross-reactive hypersensitivity may occur (CDC 2023a).

Other warnings/precautions:

• Effective immunity: Vaccination may not result in effective immunity in all patients. Response depends upon multiple factors (eg, type of vaccine, age of patient) and may be improved by administering the vaccine at the recommended dose, route, and interval (ACIP [Kroger 2022]). Vaccines may not be effective if administered during periods of altered immune competence (ACIP [Kroger 2022]; CDC 2023a).

• Mammograms: Temporary contralateral or ipsilateral lymphadenopathy after a COVID-19 vaccination has been reported. To avoid possible misinterpretation of mammogram screening, mammograms are recommended prior to vaccination or 4 to 6 weeks after the second dose. When this is not possible, the mammogram technologist or radiologist should be informed when and which vaccine was administered and what arm the injection was given (ACOG 2022). Imaging needed for acute symptoms, or urgent treatment planning or complications, should not be delayed (Becker 2021).

Product Availability

The Janssen COVID-19 Vaccine emergency use authorization (EUA) for active immunization to prevent COVID-19 in the United States has been revoked as of June 1, 2023.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Suspension, Intramuscular [preservative free]:

Janssen COVID-19 Vaccine: 50 billion viral particles per 0.5 mL (2.5 mL [DSC]) [contains alcohol, usp, polysorbate 80]

Generic Equivalent Available: US

Yes

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution, Intramuscular:

Vaxzevria: 50 billion viral particles per 0.5 mL ([DSC]) [contains alcohol, usp, edetate (edta) disodium, polysorbate 80]

Generic: 50 billion viral particles per 0.5 mL ([DSC])

Suspension, Intramuscular:

Jcovden: 50 billion viral particles per 0.5 mL ([DSC]) [contains alcohol, usp, polysorbate 80]

Administration: Adult

IM: Do not shake. For the Janssen product, gently swirl the vial in an upright position for 10 seconds before withdrawing each dose of vaccine. Administer IM in the deltoid muscle or anterolateral thigh (Ref). Use proper injection technique in the deltoid muscle (eg, injecting in the central, thickest part of the muscle) to reduce the risk of shoulder injury related to vaccine administration (Ref). To prevent syncope-related injuries, adolescents and adults should be vaccinated while seated or lying down (Ref).

If administering simultaneously with other vaccines, administer each vaccine at a different injection site, at least 1 inch apart if possible (Ref).

Patients at risk for hemorrhage: For patients at risk of hemorrhage following IM injection, the vaccine should be administered IM if, in the opinion of the physician familiar with the patient's bleeding risk, the vaccine can be administered by this route with reasonable safety. If the patient receives antihemophilia or other similar therapy, IM vaccination can be scheduled shortly after such therapy is administered. A fine needle (≤23 gauge) can be used for the vaccination and firm pressure applied to the site (without rubbing) for at least 2 minutes. The patient should be instructed concerning the risk of hematoma from the injection. Patients on anticoagulant therapy should be considered to have the same bleeding risks and treated as those with clotting factor disorders (Ref).

Use: Labeled Indications

COVID-19 prevention (AstraZeneca [Vaxzevria] and Janssen COVID-19 Vaccines [Canadian products]): Health Canada approved the AstraZeneca and Janssen COVID-19 Vaccines for active immunization to prevent COVID-19 in persons ≥18 years of age.

Canadian Guidance: The National Advisory Committee on Immunization (NACI) has made recommendations on the use of COVID-19 vaccines; see recommendations for details (NACI 2023).

Note: The FDA Janssen COVID-19 Vaccine emergency use authorization (EUA) for active immunization to prevent COVID-19 in the United States has been revoked as of June 1, 2023. Refer to CDC for current COVID-19 guidance.

Medication Safety Issues

Sound-alike/look-alike issues:

Similarity of COVID-19 vaccine names may lead to confusion among products with subtle differences (eg, dosage volumes, dosing schedules, storage requirements, preparation for administration).

COVID-19 vaccine may be confused with influenza virus vaccine. Medication errors have occurred when COVID-19 vaccine was inadvertently administered instead of influenza virus vaccine (and vice versa). These products may be stored in close proximity to each other. Confirm the correct vaccine has been selected prior to administration (ISMP/NAN 2021).

COVID-19 vaccine may be confused with epinephrine injection. Medication errors have occurred when epinephrine injection was inadvertently administered instead of COVID-19 vaccine. Most mix-ups were due to look-alike, predrawn syringes of epinephrine and the vaccine, which were stored in close proximity (ISMP [Smetzer 2022]).

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Abatacept: May diminish the therapeutic effect of COVID-19 Vaccines. Management: Rheumatology guidelines recommend holding SQ abatacept for 1 to 2 weeks after each vaccine dose and timing vaccine dose so that it is given 1 week prior to the next IV abatacept dose. Risk D: Consider therapy modification

Acetaminophen: May diminish the therapeutic effect of Vaccines. Management: Consider avoiding routine prophylactic use of acetaminophen before or during vaccine administration when possible. Acetaminophen is still recommended to treat fevers and/or pain that occurs after vaccination. Risk D: Consider therapy modification

Anti-CD20 B-Cell Depleting Therapies: May diminish the therapeutic effect of COVID-19 Vaccines. Management: Administer COVID-19 vaccine 2 to 4 weeks prior to the next scheduled dose of anti-CD20 therapy, if used chronically for the treatment of autoimmune disease. Revaccinate 6 months after completion of anti-CD20 therapy if used over a limited period. Risk D: Consider therapy modification

Apremilast: May diminish the therapeutic effect of COVID-19 Vaccines. Management: Rheumatology guidelines recommend holding apremilast for 1 to 2 weeks after vaccine administration as permitted by the underlying disease. These guidelines consider apremilast to be an immunomodulatory or immunosuppressive medication. Risk D: Consider therapy modification

AzaTHIOprine: May diminish the therapeutic effect of COVID-19 Vaccines. Management: Rheumatology guidelines recommend holding azathioprine for 1 to 2 weeks after each vaccine dose as permitted by the underlying disease. This recommendation is specific to patients using azathioprine for rheumatic and musculoskeletal disease. Risk D: Consider therapy modification

Baricitinib: May diminish the therapeutic effect of COVID-19 Vaccines. Management: Rheumatology guidelines recommend holding baricitinib, tofactinib, or upadacitinib for 1 to 2 weeks after vaccine administration as permitted by the underlying disease. Risk D: Consider therapy modification

Belimumab: May diminish the therapeutic effect of COVID-19 Vaccines. Management: Rheumatology guidelines recommend holding subcutaneous belimumab doses for 1 to 2 weeks after each COVID-19 vaccine dose as disease activity permits. The recommendation specifies subcutaneous belimumab and does not mention intravenous belimumab. Risk D: Consider therapy modification

Calcineurin Inhibitors (Systemic): May diminish the therapeutic effect of COVID-19 Vaccines. Management: Rheumatology guidelines recommend holding calcineurin inhibitors for 1 to 2 weeks after each vaccine dose as permitted by the underlying disease. This is specific to the use of calcineurin inhibitors for rheumatologic or musculoskeletal disease. Risk D: Consider therapy modification

CAR-T Cell Immunotherapy: May diminish the therapeutic effect of COVID-19 Vaccine (Adenovirus Vector). Management: The CDC recommends that CAR-T-cell recipients who received COVID-19 vaccine prior to or during treatment with CAR-T-cell therapy should be revaccinated with a primary mRNA vaccine series at least 3 months (12 weeks) after CAR-T-cell therapy. Risk D: Consider therapy modification

CloZAPine: COVID-19 Vaccines may enhance the adverse/toxic effect of CloZAPine. COVID-19 Vaccines may increase the serum concentration of CloZAPine. Risk C: Monitor therapy

Corticosteroids (Systemic): May diminish the therapeutic effect of COVID-19 Vaccine (Adenovirus Vector). Management: Administer a 2nd dose using an mRNA COVID-19 vaccine (at least 4 weeks after the primary vaccine dose) and a bivalent booster dose (at least 2 months after the additional mRNA dose or any other boosters) Risk D: Consider therapy modification

CycloPHOSphamide: May diminish the therapeutic effect of COVID-19 Vaccines. Management: Adjust timing of intravenous cyclophosphamide so that administration occurs 1 week after each vaccine dose, if feasible; hold oral cyclophosphamide for 1 to 2 weeks after vaccine administration as permitted by the underlying disease. Risk D: Consider therapy modification

Elivaldogene Autotemcel: May enhance the adverse/toxic effect of Vaccines. Specifically, there may be a greater risk for contracting an infection from any live vaccine. Elivaldogene Autotemcel may diminish the therapeutic effect of Vaccines. Management: Administration of vaccines is not recommended in the 6 weeks before myeloablative conditioning, and until hematologic recovery after elivaldogene autotemcel treatment. Risk X: Avoid combination

Immunosuppressants (Cytotoxic Chemotherapy): May diminish the therapeutic effect of COVID-19 Vaccine (Adenovirus Vector). Management: Administer a 2nd dose using an mRNA COVID-19 vaccine (at least 4 weeks after the primary vaccine dose) and a bivalent booster dose (at least 2 months after the additional mRNA dose or any other boosters). Risk D: Consider therapy modification

Immunosuppressants (Miscellaneous Oncologic Agents): May diminish the therapeutic effect of COVID-19 Vaccine (Adenovirus Vector). Management: Administer a 2nd dose using an mRNA COVID-19 vaccine (at least 4 weeks after the primary vaccine dose) and a bivalent booster dose (at least 2 months after the additional mRNA dose or any other boosters). Risk D: Consider therapy modification

Immunosuppressants (Therapeutic Immunosuppressant Agents): May diminish the therapeutic effect of COVID-19 Vaccine (Adenovirus Vector). Management: Administer a 2nd dose using an mRNA COVID-19 vaccine (at least 4 weeks after the primary vaccine dose) and a bivalent booster dose (at least 2 months after the additional mRNA dose or any other boosters). Risk D: Consider therapy modification

Leflunomide: May diminish the therapeutic effect of COVID-19 Vaccines. Management: Rheumatology guidelines recommend holding leflunomide for 1 to 2 weeks after vaccine administration as permitted by the underlying disease. Risk D: Consider therapy modification

Methotrexate: May diminish the therapeutic effect of COVID-19 Vaccines. Management: Rheumatology guidelines recommend holding methotrexate for 1 to 2 weeks after vaccine administration as permitted by underlying disease. This is specific to patients using methotrexate for rheumatic and musculoskeletal disease. Risk D: Consider therapy modification

Mycophenolate: May diminish the therapeutic effect of COVID-19 Vaccines. Management: Rheumatology guidelines recommend holding mycophenolate for 1 to 2 weeks after each vaccine dose as permitted by the underlying disease. This recommendation is specific to patients using mycophenolate for rheumatic and musculoskeletal diseases. Risk D: Consider therapy modification

Propacetamol: May diminish the therapeutic effect of Vaccines. Management: Consider avoiding routine prophylactic use of propacetamol before or during vaccine administration when possible. Propacetamol is still recommended to treat fevers and/or pain that occurs after vaccination. Risk D: Consider therapy modification

SulfaSALAzine: May diminish the therapeutic effect of COVID-19 Vaccines. Management: Rheumatology guidelines recommend holding sulfasalazine for 1 to 2 weeks after vaccine administration as permitted by the underlying disease. These guidelines consider sulfasalazine to be an immunomodulatory or immunosuppressive medication. Risk D: Consider therapy modification

Teplizumab: May diminish the therapeutic effect of COVID-19 Vaccine (Adenovirus Vector). Management: Administration of inactivated vaccines is not recommended during the 2 weeks prior to teplizumab treatment, during therapy, or for 6 weeks following completion of therapy. Risk D: Consider therapy modification

Tixagevimab and Cilgavimab: May diminish the therapeutic effect of COVID-19 Vaccines. Management: Wait at least 2 weeks after receipt of a COVID-19 vaccine before administering tixagevimab and cilgavimab for pre-exposure prophylaxis. Risk D: Consider therapy modification

Tofacitinib: May diminish the therapeutic effect of COVID-19 Vaccines. Management: Rheumatology guidelines recommend holding baricitinib, tofactinib, or upadacitinib for 1 to 2 weeks after vaccine administration as permitted by the underlying disease. Risk D: Consider therapy modification

Upadacitinib: May diminish the therapeutic effect of COVID-19 Vaccines. Management: Rheumatology guidelines recommend holding baricitinib, tofactinib, or upadacitinib for 1 to 2 weeks after vaccine administration as permitted by the underlying disease. Risk D: Consider therapy modification

Reproductive Considerations

The Janssen COVID-19 (adenovirus vector) Vaccine is no longer available in the United States (CDC 2023a).

Due to the risk of severe illness, pregnancy complications, and death from COVID-19 infection during pregnancy, staying current with COVID-19 vaccination is strongly recommended for all patients planning a pregnancy, patients trying to become pregnant now, and patients who might become pregnant in the future, including those patients previously diagnosed with COVID-19 infection (ACOG 2023; CDC 2023). Refer to current CDC guidelines for vaccination of adults.

Refer to country-specific recommendations for AstraZeneca COVID-19 (adenovirus vector) Vaccine (not available in the United States.)

Pregnancy Considerations

The Janssen COVID-19 (adenovirus vector) Vaccine is no longer available in the United States (CDC 2023a).

The risk of severe illness from COVID-19 infection is increased in symptomatic pregnant patients compared to nonpregnant patients. Pregnant and recently pregnant patients with moderate or severe infection are at increased risk of complications such as hypertensive disorders of pregnancy, postpartum hemorrhage, or other infections compared to pregnant patients without COVID. Pregnant patients with symptoms may require ICU admission, mechanical ventilation, or ventilatory support (ECMO) compared to symptomatic nonpregnant patients. Other adverse pregnancy outcomes include preterm birth and stillbirth. The risk of coagulopathy, cesarean delivery, and maternal death may be increased; neonates have an increased risk for NICU admission. Maternal age and comorbidities such as diabetes, hypertension, lung disease, and obesity may also increase the risk of severe illness in pregnant and recently pregnant patients (ACOG FAQ 2023; NIH 2023).

Refer to country-specific recommendations for AstraZeneca COVID-19 (adenovirus vector) Vaccine (not available in the United States).

Data collection to monitor maternal and infant outcomes following exposure to COVID-19 vaccines during pregnancy is ongoing:

Pregnant patients who are vaccinated with the Janssen COVID-19 Vaccine (adenovirus vector) vaccine are encouraged to enroll in the International Registry of Coronavirus Exposure in Pregnancy (IRCEP) (https://c-viper.pregistry.com/).

Breastfeeding Considerations

It is not known if components of the Janssen COVID-19 (adenovirus vector) Vaccine are present in breast milk.

The Janssen COVID-19 (adenovirus vector) Vaccine is no longer available in the United States (CDC 2023a).

The risk of severe illness from COVID-19 infection is increased in recently pregnant patients compared to nonpregnant patients (ACOG FAQ 2023). Staying current with COVID-19 vaccination is recommended for all lactating patients who do not otherwise have contraindications to the vaccine (CDC 2023). Refer to current CDC guidelines for vaccination of adults.

Refer to country-specific recommendations for AstraZeneca COVID-19 (adenovirus vector) Vaccine (not available in the United States).

Monitoring Parameters

Monitor for hypersensitivity and syncope for 15 minutes following administration (ACIP [Kroger 2022]). Observe patients for 30 minutes after vaccination in patients with the following: a history of nonsevere, immediate (within 4 hours) allergic reaction after receipt of a previous dose of COVID-19 vaccine; a history of anaphylaxis following receipt of a non–COVID-19 vaccine or injectable therapy; or a person with an allergy-related contraindication to a different type of COVID-19 vaccine (CDC 2023a). If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion.

Antibody testing to assess for SARS-CoV-2 immunity before or following vaccination is not currently recommended (CDC 2023a).

Mechanism of Action

Promotes active immunity against COVID-19 caused by SARS-CoV-2 virus. The adenovirus vector in the vaccine is a recombinant, replication-incompetent adenovirus vector that expresses the SARS-CoV-2 spike (S) antigen without virus propagation. The vaccine then elicits an immune response to the S antigen, which contributes to protection against COVID-19 disease. The Janssen vaccine contains a human adenovirus type 26 (Ad26) vector (FDA 2023). The AstraZeneca vaccine [Canadian product] contains a chimpanzee adenovirus (ChAdOx1) vector.

Pharmacokinetics (Adult Data Unless Noted)

Onset of action:

Janssen COVID-19 Vaccine: Vaccine efficacy assessment for moderate to severe/critical laboratory-confirmed COVID-19 and severe/critical COVID-19 was based on disease cases occurring from day 14 onward after the single dose. Vaccine efficacy assessment for severe/critical COVID-19 was based on cases occurring from day 28 onward after the single dose (FDA 2023).

AstraZeneca COVID-19 Vaccine [Canadian product]: Protection was shown to begin ~3 weeks after the first dose.

Brand Names: International

International Brand Names by Country

For country code abbreviations (show table)

(AT) Austria: COVID-19 vaccine AstraZeneca | COVID-19 vaccine Janssen | Jcovden | Vaxzevria;
(AU) Australia: COVID-19 vaccine AstraZeneca | COVID-19 vaccine Janssen | Vaxzevria;
(BE) Belgium: COVID-19 vaccine AstraZeneca | COVID-19 vaccine Janssen | Jcovden | Vaxzevria;
(BG) Bulgaria: COVID-19 vaccine AstraZeneca | COVID-19 vaccine Janssen | Jcovden | Vaxzevria;
(BR) Brazil: Covishield | Vacina COVID-19 (recombinante) | Vaxzevria;
(CL) Chile: COVID-19 vaccine AstraZeneca;
(CN) China: Convidecia;
(CO) Colombia: COVID-19 vaccine AstraZeneca | COVID-19 vaccine Janssen | Vacuna COVID-19 Janssen | Vaxzevria;
(CY) Cyprus: COVID-19 vaccine AstraZeneca | COVID-19 vaccine Janssen | Jcovden | Vaxzevria;
(CZ) Czech Republic: COVID-19 vaccine AstraZeneca | COVID-19 vaccine Janssen | Jcovden | Vaxzevria;
(DE) Germany: COVID-19 vaccine AstraZeneca | COVID-19 vaccine Janssen | Vaxzevria;
(DK) Denmark: COVID-19 vaccine AstraZeneca | COVID-19 vaccine Janssen | Jcovden | Vaxzevria;
(EE) Estonia: COVID-19 vaccine AstraZeneca | COVID-19 vaccine Janssen | Jcovden | Vaxzevria;
(ES) Spain: COVID-19 vaccine AstraZeneca | COVID-19 vaccine Janssen | Jcovden | Vaxzevria;
(ET) Ethiopia: COVID-19 vaccine AstraZeneca | COVID-19 vaccine Janssen | Covishield;
(FI) Finland: COVID-19 vaccine AstraZeneca | COVID-19 vaccine Janssen | Jcovden | Vaxzevria;
(FR) France: COVID-19 vaccine AstraZeneca | COVID-19 vaccine Janssen | Jcovden | Vaxzevria;
(GB) United Kingdom: COVID-19 vaccine Janssen | Jcovden | Vaxzevria;
(GH) Ghana: Covishield | Sputnik V | Sputnik V component 2;
(GR) Greece: COVID-19 vaccine AstraZeneca | COVID-19 vaccine Janssen | Jcovden | Vaxzevria;
(HR) Croatia: COVID-19 vaccine AstraZeneca | COVID-19 vaccine Janssen | Jcovden | Vaxzevria;
(HU) Hungary: COVID-19 vaccine AstraZeneca | COVID-19 vaccine Janssen | Gam-COVID-Vac | Gam-COVID-Vac component 2 | Jcovden | Vaxzevria;
(ID) Indonesia: COVID-19 vaccine AstraZeneca | KconecaVac;
(IE) Ireland: COVID-19 vaccine AstraZeneca | COVID-19 vaccine Janssen | Jcovden | Vaxzevria;
(IN) India: Covishield | Janssen COVID-19 vaccine | Sputnik V | Sputnik V component 2;
(IS) Iceland: COVID-19 vaccine AstraZeneca | COVID-19 vaccine Janssen | Jcovden | Vaxzevria;
(IT) Italy: COVID-19 vaccine AstraZeneca | COVID-19 vaccine Janssen | Jcovden | Vaxzevria;
(JP) Japan: Vaxzevria;
(KR) Korea, Republic of: AstraZeneca Korea Vaxzevria | COVID-19 vaccine Janssen | Korea AstraZeneca COVID-19 vaccine | Vaxzevria;
(LT) Lithuania: COVID-19 vaccine AstraZeneca | COVID-19 vaccine Janssen | Jcovden | Vaxzevria;
(LU) Luxembourg: COVID-19 vaccine AstraZeneca | COVID-19 vaccine Janssen | Jcovden | Vaxzevria;
(LV) Latvia: COVID-19 vaccine AstraZeneca | COVID-19 vaccine Janssen | Jcovden | Vaxzevria;
(MT) Malta: COVID-19 vaccine AstraZeneca | COVID-19 vaccine Janssen | Jcovden | Vaxzevria;
(MX) Mexico: Vacuna COVID-19 Janssen | Vaxzevria;
(MY) Malaysia: Convidecia | COVID-19 vaccine AstraZeneca | Janssen COVID-19 vaccine;
(NG) Nigeria: Covishield | Janssen COVID-19 vaccine | Sputnik V | Sputnik V component 2 | Vaxzevria;
(NL) Netherlands: COVID-19 vaccine AstraZeneca | COVID-19 vaccine Janssen | Jcovden | Vaxzevria;
(NO) Norway: COVID-19 vaccine AstraZeneca | COVID-19 vaccine Janssen | Jcovden | Vaxzevria;
(NZ) New Zealand: COVID-19 vaccine AstraZeneca | COVID-19 vaccine Janssen | Vaxzevria;
(PA) Panama: Gam-COVID-Vac | Gam-COVID-Vac component 2 | Vacuna COVID-19 AstraZeneca;
(PE) Peru: COVID-19 vaccine AstraZeneca | Vacuna COVID-19 AstraZeneca | Vaxzevria;
(PH) Philippines: COVID-19 vaccine AstraZeneca | Gam-COVID-Vac | Gam-COVID-Vac component 2 | Janssen COVID-19 vaccine;
(PK) Pakistan: Convidecia | Covishield | Gam-COVID-Vac | Gam-COVID-Vac component 2 | PakVac;
(PL) Poland: COVID-19 vaccine AstraZeneca | COVID-19 vaccine Janssen | Jcovden | Vaxzevria;
(PR) Puerto Rico: Janssen COVID-19 vaccine;
(PT) Portugal: COVID-19 vaccine AstraZeneca | COVID-19 vaccine Janssen | Jcovden | Vaxzevria;
(PY) Paraguay: Vaxzevria;
(RO) Romania: COVID-19 vaccine AstraZeneca | COVID-19 vaccine Janssen | Jcovden | Vaxzevria;
(RU) Russian Federation: Gam-COVID-Vac | Gam-COVID-Vac component 2 | Sputnik light;
(SA) Saudi Arabia: AstraZeneca COVID-19 vaccine;
(SE) Sweden: COVID-19 vaccine AstraZeneca | COVID-19 vaccine Janssen | Jcovden | Vaxzevria;
(SI) Slovenia: COVID-19 vaccine AstraZeneca | COVID-19 vaccine Janssen | Jcovden | Vaxzevria;
(SK) Slovakia: COVID-19 vaccine AstraZeneca | COVID-19 vaccine Janssen | Jcovden | Vaxzevria;
(TH) Thailand: COVID-19 vaccine AstraZeneca | COVID-19 vaccine Janssen;
(TN) Tunisia: Janssen COVID-19 vaccine;
(TR) Turkey: Sputnik V | Sputnik V component 2;
(TW) Taiwan: AstraZeneca COVID-19 vaccine;
(UA) Ukraine: COVID-19 vaccine AstraZeneca | COVID-19 vaccine Janssen | Covishield;
(ZA) South Africa: COVID-19 vaccine Janssen | Sputnik V

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Topic 130461 Version 133.0

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COVID-19 adenovirus vector vaccines (United States: Not available): Drug information