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COVID-19 adenovirus vector vaccines (United States and Canada: Authorized for use): Drug information

COVID-19 adenovirus vector vaccines (United States and Canada: Authorized for use): Drug information
(For additional information see "COVID-19 adenovirus vector vaccines (United States and Canada: Authorized for use): Pediatric drug information" and see "COVID-19 adenovirus vector vaccines (United States and Canada: Authorized for use): Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Special Alerts
COVID-19 Vaccine (Adenovirus Vector): Health Canada Approves AstraZeneca and Johnson & Johnson's Janssen Vaccines Updated November 2021

Health Canada has approved AstraZeneca's COVID-19 Vaccine (adenovirus vector) and Janssen's (Johnson & Johnson) COVID-19 vaccine (adenovirus vector). The AstraZeneca COVID-19 vaccine is a ChAdOx1-S recombinant vaccine developed by the University of Oxford and AstraZeneca. Covishield (manufactured by Serum Institute of India under license from AstraZeneca) was previously authorized via an interim order, which expired in September 2021.

Further information may be found at:

Product Monographs:

AstraZeneca Vaccine: https://covid-vaccine.canada.ca/info/pdf/astrazeneca-covid-19-vaccine-pm-en.pdf

Covishield: https://covid-vaccine.canada.ca/info/pdf/covishield-pm-en.pdf

Janssen Vaccine: https://covid-vaccine.canada.ca/info/pdf/janssen-covid-19-vaccine-pm-en.pdf

Regulatory Decision Summaries:

AstraZeneca Vaccine: https://covid-vaccine.canada.ca/info/regulatory-decision-summary-detail.html?linkID=RDS00889

Janssen (Johnson & Johnson) Vaccine: https://covid-vaccine.canada.ca/info/regulatory-decision-summary-detail.html?linkID=RDS00890

NACI: https://www.canada.ca/en/public-health/services/immunization/national-advisory-committee-on-immunization-naci/recommendations-use-covid-19-vaccines.html

Brand Names: US
  • Janssen COVID-19 Vaccine
Brand Names: Canada
  • AstraZeneca COVID-19 Vaccine [DSC];
  • Covishield [DSC];
  • Janssen COVID-19 Vaccine;
  • Vaxzevria
Pharmacologic Category
  • Vaccine;
  • Vaccine, Adenovirus Vector
Dosing: Adult

COVID-19 prevention:

Janssen COVID-19 Vaccine:

Note: The Advisory Committee on Immunization Practices/CDC preferentially recommend mRNA COVID-19 vaccines for primary series and booster dose; however, the Janssen COVID-19 Vaccine may be considered in some situations and is preferable to no COVID-19 vaccine (CDC 2022).

Primary dose: IM: 0.5 mL as a single dose (FDA 2021).

Booster dose: Note: Recommended for all persons ≥18 years of age (CDC 2022).

Following Janssen primary dose: IM: 0.5 mL administered ≥2 months after the primary dose (CDC 2022; FDA 2021).

Following mRNA vaccine (Moderna, Pfizer-BioNTech) primary series: IM: 0.5 mL administered ≥6 months following completion of the mRNA vaccine primary series (CDC 2022; FDA 2021).

Revaccination: Note: In patients who were vaccinated prior to receiving a hematopoietic cell transplant (HCT) or chimeric antigen receptor (CAR)-T-cell therapy, revaccination with a primary series (preferably with an mRNA vaccine) is recommended for patients who are ≥3 months post HCT or CAR-T-cell therapy (CDC 2022).

Interchangeability:

Following the first primary series dose with an mRNA COVID-19 vaccine: In limited, exceptional situations where a patient's first dose was an mRNA vaccine and they are unable to complete the series with the same or different mRNA vaccine (eg, due to a contraindication), then a single dose of the Janssen vaccine may be considered at a minimum interval of 28 days from the mRNA vaccine dose (CDC 2022).

Following a non–FDA-approved/authorized COVID-19 vaccine: If a non–FDA-approved/authorized COVID-19 vaccine (or WHO-listed vaccine) has been administered, allow a minimum interval of 28 days between the non–FDA-approved/authorized vaccine (or WHO-listed vaccine) and an FDA-approved/authorized vaccine (CDC 2022).

Booster dose: Following completion of the primary vaccination with an FDA-approved/authorized COVID-19 vaccine, a different COVID-19 vaccine may be used for the booster dose; mRNA vaccines are preferred even if the Janssen vaccine was received for the primary series (CDC 2022).

AstraZeneca COVID-19 Vaccine [Canadian product]:

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 (NACI 2021). 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 (WHO 2021).

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 (NACI 2021).

Booster dose: A booster dose for long-term care residents and older adults living in congregate settings may be considered ≥6 months following completion of the primary series, ONLY when other authorized COVID-19 vaccines (ie, mRNA vaccines) are contraindicated or inaccessible (NACI 2021).

Premedication: The CDC does not recommend routine prophylactic administration of antihistamines, antipyretic/analgesic medications (eg, acetaminophen, nonsteroidal anti-inflammatory drugs), or aspirin/anticoagulants for the purpose of preventing postvaccination symptoms. Antihistamines may mask cutaneous symptoms of anaphylaxis, which could delay the diagnosis and management of the reaction. The impact of antipyretic/analgesic medications on antibody response is unknown. Antipyretic/analgesic medications may be taken after vaccination for the treatment of postvaccination local/systemic symptoms (if medically appropriate) (CDC 2022).

Dosing recommendations for deviation in administration, preparation, or storage (CDC 2022):

• If dose volume was too low, repeat dose immediately (no minimum interval).

• If dose volume was too high, do not repeat dose; administer subsequent dose (eg, booster, if needed) at the appropriate interval.

• If a Janssen COVID-19 Vaccine booster dose is administered too early (ie, <6 months after the mRNA vaccine primary series or <2 months after a Janssen primary dose), do not repeat dose.

• If vaccine was stored or handled inappropriately (eg, temperature excursion, dose administered past expiration date) and the manufacturer does not have supportive stability data, repeat dose immediately (no minimum interval).

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: Pediatric

(For additional information see "COVID-19 adenovirus vector vaccines (United States and Canada: Authorized for use): Pediatric drug information")

COVID-19 prevention:

Janssen vaccine: Note: The ACIP/CDC preferentially recommend mRNA COVID-19 vaccines for primary series and booster dose; however, the Janssen COVID-19 Vaccine may be considered in some situations and is preferable to no COVID-19 vaccine (CDC 2021a).

Adolescents ≥18 years:

Primary dose: IM: 0.5 mL as a single dose (FDA 2021).

Booster dose: Note: Recommended for all persons ≥18 years of age (CDC 2021a).

Following Janssen primary dose: IM: 0.5 mL administered ≥2 months after the primary dose (CDC 2021a; FDA 2021).

Following mRNA vaccine (Moderna, Pfizer-BioNTech) primary series: IM: 0.5 mL administered ≥6 months following completion of the mRNA vaccine primary series (CDC 2021a; FDA 2021).

Revaccination: In patients who were vaccinated prior to or while receiving a hematopoietic cell transplant (HCT) or chimeric antigen receptor (CAR)-T-cell therapy, revaccination with a primary series (preferably with an mRNA vaccine) is recommended for patients who are ≥3 months post HCT or CAR-T-cell therapy (CDC 2021a).

Interchangeability:

Following the first primary series dose with an mRNA COVID-19 vaccine: In limited, exceptional situations where a patient's first dose was an mRNA vaccine and they are unable to complete the series with the same or different mRNA vaccine (eg, due to a contraindication), then a single dose of the Janssen vaccine may be considered (if age appropriate) at a minimum interval of 28 days from the mRNA vaccine dose (CDC 2021a).

Following a non–FDA-approved/authorized COVID-19 vaccine: If a non–FDA-approved/authorized COVID-19 vaccine (or WHO-listed vaccine) has been administered, allow a minimum interval of 28 days between the non–FDA-approved/authorized vaccine (or WHO-listed vaccine) and an FDA-approved/authorized vaccine (CDC 2021a).

Booster dose: Following completion of the primary vaccination with an FDA-approved/authorized COVID-19 vaccine, a different COVID-19 vaccine may be used for the booster dose; mRNA vaccines are preferred even if the Janssen vaccine was received for the primary series (CDC 2021c).

AstraZeneca vaccine [Canadian product]:

Adolescents ≥18 years:

Primary series: IM: 0.5 mL per dose for 2 doses administered 28 to 84 days (4 to 12 weeks) apart. Note: 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 (NACI 2021). 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 (WHO 2021).

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 (NACI 2021).

Booster dose: A booster dose for long-term care residents and older adults living in congregate settings may be considered ≥6 months following completion of the primary series, ONLY when other authorized COVID-19 vaccines (ie, mRNA vaccines) are contraindicated or inaccessible (NACI 2021).

Premedication: The Centers for Disease Control and Prevention (CDC) does not recommend routine prophylactic administration of antihistamines, antipyretic/analgesic medications (eg, acetaminophen, nonsteroidal anti-inflammatory drugs), or aspirin/anticoagulants for the purpose of preventing postvaccination symptoms. Antihistamines may mask cutaneous symptoms of anaphylaxis, which could delay the diagnosis and management of the reaction. The impact of antipyretic/analgesic medications on antibody response is unknown. Antipyretic/analgesic medications may be taken after vaccination for the treatment of postvaccination local/systemic symptoms (if medically appropriate). Aspirin or anticoagulants as part of routine drug therapy do not need to be stopped prior to vaccination (CDC 2021a).

Dosing recommendations for deviation in dose storage, preparation, or administration (CDC 2021a):

• If dose volume was too low, repeat dose immediately (no minimum interval).

• If dose volume was too high, do not repeat dose and administer subsequent dose (eg, booster, if needed) at the appropriate interval.

• If a Janssen COVID-19 vaccine booster dose is administered too early (ie, <6 months after the mRNA vaccine primary series or <2 months after a Janssen primary dose), do not repeat dose.

• If Janssen COVID-19 vaccine administered to persons 5 to 17 years of age, consider administering a single dose of correct Pfizer-BioNTech vaccine formulation ≥2 months after the Janssen vaccine dose.

• If vaccine stored or handled inappropriately (eg, temperature excursion, dose administered past expiration date) and the manufacturer does not have supportive stability data, repeat dose immediately (no minimum interval).

Dosing: Kidney Impairment: Pediatric

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

Dosing: Hepatic Impairment: Pediatric

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

Dosing: Older Adult

Refer to adult dosing.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Suspension, Intramuscular [preservative free]:

Janssen COVID-19 Vaccine: 50 billion viral particles per 0.5 mL (2.5 mL) [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 (5 mL) [contains alcohol, usp, edetate (edta) disodium, polysorbate 80]

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

Suspension, Intramuscular:

Generic: 50 billion viral particles per 0.5 mL (2.5 mL)

Prescribing and Access Restrictions

The Janssen COVID-19 Vaccine is not commercially available; it is available under emergency use authorization (EUA) from the FDA. The US federal government, in conjunction with state health departments, will allocate supply to individual sites of care across the United States.

As part of the EUA, information consistent with fact sheets pertaining to emergency use of the COVID-19 vaccines must be provided to recipients/caregivers, and certain mandatory requirements for administration under the EUA must be met as outlined in the FDA EUA letter.

Janssen COVID-19 Vaccine: The health care provider fact sheet is located at: https://www.fda.gov/media/146304/download. The patient fact sheet is located at: https://www.fda.gov/media/146305/download.

The vaccine provider should include vaccination information in the state/local jurisdiction Immunization Information System (IIS) or other designated system and provide a paper record card as a backup.

Additionally, the vaccination provider is responsible for mandatory reporting of the following to the Vaccine Adverse Event Reporting System (VAERS) (https://vaers.hhs.gov/reportevent.html or 1-800-822-7967):

  • vaccine administration errors whether or not associated with an adverse event

  • serious adverse events (irrespective of attribution to vaccination)

  • cases of multisystem inflammatory syndrome (MIS) in adults

  • cases of COVID-19 that result in hospitalization or death

The vaccination provider is also responsible for responding to FDA requests for more information. Additional adverse events may be reported to VAERS and the manufacturer. Adverse events related to the Janssen vaccine may be reported to Janssen Biotech, Inc via email: JNJvaccineAE@its.jnj.com; phone: 1-800-565-4008; or fax: 1-215-293-9955.

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 (FDA 2021). Administer IM in the deltoid muscle (FDA 2021). 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 (Cross 2016; Foster 2013). To prevent syncope-related injuries, adolescents and adults should be vaccinated while seated or lying down (ACIP [Kroger 2021]).

If administering simultaneously with other vaccines, administer each vaccine at a different injection site, at least 1 inch apart if possible; if administering simultaneously with vaccines that are likely to cause a local reaction, administer COVID-19 vaccine in a different limb if possible (CDC 2022).

Inappropriate administration technique: If administered SUBQ or into a muscle other than the deltoid or anterolateral thigh (alternate administration site), do not repeat dose. If an additional dose (ie, booster) is needed, administer at the recommended interval (CDC 2022).

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 (ACIP [Kroger 2021]).

Administration: Pediatric

Parenteral: IM: Adolescents ≥18 years: Do not shake. For the Janssen product, gently swirl the vial in an upright position for 10 seconds before withdrawing each dose of vaccine (FDA 2021). Administer IM in the deltoid muscle (FDA 2021). 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 (Cross 2016; Foster 2013). To prevent syncope-related injuries, adolescents and adults should be vaccinated while seated or lying down (ACIP [Kroger 2021]).

If administering simultaneously with other vaccines, administer each vaccine at a different injection site, at least 1 inch apart if possible; if administering simultaneously with vaccines that are likely to cause a local reaction, administer COVID-19 vaccine in a different limb if possible (CDC 2022).

Inappropriate administration technique: If administered SubQ or into a muscle other than the deltoid or anterolateral thigh (alternate administration site), do not repeat dose. If an additional dose (ie, booster) is needed, administer at the recommended interval (CDC 2022).

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 or smaller) 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 (ACIP [Kroger 2021]).

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. Note: Health Canada’s interim order for use of Covishield has expired.

Canadian Guidance: The National Advisory Committee on Immunization (NACI) has made recommendations on the use of COVID-19 vaccines; see recommendations for details (Health Canada 2021).

For US product, see "Use: Off-Label: Adult."

Use: Off-Label: Adult

COVID-19 prevention

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).

Adverse Reactions (Significant): Considerations

Janssen :

Hypersensitivity reactions

Hypersensitivity reactions, including anaphylaxis, have been reported with the Janssen COVID-19 Vaccine during clinical trials. Angioedema (not associated with respiratory distress) and urticaria (nonserious) have also been reported (Ref). Immediate treatment (including epinephrine 1 mg/mL) for anaphylactoid and/or hypersensitivity reactions should be available during vaccine use (Ref). Of importance, polysorbate 80 is an ingredient in the COVID-19 adenovirus vector vaccines (Janssen COVID-19 Vaccine and the AstraZeneca (Vaxzevria) COVID-19 Vaccine [adenovirus vector])/Covishield [Canadian products]) and is a contraindication in patients with a known hypersensitivity. Polyethylene glycol (PEG) is an ingredient in another type of COVID-19 vaccine (eg, mRNA). Polysorbate and PEG are structurally related; therefore, cross-sensitivity may occur (Ref).

Onset: Anaphylaxis: Onset of the single case reported with Janssen COVID-19 Vaccine is unknown; however, drug-induced anaphylaxis, in general, is IgE-mediated with rapid onset (ie, within 1 hour of administration, but may occur up to 6 hours after exposure) (Ref). Angioedema: Rapid; in the single reported case, onset was 4 days after vaccination (Ref) and was associated with urticaria. Urticaria: Varied; in reported cases, onset was 2 to 7 days after vaccination (Ref).

Risk factors:

Precautions (but not contraindications) include:

• History of any immediate allergic reaction (eg, anaphylaxis) to any other vaccine or injectable therapy (eg, IM, IV, or SubQ vaccines or therapies [excluding SubQ immunotherapy for allergies]) (Ref)

• History of any immediate allergic reaction (eg, anaphylaxis) to PEG due to a potential for cross-sensitivity between PEG and polysorbate 80, which is a component of the COVID-19 adenovirus vector vaccines (Ref)

• Patients with a contraindication to another type of COVID-19 vaccine (eg, mRNA) (certain measures must be taken before a different type of COVID-19 [eg, adenovirus vector] is administered to these patients) (Ref)

Local reactions

Local reactions include erythema at injection site, pain at injection site, and swelling at injection site. Local reactions were reported more frequently in younger patients (18 to 59 years of age) compared to patients ≥60 years of age with the Janssen COVID-19 Vaccine primary series. Local reactions were similar to the primary series and were reported more frequently in younger patients (18 to 55 years of age) compared to patients ≥65 years of age with the Janssen COVID-19 Vaccine (mRNA) booster dose. In general, local reactions were mild to moderate in severity and resolved after a median duration of 1 to 2 days. One case of severe pain at injection site, persistent (74 days following vaccination) and nonresponsive to analgesics was reported (Ref).

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

Systemic reactions (excluding hypersensitivity)

Systemic reactions include asthenia, fatigue, fever, headache, myalgia, and nausea. Systemic reactions were reported more frequently in younger patients (18 to 59 years of age) compared to patients ≥60 years of age with the Janssen COVID-19 Vaccine primary series. Systemic reactions were similar to the primary series and were reported more frequently in younger patients (18 to 55 years of age) compared to patients ≥65 years of age with the Janssen COVID-19 Vaccine (mRNA) booster dose. In general, local reactions were mild to moderate in severity and resolved after a median duration of 1 to 2 days (Ref).

Onset: Varied; within 7 days after vaccination (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 Janssen COVID-19 Vaccine. Thrombotic events (including fatal cases) primarily included cerebral sinus thrombosis (in some cases accompanied by cerebral hemorrhage). Other reported thrombotic events included portal vein thrombosis, thrombosis of the splanchnic-vein, and arterial thrombosis. Cases have occurred in both females and males; however, the majority of cases have occurred in females between the ages of 30 to 49 years (Ref). Approximately 15% of cases have been fatal (Ref). Reported cases of TTS with the Janssen COVID-19 Vaccine are similar to reported cases of thrombosis with thrombocytopenia (also referred to as vaccine-induced thrombotic thrombocytopenia [VITT]) with the AstraZeneca (Vaxzevria) COVID-19 Vaccine. Patients with neurological symptoms (including severe or persistent headaches or blurred vision), persistent abdominal pain, chest pain, leg swelling, shortness of breath, or petechiae beyond the site of vaccination should seek immediate medical care. Health care professionals should be aware that the use of heparin may be harmful and alternative treatments may be needed; hematology consultation is strongly recommended (Ref). Administration of the Janssen COVID-19 Vaccine is contraindicated in patients with a history of TTS following the Janssen COVID-19 Vaccine or any other adenovirus vector-based COVID-19 Vaccine (Ref).

Mechanism: Not clearly established; may be immune-mediated, involving platelet-activating antibodies against platelet factor 4 (PF4) (CDC 2021d).

Onset: Varied; median 8 days (range 6 to 15) after vaccination (CDC 2021d).

AstraZeneca (Vaxzevria)/Covishield (Canadian products):

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.

Local reactions

Local reactions 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 AstraZeneca (Vaxzevria) COVID-19 Vaccine (adenovirus vector)/Covishield [Canadian products]; 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 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 AstraZeneca (Vaxzevria) COVID-19 Vaccine (adenovirus vector)/Covishield [Canadian products]; 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

Thrombosis with thrombocytopenia, (also referred to as vaccine-induced thrombotic thrombocytopenia [VITT]), which clinically mimics autoimmune heparin-induced thrombocytopenia, has been reported rarely with the AstraZeneca (Vaxzevria) COVID-19/Covishield Vaccine (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). 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 AstraZeneca (Vaxzevria) COVID-19 Vaccine/Covishield should not receive a second dose of the AstraZeneca (Vaxzevria) COVID-19 Vaccine/Covishield. Treatment may differ from management of other thromboses; consult current guidance and hematology specialists (Ref).

Mechanism: Immune-mediated; vaccine-induced platelet-activating antibodies against platelet factor 4 (PF4). This proposed mechanism is based on the observation that affected patients tested positive for antibodies against PF4-heparin; however, none of the patients received heparin prior to onset (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 FDA-issued emergency use authorization (EUA) for the Janssen COVID-19 Vaccine primary series and booster dose and the product information for the AstraZeneca (Vaxzevria) COVID-19 Vaccine (adenovirus vector)/Covishield [Canadian products], unless otherwise specified. Refer to EUA and Canadian product information for respective products for information regarding reporting adverse reactions (Vaxzevria Canadian product monograph; Covishield Canadian product monograph; FDA 2021).

Janssen:

>10%:

Gastrointestinal: Nausea (2% to 16%) (table 1)

COVID-19 Vaccine (Adenovirus Vector): Adverse Reaction: Nausea

Drug (COVID-19 Vaccine [Adenovirus Vector])

Placebo

Population

Number of Patients (COVID-19 Vaccine [Adenovirus Vector])

Number of Patients (Placebo)

Comments

16%

9%

18 to 59 years of age

2,036

2,049

Primary series

12%

11%

≥60 years of age

1,320

1,331

Primary series

10%

N/A

18 to 55 years of age

89

N/A

Booster dose

2%

N/A

≥65 years of age

48

N/A

Booster dose

Local: Pain at injection site (21% to 60%) (table 2)

COVID-19 Vaccine (Adenovirus Vector): 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

59%

17%

18 to 59 years of age

2,036

2,049

Primary series

33%

16%

≥60 years of age

1,320

1,331

Primary series

60%

N/A

18 to 55 years of age

89

N/A

Booster dose

21%

N/A

≥65 years of age

48

N/A

Booster dose

Nervous system: Fatigue (30% to 52%) (table 3), headache (27% to 44%) (table 4)

COVID-19 Vaccine (Adenovirus Vector): Adverse Reaction: Fatigue

Drug (COVID-19 Vaccine [Adenovirus Vector])

Placebo

Population

Number of Patients (COVID-19 Vaccine [Adenovirus Vector])

Number of Patients (Placebo)

Comments

44%

22%

18 to 59 years of age

2,036

2,049

Primary series

30%

21%

≥60 years of age

1,320

1,331

Primary series

52%

N/A

18 to 55 years of age

89

N/A

Booster dose

33%

N/A

≥65 years of age

48

N/A

Booster dose

COVID-19 Vaccine (Adenovirus Vector): Adverse Reaction: Headache

Drug (COVID-19 Vaccine [Adenovirus Vector])

Placebo

Population

Number of Patients (COVID-19 Vaccine [Adenovirus Vector])

Number of Patients (Placebo)

Comments

44%

25%

18 to 59 years of age

2,036

2,049

Primary series

30%

22%

≥60 years of age

1,320

1,331

Primary series

42%

N/A

18 to 55 years of age

89

N/A

Booster dose

27%

N/A

≥65 years of age

48

N/A

Booster dose

Neuromuscular & skeletal: Myalgia (10% to 39%) (table 5)

COVID-19 Vaccine (Adenovirus Vector): Adverse Reaction: Myalgia

Drug (COVID-19 Vaccine [Adenovirus Vector])

Placebo

Population

Number of Patients (COVID-19 Vaccine [Adenovirus Vector])

Number of Patients (Placebo)

Comments

39%

12%

18 to 59 years of age

2,036

2,049

Primary series

24%

14%

≥60 years of age

1,320

1,331

Primary series

36%

N/A

18 to 55 years of age

89

N/A

Booster dose

10%

N/A

≥65 years of age

48

N/A

Booster dose

Miscellaneous: Fever (0% to 13%) (table 6)

COVID-19 Vaccine (Adenovirus Vector): Adverse Reaction: Fever

Drug (COVID-19 Vaccine [Adenovirus Vector])

Placebo

Population

Number of Patients (COVID-19 Vaccine [Adenovirus Vector])

Number of Patients (Placebo)

Comments

13%

0.7%

18 to 59 years of age

2,036

2,049

Primary series

3%

0.5%

≥60 years of age

1,320

1,331

Primary series

6%

N/A

18 to 55 years of age

89

N/A

Booster dose

0%

N/A

≥65 years of age

48

N/A

Booster dose

1% to 10%: Local: Erythema at injection site (0% to 9%) (table 7), swelling at injection site (0% to 7%) (table 8)

COVID-19 Vaccine (Adenovirus Vector): 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%

4%

18 to 59 years of age

2,036

2,049

Primary series

5%

3%

≥60 years of age

1,320

1,331

Primary series

1%

N/A

18 to 55 years of age

89

N/A

Booster dose

0%

N/A

≥65 years of age

48

N/A

Booster dose

COVID-19 Vaccine (Adenovirus Vector): 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

2,036

2,049

Primary series

3%

2%

≥60 years of age

1,320

1,331

Primary series

0%

N/A

18 to 55 years of age

89

N/A

Booster dose

0%

N/A

≥65 years of age

48

N/A

Booster dose

Frequency not defined:

Cardiovascular: Thromboembolism (including deep vein thrombosis, pulmonary embolism, and transverse sinus thrombosis; unsolicited; data insufficient to determine causal relationship)

Dermatologic: Urticaria

Hypersensitivity: Anaphylaxis, angioedema, hypersensitivity reaction

Nervous system: Seizure (unsolicited; data insufficient to determine causal relationship)

Neuromuscular & skeletal: Asthenia

Otic: Tinnitus (unsolicited; data insufficient to determine causal relationship)

Post-authorization:

Cardiovascular: Arterial thrombosis, capillary leak syndrome, portal vein thrombosis, thrombosis (splanchnic-vein), venous thromboembolism

Gastrointestinal: Diarrhea, vomiting

Hematologic & oncologic: Immune thrombocytopenia (risk may be increased in the 42 days after vaccination and in patients with a history of immune thrombocytopenia), lymphadenopathy, thrombocytopenia (syndrome in combination with thrombosis [TTS]) (CDC 2021d)

Nervous system: Cerebral hemorrhage, cerebral sinus thrombosis, Guillain-Barre syndrome (highest risk in males 50 to 64 years of age in the 42 days after vaccination) (CDC 2022), hypoesthesia, paresthesia, syncope

AstraZeneca (Vaxzevria)/Covishield (Canadian products):

>10%:

Gastrointestinal: Nausea (6% to 24%) (table 9)

COVID-19 Vaccine (Adenovirus Vector): 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

24%

12%

18 to 64 years of age

1,323

1,260

Dose 1

10%

10%

18 to 64 years of age

573

486

Dose 2

8%

7%

≥65 years of age

399

318

Dose 1

6%

3%

≥65 years of age

265

227

Dose 2

Local: Pain at injection site (10% to 60%) (table 10), tenderness at injection site (32% to 79%) (table 11), warm sensation at injection site (4% to 17%) (table 12)

COVID-19 Vaccine (Adenovirus Vector): 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

60%

37%

18 to 64 years of age

1,323

1,260

Dose 1

34%

33%

18 to 64 years of age

567

484

Dose 2

23%

14%

≥65 years of age

399

318

Dose 1

10%

5%

≥65 years of age

256

223

Dose 2

COVID-19 Vaccine (Adenovirus Vector): 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

79%

79%

18 to 64 years of age

1,323

1,260

Dose 1

60%

52%

18 to 64 years of age

567

484

Dose 2

51%

30%

≥65 years of age

399

318

Dose 1

32%

18%

≥65 years of age

256

223

Dose 2

COVID-19 Vaccine (Adenovirus Vector): Adverse Reaction: Warm Sensation 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

17%

14%

18 to 64 years of age

1,323

1,260

Dose 1

11%

12%

18 to 64 years of age

567

484

Dose 2

11%

7%

≥65 years of age

399

318

Dose 1

4%

4%

≥65 years of age

256

223

Dose 2

Nervous system: Chills (2% to 37%) (table 13), fatigue (27% to 65%) (table 14), headache (20% to 61%) (table 15), malaise (10% to 48%) (table 16)

COVID-19 Vaccine (Adenovirus Vector): 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

37%

8%

18 to 64 years of age

1,323

1,260

Dose 1

7%

5%

18 to 64 years of age

573

486

Dose 2

11%

4%

≥65 years of age

399

318

Dose 1

2%

3%

≥65 years of age

265

227

Dose 2

COVID-19 Vaccine (Adenovirus Vector): 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

65%

46%

18 to 64 years of age

1,323

1,260

Dose 1

43%

34%

18 to 64 years of age

573

486

Dose 2

41%

27%

≥65 years of age

399

318

Dose 1

27%

21%

≥65 years of age

265

227

Dose 2

COVID-19 Vaccine (Adenovirus Vector): 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

61%

42%

18 to 64 years of age

1,323

1,260

Dose 1

38%

30%

18 to 64 years of age

573

486

Dose 2

32%

24%

≥65 years of age

399

318

Dose 1

20%

14%

≥65 years of age

265

227

Dose 2

COVID-19 Vaccine (Adenovirus Vector): 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

48%

19%

18 to 64 years of age

1,323

1,260

Dose 1

22%

13%

18 to 64 years of age

573

486

Dose 2

17%

10%

≥65 years of age

399

318

Dose 1

10%

7%

≥65 years of age

265

227

Dose 2

Neuromuscular & skeletal: Arthralgia (7% to 28%) (table 17), myalgia (14% to 52%) (table 18)

COVID-19 Vaccine (Adenovirus Vector): Adverse Reaction: Arthralgia

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

28%

9%

18 to 64 years of age

1,323

1,260

Dose 1

12%

7%

18 to 64 years of age

573

486

Dose 2

13%

8%

≥65 years of age

399

318

Dose 1

7%

7%

≥65 years of age

265

227

Dose 2

COVID-19 Vaccine (Adenovirus Vector): 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

52%

24%

18 to 64 years of age

1,323

1,260

Dose 1

26%

15%

18 to 64 years of age

573

486

Dose 2

23%

11%

≥65 years of age

399

318

Dose 1

14%

9%

≥65 years of age

265

227

Dose 2

Miscellaneous: Fever (≤12%; feverishness: 4% to 39%) (table 19)

COVID-19 Vaccine (Adenovirus Vector): 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

12%

0.4%

18 to 64 years of age

1,323

1,260

Dose 1

0.7%

0.6%

18 to 64 years of age

573

486

Dose 2

1%

0.3%

≥65 years of age

399

318

Dose 1

0%

0%

≥65 years of age

265

227

Dose 2

39%

10%

18 to 64 years of age

1,323

1,260

Dose 1, feverishness

12%

7%

18 to 64 years of age

573

486

Dose 2, feverishness

9%

4%

≥65 years of age

399

318

Dose 1, feverishness

4%

3%

≥65 years of age

265

227

Dose 2, feverishness

1% to 10%:

Gastrointestinal: Vomiting (≤2%) (table 20)

COVID-19 Vaccine (Adenovirus Vector): 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%

0.8%

18 to 64 years of age

1,323

1,260

Dose 1

0.9%

0.4%

18 to 64 years of age

573

486

Dose 2

0.3%

0.6%

≥65 years of age

399

318

Dose 1

0%

0.4%

≥65 years of age

265

227

Dose 2

Local: Erythema at injection site (≤3%) (table 21), induration at injection site (≤3%) (table 22), injection site pruritus (2% to 7%) (table 23), swelling at injection site (≤3%) (table 24)

COVID-19 Vaccine (Adenovirus Vector): 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%

2%

18 to 64 years of age

1,323

1,260

Dose 1

1%

0.8%

18 to 64 years of age

567

484

Dose 2

2%

0.9%

≥65 years of age

399

318

Dose 1

0.4%

0%

≥65 years of age

256

223

Dose 2

COVID-19 Vaccine (Adenovirus Vector): 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%

2%

18 to 64 years of age

1,323

1,260

Dose 1

0.7%

2%

18 to 64 years of age

567

484

Dose 2

1%

0%

≥65 years of age

399

318

Dose 1

0.4%

0%

≥65 years of age

256

223

Dose 2

COVID-19 Vaccine (Adenovirus Vector): Adverse Reaction: Injection Site Pruritus

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

7%

4%

18 to 64 years of age

1,323

1,260

Dose 1

4%

3%

18 to 64 years of age

567

484

Dose 2

4%

5%

≥65 years of age

399

318

Dose 1

2%

2%

≥65 years of age

256

223

Dose 2

COVID-19 Vaccine (Adenovirus Vector): Adverse Reaction: Swelling 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%

2%

18 to 64 years of age

1,323

1,260

Dose 1

0.9%

1%

18 to 64 years of age

567

484

Dose 2

2%

0.3%

≥65 years of age

399

318

Dose 1

0.8%

0.4%

≥65 years of age

256

223

Dose 2

<1%:

Dermatologic: Diaphoresis, pruritus, skin rash

Gastrointestinal: Decreased appetite (table 25)

COVID-19 Vaccine (Adenovirus Vector): 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

12,021

11,724

Nervous system: Dizziness, drowsiness

Frequency not defined:

Nervous system: Facial nerve paralysis (unsolicited; possibly related; 14 days after the second dose)

Neuromuscular & skeletal: Asthenia

Post-authorization:

Cardiovascular: Arterial thrombosis, capillary leak syndrome, portal vein thrombosis (Greinacher 2021), pulmonary embolism (Greinacher 2021), thrombosis (splanchnic-vein and other) (Greinacher 2021)

Hematologic & oncologic: Disseminated intravascular coagulation (Greinacher 2021), thrombocytopenia (in combination with thrombosis; also referred to as vaccine-induced [VITT]) (Greinacher 2021; Merchant 2021)

Nervous system: Cerebral hemorrhage (Greinacher 2021; Schultz 2021), cerebral sinus thrombosis (Greinacher 2021; Merchant 2021), Guillain-Barre syndrome

Contraindications

History of a severe allergic reaction (eg, anaphylaxis) after a previous dose or to a component of the formulation; history of immediate allergic reaction (regardless of severity and occurring within 4 hours) to a previous dose; known allergy to any component of the formulation (eg, polysorbate 80) (CDC 2022); history of thrombosis with thrombocytopenia following previous dose of Janssen COVID-19 Vaccine or any other adenovirus vector COVID-19 vaccine (eg, AstraZeneca COVID-19 Vaccine).

AstraZeneca COVID-19 Vaccine/Covishield [Canadian labeling]: Major venous and/or arterial thrombosis with thrombocytopenia following previous dose of AstraZeneca COVID-19 Vaccine or Covishield; history of capillary leak syndrome.

Janssen COVID-19 Vaccine [Canadian 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 2021]).

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 2021]). 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 2021]). 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).

• 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; an 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 2022).

Multisystem inflammatory syndrome: Delay COVID-19 vaccination until resolution of illness and for 90 days after diagnosis in patients with a history of multisystem inflammatory syndrome in children (MIS-C) or adults (MIS-A). There are limited data on the safety of COVID-19 vaccination following MIS-C or MIS-A; 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) (CDC 2021c).

• SARS-CoV-2 infection or exposure (CDC 2022):

- Persons with current or prior history of COVID-19 or asymptomatic SARS-CoV-2 infection: Vaccination should be offered to persons regardless of history of symptomatic or asymptomatic SARS-CoV-2 infection, including those with prolonged symptoms. Based on data from clinical trials, vaccination in persons with evidence of prior SARS-CoV-2 infection is safe. Defer vaccination in persons with known current SARS-CoV-2 infection until the person has recovered from acute illness (if symptomatic) and no longer requires isolation. This applies to those persons who develop SARS-CoV-2 infection before receiving any vaccine doses and also those who develop infection after the first dose but before the second dose.

- Persons who received passive antibody COVID-19 therapy: As a precaution, it is recommended to defer vaccination (first dose or subsequent doses) for 30 days following receipt of passive antibody therapy for COVID-19 postexposure prophylaxis and for 90 days following receipt of passive antibody therapy for COVID-19 treatment. Vaccination within these deferral periods (30 or 90 days) does not need to be repeated.

- Persons who received antibody therapies that are not specific to COVID-19: There is no recommended minimum interval between vaccination and antibody therapies that are not specific to COVID-19 (eg, IVIG, hepatitis B immune globulin) (CDC 2022).

- Vaccinated persons who subsequently develop COVID-19: Prior receipt of a COVID-19 vaccine should not affect treatment decisions (eg, monoclonal antibodies, convalescent plasma) or timing of such treatments (CDC 2022). If a person is fully vaccinated and ≥2 weeks postvaccination and tests positive for SARS-CoV-2, the CDC recommends holding the specimen and contacting the state health department.

- Persons with known SARS-CoV-2 exposure: Vaccination for outbreak management or postexposure prophylaxis is not currently recommended. Persons with known exposure should wait to seek vaccination until after their quarantine period has ended. For persons in congregate settings (eg, long-term care facilities, correctional facilities, homeless shelters), residents with known exposure may be vaccinated unless they have symptoms consistent with COVID-19.

Concurrent drug therapy issues:

• Anticoagulant or aspirin therapy: Prophylactic aspirin or anticoagulant administration is not recommended (CDC 2022). Clinicians administering vaccine should be aware of potential bleeding or hematoma that could occur due to IM administration (ACIP [Kroger 2021]).

• 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). However, routine prophylactic administration of these medications for the purpose of preventing postvaccination symptoms is not currently recommended; impact on antibody response is unknown (CDC 2022).

• 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 2021; CDC 2022). 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 2022).

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 (CDC 2022; NACI 2021). If possible, complete COVID-19 vaccination ≥2 weeks prior to initiation of immunosuppressive therapy (CDC 2022; NACI 2021). For more information on administering COVID-19 vaccine in specific disease states, see society recommendations (eg, American Cancer Society, National Multiple Sclerosis Society).

• Autoimmune conditions: The safety and efficacy of COVID-19 vaccines in persons with autoimmune conditions were similar to the general population. The CDC and the Canadian National Advisory Committee on Immunization recommend vaccination of patients with autoimmune conditions if there are no contraindications; as with the general population, mRNA vaccines are preferred (CDC 2022; NACI 2021).

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 2022).

• Traceability: The vaccine name, batch/lot number, expiration date, and other administration details must be recorded in order to improve traceability (FDA 2021).

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 2021]). Vaccines may not be effective if administered during periods of altered immune competence (ACIP [Kroger 2021]).

• 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 2021). Imaging needed for acute symptoms, or urgent treatment planning or complications, should not be delayed (Becker 2021).

Metabolism/Transport Effects

None known.

Drug Interactions

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

Antihistamines: May enhance the adverse/toxic effect of COVID-19 Vaccine (Adenovirus Vector). Specifically, the prophylactic use of antihistamines may mask symptoms and delay diagnosis and management of anaphylaxis. Management: Do not administer antihistamines to COVID-19 adenovirus vector vaccine recipients prior to vaccination to prevent allergic reactions. Use may mask cutaneous symptoms, which could lead to a delay in the diagnosis and management of anaphylaxis. 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 vaccine series at least 3 months (12 weeks) after CAR-T-cell therapy. Risk D: Consider therapy modification

Corticosteroids (Systemic): May diminish the therapeutic effect of COVID-19 Vaccine (Adenovirus Vector). Risk C: Monitor therapy

Immunosuppressants (Cytotoxic Chemotherapy): May diminish the therapeutic effect of COVID-19 Vaccine (Adenovirus Vector). Risk C: Monitor therapy

Immunosuppressants (Miscellaneous Oncologic Agents): May diminish the therapeutic effect of COVID-19 Vaccine (Adenovirus Vector). Risk C: Monitor therapy

Immunosuppressants (Therapeutic Immunosuppressant Agents): May diminish the therapeutic effect of COVID-19 Vaccine (Adenovirus Vector). Risk C: Monitor therapy

Methotrexate: May diminish the therapeutic effect of COVID-19 Vaccine (Adenovirus Vector). Management: Consider holding methotrexate therapy for 2 weeks after the single vaccine dose when possible for patients with stable underlying disease. This is specific to patients using methotrexate for rheumatic and musculoskeletal disease and not other uses. 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

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

Reproductive Considerations

The Janssen COVID-19 (adenovirus vector) Vaccine is an investigational vaccine permitted for use under FDA emergency use authorization (EUA). Based on data from the Delta variant, the risk of severe illness from COVID-19 infection is increased in nonpregnant patients of reproductive potential (ACOG FAQ 2022). Due to the risk of severe illness, pregnancy complications, and death from COVID-19 infection during pregnancy, the CDC strongly recommends vaccination 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 (CDC 2021b). Pregnancy does not need to be delayed following vaccination. Pregnancy testing is not required prior to vaccination (ACOG 2022; CDC 2022).

There is no evidence that COVID-19 vaccines affect fertility (ACOG 2022; CDC 2022).

There have been anecdotal reports of temporary menstrual changes following vaccination. Vaccines have not previously been associated with menstrual disturbances. Environmental stresses can impact menses. COVID-19 vaccines may be given to patients who are menstruating, and vaccination does not need to be scheduled based on menstrual cycle. Based on available data, any effect of the COVID-19 vaccine on menstruation is minimal and temporary; not a reason to avoid vaccination (ACOG 2022).

• Menstrual cycle length was evaluated in a retrospective analysis of prospectively collected data from vaccinated (n=2,403) and unvaccinated individuals (n=1,556) who were tracking menstrual cycles for nonhormonal pregnancy prevention or planning. Included were persons 18 to 45 who had normal menstrual cycle lengths, provided 6 consecutive cycles of data, and had not been pregnant or used hormonal contraception for ≥3 cycles. Vaccinated patients received the Pfizer-BioNTech COVID-19 Vaccine (55%), Moderna COVID-19 Vaccine (35%) or the Janssen COVID-19 (adenovirus vector) Vaccine (7%). When adjusting for age, race, BMI, education, parity, and relationship status, the length of a menstrual cycle differed by less than 1 day following vaccination. This was not considered clinically significant. A small subgroup of patients (n=358) received 2 vaccine doses within the same cycle; these patients had an increase in cycle length by 2 days (Edelman 2022).

Thrombosis with thrombocytopenia syndrome (TTS) has been reported with use of the Janssen COVID-19 (adenovirus vector) Vaccine; although rare, the highest rate reported is in females 30 to 49 years of age. The risk of TTS is not increased with the use of hormonal contraceptives (CDC 2022).

Current CDC recommendations prefer an age-appropriate, FDA-approved or FDA-authorized mRNA vaccine for patients who may become pregnant and who do not otherwise have contraindications to the vaccine. Patients who are to be vaccinated with the Janssen COVID-19 Vaccine should be counseled about the risk of TTS, which usually occurs within 2 weeks of vaccination, and the need for a booster 2 or more months after the initial dose (CDC 2022).

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 an investigational vaccine permitted for use under FDA emergency use authorization (EUA). Pregnant patients were excluded in the original clinical studies (Sadoff 2021). Adverse events were not observed in animal reproduction studies.

Outcome information following COVID-19 vaccination during pregnancy is being collected. The Janssen COVID-19 (adenovirus vector) Vaccine is an Ad26-vectored vaccine; other Ad26-vectored vaccines have acceptable safety profiles when used during pregnancy. Studies in pregnant patients have begun or are planned (CDC 2022).

• A retrospective cohort study evaluated maternal and cord blood levels of antispike IgG antibodies following COVID-19 vaccination. Of 1,359 participants in the study, 33 received the Janssen COVID-19 (adenovirus vector) Vaccine. Vaccine initiation occurred during the first trimester (n=7), second trimester (n=14), or the third trimester (n=12). All but 2 women received the Janssen COVID-19 (adenovirus vector) Vaccine ≥14 days prior to the study, and none were vaccinated prior to pregnancy. All women delivered ≥34 weeks' gestation. Regardless of when the vaccine was administered, all fully vaccinated women in this study had detectable antispike levels of IgG at delivery. There was no statistically significant difference in maternal antispike IgG levels at delivery regardless of trimester of vaccination with the Janssen COVID-19 (adenovirus vector) Vaccine. Among all women in the study, umbilical cord blood antispike IgG levels correlated with those in the maternal serum; the median placental transfer ratio ranged between 1 and 2 except when vaccination was initiated after 32 weeks' gestation, then the ratio decreased to below 1 (Yang 2021).

• Data from the Vaccine Safety Datalink evaluated the risk of preterm birth or small for gestational age (SGA) at birth following COVID-19 vaccination. Data was collected from 8 US health care systems between December 15, 2020 and July 22, 2021. Included were 10,064 vaccinated patients and 36,015 unvaccinated patients. Vaccinated patients received either the Pfizer-BioNTech COVID-19 Vaccine (54.4%), Moderna COVID-19 Vaccine (41.4%), or the Janssen COVID-19 (adenovirus vector) Vaccine (4.2%) during the first (1.7%), second (36.5%), or third (61.8%) trimester of pregnancy. The risk of SGA (birthweight <10th percentile for GA) and preterm birth (<37 weeks' gestation) was not increased following maternal vaccination. Patients eligible for an additional or booster dose of the vaccine could not be included in the study (Lipkind 2022).

The risk of severe illness from COVID-19 infection is increased in pregnant and recently pregnant patients compared to nonpregnant patients. Patients with severe illness may require ICU admission, mechanical ventilation, or ventilatory support (ECMO). Other adverse pregnancy outcomes include preterm birth and stillbirth. The risk of preeclampsia, coagulopathy, cesarean delivery, and maternal death may be increased; neonates have an increased risk for NICU admission. Maternal age and comorbidities may also increase the risk of severe illness in pregnant and recently pregnant patients (ACOG FAQ 2022; NIH 2022). COVID-19 vaccines (adenovirus) cannot cause infection in the pregnant patient or fetus (CDC 2022).

Due to the risk of severe illness, pregnancy complications, and death from COVID-19 infection during pregnancy, the CDC strongly recommends pregnant patients be vaccinated. The COVID-19 vaccine is recommended for all pregnant patients who otherwise meet the criteria for vaccination, including those previously diagnosed with COVID-19 infection (ACOG 2022; CDC 2022; CDC 2021b). Pregnant patients (including pregnant health care workers) should receive a booster dose at the recommended interval after completing the initial series (CDC 2022).

Vaccination of pregnant patients may be done in any setting authorized to administer the vaccine (ACOG 2022). COVID-19 vaccines may be administered simultaneously with other vaccines routinely administered during pregnancy. The COVID-19 vaccine may be administered in any trimester and should be given as soon as possible to maximize maternal health (ACOG 2022; CDC 2022) Vaccination status should be documented for all pregnant patients; for patients who do not receive the COVID-19 vaccine, the discussion should be documented in the medical record and vaccination offered again at subsequent visits (ACOG 2022).

Current recommendations prefer an age-appropriate, FDA-approved or FDA-authorized mRNA vaccine for pregnant patients who do not otherwise have contraindications to the vaccine. Patients who are to be vaccinated with the Janssen COVID-19 (adenovirus vector) Vaccine should be counseled about the risk of TTS, which usually occurs within 2 weeks of vaccination, and the need for a booster 2 or more months after the initial dose. The mRNA vaccine is preferred in pregnant patients; however, the Janssen COVID-19 (adenovirus vector) Vaccine is an option for patients who have a contraindication to an mRNA vaccine, if an mRNA vaccine is not available, or if a patient has an informed preference for the Janssen COVID-19 (adenovirus vector) Vaccine (ACOG 2022; CDC 2022).

Information related to COVID-19 vaccines continues to emerge; refer to current guidelines for vaccinating pregnant patients.

Rho(D) immune globulin is not expected to interfere with an immune response to the COVID-19 vaccine. Treatment should not be withheld in patients planning to be vaccinated or who recently received the COVID-19 vaccine. There is no recommended minimum interval between COVID-19 vaccination and Rho(D) immune globulin administration (ACOG 2022; CDC 2022).

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/).

All patients who receive a COVID-19 vaccine are encouraged to enroll in the CDC V-SAFE monitoring program (https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/vsafe.html) (ACOG 2022; CDC 2022).

Health care providers are encouraged to enroll pregnant patients exposed to COVID-19 vaccines in the Organization of Teratology Information Specialists (OTIS) pregnancy registry (1-877-311-8972; https://mothertobaby.org/join-study/).

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 an investigational vaccine permitted for use under FDA emergency use authorization (EUA). Patients who were breastfeeding were excluded from the original clinical trials (Sadoff 2021). There are limited data on the effects of the COVID-19 vaccines on the breastfed infant or on milk production/excretion (CDC 2022).

Nonreplicating viral vector vaccines cannot cause infection in the mother or breastfed infant (CDC 2022).

The risk of severe illness from COVID-19 infection is increased in recently pregnant patients compared to nonpregnant patients (ACOG FAQ 2022). The CDC strongly recommends all recently pregnant patients (including those who are lactating) be vaccinated (CDC 2022; CDC 2021b). The COVID-19 vaccine is recommended for all lactating patients who otherwise meet the criteria for vaccination, including those previously diagnosed with COVID-19 infection. The initiation of breastfeeding does not need to be avoided, and breastfeeding does not need to be discontinued in patients who are vaccinated (ACOG 2022).

Current recommendations prefer an age-appropriate, FDA-approved or FDA-authorized mRNA vaccine for patients who are lactating and who do not otherwise have contraindications to the vaccine. Patients who are to be vaccinated with the Janssen COVID-19 (adenovirus vector) Vaccine should be counseled about the risk of TTS, which usually occurs within 2 weeks of vaccination, and the need for a booster 2 or more months after the initial dose. The mRNA vaccine is preferred for lactating patients; however, the Janssen COVID-19 (adenovirus vector) Vaccine is an option for patients who have a contraindication to an mRNA vaccine, if an mRNA vaccine is not available, or if a patient has an informed preference for the Janssen COVID-19 (adenovirus vector) Vaccine (ACOG 2022; CDC 2022).

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

Health care providers are encouraged to enroll breastfeeding patients exposed to COVID-19 vaccines in the Organization of Teratology Information Specialists (OTIS) pregnancy registry (1-877-311-8972; https://mothertobaby.org/join-study/).

Monitoring Parameters

Monitor for hypersensitivity and syncope for 15 minutes following administration (ACIP [Kroger 2021]). Observe patients for 30 minutes after vaccination in patients with the following: a history of anaphylaxis (due to any cause); a history of an allergic reaction of any severity within 4 hours of receipt of a vaccine or injectable therapy; or a person with a contraindication to a different type of COVID-19 vaccine (CDC 2022). 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 following vaccination is not currently recommended (CDC 2022).

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 (FDA 2021). The Janssen vaccine contains a human adenovirus type 26 (Ad26) vector (FDA 2021). The AstraZeneca vaccine [Canadian product] contains a chimpanzee adenovirus (ChAdOx1) vector.

Pharmacokinetics

Onset of action:

Janssen COVID-19 Vaccine: The vaccine efficacy values of ~67% for moderate to severe/critical laboratory-confirmed COVID-19 and ~77% for severe/critical COVID-19 is based on disease cases occurring from day 14 onward after the single dose. Vaccine efficacy of ~85% for severe/critical COVID-19 was based on cases occurring from day 28 onward after the single dose (FDA 2021).

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

Duration: Data are currently insufficient to determine; clinical trials and epidemiologic surveillance are ongoing to evaluate break-through infections in vaccine recipients.

Brand Names: International
  • Covid-19 vaccine (ES);
  • Vaxzevria (AT, AU, CZ, DE, FR, GB, HR, LT, LV, MT, NL, NO, NZ, PT, SK)


For country abbreviations used in Lexicomp (show table)

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