Vaccine Information: Janssen COVID-19 Vaccine (Page 2 of 5)

1 AUTHORIZED USE

Janssen COVID-19 vaccine is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older.

2 DOSAGE AND ADMINISTRATION

For intramuscular injection only.

2.1 Preparation for Administration

  • The Janssen COVID-19 Vaccine is a colorless to slightly yellow, clear to very opalescent suspension. Visually inspect the Janssen COVID-19 Vaccine vials for particulate matter and discoloration prior to administration. If either of these conditions exists, do not administer the vaccine.
  • Before withdrawing each dose of vaccine, carefully mix the contents of the multi-dose vial by swirling gently in an upright position for 10 seconds. Do not shake.
  • Each dose is 0.5 mL. Each vial contains five doses. Do not pool excess vaccine from multiple vials.
  • The Janssen COVID-19 Vaccine does not contain a preservative. Record the date and time of first use on the Janssen COVID-19 Vaccine vial label. After the first dose has been withdrawn, hold the vial between 2° to 8°C (36° to 46°F) for up to 6 hours or at room temperature (maximally 25°C/77°F) for up to 2 hours. Discard if vaccine is not used within these times.

2.2 Administration

Visually inspect each dose in the dosing syringe prior to administration. The Janssen COVID-19 Vaccine is a colorless to slightly yellow, clear to very opalescent suspension. During the visual inspection,

  • verify the final dosing volume of 0.5 mL.
  • confirm there are no particulates and that no discoloration is observed.
  • do not administer if vaccine is discolored or contains particulate matter.

Administer the Janssen COVID-19 Vaccine intramuscularly.

2.3 Dosing and Schedule

The Janssen COVID-19 Vaccine is administered intramuscularly as a single dose (0.5 mL).

There are no data available on the use of the Janssen COVID-19 Vaccine to complete a vaccination series initiated with another COVID-19 Vaccine.

3 DOSAGE FORMS AND STRENGTHS

Janssen COVID-19 Vaccine is a suspension for intramuscular injection. A single dose is 0.5 mL.

4 CONTRAINDICATIONS

Do not administer the Janssen COVID-19 Vaccine to individuals with a known history of severe allergic reaction (e.g., anaphylaxis) to any component of the Janssen COVID-19 Vaccine [see Description (13)].

5 WARNINGS AND PRECAUTIONS

5.1 Management of Acute Allergic Reactions

Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of the Janssen COVID-19 Vaccine.

Monitor Janssen COVID-19 Vaccine recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control and Prevention guidelines (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html).

5.2 Thrombosis with Thrombocytopenia

Reports of adverse events following use of the Janssen COVID-19 Vaccine under emergency use authorization suggest an increased risk of thrombosis involving the cerebral venous sinuses and other sites (including but not limited to the large blood vessels of the abdomen and the veins of the lower extremities) combined with thrombocytopenia and with onset of symptoms approximately one to two weeks after vaccination [see Overall Safety Summary (6.2)]. The reporting rate of thrombosis with thrombocytopenia following administration of the Janssen COVID-19 Vaccine has been highest in females ages 18 through 49 years; some cases have been fatal. The clinical course of these events shares features with autoimmune heparin-induced thrombocytopenia. Specific risk factors for thrombosis with thrombocytopenia following administration of the Janssen COVID-19 Vaccine and the level of potential excess risk due to vaccination are under investigation. Based on currently available evidence, a causal relationship between thrombosis with thrombocytopenia and the Janssen COVID-19 Vaccine is plausible.

Healthcare professionals should be alert to the signs and symptoms of thrombosis with thrombocytopenia in individuals who receive the Janssen COVID-19 Vaccine. In individuals with suspected thrombosis with thrombocytopenia following administration of the Janssen COVID-19 Vaccine, the use of heparin may be harmful and alternative treatments may be needed. Consultation with hematology specialists is strongly recommended. The American Society of Hematology has published considerations relevant to the diagnosis and treatment of thrombosis with thrombocytopenia following administration of the Janssen COVID-19 Vaccine (https://www.hematology.org/covid-19/vaccine-induced-immune-thrombotic-thrombocytopenia).

Recipients of Janssen COVID-19 Vaccine should be instructed to seek immediate medical attention if they develop shortness of breath, chest pain, leg swelling, persistent abdominal pain, neurological symptoms (including severe or persistent headaches or blurred vision), or petechiae beyond the site of vaccination.

5.3 Guillain-Barré Syndrome

Reports of adverse events following use of the Janssen COVID-19 Vaccine under emergency use authorization suggest an increased risk of Guillain-Barré syndrome during the 42 days following vaccination.

5.4 Syncope

Syncope (fainting) may occur in association with administration of injectable vaccines. Procedures should be in place to avoid injury from fainting.

5.5 Altered Immunocompetence

Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Janssen COVID-19 Vaccine.

5.6 Limitations of Vaccine Effectiveness

The Janssen COVID-19 Vaccine may not protect all vaccinated individuals.

6 OVERALL SAFETY SUMMARY

It is MANDATORY for vaccination providers to report to the Vaccine Adverse Event Reporting System (VAERS) all vaccine administration errors, all serious adverse events, cases of Multisystem Inflammatory Syndrome (MIS) in adults, and hospitalized or fatal cases of COVID-19 following vaccination with the Janssen COVID-19 Vaccine. To the extent feasible, provide a copy of the VAERS form to Janssen Biotech, Inc. Please see the REQUIREMENTS AND INSTRUCTIONS FOR REPORTING ADVERSE EVENTS AND VACCINE ADMINISTRATION ERRORS section for details on reporting to VAERS or Janssen Biotech, Inc.

Adverse Reactions in Clinical Trials

In study COV3001, the most common local solicited adverse reaction (≥10%) reported was injection site pain (48.6%). The most common systemic adverse reactions (≥10%) were headache (38.9%), fatigue (38.2%), myalgia (33.2%), and nausea (14.2%) (see Tables 1 to 4).

Severe allergic reactions, including anaphylaxis, have been reported following administration of the Janssen COVID-19 vaccine.

Adverse Reactions Identified during Post Authorization Use

Severe allergic reactions (including anaphylaxis), thrombosis with thrombocytopenia, Guillain-Barré syndrome, and capillary leak syndrome have been reported following administration of the Janssen COVID-19 Vaccine during mass vaccination outside of clinical trials.

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of the Janssen COVID-19 Vaccine has been assessed in an ongoing Phase 3 Study (COV3001). A total of 43,783 individuals were enrolled in this study, of whom 21,895 adults aged 18 years and older received the Janssen COVID-19 Vaccine [Full Analysis Set (FAS)]. This study is being conducted in the United States (n=19,302), Brazil (n=7,278), South Africa (n=6,576), Colombia (n=4,248), Argentina (n=2,996), Peru (n=1,771), Chile (n=1,133), Mexico (n=479). In this study, 45.0% were female, 54.9% were male, 58.7% were White, 19.4% were Black or African American, 45.3% were Hispanic or Latino, 3.3% were Asian, 9.5% were American Indian/Alaska Native and 0.2% were Native Hawaiian or other Pacific Islander, 5.6% were from multiple racial groups and 1.4% were unknown races (see Table 5). The median age of individuals was 52.0 years (range: 18–100). There were 4,217 (9.6%) individuals who were SARS-CoV-2 seropositive at baseline and who were included in the study. In the United States, 838 of 19,302 (4.3%) individuals were SARS-CoV-2 seropositive. Demographic characteristics were similar among individuals who received the Janssen COVID-19 Vaccine and those who received saline placebo.

The safety subset includes 6,736 individuals (3,356 from the Janssen COVID-19 Vaccine group, 3,380 from the placebo group). The demographic profile in the safety subset was similar in terms of age and gender compared to the FAS. A larger percentage of individuals in the safety subset were White (83.4%) compared to the FAS (58.7%). Geographically, the safety subset was limited to individuals from the United States (51.4%), Brazil (38.5%) and South Africa (10.2%). Fewer individuals in the safety subset compared to the FAS were SARS-CoV-2 seropositive at baseline, 4.5% vs. 9.6%, and had at least one comorbidity 34.1% vs 40.8%.

Safety monitoring in the clinical study consisted of monitoring for: (1) solicited local and systemic reactions occurring in the 7 days following vaccination in a subset of individuals (safety subset), (2) unsolicited adverse events (AEs) occurring in the 28 days following vaccination in the safety subset, (3) medically-attended AEs (MAAEs) occurring in the 6 months following vaccination in the entire study population (FAS), (4) serious AEs (SAEs) and AEs leading to study discontinuation for the duration of the study in the entire study population.

Solicited adverse reactions

Shown below are the frequencies of solicited local adverse reactions (Tables 1 and 2) and systemic adverse reactions (Tables 3 and 4) reported in adults by age group in the ongoing Phase 3 clinical trial (COV3001) in the 7 days following vaccination.

Table 1: Solicited Local Adverse Reactions Reported in the 7 Days Following Vaccination — Individuals 18 to 59 Years of Age
Adverse Reactions Janssen COVID-19 VaccineN=2,036n(%) PlaceboN=2,049n(%)
*
Grade 3 injection site pain: Defined as incapacitating symptoms; inability to do work, school, or usual activities; use of narcotic pain reliever.
Grade 3 injection site swelling and erythema: Defined as >100 mm.
Injection Site Pain
Any 1,193 (58.6) 357 (17.4)
Grade 3* 8 (0.4) 0
Injection Site Erythema
Any (≥25 mm) 184 (9.0) 89 (4.3)
Grade 3 6 (0.3) 2 (0.1)
Injection Site Swelling
Any (≥25 mm) 142 (7.0) 32 (1.6)
Grade 3 5 (0.2) 2 (0.1)
Table 2: Solicited Local Adverse Reactions Reported in the 7 Days Following Vaccination — Individuals 60 Years of Age and Older
Adverse Reactions Janssen COVID-19 VaccineN=1,320n(%) PlaceboN=1,331n(%)
*
Grade 3 injection site pain: Defined as incapacitating symptoms; inability to do work, school, or usual activities; use of narcotic pain reliever.
Grade 3 injection site swelling and erythema: Defined as >100 mm.
Injection Site Pain
Any 439 (33.3) 207 (15.6)
Grade 3* 3 (0.2) 2 (0.2)
Injection Site Erythema
Any (≥25 mm) 61 (4.6) 42 (3.2)
Grade 3 1 (0.1) 0
Injection Site Swelling
Any (≥25 mm) 36 (2.7) 21 (1.6)
Grade 3 2 (0.2) 0
Table 3: Solicited Systemic Adverse Reactions Reported in the 7 Days Following Vaccination — Individuals 18 to 59 Years of Age
Adverse Reactions Janssen COVID-19 VaccineN=2,036n(%) PlaceboN=2,049n(%)
*
Grade 3 headache: Defined as incapacitating symptoms; requires bed rest and/or results in loss of work, school, or cancellation of social activities; use of narcotic pain reliever.
Grade 3 fatigue, myalgia, nausea: Defined as incapacitating symptoms; requires bed rest and/or results in loss of work, school, or cancellation of social activities; use of narcotic pain reliever.
Fever of any grade: Defined as body temperature ≥38°C/100.4°F. Grade 3 fever: Defined as 39.0°C – 40.0°C (102.1°F – 104.0°F).
Headache
Any 905 (44.4) 508 (24.8)
Grade 3* 18 (0.9) 5 (0.2)
Fatigue
Any 891 (43.8) 451 (22.0)
Grade 3 25 (1.2) 4 (0.2)
Myalgia
Any 796 (39.1) 248 (12.1)
Grade 3 29 (1.4) 1 (<0.1)
Nausea
Any 315 (15.5) 183 (8.9)
Grade 3 3 (0.1) 3 (0.1)
Fever
Any 261 (12.8) 14 (0.7)
Grade 3 7 (0.3) 0
Use of antipyretic or pain medication 538 (26.4) 123 (6.0)
Table 4: Solicited Systemic Adverse Reactions Reported in the 7 Days Following Vaccination — Individuals 60 Years of Age and Older
Adverse Reactions Janssen COVID-19 VaccineN=1,320n(%) PlaceboN=1,331n(%)
*
Grade 3 headache: Defined as incapacitating symptoms; requires bed rest and/or results in loss of work, school, or cancellation of social activities; use of narcotic pain reliever
Grade 3 fatigue, myalgia, nausea: Defined as incapacitating symptoms; requires bed rest and/or results in loss of work, school, or cancellation of social activities; use of narcotic pain reliever.
Fever of any grade: Defined as body temperature ≥38°C/100.4°F. Grade 3 fever: Defined as 39.0°C – 40.0°C (102.1°F – 104.0°F).
Headache
Any 401 (30.4) 294 (22.1)
Grade 3* 5 (0.4) 4 (0.3)
Fatigue
Any 392 (29.7) 277 (20.8)
Grade 3 10 (0.8) 5 (0.4)
Myalgia
Any 317 (24.0) 182 (13.7)
Grade 3 3 (0.2) 5 (0.4)
Nausea
Any 162 (12.3) 144 (10.8)
Grade 3 3 (0.2) 3 (0.2)
Fever
Any 41 (3.1) 6 (0.5)
Grade 3 1 (0.1) 0
Use of antipyretic or pain medication 130 (9.8) 68 (5.1)

Solicited local and systemic adverse reactions reported following administration of the Janssen COVID-19 Vaccine had a median duration of 1 to 2 days.

Unsolicited adverse events

Individuals within the safety subset in study COV3001 (N=6,736) were monitored for unsolicited adverse events (AEs) for 28 days following vaccination with 99.9% (N= 6,730) of individuals completing the full 28 days of follow-up. The proportion of individuals who reported one or more unsolicited AEs was similar among those in the Janssen COVID-19 Vaccine group (13.1%) and those in the placebo group (12.0%).

Serious Adverse Events (SAEs) and other events of interest

In study COV3001, up to a cut-off date of January 22, 2021, 54.6% of individuals had follow-up duration of 8 weeks. The median follow-up duration for all individuals was 58 days. SAEs, excluding those related to confirmed COVID-19, were reported by 0.4% (n=83) of individuals who received the Janssen COVID-19 Vaccine (N= 21,895) and 0.4% (n=96) of individuals who received placebo (N= 21,888).

Additional adverse events of interest, including but not limited to allergic, neurologic, inflammatory, vascular, and autoimmune disorders, were analyzed among all adverse events collected through protocol-specified safety monitoring procedures as well as unsolicited reporting.

Urticaria (all non-serious) was reported in five vaccinated individuals and 1 individual who received placebo in the 7 days following vaccination. In addition, an SAE of hypersensitivity, not classified as anaphylaxis, was reported in 1 vaccinated individual with urticaria beginning two days following vaccination and angioedema of the lips with no respiratory distress beginning four days following vaccination. The event was likely related to the vaccine.

An SAE of severe pain in the injected arm, not responsive to analgesics, with immediate onset at time of vaccination, and that was ongoing 74 days following vaccination was reported in an individual who received the Janssen COVID-19 Vaccine. An SAE of severe generalized weakness, fever, and headache, with onset on the day following vaccination and resolution three days following vaccination was reported in an individual who received the Janssen COVID-19 Vaccine. Both SAEs are likely related to the vaccine.

Numerical imbalances, with more events in vaccine than placebo recipients, were observed for the following serious and other adverse events of interest in individuals receiving the vaccine or placebo, respectively:

  • Thromboembolic events:
    • Deep vein thrombosis: 6 events (2 serious; 5 within 28 days of vaccination) vs. 2 events (1 serious; 2 within 28 days of vaccination).
    • Pulmonary embolism: 4 events (3 serious; 2 within 28 days of vaccination) vs. 1 event (serious and within 28 days of vaccination).
    • Transverse sinus thrombosis with thrombocytopenia: 1 event (serious, with onset of symptoms 8 days post- vaccination) vs. 0.
  • Seizures: 4 events (1 serious; 4 within 28 days of vaccination) vs. 1 event (0 serious and 0 within 28 days following vaccination).
  • Tinnitus: 6 events (0 serious; 6 within 28 days of vaccination, including 3 within 2 days of vaccination) vs. 0.

For these events, a causal relationship with the Janssen COVID-19 vaccine could not be determined based on study COV3001. The assessment of causality was confounded by the presence of underlying medical conditions that may have predisposed individuals to these events. However, taking into consideration post-authorization experience, a causal relationship with Janssen COVID-19 Vaccine is plausible for thrombosis with thrombocytopenia [see Warnings and Precautions (5.2) and Overall Safety Summary (6.2)].

There were no additional notable patterns or numerical imbalances between treatment groups for specific categories of serious adverse events (including neurologic, neuro-inflammatory, and cardiovascular events) that would suggest a causal relationship to the Janssen COVID-19 Vaccine.

VxLabels.com provides trustworthy package insert and label information about marketed drugs and vaccines as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by VxLabels.com. Every individual vaccine label and package insert entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.

Vaccine Sections

Vaccine Information by RSS

As the leading independent provider of trustworthy vaccine information, our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. VxLabels.com provides the full vaccine subset of the FDA's repository. Vaccine information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2021. All Rights Reserved.