COVID-19 vaccine, viral vector-Janssen

COVID-19 vaccine, viral vector-Janssen (Investigational) is used as immunization to prevent Coronavirus disease. 

• COVID-19 vaccine, viral vector-Janssen (Investigational) is available under the following different brand names: Ad26.COV2.S (Johnson & Johnson)

Adult dosage

Injection, suspension

• 5x10 10 virus particles/0.5mL (5 doses per vial)

COVID-19 Disease Prevention

Adult dosage

• 0.5 mL IM as a single dose

Booster dose

• Patients aged 18 years or older: 0.5 mL IM

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”.

Common side effects of COVID-19 vaccine, viral vector-Janssen (Investigational) include:

• injection site pain, 
• headache, 
• fatigue, 
• muscle and joint pain, 
• nausea, 
• fever, and
• swelling at the injection site

Serious side effects of COVID-19 vaccine, viral vector-Janssen (Investigational) include:

• hives, 
• difficulty breathing, 
• swelling of the face, lips, tongue, or throat, 
• Thrombosis with Thrombocytopenia Syndrome (TTS)
• Guillain-Barré Syndrome
• Altered immunocompetence, 
• fainting

Rare side effects of COVID-19 vaccine, viral vector-Janssen (Investigational) include:

• none 

This is not a complete list of side effects and other serious side effects or health problems may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first

• COVID-19 vaccine, viral vector-Janssen (Investigational) has severe interactions with no other drugs.
• COVID-19 vaccine, viral vector-Janssen (Investigational) has serious interactions with no other drugs.
• COVID-19 vaccine, viral vector-Janssen (Investigational) has moderate interactions with no other drugs.
• COVID-19 vaccine, viral vector-Janssen (Investigational) has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this drug, tell your doctor or pharmacist of all the drugs you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Contraindications

• Known history of a severe allergic reaction (eg, anaphylaxis) to any component in the vaccine
• History of thrombosis with thrombocytopenia following the Janssen COVID-19 Vaccine or any other adenovirus vectored COVID-19 vaccine (eg, AstraZeneca COVID-19 vaccine which is not authorized or approved in the United States)

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using COVID-19 vaccine, viral vector-Janssen (Investigational)?”

Long-Term Effects

• See “What Are Side Effects Associated with Using COVID-19 vaccine, viral vector-Janssen (Investigational)?”

Cautions

• Vaccines may not protect all vaccine recipients
• Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have diminished immune response to the vaccine
• Post authorization reports suggest an increased risk of Guillain-Barré syndrome during the 42 days following vaccination
• Syncope (fainting) may occur; procedures should be in place to avoid injury from fainting
• Allergic reactions
  • Appropriate medical treatment used to manage immediate allergic reactions must be immediately available following vaccination
  • Individuals with histories of severe allergic reaction to vaccines should consult their doctors about the COVID-19 vaccine
  • Monitor vaccine recipients for immediate adverse reactions according to the Centers for Disease Control and Prevention guidelines
• Thrombosis with thrombocytopenia syndrome (TTS)
  • Extremely rare cases reported 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
  • The onset of symptoms within 1-2 weeks after vaccination
  • Reporting rate of thrombosis and thrombocytopenia has been highest in females aged 18-49 years; some have been fatal
  • Healthcare professionals should be alert to the signs and symptoms of thrombosis with thrombocytopenia in individuals who received the Ad26.COV2-2 vaccine
• TTS definition
  • Thrombosis in an unusual location for a thrombus (ie, cerebral vein, visceral artery or vein, extremity artery, central artery or vein) and new-onset thrombocytopenia (ie, platelet count less than 150,000/μL) occurring any time after vaccination, OR
  • New-onset thrombocytopenia, thrombosis in an extremity vein or pulmonary artery in absence of thrombosis at an unusual location, and a positive anti-PF4 antibody ELISA test or functional heparin-induced thrombocytopenia (HIT) platelet test occurring any time after vaccination
• Clinical course
  • The clinical course shares feature with autoimmune HIT
  • Use of heparin may be harmful in individuals with suspected thrombosis with thrombocytopenia following vaccination; alternant treatments may be needed
  • Diagnosis must include the following 4 criteria: 1) Ad26.COV2-2 vaccine 4-30 days previously; 2) thrombosis (often cerebral or abdominal); 3) thrombocytopenia; 4) positive PF4 HIT ELISA
  • NOTE: If a patient presents with thrombosis and a normal platelet count post-vaccination, they might be in an early stage of VITT; continued assessment for the development of thrombocytopenia/VITT required
  • Cases reported in males and females, in wide age range (18 years or older), with the highest reporting rate ( approximately case/100,000 doses administered) in females aged 30-49 years of age
  • Overall, approximately 15% of TTS cases have been fatal
• Hematology consultation
  • Consultation with hematology specialists is strongly recommended
  • American Society of Hematology has published considerations relevant to the diagnosis and treatment of thrombosis with thrombocytopenia following vaccination
  • Urgent medical evaluation for vaccine-induced immune thrombotic thrombocytopenia (VITT) indicated if any of the following develops: severe headache, visual changes, abdominal pain, nausea/vomiting, backache, shortness of breath, leg pain/swelling, or petechiae/easy bruising

Drug interaction overview

• Data are not available to assess concomitant administration with other vaccines

Pregnancy and Lactation

• Data are insufficient to inform of vaccine-associated risks in pregnancy. 
• Women vaccinated with the Janssen COVID-19 vaccine are encouraged to enroll in the pregnancy exposure registry. 
• A smartphone app, v-safe, is also available to report adverse effects to the CDC following vaccination with a COVID-19 vaccine
• CDC guidelines for vaccination of pregnant or lactating women
• Data are not available to assess effects on breastfed infants or on milk production/excretion