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Sars-Cov-2 (Covid-19) Ad26 Vaccine, Recombinant Dosage

Medically reviewed by Drugs.com. Last updated on Jun 3, 2022.

Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for COVID-19

For investigational use only

Primary series: 0.5 mL IM once

Booster Dose: 0.5 mL IM, at least 2 months after completing a primary series of COVID-19 vaccination.

  • The eligible populations and dosing interval for heterologous booster are the same as for a booster dose of the vaccine used for primary vaccination.

Comments:
  • This drug is not approved by the FDA to prevent COVID-19. The FDA has issued an Emergency Use Authorization (EUA) for the use of this drug to prevent COVID-19.
  • No data available regarding use of this vaccine to complete a coronavirus disease 2019 (COVID-19) vaccine series initiated with another vaccine.

Use: Active immunization to prevent COVID-19 disease caused by SARS-CoV-2

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

  • This EUA is for the use of an experimental vaccine to prevent COVID-19.
  • ClinicalTrials.gov should be consulted for information on clinical trials testing this drug in COVID-19.

CONTRAINDICATIONS:
  • History of thrombosis with thrombocytopenia following administration of this or any other adenovirus-vectored COVID-19 vaccine
  • Severe allergic reaction (e.g. anaphylaxis) to any of the ingredients

Safety and efficacy have not been established in patients younger than 18 years.
This drug is not recommended for use in children.

To report suspected adverse reactions, contact the Vaccine Adverse Event Reporting System (VAERS) at: https://vaers.hhs.gov

Dialysis

Data not available

Other Comments

Administration advice:

  • For intramuscular administration only.

Storage requirements:
Prior to first puncture of vial:
  • Store at 2 to 8C, protect from light, do not freeze
  • Unpunctured vials may be stored between 9 and 25C for up to 12 hours.
  • Manufacturer initially stores vials frozen and ships at 2 to 8C; if still frozen upon arrival, thaw at 2 to 8C. If needed immediately, thaw at room temperature (maximally 25C) - a carton of 10 vials will take approximately 2 hours to thaw, an individual vial will thaw in approximately one hour.
  • Do not refreeze once thawed.
After first puncture of vial:
  • After first dose is withdrawn, store between 2 to 8C for up to 6 hours, or at room temperature (maximally 25C) for up to 2 hours.
  • Discard open vial if not used within the above time frames.

Reconstitution/preparation techniques:
  • The product is a colorless to slightly yellow, clear to very opalescent suspension; do not use if discolored or particulate matter is present.
  • Before withdrawing each dose, carefully mix vial contents by swirling gently in an upright position for 10 seconds; DO NOT SHAKE.
  • Each vial contains multiple doses; do not pool excess vaccine from multiple vials.
  • Preservative free
  • Record date and time of first use on vaccine vial label.

General:
  • Appropriate medical management of immediate allergic reactions must be available for acute anaphylactic reactions.
  • Extremely cases of a rare and severe type of blood clot called cerebral venous sinus thrombosis (CVST) were seen in combination with low levels of blood platelets (thrombocytopenia). Six US cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination, one death occurred.
  • Maintain a high index of suspicion for symptoms that might represent serious thrombotic events or thrombocytopenia in recently vaccinated patients, including severe headache, backache, new neurologic symptoms, severe abdominal pain, shortness of breath, leg swelling, petechiae (tiny red spots on the skin), or new or easy bruising.
  • Obtain platelet counts and screen for evidence of immune thrombotic thrombocytopenia.
  • In patients with a thrombotic event and thrombocytopenia after the vaccine, evaluate initially with a screening PF4 enzyme-linked immunosorbent (ELISA) assay as would be performed for autoimmune heparin induced thrombocytopenia (HIT). Consultation with a hematologist is strongly recommended.
  • Do not treat patients with thrombotic events and thrombocytopenia following this vaccine with heparin, unless HIT testing is negative. In this setting, administration of heparin may be dangerous, and alternative treatments need to be given.
  • If HIT testing is positive or unable to be performed in patient with thrombotic events and thrombocytopenia following vaccination, non-heparin anticoagulants and high-dose intravenous immune globulin should be strongly considered.

Patient advice:
  • People who develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their health care provider.

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