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

Comments:

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

Use: For active immunization to prevent COVID-19 due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) for whom other US FDA-authorized or approved COVID-19 vaccines are not accessible or clinically appropriate and in those who elect to receive this vaccine because they would otherwise not receive a COVID-19 vaccine

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

US BOXED WARNING:
THROMBOSIS WITH THROMBOCYTOPENIA SYNDROME (TTS):

• This vaccine can cause TTS, which may be life-threatening.
• TTS may involve thrombosis at unusual locations for a thrombus (e.g., central artery/vein, cerebral vein, extremity artery, visceral artery/vein) or in an extremity vein or pulmonary artery.
• Among reported cases of TTS following administration of this vaccine, symptoms began approximately 1 to 2 weeks after vaccination.
• The clinical course of TTS following administration of this vaccine shares features with autoimmune heparin-induced thrombocytopenia (HIT). In patients with suspected TTS, the use of heparin may be harmful, and alternative treatments may be needed.

Recommendations:

• Vaccine recipients should be instructed to seek immediate medical attention for chest pain, leg pain, neurological symptoms (e.g., severe/persistent headaches or blurred vision), persistent abdominal pain, petechiae beyond the site of vaccination, or shortness of breath.
• This vaccine should not be administered to individuals with a history of thrombosis with thrombocytopenia following this vaccine or any other adenovirus-vectored COVID-19 vaccine.

CONTRAINDICATIONS:

• Patients with a severe allergic reaction (e.g., anaphylaxis) to any of the ingredients
• Those with a history of TTS following administration of this or any other adenovirus-vectored COVID-19 vaccine

Safety and efficacy have not been established in patients younger than 18 years.

Dialysis

Data not available

Other Comments

Administration advice:

• For IM administration only.

Storage requirements:

• Prior to first puncture of vial, store at 2C to 8C (36F to 46F) and protect from light; do not freeze.
• Unpunctured vials may be stored between 9C to 25C (47F to 77F) for up to 12 hours.
• The manufacturer initially stores vials frozen and ships at 2C to 8C (36F to 46F); if it is still frozen upon arrival, thaw at 2C to 8C (36F to 46F).
• If needed immediately, thaw at room temperature (maximally 25C [77F]).
• Note: A carton of 10 vials will take approximately 2 hours to thaw, an individual vial will thaw in approximately 1 hour.
• Do not refreeze once thawed.
• After first puncture of vial AND once the first dose is withdrawn, store between 2C to 8C (36F to 46F) for up to 6 hours, or at room temperature (maximally 25C [77F]) for up to 2 hours; discard the open vial if not used within the 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.
• Once opened, record the date and time of first use on the vaccine vial label.

General:

• This vaccine is preservative free.
• Appropriate medical management of immediate allergic reactions must be available for acute anaphylactic reactions.

Patient advice:

• Read the Fact Sheet for Recipients and Caregivers.