Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: AstraZeneca AB, SE-151 85 Södertälje, Sweden
Vaxzevria is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 18 years of age and older.
The use of this vaccine should be in accordance with official recommendations.
The Vaxzevria primary vaccination course consists of two separate doses of 0.5 ml each. The second dose should be administered between 4 and 12 weeks (28 to 84 days) after the first dose (see section 5.1).
A booster dose (third dose) of 0.5 ml may be given to individuals who completed the primary vaccination course with Vaxzevria or an mRNA COVID-19 vaccine (see sections 4.8 and 5.1). The third dose should be administered at least 3 months after completing the primary vaccination course.
No dose adjustment is required. See also section 5.1.
The safety and efficacy of Vaxzevria in children and adolescents (less than 18 years of age) have not yet been established. No data are available.
Vaxzevria is for intramuscular injection only, preferably in the deltoid muscle of the upper arm.
Do not inject the vaccine intravascularly, subcutaneously or intradermally.
The vaccine should not be mixed in the same syringe with any other vaccines or medicinal products.
For precautions to be taken before administering the vaccine, see section 4.4.
For instructions on handling and disposal, see section 6.6.
There is no specific treatment for an overdose with Vaxzevria. In the event of an overdose, the individual should be monitored and provided with symptomatic treatment as appropriate.
9 months when stored in a refrigerator (2°C–8°C).
The following information is intended to guide healthcare professionals only in case of an unforeseen temporary temperature excursion. It is not a recommended storage or shipping condition.
The shelf-life of unopened vials includes the following unforeseen excursions from refrigerated storage (2°C–8°C) for a single period of:
Unopened vials must always be returned to refrigerated storage (2°C–8°C) following a temperature excursion.
The occurrence of a temperature excursion for unopened vials does not impact how the vials should be stored after first opening (first vial puncture).
Chemical and physical in-use stability have been demonstrated for 6 hours when stored at temperatures up to 30°C and for 48 hours when stored in a refrigerator (2°C–8°C). After this time, the vial must be discarded. Do not return it to the refrigerator after storage outside the refrigerator.
Alternatively, an opened vial may be stored in a refrigerator (2°C–8°C) for a maximum of 48 hours if it is immediately returned to the refrigerator following each puncture.
From a microbiological point of view, after first opening the vaccine should be used immediately. If the vaccine is not used immediately, in-use storage times and conditions are the responsibility of the user.
Store in a refrigerator (2°C–8°C).
Do not freeze.
Keep vials in outer carton in order to protect from light.
For storage conditions after first opening of the medicinal product, see section 6.3.
8-dose vial: 4 mL of suspension in an 8-dose vial (clear type I glass) with stopper (elastomeric with aluminium overseal). Each vial contains 8 doses of 0.5 mL. Pack sizes of 10 multidose vials.
10-dose vial: 5 mL of suspension in a 10-dose vial (clear type I glass) with stopper (elastomeric with aluminium overseal). Each vial contains 10 doses of 0.5 mL. Pack sizes of 10 multidose vials.
Not all pack sizes may be marketed.
This vaccine should be handled by a healthcare professional using aseptic technique to ensure the sterility of each dose.
Do not use this vaccine after the expiry date which is stated on the label after EXP.
Unopened multidose vial should be stored in a refrigerator (2°C–8°C). Do not freeze.
Keep the vials in outer carton in order to protect from light.
The vaccine should be inspected visually for particulate matter and discolouration prior to administration. Vaxzevria is a colourless to slightly brown, clear to slightly opaque suspension. Discard the vial if the suspension is discoloured or visible particles are observed. Do not shake. Do not dilute the suspension.
The vaccine should not be mixed in the same syringe with any other vaccines or medicinal products.
The Vaxzevria vaccination course consists of two separate doses of 0.5 mL each. The second dose should be administered between 4 and 12 weeks after the first dose. Individuals who have received the first dose of Vaxzevria should receive the second dose of the same vaccine to complete the vaccination course.
Each vaccine dose of 0.5 mL is withdrawn into a syringe for injection to be administered intramuscularly, preferably in the deltoid muscle of the upper arm. Use a new needle for administration, when possible.
It is normal for liquid to remain in the vial after withdrawing the final dose. An additional overfill is included in each vial to ensure that 8 doses (vial of 4 mL) or 10 doses (vial of 5 mL) of 0.5 mL can be delivered. Do not pool excess vaccine from multiple vials. Discard any unused vaccine.
From the time of vial opening (first needle puncture) use within 6 hours when stored at temperatures up to 30°C. After this time, the vial must be discarded. Do not return it to the refrigerator. Alternatively, an opened vial may be stored in a refrigerator (2°C–8°C) for a maximum of 48 hours if it is immediately returned to the refrigerator following each puncture.
Any unused vaccine or waste material should be disposed of in compliance with the local guidance for pharmaceutical waste. Potential spills should be disinfected using agents with viricidal activity against adenovirus.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
