VIDPREVTYN BETA Solution and emulsion for emulsion for injection Ref.[50347] Active ingredients: SARS-CoV-2 spike glycoprotein (B.1 strains)

Posology

Individuals 18 years of age and older

VidPrevtyn Beta is administered intramuscularly as a single dose of 0.5 mL at least 4 months after a previous COVID-19 vaccine. VidPrevtyn Beta may be given once as a booster to adults that have received prior vaccination series with either mRNA or adenoviral vector COVID-19 vaccines (see section 5.1).

Elderly

No dose adjustment is required in elderly individuals ≥65 years of age.

Paediatric population

The safety and efficacy of VidPrevtyn Beta in children and adolescents less than 18 years of age have not yet been established. No data are available.

Method of administration

VidPrevtyn Beta is for intramuscular injection only after mixing. The preferred site is the deltoid muscle of the upper arm.

Do not inject this 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 mixing, handling and disposal of the vaccine, see section 6.6.

There is no specific treatment for an overdose with VidPrevtyn Beta. In the event of an overdose, the individual should be monitored and provided with symptomatic treatment as appropriate.

1 year.

After mixing, the product should be used within 6 hours, if stored at 2°C–8°C and protected from light.

Store in a refrigerator (2°C–8°C). Do not freeze.

Keep the vials in the outer carton in order to protect from light.

For storage conditions after mixing of the medicinal product, see section 6.3.

VidPrevtyn Beta is presented as:

• 2.5 mL antigen solution in a multidose vial (type 1 glass) with a stopper (chlorobutyl) and an aluminium seal with a green plastic flip-off cap;
• 2.5 mL adjuvant emulsion in a multidose vial (type 1 glass) with a stopper (chlorobutyl) and an aluminium seal with a yellow plastic flip-off cap.

Each pack contains 10 multidose antigen vials and 10 multidose adjuvant vials.

Handling instructions

This vaccine should be handled by a healthcare professional using aseptic technique to ensure the sterility of each dose.

Instructions for mixing

VidPrevtyn Beta is supplied as 2 separate vials: an antigen vial and an adjuvant vial. Prior to administration, the two components must be mixed as per steps below.

Step 1: Place the vials at room temperature (up to 25 °C) for a minimum of 15 minutes before mixing, protecting them from light.

Step 2: Invert (without shaking) each vial and inspect them visually for any particulate matter or discoloration. If either of these conditions exist, do not administer the vaccine.

Step 3: After removing the flip-off caps, cleanse both vial stoppers with antiseptic swabs.

Step 4:

Using a sterile 21-gauge or narrower needle and a sterile syringe, withdraw the entire contents from the adjuvant vial (yellow cap) into a syringe. Invert the adjuvant vial to facilitate the withdrawal of the full contents.

Vial 2 of 2:

Step 5:

Transfer the full syringe contents into the antigen vial (green cap).

Vial 1 of 2:

Step 6:

Remove the syringe with the needle from the antigen vial. Mix the contents by inverting the vial 5 times. Do not shake.

The mixed vaccine is a whitish to yellowish homogeneous milky liquid emulsion.

Vial 1 of 2:

Step 7: Record the discard date and time (6 hours after mixing) on designated area of vial label.

The volume of the vaccine after mixing is at least 5 mL. It contains 10 doses of 0.5 mL. An additional overfill is included in each vial to ensure that 10 doses of 0.5 mL can be delivered.

After mixing, administer immediately or store the vaccine at 2°C to 8°C, protected from light, and use within 6 hours (see section 6.3). After this time period, discard the vaccine.

Preparation of individual doses

Prior to each administration, mix the vial thoroughly by inversion 5 times. Do not shake. Visually inspect it for any particulate matter and discoloration (see Step 6 for the aspect of the vaccine). If either of these conditions exists, do not administer the vaccine.

Using appropriate syringe and needle, withdraw 0.5 mL from the vial containing the mixed vaccine and administer intramuscularly (see section 4.2).

Disposal

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.