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Product Information Leaflet (PIL) for VidPrevtyn Beta dispersion for injection

Updated 20 April 2023

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you receive this vaccine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What VidPrevtyn Beta is and what it is used for
2. What you need to know before you receive VidPrevtyn Beta
3. How VidPrevtyn Beta is given
4. Possible side effects
5. How to store VidPrevtyn Beta
6. Contents of the pack and other information

1. What VidPrevtyn Beta is and what it is used for

VidPrevtyn Beta is a vaccine used for preventing COVID-19.

VidPrevtyn Beta is given to adults who previously received either mRNA or adenoviral vector COVID-19 vaccine.

The vaccine stimulates the immune system (the body’s natural defences) to produce specific antibodies that work against the virus, giving protection against COVID-19. None of the ingredients in this vaccine can cause COVID-19.

2. What you need to know before you receive VidPrevtyn Beta

Do not use VidPrevtyn Beta:

• if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6);

• if you are allergic to octylphenol ethoxylate, a substance that is used in the manufacturing process. Small amounts of this substance may remain after manufacturing.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before you are given the vaccine if:

• you have ever had a severe allergic reaction after any other vaccine injection or after you were given VidPrevtyn Beta in the past;
• you have ever fainted following any needle injection;
• you have a severe illness or infection with a high temperature (over 38°C). However, you can have your vaccination if you have a mild fever or upper airway infection like a cold.
• you have a bleeding problem, you bruise easily or you use a medicine to prevent blood clots.
• you have a weakened immune system (immunodeficiency) or you are using medicines that weaken the immune system (such as high-dose corticosteroids or cancer medicines).

As with any vaccine, VidPrevtyn Beta may not fully protect all those who receive it. It is not known how long you will be protected.

Children and adolescents

VidPrevtyn Beta is not recommended for children aged under 18 years. Currently there is no information available on the use of VidPrevtyn Beta in children and adolescents younger than 18 years of age.

Other medicines and VidPrevtyn Beta

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines or vaccines.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before you receive this vaccine.

Driving and using machines

Some of the side effects of VidPrevtyn Beta mentioned in section 4 (Possible side effects) may temporarily affect your ability to drive or use machines. Wait until these effects have worn off before you drive or use machines.

VidPrevtyn Beta contains sodium and potassium

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

This medicine contains less than 1 mmol potassium (39 mg) per dose, that is to say essentially ‘potassium-free’.

3. How VidPrevtyn Beta is given

Your doctor, pharmacist or nurse will inject the vaccine into a muscle, usually in your upper arm.

You will receive one injection.

It is recommended that you receive VidPrevtyn Beta once as a booster dose at minimum 4 months following the prior vaccination series with either mRNA or adenoviral vector COVID-19 vaccine.

After the injection your doctor, pharmacist or nurse will watch over you for around 15 minutes to monitor for signs of an allergic reaction.

If you have any further questions on the use of this vaccine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Most of the side effects occur within 3 days of getting the vaccine and go away within a few days of appearing. If symptoms persist, contact your doctor, pharmacist or nurse.

Get urgent medical attention if you get symptoms of a severe allergic reaction shortly after vaccination. Such symptoms may include:

• feeling faint or light-headed
• changes in your heartbeat
• shortness of breath
• wheezing
• swelling of your lips, face, or throat
• itchy swelling under the skin (hives) or rash
• feeling sick (nausea) or vomiting
• stomach pain

The following side effects may occur with VidPrevtyn Beta. Side effects which may affect up to 1 in 100 people may not have all been detected in the clinical studies done to date.

Very common (may affect more than 1 in 10 people)

• headache
• muscle pain
• joint pain
• feeling unwell
• chills
• pain where the vaccine is injected

Common (may affect up to 1 in 10 people)

• fever (>38°C)
• tiredness
• feeling sick (nausea)
• diarrhoea
• redness or swelling where the vaccine is injected

Uncommon (may affect up to 1 in 100 people)

• enlarged lymph nodes
• itching, bruising or warmth where the vaccine is injected

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. If you are concerned about a side effect it can be reported directly via the Yellow Card reporting site www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store and include batch/lot number if available. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store VidPrevtyn Beta

Keep this vaccine out of the sight and reach of children.

Information about storage, use and handling are described in the section intended for healthcare professionals at the end of the package leaflet.

6. Contents of the pack and other information

What VidPrevtyn Beta contains

• There are two multidose vials (antigen vial and adjuvant vial) that must be mixed before use. After mixing, the vaccine vial contains 10 doses of 0.5 mL.
• One dose (0.5 mL) contains 5 micrograms of recombinant SARS-CoV-2 spike protein antigen (B.1.351 strain).
• AS03 is included in this vaccine as an adjuvant to enhance production of specific antibodies. This adjuvant contains squalene (10.69 milligrams), DL-α-tocopherol (11.86 milligrams) and polysorbate 80 (4.86 milligrams).
• The other ingredients are: sodium dihydrogen phosphate monohydrate, disodium phosphate dodecahydrate, sodium chloride, polysorbate 20, disodium hydrogen phosphate, potassium dihydrogen phosphate, potassium chloride, water for injections.

What VidPrevtyn Beta looks like and contents of the pack

• The antigen solution is a colourless, clear liquid.
• The adjuvant emulsion is a whitish to yellowish homogeneous milky liquid.
• Prior to administration, the two components should be mixed. The mixed vaccine is a whitish to yellowish homogeneous milky liquid emulsion.

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

• Each antigen vial contains 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.
• Each adjuvant vial contains 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.

After mixing the antigen solution with the adjuvant emulsion, the vial contains 10 doses of 0.5 mL.

Marketing Authorisation Holder

Sanofi Pasteur
14 Espace Henry Vallée
69007 Lyon
France

Distributed by:

Sanofi
410 Thames Valley Park Drive
Reading
Berkshire
RG6 1PT
UK

Tel: 0800 035 2525

Manufacturer

Sanofi Pasteur
1541 Avenue Marcel Mérieux
69280 Marcy l'Etoile
France

This leaflet was last revised in November 2022