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

Updated 20 April 2023

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This publication is available at https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-vidprevtyn-beta/product-information-leaflet-pil-for-vidprevtyn-beta-dispersion-for-injection

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.

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.

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.

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

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.

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.

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

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.

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.

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’.

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.

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:

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.

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.

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.

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

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

Sanofi Pasteur14 Espace Henry Vallée69007 LyonFrance

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Tel: 0800 035 2525

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This leaflet was last revised in November 2022