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Patient Information Leaflet for COVID-19 Vaccine Valneva

Updated 13 July 2022

COVID-19 Vaccine Valneva, suspension for injection, COVID-19 vaccine (inactivated, adjuvanted, adsorbed)

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

0.1 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 your child gets any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

0.2 What is in this leaflet

1. What COVID-19 Vaccine Valneva is and what it is used for
2. What you need to know before you are given COVID-19 Vaccine Valneva
3. How COVID-19 Vaccine Valneva is given
4. Possible side effects
5. How to store COVID-19 Vaccine Valneva
6. Contents of the pack and other information

1. 1.What COVID-19 Vaccine Valneva is and what it is used for

COVID-19 Vaccine Valneva is a vaccine used to prevent COVID-19 caused by SARS-CoV-2.

COVID-19 Vaccine Valneva is given to adults aged between 18 and 50 years.

The vaccine causes the immune system (the body’s natural defences) to produce antibodies and blood cells that works against the virus so giving protection against COVID-19.

None of the ingredients in this vaccine can cause COVID-19.

2. 2.What you need to know before your child receives Comirnaty

2.1 COVID-19 Vaccine Valneva must not be given

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

2.2 Warnings and precautions

Tell your doctor, pharmacist or nurse before you are given COVID-19 Vaccine Valneva if:

• you have previously had a severe, life-threatening allergic reaction after any other vaccine injection or after you were given COVID-19 Vaccine Valneva in the past
• you have ever fainted following any needle injection or if you have anxiety related to injections
• you have a severe illness or infection with high fever. You can have your vaccination if you have a mild fever or upper airway infection like a cold
• you have a problem with bleeding, you bruise easily or if you use a medicine to prevent blood clots
• you have a weakened immune system because of a disease such as HIV infection or you are taking medicines, such as corticosteroid, that affect your immune system

Two doses of COVID-19 Vaccine Valneva are necessary to start protecting you. As with any vaccine, even the 2-dose vaccination course may not fully protect all those who receive it and it is not known how long you will be protected. No data are currently available in individuals with a weakened immune system or who are taking chronic treatment that suppresses or prevents immune responses.

2.3 Children and adolescents

COVID-19 Vaccine Valneva is not recommended for children and adolescents aged below 18 years. Currently there is not enough information available on the use of COVID-19 Vaccine Valneva in children and adolescents younger than 18 years of age.

2.4 Other medicines and COVID-19 Vaccine Valneva

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

2.5 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 or pharmacist for advice before you receive this vaccine.

2.6 Driving and using machines

Some of the side effects of COVID-19 Vaccine Valneva listed in section 4 may temporarily affect your ability to drive and use machines. Do not drive or use machines if you are feeling unwell after vaccination. Wait until any effects of the vaccine have worn off before you drive or use machines.

2.7 COVID-19 Vaccine Valneva contains potassium and sodium

This vaccine contains potassium, less than 1 mmol (39 mg) per 0.5 mL dose, i.e. essentially ‘potassium-free’.

This vaccine contains less than 1 mmol sodium (23 mg) per 0.5 mL dose, that is to say essentially ‘sodium-free’.

3. 3.How COVID-19 Vaccine Valneva is given

COVID-19 Vaccine Valneva is given as an injection of 0.5 mL into a muscle of your upper arm.

You will receive 2 injections of the same vaccine, given at least 28 days apart to complete the vaccination course.

If you miss an appointment for your second injection of COVID-19 Vaccine Valneva, it is important that you return for your second injection as you are not protected against COVID-19.

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

4. 4.Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may occur with COVID-19 Vaccine Valneva:

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

• headache
• nausea
• vomiting
• muscle pain
• tiredness
• injection site pain

4.2 Common side effects (may affect up to 1 in 10 people)

• injection site: itching, hardening, swelling, redness
• fever

4.3 Uncommon side effects (may affect up to 1 in 100 people)

• enlarged lymph nodes
• dizziness
• deep unresponsiveness (lethargy)
• decreased or abnormal sensation of skin (for example pins and needles)
• taste disturbance
• diarrhoea
• belly pain
• chills
• excessive sweating
• rash
• pain in leg or arm
• joint pain
• muscle cramps

4.4 Rare side effects (may affect up to 1 in 1,000 people)

• hives

4.5 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 Coronavirus Yellow Card reporting site https://coronavirus-yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in the Google Play or Apple App Store. When completing a report please include the vaccine brand and batch/Lot number if available. By reporting side effects you can help provide more information on the safety of this medicine.

5. 5.How to store COVID-19 Vaccine Valneva

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

Do not use this medicine after the expiry date which is stated on the carton and label after “EXP”. The expiry date refers to the last day of that month.

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

6. 6.Contents of the pack and other information

6.1 What COVID-19 Vaccine Valneva contains

The active substance is a highly purified whole virus SARS-CoV-2 antigen¹, inactivated² and adjuvanted with CpG 1018³ in combination with aluminium hydroxide⁴.

One multi-dose vial contains 10 single doses of 0.5 mL.

One dose (0.5 mL) contains no less than 25 Antigen Units (AU) of inactivated SARS-CoV-2.

¹ Produced on Vero cells

² Inactivated with beta-propiolactone

³ 1 mg CpG 1018 (cytosine phospho-guanine) adjuvant/0.5 mL dose

⁴ Adsorbed on aluminium hydroxide (0.5 mg Al3+)/0.5 mL dose

The other ingredients are: sodium chloride, sodium phosphate dibasic anhydrous, potassium phosphate mono anhydrous, potassium chloride, water for injections and recombinant human albumin (rHA) containing sodium, octanoate, and polysorbate 80.

6.2 What COVID-19 Vaccine Valneva looks like and contents of the pack

White to off-white suspension for injection (injection) in a glass multi-dose vial closed with rubber stopper and a flip-off plastic cap with aluminium seal.

Pack size: 10 multi-dose vials

6.3 Marketing Authorisation Holder

Valneva Austria GmbH
Campus Vienna Biocenter 3
1030 Vienna
Austria

6.4 Manufacturers

Valneva Scotland Limited
Oakbank Park Road
Livingston EH53 OTG
Scotland, UK

For any information about this medicine, please contact the Marketing Authorisation Holder by the following email-address: covid19@valneva.com

6.5 This leaflet was last revised in 04/2022

This medicinal product has been authorised under a so-called ‘conditional approval’ scheme. This means that further evidence on this medicinal product is awaited. New information on this medicinal product will be reviewed at least every year and this leaflet will be updated as necessary.