Vaxneuvance® suspension for injection in pre-filled syringe

Pneumococcal polysaccharide conjugate vaccine (15-valent, 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 you or your child may get. See the end of section 4 for how to report side effects.

Vaxneuvance is a pneumococcal vaccine given to:

• children from 6 weeks to less than 18 years of age to help protect against diseases such as lung infection (pneumonia), inflammation of the coverings of the brain and spinal cord (meningitis), a severe infection in the blood (bacteraemia) and ear infections (acute otitis media),
• individuals 18 years of age and older to help protect against diseases such as lung infection (pneumonia), inflammation of the coverings of the brain and spinal cord (meningitis) and a severe infection in the blood (bacteraemia), caused by 15 types of bacteria called Streptococcus pneumoniae or pneumococcus.

Tell your doctor, pharmacist, or nurse if you or your child has been given a pneumococcal vaccine before.

Your doctor or nurse will give the vaccine into your arm muscle or into your child's arm or leg muscle.

Infants and children aged 6 weeks to less than 2 years

Your child should receive an initial course of 2 injections of the vaccine followed by a booster dose.

• The first injection may be given as early as 6 weeks of age.
• A second injection is administered 2 months later.
• A third injection (booster) will be given between 11 through 15 months of age.

You will be told when your child should come back for each injection.

According to official recommendations in your country, an alternative schedule of 3 injections followed by a booster dose may be used by your healthcare provider. Please speak to your doctor, pharmacist, or nurse for more information.

Premature infants (born earlier than 37 weeks of pregnancy)

Your child should receive an initial course of 3 injections of the vaccine followed by a booster dose.

• The first injection may be given as early as 6 weeks of age.
• The second and third injections are given thereafter with an interval of 4 to 8 weeks between doses.
• A fourth injection (booster) will be given between 11 through 15 months of age.

Infants, children and adolescents starting the vaccination at 7 months of age or older

Infants 7 to less than 12 months of age should receive a total of 3 injections. The first two injections will be given at least 1 month apart. The third injection (booster) will be given after 12 months of age and at least 2 months after the second injection.

Children 12 months to less than 2 years of age should receive a total of 2 injections. The two injections will be given at least 2 months apart.

Children and adolescents 2 to less than 18 years of age should receive 1 injection.

Adults

Adults should receive 1 injection.

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

Like all vaccines, Vaxneuvance can cause side effects, although not everybody gets them.

Get medical care right away if you or your child has symptoms of an allergic reaction, which may include:

• Wheezing or trouble breathing
• Swelling of the face, lips, or tongue
• Hives
• Rash

The following side effects can be seen after the use of Vaxneuvance in infants, children and adolescents:

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

• Fever (temperature of 38 °C or higher in those 6 weeks to less than 2 years of age)
• Irritability (in those 6 weeks to less than 2 years of age)
• Drowsiness (in those 6 weeks to less than 2 years of age)
• Pain, redness or swelling at the injection site
• Decreased appetite (in those 6 weeks to less than 2 years of age)
• Hardness at the injection site (in those 6 weeks to less than 2 years of age)
• Muscle aches (in those 2 to less than 18 years of age)
• Feeling tired (in those 2 to less than 18 years of age)
• Headache (in those 2 to less than 18 years of age)

Common (may affect up to 1 in 10 people):

• Hardness at the injection site (in those 2 to less than 18 years of age)
• Hives
• Fever (temperature of 38 °C or higher in those 2 to less than 18 years of age)
• Vomiting (in those 6 weeks to less than 2 years of age)
• Rash (in those 6 weeks to less than 2 years of age)
• Irritability (in those 2 to less than 18 years of age)
• Drowsiness (in those 2 to less than 18 years of age)
• Decreased appetite (in those 2 to less than 18 years of age)
• Bruising at the injection site
• Nausea (in those 2 to less than 18 years of age)

Uncommon (may affect up to 1 in 100 people):

• Vomiting (in those 2 to less than 18 years of age)

Not known (cannot be estimated from the available data):

• Rash (in those 2 to less than 18 years of age)

The following side effects can be seen after the use of Vaxneuvance in adults:

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

• Pain, swelling, or redness at the injection site
• Feeling tired
• Muscle aches
• Headaches
• Joint pain (in those 18 to 49 years of age)

Common (may affect up to 1 in 10 people):

• Joint pain (in those 50 years of age and older)
• Nausea (in those 18 to 49 years of age)
• Fever (in those 18 to 49 years of age)
• Itchiness at the injection site
• Dizziness (in those 18 to 49 years of age)
• Chills (in those 18 to 49 years of age)

Uncommon (may affect up to 1 in 100 people):

• Fever (in those 50 years of age and older)
• Warmth at the injection site
• Bruising at the injection site
• Dizziness (in those 50 years of age and older)
• Nausea (in those 50 years of age and older)
• Vomiting
• Chills (in those 50 years of age and older)
• Rash

Rare (may affect up to 1 in 1,000 people):

• Allergic reaction such as hives, tongue swelling, flushing, and throat tightness

These side effects are generally mild and last a short time.

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

Do not use this vaccine after the expiry date which is stated on the carton and syringe label after EXP.

The expiry date refers to the last day of that month.

Store in a refrigerator (2 °C – 8 °C). Do not freeze. Keep the pre-filled syringe in the outer carton in order to protect from light.

Vaxneuvance should be administered as soon as possible after being removed from the refrigerator.

However, in circumstances where Vaxneuvance is temporarily held outside of refrigeration, the vaccine is stable at temperatures up to 25 °C for 48 hours.