Synflorix (Pneumococcal Conjugate Vaccine) contains ten serotypes of streptococcus pneumoniae. It is indicated for the primary and secondary prevention of children from infections caused by streptococcus pneumoniae.

Synflorix (Pneumococcal Conjugate Vaccine) Uses:

Note: Not approved in the US

• Pneumococcal disease prevention:
  • Used to prevent pneumonia, acute otitis media, and invasive infections caused by serotypes in the vaccination produced by Streptococcus pneumoniae in babies under 6 weeks of age and children up to age 5.

Use in adults:

Not recommended.   

Dose in Children

Dose for Primary immunization: IM:

• Infants 6 weeks to 6 months:
  • Healthy newborns or those with conditions like HIV or sickle cell anaemia who are at high risk for invasive pneumococcal disease:
    • The second and third dosages should be administered at 4 and 6 months of age, respectively. The first three doses should be spaced apart by at least one month, and at least six months should pass between the third treatment and the booster dose. Even though the booster dose can be given as early as nine months of age, it's usually administered between twelve and fifteen.
    • 0.5 mL each dose for the first three doses of the three-dose primary series, followed by 0.5 mL as a booster dose (for a total of 4 doses). Although the first dose can be given as early as six weeks old, most people start taking medication at eight weeks.
  • Healthy infants: Alternatively, healthy infants 2 to 6 months may receive a two-dose primary series:
    • two doses of 5 mL each, followed by a 0.5 mL booster dose (for a total of three doses). The first dose can be given as early as 6 weeks of age, but 8 weeks is the most typical age. Give the second dose when the baby is four months old.
    • The booster dose may be administered as early as 9 months of age, however it is often administered between 11 and 12 months. Between the first and second doses, there should be a minimum of two months, and between the second dose and the booster dose, there should be six months.
    • Note: It's possible that some babies who are at high risk for pneumococcal illness won't receive the best protection (eg, asplenia, sickle-cell disease, immunosuppressed).

Synflorix (Pneumococcal Conjugate Vaccine) dose in previously unvaccinated Older Infants and Children: IM:

• Infants 7 to 11 months:
  • 5 mL each dose for a total of three doses; the first two doses must be spaced at least four weeks apart, and the third dose must be given after the child reaches the age of 12 months and at least two months after the first.
• Children 12 to 23 months:
  • 5 mL per dosage, totalling two treatments, with a minimum of 8-week intervals between them. Note: Children 12 to 23 months old who are at high risk for pneumococcal illness may not receive the best protection with a 2-dose regimen (eg, asplenia, sickle-cell disease, immunosuppressed).
• Healthy children ≥24 months to <6 years:
  • 5 mL per dosage, totalling two treatments, with a minimum of 8-week intervals between them

Pregnancy Risk Category: B2

• There have not been any animal reproduction studies.
• Inactivated vaccines do not increase the risk for the foetus.
• This product can be used by infants and young children.

Use during breastfeeding:

• It is safe to give vaccines to breastfeeding mothers.
• Infants who are being breastfed should receive their recommended schedule of vaccinations.

Dose in Kidney Disease:

No dosage adjustments have been provided in the manufacturer’s labelling.   

Dose in Liver disease:

No dosage adjustments have been provided in the manufacturer’s labelling.   

Side Effects of Synflorix (Pneumococcal Conjugate Vaccine):

• Central Nervous System:
  • Irritability
  • Drowsiness
• Gastrointestinal:
  • Anorexia
• Miscellaneous:
  • Fever
• Local:
  • Pain At Injection Site
  • Induration at the injection site
  • Erythema At Injection Site Swelling At Injection Site

Contraindications to Synflorix (Pneumococcal Conjugate Vaccine):

• Hypersensitivity to any vaccine component

Warnings and precautions

• Anaphylactoid/hypersensitivity reactions:
  • Treatment should be given right away for anaphylactoid or hypersensitive responses, including epinephrine 1, mg/mL.
• Syncope
  • Injectable vaccines can cause syncope, which may lead to serious secondary injuries (eg skull fracture, cerebral haemorrhage).
  • This is most common in adolescents and young adults, but it may also occur in children as soon as the vaccine has been administered. 
  • If syncope does occur, procedures should be performed in an area that prevents injuries from falling and allows cerebral perfusion to be restored.
• Acute illness:
  • It is important to determine if you should delay or administer vaccinations due to current or recent febrile illnesses.
  • Based on the illness aetiology and the severity of the symptoms, this will be decided.
  • People with severe or moderate acute illnesses (with or without fever) should have their vaccinations postponed, whereas patients with light acute illnesses shouldn't have their vaccinations delayed (with fever or without).
• Bleeding disorders:
  • People with a history of bleeding disorders should be cautious. Intramuscular (IM), intramuscular (IM), administration can cause bleeding/hematoma. If the patient is receiving anti-haemophilia therapy, it is important to schedule an IM injection within a few hours.
• Pneumococcal Infections:
  • This product is not recommended for the treatment of pneumococcal infection.

Monitoring parameters:

• Monitoring respiratory status for 48 to 72 hours should be considered in premature infants (born ≤28 weeks gestation) due to the risk of apnea.
• Monitoring should be done for anaphylaxis and syncope for 15 minutes after administration.
• In case of seizure-like activity associated with syncope, the patient should be maintained in a supine or Trendelenburg position to re-establish adequate cerebral perfusion.   

How to administer Synflorix (Pneumococcal Conjugate Vaccine)?

IM:

• Shake well before use.
• Administration should only be done intramuscularly (IM), ideally into the deltoid in children and the anterolateral thigh in infants.
• Not to be administered intravenously or intradermally.
• Studies are not available for SubQ administration.
• Not to be mixed with other vaccines or injections; use separate needles and syringes for each injection.
• As per recommendations from NACI all patients with bleeding disorders should receive all routinely recommended vaccinations according to schedule.
• Correct bleeding disorders prior to immunization (when possible) or schedule immunization shortly after antihemophilic or other similar therapy.
• In patients with a bleeding disorder that cannot be corrected, avoid(if possible) IM gluteal injections.
• When delivering a vaccination to those with bleeding issues, use a fine-gauge needle of the appropriate length and apply firm pressure to the spot (without rubbing) for at least five minutes.
• Instruct the patient regarding the risk of hematoma formation at the injection site.
• May give vaccine via IM route in patients on anticoagulant therapy (eg, aspirin, warfarin, heparin) without discontinuation of their anticoagulant therapy.   

Mechanism of action of Synflorix (Pneumococcal Conjugate Vaccine):

• Active immunization against S. pneumoniae capsular serotypes 1, 5, 6, 6B, 7F and 9V, 14-18C, 19F and 23F is encouraged.
• The antibody response to the aluminum salt (a mineral adjuvant) is increased.   

International Brand Names of Pneumococcal conjugate vaccine:

• Synflorix

Pneumococcal conjugate vaccine Brand Names in Pakistan:

No Brands Available in Pakistan.