Prevenar

What it is

Prevenar 13 is a pneumococcal polysaccharide conjugate vaccine, 13-valent adsorbed. Each 0.5 mL dose contains 2.2 μg of pneumococcal purified capsular polysaccharides for serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F and 23F, and 4.4 μg for serotype 6B. Each serotype is individually conjugated to non-toxic diphtheria CRM 197 protein and adsorbed on aluminium phosphate. Prevenar 13 is a ready to use homogeneous white suspension for intramuscular injection supplied as a pre-filled syringe.

Approved indications —

Active immunisation for the prevention of pneumococcal disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F in adults and children aged more than 6 weeks of age.

Dosing overview

The dose of Prevenar 13 is 0.5 mL given intramuscularly only. For infants aged 6 weeks to 6 months, the primary infant series consists of three doses, each of 0.5 mL, with the first dose usually given at 2 months of age and with an interval of at least 1 month between doses. A fourth (booster) dose is recommended after 12 months of age, and at least 2 months after the third dose. For adults, one single dose is given, including those previously vaccinated with pneumococcal polysaccharide vaccine.

Key safety warnings

Appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine. The administration of Prevenar 13 should be postponed in individuals suffering from acute moderate or severe febrile illness. Prevenar 13 will not protect against Streptococcus pneumoniae serotypes other than those included in the vaccine nor other micro-organisms that cause invasive disease, pneumonia, or otitis media. This vaccine should not be given to individuals with thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection unless the potential benefit clearly outweighs the risk of administration. The potential risk of apnoea and the need for respiratory monitoring for 48–72 hours should be considered when administering the primary immunisation series to very premature infants (born ≤30 weeks of gestation) and particularly for those with a previous history of respiratory immaturity.

Contraindications

Hypersensitivity to the active substances or to any of the excipients, or to diphtheria toxoid. Allergic reaction or anaphylactic reaction following prior administration of Prevenar (7-valent).

PBS listing

Prevenar 13 is available on the PBS as a designated vaccine for prevention of pneumococcal disease. A single dose of 13vPCV is recommended for pneumococcal naive non-Indigenous adults aged 65 years and over and Indigenous adults aged 50 years and over. In November 2022, Prevenar 13 was recommended for individuals with at-risk conditions aged 18 years and older, non-Indigenous adults aged 70 years and older, and Aboriginal and Torres Strait Islander adults aged 25 years and older.

Regulatory history

Prevenar 13 was first listed on the ARTG on 29 March 2010. The TGA approved an extension of the indication on 30 August 2013 for active immunisation to prevent pneumococcal disease in children aged 6 to 17 years of age. In July 2016, the PBAC recommended Prevenar 13 for prevention of pneumococcal pneumonia and invasive pneumococcal disease in adults on the basis of cost-effectiveness compared with 23-valent pneumococcal polysaccharide vaccine. In November 2017, the PBAC recommended an amendment to expand eligibility criteria to include individuals aged 65 years and older. In March 2018, the PBAC recommended changes to the NIP infant schedule from 3+0 to 2+1.