Government of New Brunswick

What is the difference between Prevnar® and Prevnar®13?

Prevnar®13 offers protection against six additional serotypes of pneumococcal bacteria.
The six new serotypes in Prevnar®13 (1, 3, 5, 6A, 7F and 19A) are in addition to those serotypes contained in Prevnar® (4, 6B, 9V, 14, 18C, 19F, and 23F).

Will these six serotypes make a difference?

YES. In New Brunswick between 2006 and 2008 there were 40 cases of IPD caused by the six new serotypes contained in the Prevnar®13 vaccine.

What is the immunization schedule for Prevnar®13?

The New Brunswick immunization schedule for pneumococcal conjugate vaccine has changed as of July 1st 2010. The pneumococcal conjugate vaccine schedule changed from a 3+1 to a 2+1 schedule. Prevnar®13, the successor to Prevnar®, will be given at 2, 4 and 12 months of age. This schedule was shown to be equivalent to the previous NB immunization schedule with Prevnar®, which was given at 2,4,6, and 18 months of age.

For healthy infants:

Unimmunized infants aged 2 to 12 months; three doses of Prevnar®13 vaccine given at 2, 4 and 12 months of age. The first two doses must be given at least 8 weeks apart.

Infants who have started a series of Prevnar®: Complete any remaining doses as per NB transition table with Prevnar®13 (i.e., simply switch to using Prevnar®13).

Infants who have completed their Prevnar® series: An additional dose of Prevnar®13 will be given to children up to the age of 23 months until the 31 March 2011.

For high risk infants:

Unimmunized infants doses of Prevnar®13 vaccine given at 2, 4, and 12 months of age.

Infants who have started a series of Prevnar®: Complete any remaining doses in the series with Prevnar®13 (i.e., simply switch to using Prevnar®13).

Infants who have completed their Prevnar® series: One dose of Prevnar®13 should be given to high risk children aged 12 to 59 months of age who have completed age appropriate pneumococcal conjugate vaccine series with the Prevnar® or 10-valent (SYNFLORIX™) vaccine. This dose should be given no sooner than 8 weeks following the last dose of pneumococcal conjugate vaccine. This single dose elicits a good immune response to the six additional serotypes in >90% of children.

High risk children will continue to receive a dose of the 23 valent pneumococcal polysaccharide vaccine at 24 months of age and above and no sooner than 8 weeks following a pneumococcal conjugate vaccine dose.

Table 1

Conditions considered to place children at high risk of IPD
Asplenia (functional or anatomic)
Chronic cardiac or pulmonary disease (excluding asthma)
Poorly controlled diabetes mellitus
CSF leak

Chronic neurologic condition that may impair clearance of oral secretions

Cochlear implants (including those children who are to receive implants)
Sickle cell disease or other hemoglobinopathies

Congenital immunodeficiencies involving any part of the immune system, including B-lymphocyte (humoral) immunity, T-lymphocyte (cell) mediated immunity, complement system (properdin, or factor D deficiencies), or phagocytic functions.

Hematopoietic stem cell transplant (candidate or recipient)
Human immunodeficiency virus (HIV) infection

Immunosuppressive therapy including use of long term corticosteroids, chemotherapy, radiation therapy, post-organ-transplant therapy, and certain anti-rheumatic drugs

Chronic kidney disease, including nephrotic syndrome
Chronic liver disease (including hepatitis B and C, and hepatic cirrhosis due to any cause)
Malignant neoplasms including leukemia and lymphoma
Solid organ or islet cell transplant (candidate or recipient)

Has the 3-dose schedule for Prevnar®13 for healthy
children been approved by Health Canada?

YES. The three dose schedule is now an approved schedule for routine infant immunization. The product monograph refers to this as a “2 + 1” schedule: 2 primary doses and 1 “booster dose” at 12 months of age. Lower immunogenicity response for serotypes 6B and 23F have been observed after the first two doses in some infants, but after the dose at 12 months of age, there was a good immune response for all vaccine serotypes. This emphasizes the importance of the vaccine dose at 12 months of age.

If a child has already had pneumococcal disease, is immunization still necessary?

YES. While serotype –specific immunity may follow infection and last for years, there are 90 pneumococcal bacteria serotypes, and providing vaccine offers the child broader protection.

What if a child has received different pneumococcal conjugate vaccine doses prior to presentation at New Brunswick immunization clinic?

(SYNFLORIX™) the ten-valent pneumococcal conjugate vaccine is provided in some Canadian provinces/territories. Therefore, children who have moved to New Brunswick from another province/territory may have received this vaccine. Prevnar®13 can be given for the next and subsequent scheduled dose(s) to complete their series.

Does the new vaccine change the informed consent process?

NO. When a series was started with Prevnar®, inform the parent that the series will be completed with Prevnar®13, a vaccine that provides protection against 6 additional pneumococcal serotypes.

Can Prevnar®13 be given at the same clinic visit with other vaccines?

YES. Prevnar®13 can be given, at a separate injection site, using a separate syringe, with the following antigens: diphtheria, tetanus, acellular pertussis, inactivated polio, Hib, hepatitis B, meningococcal conjugate C, measles, mumps, rubella and varicella. These are the other vaccines given routinely to children under 2 years old. Clinical trials demonstrated that the immune responses and safety profiles of these antigens were unaffected when given at the same time as Prevnar®13.

What are the components of Prevnar®13?

Prevnar®13 contains pneumococcal polysaccharide (2.2-4.4 µg depending on the serotype), diphtheria CRM197 protein (~32 µg), aluminum phosphate, succinic acid, and polysorbate 80. Aluminum phosphate is the same adjuvant used in Prevnar®. Succinic acid is added to increase buffering capacity and maintain product stability and polysorbate 80 is used as an emulsifier.

What are the expected adverse events following immunization with Prevnar®13?

The expected adverse events following immunization with Prevnar® 13 are similar to those seen with Prevnar®: local reactions such as redness, swelling and pain, and systemic reactions such as sleepiness, irritability, decreased appetite, vomiting or diarrhea. Injection site erythema or induration/swelling 2.5 cm-7.0 cm (after booster dose & in children age 2-5 yrs) is described as very common. No new or important safety signals have been identified.

The safety profile of Prevnar® 13 was assessed in 13 controlled clinical trials, in which ~ 15,000 doses were given to 4,729 healthy infants who were 6 weeks to 16 months of age. In a catch-up study, 354 children, ranging in age from 7 months to 5 years of age, and receiving at least 1 dose of Prevnar®13, were assessed for safety.

Results are shown in the following table:

Frequency Adverse event

Very Common

(≥ 10%)

decreased appetite

irritability

sleep disturbance (drowsiness/increased sleep; restless sleep/decreased sleep)

fever

any injection site erythema, induration, swelling or pain/tenderness

injection site erythema or induration/swelling 2.5 cm-7.0 cm (after booster dose & in children age 2-5 yrs)

Common

( ≥ 1% and < 10%)

diarrhea

vomiting

rash

fever > 39°C

injection site erythema or induration/swelling 2.5 cm-7.0 cm (after infant series)

injection-site pain/tenderness interfering with movement

Uncommon

(≥ 0.1% and < 1%)

crying

seizures (including febrile)

urticaria or urticaria-like rash

injection site induration/swelling or erythema > 7.0 cm

Rare

( ≥ 0.01% and < 0.1%)

 

hypersensitivity reaction

 

How is Prevnar®13 supplied?

Prevnar®13 is supplied in a single dose, latex-free, prefilled syringe (0.5 ml) with leur lock. The pack size is 10 doses, without needles. The box size is the same as the Prevnar® box. The vaccine should be shaken well to obtain a homogeneous white suspension prior to administration.

What do we do with remaining stock of Prevnar®?

Quarantine all remaining Prevnar® stock in your vaccine refrigerator at the end of the business day, 30 June 2010.

Return this stock under cold chain conditions to the Central Serum Depot or your local Sub Serum Depot.

Where can I get more information on Prevnar®13?

Further information on Prevnar®13 is available in the product monograph. All health-care providers should read this information before administering Prevnar®13 vaccine.

References

Centers for Disease Control and Prevention (2010), Invasive pneumococcal disease in young children before licensure of 13-valent pneumococcal conjugate vaccine – United States, 2007. Morbidity and Mortality Weekly Report, Vol.59, No.9.