Prevenar 13

Prevenar 13® use extended to adults in US and Canada

Wednesday, 15 February 2012

The license for use of Prevenar 13® has been extended to include adults 50 years and older in America and Canada.

The vaccine is used to reduce the risk of invasive pneumococcal disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F in young children and now older adults.

In New Zealand Prevenar 13® is recommended for children with conditions that increase their risk of invasive pneumococcal disease and an alternative vaccine is used for adults.

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Prevenar 13 vaccine extended to adults over 50

Friday, 6 January 2012

The U.S. Food and Drug Administration (FDA) has approved the use of Prevenar 13®, the 13-valent pneumococcal conjugate vaccine, for adults aged 50 years and older.

In randomised, multi-center studies in the United States and Europe, adults aged 50 and older received either Prevenar 13®, which contains 13 different serotypes of the bacterium Streptococcus pneumonia or Pneumovax® 23, the pneumococcal polysaccharide vaccines which conatins 23 different serotypes of the bacterium. The studies showed that for the 12 serotypes common to both vaccines, Prevenar 13® induced antibody levels that were either comparable to or higher than the levels induced by Pneumovax® 23.

The safety of Prevenar 13 was evaluated in about 6,000 adults aged 50 and older who received Prevenar 13® and who had and had not previously received Pneumovax® 23. Common adverse reactions reported with Prevenar 13® were pain, redness, and swelling at the injection site, limitation of movement of the injected arm, fatigue, headache, chills, decreased appetite, generalized muscle pain, and joint pain. Similar reactions were observed in those who received Pneumovax® 23.

The new use for Prevenar 13® was approved under the agency's accelerated approval pathway, which allows for earlier approval of treatments for serious and life-threatening illnesses, to prevent pneumonia and invasive disease caused by the bacterium in older adults. The pathway allows for the demonstration of effectiveness of a vaccine using an immune marker that is reasonably likely to predict clinical benefit.

Accelerated approval is granted on the condition that a clinical trial is conducted during the post-approval marketing of the vaccine to verify the anticipated clinical benefit in adults 50 years of age and older. An additional trial in 85,000 adults aged 65 and older, with no previous history of receiving Pneumovax® 23, is underway to confirm the clinical benefit of Prevenar 13® in the prevention of pneumococcal pneumonia.

 

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Prevenar 13® for 50 years and over

Wednesday, 13 June 2012

Prevenar 13® is now licensed for adults aged 50 years and over.

Medsafe extended the license for Prevenar 13® to include adults from 50 years of age and over on 31 May 2012, in keeping with the extended use in the US and Canada. Prevenar 13® is a pneumococcal conjugate vaccine to protect against 13 strains of the bacteria Streptococcus pneumoniae. Advantages of using this vaccine for adults at high risk of pneumococcal disease, e.g. those who are pre- or post-splenectomy, have had a bone marrow transplant or who have chronic respiratory disease, eight weeks before administering the Pneumovax® 23 polysaccharide vaccine is the vaccine's ability to develop immune system memory against the 13 strains that can be boosted by future pneumococcal immunisation and the development a better quality and longer lasting circulating protection.

Prevenar 13® is licensed for infants and children from 6 weeks to 5 years of age and adults 50 years and over but can be used in the 5-49 year age group out of licensure. No safety concerns are expected with use of the vaccine in this age group.

Only children less than 5 years of age with specified medical conditions and children and adolescents up to 16 years of age who have functional asplenia or are pre- or post-splenectomy are eligible to receive this vaccine for free. Other people requesting the vaccine for themselves or their children need to purchase their vaccine through their general practice.

If you are interested in receiving the Prevenar 13® vaccine please talk to your Doctor or Practice Nurse or phone 0800 IMMUNE (0800 466 863) and talk to one of our Immunisation Advisors.

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Prevenar 13® for 18-49 year olds

Thursday, 4 October 2012

Pfizer have announced top-line data assessing immunogenicity, tolerability and safety of Prevenar 13® in adults aged 18-49 years of age.

These data support a recent regulatory submission to expand the indication of Prevenar 13® in the European Union to include adults between 18 and 49 years old, and will be used to support similar planned submissions in other countries around the world in the future.

The primary objective of this study was to demonstrate that the immune response to Prevenar 13® in the 18 to 49 year old age group is noninferior to the immune response to Prevenar 13® in the 60 to 64 year old age group as measured by serotype specific opsonophagocytic assay (OPA) titers one month after vaccination. The primary objective was met for all 13 serotypes in Prevenar 13®.

Prevenar 13® is currently licensed in New Zealand for infants and children six weeks to five years of age and adults aged 50 years and over.

The vaccine is recommended and funded for:

  • Children up to five years of age who meet the eligibility criteria for the High Risk Pneumococcal Programme, and
  • Children up to their 16th birthday* with functional asplenia and who are pre-post splenectomy.

The vaccine is also recommended but NOT funded for:

  • Children from five years of age* and adults* from 16 years of age with other medical conditions that increase their risk of invasive pneumococcal disease, and
  • Adults* from 16 years of age who are pre/post splenectomy.

* Use of Prevenar 13® for the age group five to 49 years is outside the New Zealand license however no safety concerns are expected from its use in this age group.

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Prevenar 13®

PCV13

Prevenar 13® is used for primary and booster immunisation of infants and children and primary immunisation of adults at increased risk of pneumococcal disease to protect against disease caused by 13 types of Streptococcus pneumoniae.
The vaccine is licensed for use in infants and children up to their 5th birthday and for adults from 50 years of age. It is used out of licensure in adolescents/adults between 18-49 years of age as there is no alternative pneumococcal conjugate vaccine available in New Zealand for this age group. When the vaccine is administered to individuals between 5-49 years of age, use will be outside of current licensure. There are not expected to be any safety concerns for use in this age group.

What is the difference between Prevenar®, Synflorix® and Prevenar 13®?

Answer: 

A pneumococcal conjugate vaccine called Synflorix® is replacing Prevenar® at the scheduled visits of 6 weeks, 3 months, 5 months and 15 months of age. Synflorix® covers the same seven pneumococcal types that Prevenar® does plus three more types.

From 1 July 2011 Prevenar 13® replaced Prevenar® for children with particular medical conditions eligible for the High Risk Pneumococcal Immunisation Programme. Prevenar 13® covers the same seven pneumococcal types that Prevenar® does plus six more types. Prevenar 13® is to be used in these children instead of Synflorix®. The safety profile for all three vaccines is similar.

The body’s immune responses to both Synflorix® and Prevenar 13® are comparable to the responses to Prevenar® for the pneumococcal bacteria types they have in common. Therefore, both Synflorix® and Prevenar 13® are expected to be as least as effective as Prevenar® in preventing serious infections. However, until Synflorix® and Prevenar 13® have been used for many years, like Prevenar® has, there will be no data to show how much more effective they may be. The new vaccines also generate a protective response against additional pneumococcal types not covered by Prevenar®.

A child who has started their course of pneumococcal protection with Prevenar® can complete their course with Synflorix®. When this occurs the child is expected to develop full protection for the seven types of pneumococcal bacteria in both vaccines. They may also develop partial protection for the extra three types in Synflorix®.

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What is the difference between Prevenar®, Prevenar 13® or Synflorix® and Pneumovax® 23?

Answer: 

Prevenar®, Prevenar 13®, Synflorix® and Pneumovax® 23 are all vaccines against pneumococcal disease, a leading cause of serious illness in children and some adults, but there are differences in the way they are made.

Prevenar®, Prevenar 13® and Synflorix® are conjugate vaccines. The sugar molecules from the outside of the bacteria have been attached to a special protein to make them better at stimulating the immune system. Young infants respond well to this type of vaccine. Prevenar® offers protection against seven common types of pneumococcal bacteria, Prevenar 13® against 13 types and Synflorix® offers protection against 10 common strains of pneumococcal types.

Pneumovax® 23 is a polysaccharide vaccine. It is made using the sugar molecules from the outside of the bacteria. It is not very effective in infants under two years of age as their immune systems are too immature to generate a strong, protective response to this kind of vaccine. Older children and adults do respond to Pneumovax® 23 but not as well as they do to the conjugate vaccines. The advantage of Pneumovax® 23 is that it protects against 23 types of pneumococcal bacteria.

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