Preterm InfantsPreterm infants (gestational age 19 to 36 weeks) have an increased risk for pneumococcal disease compared with infants born full term (gestational age 37 to 42 weeks), according to studies. 2 A Phase 4 study of Prevenar 13 administered at 2, 3, 4 and 12 months to approximately 100 preterm infants (born at 26 to 36 weeks) found a less robust immune response among preterm infants compared to term infants. An acceptable safety profile was demonstrated. 7 Adverse events were generally consistent with those expected in this study population. Sickle Cell Disease Individuals with sickle cell disease are 30 to 600 times more likely to contract invasive pneumococcal disease than healthy individuals. 3 A Phase 3, open-label, single-arm study evaluated the safety, tolerability and immunogenicity of two doses of Prevenar 13 given six months apart in 158 children and adolescents aged 6 years to 17 years with sickle cell disease who were previously vaccinated with one or more doses of the 23-valent pneumococcal polysaccharide vaccine. The study showed that Prevenar 13 elicited antibody levels after the first dose that were statistically significantly higher when compared with levels prior to vaccination. Antibody levels after the second dose were comparable to those after the first dose. An acceptable safety profile was demonstrated. 8 Adverse events were generally consistent with those expected in this study population. HIV Infection HIV-infected individuals are more vulnerable to invasive pneumococcal disease, with an incidence that has been reported to be 6 to 324 times that of uninfected adults. 4 Studies estimating the risk in the current setting of antiretroviral therapy use suggest the risk remains 20 to 40 times higher in HIV-infected adults than the general population. 5,6 A Phase 3, open-label, single-arm study assessed the safety, tolerability and immunogenicity of three doses of Prevenar 13 given six months apart in 331 individuals with HIV infection (with a CD4 count of ≥200 cells/µL, HIV viral load <50,000 copies/mL) aged 18 years or older who had been previously vaccinated with at least one dose of 23-valent pneumococcal polysaccharide vaccine. The study showed that Prevenar 13 elicited antibody levels after the first dose that were statistically significantly higher when compared with levels prior to vaccination. After the second and third doses of Prevenar 13, immune responses were comparable or higher than those after the first dose. An acceptable safety profile was demonstrated. Adverse events were generally consistent with those expected in this study population. 9 About Pneumococcal Disease Pneumococcal disease (PD) is a group of illnesses caused by the bacterium S. pneumoniae, also known as pneumococcus. 10 It includes invasive manifestations such as bacteremia (bacteria in the blood) and meningitis (infection of the tissues surrounding the brain and spinal cord), as well as non-invasive infections such as pneumonia. 11 PD can affect people of all ages, but infants and young children, older adults and individuals with immunocompromising or certain chronic medical conditions are at heightened risk of infection. 12,13 About Prevenar 13 Prevenar 13, or Prevnar 13 as it is called in the United States, Canada and Taiwan, was first introduced for use in infants and young children in December 2009 in Europe and is now approved for such use in more than 120 countries worldwide, including the United States and Japan. 14 It is the most widely used pneumococcal conjugate vaccine (PCV) in the world, and more than 575 million doses of Prevenar/Prevenar 13 have been distributed worldwide. 14 In addition, Prevenar 13 is approved for use in adults 50 years of age and older in more than 90 countries, 14 and is also approved in the United States and European Union (EU) for use in older children and adolescents aged 6 to 17 years. 1,15 Recently, Prevenar 13 was also approved in the EU for use in adults 18 to 49 years of age, 1 making it the only pneumococcal vaccine in the EU approved to help protect against invasive pneumococcal disease from infancy through adulthood. Indication for Prevenar 13 in Europe Prevenar 13 is approved in the EU for the prevention of invasive disease, pneumonia and acute otitis media caused by S. pneumoniae serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) in children and adolescents aged 6 weeks to 17 years. It is also approved in the EU for the prevention of invasive disease caused by 13 S. pneumoniae serotypes (single dose) in adults 18 years of age and older. 1 For the full prescribing information for Prevenar 13 in the EU, please see the Summary of Product Characteristics. Indication for Prevnar 13 in the United States
- Prevnar 13 is a vaccine approved for children 6 weeks through 17 years of age for the prevention of invasive disease caused by 13 S. pneumoniae strains (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F), and for children 6 weeks through 5 years for the prevention of otitis media caused by 7 of the 13 strains (4, 6B, 9V, 14, 18C, 19F, and 23F). 15
- Based upon immune responses to the vaccine, Prevnar 13 is also approved for adults 50 years of age and older for the prevention of pneumococcal pneumonia and invasive disease caused by the 13 vaccine strains. 15
- Prevnar 13 is not 100 percent effective and will only help protect against the 13 strains included in the vaccine. 15
- Effectiveness when given less than 5 years after a pneumococcal polysaccharide vaccine is not known. 15
For the full prescribing information for Prevnar 13 in the United States, please click here: http://labeling.pfizer.com/ShowLabeling.aspx?id=501.Pfizer Inc.: Working together for a healthier world™ At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. To learn more, please visit us at www.pfizer.com. DISCLOSURE NOTICE: The information contained in this release is as of October 17, 2013. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. This release contains forward-looking information about Prevnar 13/Prevenar 13 that involves substantial risks and uncertainties. Such risks and uncertainties include, among other things, whether and when the U.S. Food and Drug Administration may approve an update to the U.S. label for Prevnar 13 regarding its use in certain high-risk populations. A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K/A for the fiscal year ended December 31, 2012 and in its reports on Form 10-Q and Form 8-K. * Trademark. Prevnar 13 ® is the trade name in the United States, Canada, and Taiwan.