Prevnar 13

Publication date: 25 January 2013
Author: Pfizer

Pfizer Inc.  announced today that the U.S. Food and Drug Administration (FDA) has granted approval for the expansion of the company’s pneumococcal conjugate vaccine, Prevnar 13®* (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]), for use in older children and adolescents aged 6 years through 17 years for active immunization for the prevention of invasive disease caused by the 13 Streptococcus pneumoniae serotypes contained in the vaccine. For this age group, Prevnar 13 is administered as a one-time dose to patients who have never received Prevnar 13.1

“As a global leader in pneumococcal disease prevention, extending the impact of Prevnar 13 to older children and adolescents aged 6 through 17 years is a reflection of our dedication to improving public health worldwide,”said Susan Silbermann, president, vaccines, Pfizer. “We continue to work tirelessly to make this vaccine available to people at risk for invasive pneumococcal disease.”

The FDA approval followed submission and review of a Phase 3, open-label trial of Prevnar 13 in 592 older children and adolescents, including those with asthma.2 The study met all endpoints, demonstrating immunogenicity and establishing a safety profile in children aged 6 years through 17 years consistent with the safety profile established in previous trials in infants and young children.2

About Prevnar 13

Prevnar 13 was first introduced for use in infants and young children in December 2009 in Europe and in February 2010 in the U.S., and it is now approved for such use in nearly 120 countries worldwide. It is the most widely used pneumococcal conjugate vaccine in the world, and more than 500 million doses of Prevnar/Prevnar 13 have been distributed worldwide. Currently, Prevnar 13 is included as part of a national or regional immunization program in more than 60 countries, offering coverage against invasive pneumococcal disease to nearly 30 million children per year.3

Prevnar 13 is also approved for use in adults 50 years of age and older in more than 80 countries and it is the first and only pneumococcal vaccine to be granted World Health Organization prequalification in the adult population.3

About Pneumococcal Disease

Pneumococcal disease (PD) is a group of illnesses caused by the bacterium Streptococcus pneumoniae (S. pneumoniae), also known as pneumococcus.4 PD is associated with significant morbidity and mortality.4 Invasive manifestations of the disease include bacteremia (bacteria in the blood) and meningitis (infection of the tissues surrounding the brain and spinal cord).4 Invasive pneumococcal disease can affect people of all ages, although older adults and young children are at heightened risk.4,5,6

us fda data

STN#: 125324

Proper Name: Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM₁₉₇ Protein)
Tradename: Prevnar 13
Manufacturer: Wyeth Pharmaceuticals, Inc, License #0003

Indications:  

• Active immunization for the prevention of pneumonia and invasive disease caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F in persons 50 years of age or older.
• Active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F, for use in children 6 weeks through 17 years of age.
• Active immunization for the prevention of otitis media caused by Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F for use in children 6 weeks through 5 years of age.

Pfizer presents Phase 3 safety and immunogenicity data on Prevnar 13® in adults with HIV

Publication date: 4 March 2013
Author: Pfizer

Pfizer Inc. (NYSE:PFE) presented today the results from a Phase 3 study demonstrating the immunogenicity, tolerability and safety of Prevnar 13®(Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein])in adults infected with human immunodeficiency virus (HIV). The results were presented at the 20th Conference on Retroviruses and Opportunistic Infections (CROI) in Atlanta, Ga.

These data support planned regulatory submissions seeking to include data on HIV-infected immunocompromised adults in the Prevnar 13 label in the United States, the European Union, and other countries around the world.