Additional Data From Pfizer's Prevnar 13 Clinical Trials In Adults 50 Years And Older To Be Presented At The 49th Annual Meeting Of The Infectious Diseases Society Of America
NEW YORK--(BUSINESS WIRE)--Oct 21, 2011 - Pfizer Inc. (NYSE:PFE) announced today that additional data from several clinical studies of Prevnar 13®*(Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) conducted in adults 50 years and older will be presented during the 49th Annual Meeting of the Infectious Diseases Society of America (IDSA), which is being held Oct. 20-23, 2011, in Boston, Mass. The data from these studies provide support for the pending regulatory applications for the use of Prevnar 13 in adults 50 years and older to help prevent pneumococcal disease.
More About the Prevnar 13 Adult Clinical Studies
- Poster Title: A Phase 3, Open-label Trial Evaluating the Safety and Immunogenicity of a Subsequent Dose of 13-valent Pneumococcal Conjugate Vaccine (PCV13) in Elderly Adults Who Received PCV13 Followed by 23-valent Pneumococcal Polysaccharide Vaccine (PPSV23) in a Prior Trial
Presentation #664, Pneumococcal Vaccines Poster Session, Friday, October 21, 12:15-2:15 p.m. (ET)
- Poster Title: A Phase 3, Randomized, Active-controlled Trial to Evaluate the Safety, Tolerability, and Immunogenicity of Sequential Administration of 13-valent Pneumococcal Conjugate Vaccine (PCV13) and 23-valent Pneumococcal Polysaccharide Vaccine (PPSV23) Administered at 1-Year Intervals in PPSV23-naïve Adults 60–64 Years of Age
Presentation #665, Pneumococcal Vaccines Poster Session, Friday, October 21, 12:15-2:15 p.m. (ET)
- Poster Title: 13-valent Pneumococcal Conjugate Vaccine (PCV13) Enhances the Response to Subsequent PCV13 and 23-valent Pneumococcal Polysaccharide (PPSV23) Vaccinations in Adults 50 Years and Older
Presentation #LB-3, Late Breaker Poster Session, Saturday, October 22, 11:45 a.m.-1:45 p.m. (ET)
About Prevnar 13
Prevnar 13, which is based on the scientific foundation of Prevnar® (Pneumococcal 7-valent Conjugate Vaccine [Diphtheria CRM197 Protein]), was first introduced in December 2009 in Europe and is now approved for use in infants and young children in more than 100 countries worldwide. Prevnar 13, like Prevnar, uses company-pioneered conjugation technology that has been shown to confer a high antibody response in infants and toddlers. This has not yet been established in adults.
Pneumococcal disease (PD) is a group of illnesses caused by the bacterium Streptococcus pneumoniae (S. pneumoniae), also known as pneumococcus. The most common manifestations of PD in adults 50 years and older include invasive infections, such as bacteremia and meningitis, as well as non-invasive infections, such as non-invasive/non-bacteremic pneumonia. As adults age, they become more susceptible to infectious diseases due to their aging immune systems. PD is associated with significant morbidity and mortality and claims the lives of an estimated 1.6 million people per year, mostly in infants and older adults.
About IDSA 2011
The 49th Annual Meeting of the Infectious Diseases Society of America (IDSA) brings together physicians, scientists, and other health care professionals involved in research, patient care, public health, disease prevention, and education in the field of infectious diseases. The meeting showcases the latest news in the field of infectious diseases with emphasis on contemporary trends, including emerging infections, new diagnostic and therapeutic advances. IDSA 2011 takes place October 20-23 at the Boston Exhibition and Convention Center in Boston, Massachusetts. For more information, visit www.idsa2011.org.
Indication for Prevnar 13
In the United States, Prevnar 13 is a vaccine approved for use in children 6 weeks through 5 years of age (prior to the 6th birthday). Prevnar 13 is indicated for active immunization for the prevention of invasive disease caused by 13 strains of Streptococcus pneumoniae (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Prevnar 13 is also indicated for the prevention of otitis media (ear infection) caused by 7 strains of Streptococcus pneumoniae (4, 6B, 9V, 14, 18C, 19F, and 23F). No efficacy data for ear infections are available for strains 1, 3, 5, 6A, 7F, and 19A.
Important Safety Information for Prevnar 13
- Prevnar 13 should not be given to anyone with a severe allergic reaction to any component of Prevnar 13, Prevnar, or any diphtheria toxoid–containing vaccine.
- Prevnar 13 may not protect all individuals receiving the vaccine.
- Protection against ear infections is expected to be less than that for invasive disease.
- Children with weakened immune systems may have a reduced immune response to Prevnar 13.
- A temporary pause of breathing following vaccination has been observed in some infants born prematurely.
- The most commonly reported serious adverse events include bronchiolitis (an infection of the lungs) (0.9%, 1.1%), gastroenteritis (inflammation of the stomach and small intestine) (0.9%, 0.9%), and pneumonia (0.9%, 0.5%) for Prevnar 13 and Prevnar, respectively.
- The most common side effects are redness, swelling and tenderness at the injection site, fever, decreased appetite, irritability, increased sleep, and decreased sleep. Any side effects associated with the vaccination should be reported to your child's health care provider.
- Ask your child's health care provider about the risks and benefits of Prevnar 13. Only a health care provider can decide if Prevnar 13 is right for your child.
Pfizer Inc.: Working together for a healthier world™
At Pfizer, we apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products and many of the world's best-known consumer 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 the world's leading biopharmaceutical company, we also 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 about our commitments, please visit us at www.pfizer.com.
DISCLOSURE NOTICE: The information contained in this release is as of October 21, 2011. 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 that involves substantial risks and uncertainties regarding a potential indication for Prevnar 13 for use in adults, including its potential benefits. Such risks and uncertainties include, among other things, the uncertainties inherent in research and development; whether and when the FDA, the European Medicines Agency and regulatory authorities in other jurisdictions will approve applications that have been or may be submitted for this potential indication and their decisions regarding labelling and other matters that could affect its availability or commercial potential; and competitive developments.
A further description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2010 and in its reports on Form 10-Q and Form 8-K.
*Prevnar 13 is referred to as Prevenar 13 in most countries outside the United States.
Victoria Davis, 484-865-5194
Suzanne Harnett, 212-733-8009
Posted: October 2011