NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) appear today that the European Commission accustomed an broadcast adumbration for the use of Prevenar 13* (pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]) for the blockage of pneumonia acquired by the 13 pneumococcal serotypes in the vaccine in adults age-old 18 years and older. The Summary of Product Characteristics has additionally been adapted to accommodate ability abstracts from Pfizer’s battleground Community-Acquired Pneumonia Immunization Balloon in Adults (CAPiTA), which accustomed statistically cogent reductions in aboriginal episodes of vaccine-type pneumococcal community-acquired pneumonia (CAP), including non-invasive/non-bacteremic CAP, and invasive pneumococcal ache (IPD) in adults age-old 65 and older.
“We acceptable the approval of this new adumbration for Prevenar 13 in the EU, which will accredit healthcare professionals to advice adults abate their accident of pneumococcal pneumonia acquired by the 13 serotypes in the vaccine. This is decidedly important for earlier adults and those with medical altitude that may accomplish them added accessible to this serious, debilitating and potentially baleful disease,” said Rene Reinert, Vice President, Pfizer Vaccines Medical and Scientific Affairs, Europe. “Pfizer looks advanced to alive with vaccine abstruse committees in Europe to altercate this new adumbration and the CAPiTA data, as able-bodied as abeyant updates to recommendations for the use of Prevenar 13 in adults.”
Streptococcus pneumoniae, additionally accepted as pneumococcus, is the best accepted bacterial account of community-acquired pneumonia.1 Pneumococcal pneumonia is one of the arch causes of afterlife and analysis worldwide.2,3 Pneumococcal pneumonia can be classified as non-invasive, back bacilli account infection in the lungs but are not detected in the claret concurrently, or invasive, back bacilli additionally admission the bloodstream (bacteremic pneumonia) or accession frequently antiseptic armpit in the body.4 For every one case of invasive pneumococcal pneumonia in adults, it is estimated that at atomic three cases of non-invasive pneumococcal pneumonia occur.5 While non-invasive forms of pneumococcal ache are about added common, the invasive types of ache are about added severe.6
Pfizer conducted the CAPiTA abstraction (Community-Acquired Pneumonia Immunization Balloon in Adults) as allotment of its authoritative commitments to all-around authoritative authorities. The after-effects accept been submitted to the U.S. Food and Drug Administration and authoritative agencies in added above markets, including Australia and Canada, for admittance in the product’s labeling.
About CAPiTA (Community-Acquired Pneumonia Immunization Balloon in Adults)
This abstraction is one of the better double-blind, randomized, placebo-controlled vaccine ability trials anytime conducted in earlier adults. The abstraction accomplished its primary and accessory objectives. It complex about 85,000 capacity age-old 65 years and earlier and was conducted by Julius Clinical, an bookish analysis alignment affiliated with the University Medical Center Utrecht (UMCU) in the Netherlands. Fifty-nine bouncer hospitals were acclimated for the surveillance of CAP and IPD.
About Prevenar 13
With this approval for Prevenar 13, it is now adumbrated in the EU for alive immunization for the blockage of invasive ache and pneumonia acquired by Streptococcus pneumoniae in adults ≥18 years of age and the elderly. Prevenar 13 was aboriginal alien for use in breed and adolescent accouchement in December 2009 in Europe and is now accustomed for such use in added than 120 countries worldwide, including the United States and Japan. It is the best broadly acclimated pneumococcal conjugate vaccine (PCV) in the world, and added than 750 actor doses of Prevenar 7-valent/Prevenar 13 accept been broadcast worldwide. In addition, Prevenar 13 is accustomed for use in adults 50 years of age and earlier in added than 90 countries, and is additionally accustomed in the United States, European Union (EU) and added countries for use in earlier accouchement and adolescents age-old 6 to 17 years.
INDICATIONS FOR PREVNAR 13®
IMPORTANT SAFETY INFORMATION
For the abounding prescribing advice for Prevnar 13, amuse bang actuality http://www.pfizer.com/products/#prevnar13.
Pfizer Inc: Alive calm for a convalescent world™
At Pfizer, we administer science and our all-around assets to accompany therapies to bodies that extend and decidedly beforehand their lives. We strive to set the accepted for quality, assurance and amount in the discovery, development and accomplish of bloom affliction products. Our all-around portfolio includes medicines and vaccines as able-bodied as abounding of the world’s best-known customer bloom affliction products. Every day, Pfizer colleagues assignment beyond developed and arising markets to beforehand wellness, prevention, treatments and cures that claiming the best feared diseases of our time. Consistent with our albatross as one of the world’s arch avant-garde biopharmaceutical companies, we coact with bloom affliction providers, governments and bounded communities to abutment and aggrandize admission to reliable, affordable bloom affliction about the world. For added than 150 years, Pfizer has formed to accomplish a aberration for all who await on us. To apprentice more, amuse appointment us at www.pfizer.com.
DISCLOSURE NOTICE: The advice independent in this absolution is as of March 3, 2015. Pfizer assumes no obligation to amend advanced statements independent in this absolution as the aftereffect of new advice or approaching contest or developments.
This absolution contains advanced advice apropos Prevnar 13/Prevenar 13 that involves abundant risks and uncertainties that could account absolute after-effects to alter materially from those bidding or adumbrated by such statements. Risks and uncertainties include, amid added things, uncertainties apropos the bartering appulse of the after-effects of the CAPiTA (Community-Acquired Pneumonia Immunization Balloon in Adults) balloon and the broadcast adumbration in the EU; ambiguity apropos whether and back authoritative authorities in assorted added jurisdictions will amend the characterization and whether and back vaccine abstruse committees in assorted jurisdictions (other than the U.S. Centers for Ache Control and Prevention’s Advisory Committee on Immunization Practices) will amend their recommendations with account to the use of Prevnar 13/Prevenar 13 in adults based on the after-effects of the CAPiTA balloon and added factors; whether and back authoritative submissions may be fabricated in added jurisdictions for Prevenar 13 for the blockage of pneumococcal pneumonia in adults acquired by the 13 serotypes in Prevenar 13, and whether and back authoritative authorities in jurisdictions area such applications are awaiting or submitted will accept any such submissions, as able-bodied as their decisions apropos labeling and added affairs that could affect the availability or bartering abeyant of that added adumbration for Prevenar 13 in those jurisdictions; and aggressive developments.
A added description of risks and uncertainties can be begin in Pfizer’s Annual Report on Form 10-K for the budgetary year concluded December 31, 2014 and in our consecutive letters on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Advice That May Affect Approaching Results”, as able-bodied as in its consecutive letters on Form 8-K, all of which are filed with the SEC and accessible at www.sec.gov and www.pfizer.com.
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* Trademark. Prevnar 13® is the barter name in the United States, Canada, and Taiwan.
1 Centers for Ache Control and Prevention. Pneumonia can be prevented – vaccines can help. http://www.cdc.gov/features/pneumonia/. Accessed January 23, 2013.
2 Apple Bloom Organization. 23-valent pneumococcal polysaccharide vaccine: WHO position paper. Wkly Epidemiol Rec. 2008 Oct 17;83(42):373-384.
3 Blasi F, Mantero P, Santus P, Tarsia P. Understanding the accountability of pneumococcal ache in adults. Clin Microbiol Infect. 2012:18(Suppl. 5):1-8.
4 Centers for Ache Control and Prevention. MMWR Recommendations and Reports. Blockage of pneumococcal disease: Recommendations of the Advisory Committee on Immunization Practices (ACIP). 1997;46(RR-8):1-24.
5 Said MA, Johnson HL, Nonyane BAS, et al. Estimating the accountability of pneumococcal ache amid adults: a analytical analysis and meta-analysis of analytic techniques. PLoS ONE. 2013;8(4):e60273.
6 Apple Bloom Organization. Immunization, vaccines and biologicals. Pneumococcal vaccines. Accessible at: http://archives.who.int/vaccines/en/pneumococcus.shtml. Accessed October 20, 2014.
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