Navigation Links
FDA Expands Use of Prevnar 13 Vaccine for People Ages 50 and Older
Date:12/30/2011

SILVER SPRING, Md., Dec. 30, 2011 /PRNewswire-USNewswire/ -- Prevnar 13, a pneumococcal 13-valent conjugate vaccine, was approved today by the U.S. Food and Drug Administration for people ages 50 years and older to prevent pneumonia and invasive disease caused by the bacterium, Streptococcus pneumoniae.

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

Pneumococcal pneumonia, caused when the bacterium Streptococcus pneumoniae infects the lungs, is the most common disease caused by this bacterium in adults. When the bacterium invades parts of the body that are normally free from germs, such as the blood or spinal fluid, the disease is considered "invasive."

"According to recent information for the United States, it is estimated that approximately 300,000 adults 50 years of age and older are hospitalized yearly because of pneumococcal pneumonia," said Karen Midthun, M.D., director of FDA's Center for Biologics Evaluation and Research. "Pneumococcal disease is a substantial cause of illness and death. Today's approval provides an additional vaccine for preventing pneumococcal pneumonia and invasive disease in this age group."  

The new use for Prevnar 13 was approved under the agency's accelerated approval pathway, which allows for earlier approval of treatments for serious and life-threatening illnesses. The pathway allows for the demonstration of effectiveness of a vaccine using an immune marker that is reasonably likely to predict clinical benefit.

In randomized, multi-center studies in the United States and Europe, people 50 and older received either Prevnar 13 or Pneumovax 23, a licensed pneumococcal vaccine also approved for use in this age group. The studies showed that for the 12 common serotypes, Prevnar 13 induced antibody levels that were either comparable to or higher than the levels induced by Pneumovax 23.

The safety of Prevnar 13 was evaluated in about 6,000 p
'/>"/>

SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. Inspiration Biopharmaceuticals Expands Leadership Team with Four New Hires
2. FDA Expands Use of HIV Drug Isentress to Children and Adolescents
3. Radient Pharmaceuticals Corporation Expands Distribution of Onko-Sure® in Asia; Receives Payment on First Order of 60 Kits
4. Saladax Biomedical, Inc. Expands Distribution of My5-FU in Europe
5. Lilly for Better Health™ Expands Website to Include Spanish Health Information and Interactive Tools
6. Sony Expands Radiology Product Offerings with Full Line of Diagnostic Displays
7. Leading Indian CRO Max Neeman International Expands in Response to Positive Biosimilars Market in India
8. Panasonic Expands on Hearing Instrument Lineup
9. Gaylord Sleep Medicine Expands Sleep Apnea Management Program
10. Abbott Expands Agreement with GSK to Include Development of a Companion Diagnostic Test for an Additional Investigational Cancer Immunotherapy Antigen
11. Free Statewide Rx Assistance Program Expands
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/19/2014)... Große Pharmafirmen werden oft ... dabei ist, dass große Pharmafirmen nicht willens sind, ... Es war deshalb nicht einfach, diesen ... mehr, dass es uns gelungen ist! Wir haben ... - mit einem Vorbehalt - einige haben uns ...
(Date:10/17/2014)... CHAPEL HILL, N.C. , Oct. 17, 2014 ... healthcare landscape, the Medical Affairs function has come ... metrics, allocating resources efficiently and managing globalization.  ... at Best Practices, LLC is dedicated to providing ... issues. The Medical Affairs Consortium is a service ...
(Date:10/17/2014)... 17, 2014  Hanger, Inc. (NYSE: HGR ... results of operations for the quarter ended September 30, ... closes.  A conference call to discuss these results is ... November 7, 2014. Those wishing to participate should call ... 14, 2014 by dialing 1-855-859-2056 and referencing Conference ID ...
Breaking Medicine Technology:Vergleichsbericht zu Pharma-Kühlketten und CRT 2Early Key Findings from the Medical Affairs Consortium Research 2
... PDL BioPharma, Inc. (PDL) (NASDAQ: ... meeting of stockholders on Wednesday, June 22, 2011 at 10:00 a.m. ... The meeting will take place at the Hyatt Regency Hotel in ... PDL pioneered the humanization of monoclonal antibodies and, ...
... 18, 2011 True 2 Beauty Inc., (Pinksheets: TRTB ... leading distributor of male and female sexual potency pills and ... the launch of a new, additional line of sexual enhancement ... (for men) and Pink Diamond (for women), www.bluediamondpill.com . ...
Cached Medicine Technology:TRTB to Launch Blue Diamond Pill Targeting Ethnic Market With Sexual Enhancement Pills 2TRTB to Launch Blue Diamond Pill Targeting Ethnic Market With Sexual Enhancement Pills 3
(Date:10/20/2014)... hard to imagine what it’s like to live without shoes, ... it’s a reality. And while new shoes are considered a ... barefoot on rocky terrain or sewage-lined streets just to collect ... , Buckner International's Shoes for Orphan Souls project ... encourage support for Air1 and while also providing new shoes ...
(Date:10/20/2014)... October 20, 2014 Houston plastic surgeon ... the key elements of his innovative True Form ... plastic surgery residents and faculty at The University ... he, too, was once a medical student. Patronella, who ... private cosmetic plastic surgery practices in Texas, The ...
(Date:10/19/2014)... Hastings and Hastings, a Phoenix personal injury law firm ... Phoenix area and across Arizona reports record demand in ... accidents. Statistics have indicated a steady increase in automobile ... Hastings and Hastings has seen a steady increase in ... been injured through no fault of their own that ...
(Date:10/19/2014)... Recently, BambooIndustry.com, one of the most popular ... of bamboo deckings . Moreover, the company has ... are now available at deeply discounted rates. , ... to overstate the significance of online business nowadays. Thus, ... The company’s workers are striving to deliver both value ...
(Date:10/19/2014)... 20, 2014 This report provides ... Seizure, complete with comparative analysis at various stages, ... (MoA), route of administration (RoA) and molecule type, ... press releases. It also reviews key players involved ... special features on late-stage and discontinued projects. , ...
Breaking Medicine News(10 mins):Health News:Buckner Shoes for Orphan Souls® Garners Support from Air1 Radio 2Health News:Buckner Shoes for Orphan Souls® Garners Support from Air1 Radio 3Health News:Plastic Surgeon Patronella Presents Artistically-Inspired Tummy Tuck Method to Future Generation of Plastic Surgeons in Texas 2Health News:Hastings And Hastings Reports Record Demand In 2014 For Legal Representation With Regard To Catastrophic Automobile Accidents 2Health News:Hastings And Hastings Reports Record Demand In 2014 For Legal Representation With Regard To Catastrophic Automobile Accidents 3Health News:High Quality Bamboo Deckings, New Items Unveiled By BambooIndustry.com 2Health News:Partial Seizure Therapeutic Pipeline Market Review H2 2014 in a New Report Available at RnRMarketResearch.com 2Health News:Partial Seizure Therapeutic Pipeline Market Review H2 2014 in a New Report Available at RnRMarketResearch.com 3Health News:Partial Seizure Therapeutic Pipeline Market Review H2 2014 in a New Report Available at RnRMarketResearch.com 4
... that only hormones can reduce hot flashes effectively. The good news ... but also safely. , ... Ann Arbor, MI (PRWEB) July 21, 2008 ... experts are endlessly debating merits of synthetic or bio-identical hormones. Too much ...
... step in understanding how the nervous system and the immune system interact, ... anatomical path through which the brain and the spleen communicate. , ... ... understanding how the nervous system and the immune system interact, scientists at ...
... CHICAGO -- Olympic athletes aren,t the only ones who ... in Beijing. The dirty air may trigger serious cardiovascular ... pulmonary medicine and critical care at Northwestern University,s Feinberg ... risk groups, breathing high levels of pollution can cause ...
... Kennedy DSc, Dean of Tufts University,s Gerald J. and ... announced the 3rd Annual Friedman School Symposium, a conference ... industry, policy-makers, academics and thought leaders in the coming ... 24th to 26th, 2008. , Fifteen experts will present ...
... less, , , MONDAY, July 21 (HealthDay News) -- With the ... are likely the next biggest expense in your family,s budget. ... of the average Americans income. , During all of ... just the first five months of 2008, food prices jumped ...
... July 21 The Institute for Advanced Medical,Education ... Breast,Biopsy, its much-awaited online CME program. Produced in ... community, this course offers the 3 CME,credits required ... Breast Biopsy is a multimedia course,available online at ...
Cached Medicine News:Health News:Menopause: Hot Flashes Can Be Reduced 90% without Hormones 2Health News:Menopause: Hot Flashes Can Be Reduced 90% without Hormones 3Health News:Embargoed Until Monday, July 21 at 5 p.m. EST; Scientists Figure Out How the Immune System and Brain Communicate to Control Disease 2Health News:Embargoed Until Monday, July 21 at 5 p.m. EST; Scientists Figure Out How the Immune System and Brain Communicate to Control Disease 3Health News:Beijing pollution may trigger heart attacks, strokes 2Health News:'Nutrition Agenda 2008' is focus of Tufts Friedman School Symposium 2Health News:'Nutrition Agenda 2008' is focus of Tufts Friedman School Symposium 3Health News:Stretch That Grocery List in Lean Times 2Health News:Stretch That Grocery List in Lean Times 3
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
Medicine Products: