Navigation Links
FDA Advisory Committee Recommends US Approval of Rotavirus Vaccine
Date:2/20/2008

Vaccine has the Potential to Save Thousands of Lives in Poor Countries

GAITHERSBURG, Md., Feb. 20 /PRNewswire-USNewswire/ -- The US Advisory Committee on Vaccines and Related Biological Products issued a positive recommendation today on the use of rotavirus vaccines, potentially bringing greater protection to children in the US from this common and sometimes fatal cause of severe diarrhea. After reviewing data from clinical trials on the safety and efficacy of Rotarix(R), manufactured by GlaxoSmithKline Biologicals (GSK), the committee recommended that the US Food and Drug Administration (FDA) approve the company's application for licensure. The FDA should make its ultimate decision on Rotarix(R) licensure in the US within the coming weeks. Another rotavirus vaccine, RotaTeq(R) manufactured by Merck & Co., Inc., received FDA approval in 2006.

Globally, rotavirus accounts for more than 500,000 deaths and two million hospitalizations annually. Ready access to good medical care means that children in industrialized countries rarely die from rotavirus infection. Children in the poorest countries, however, suffer the greatest burden: more than 90 percent of deaths due to rotavirus occur in the developing world, where access to simple, lifesaving treatment is severely limited.

"Vaccines against rotavirus remain the most effective way to prevent this deadly disease," notes Dr. John Wecker, director of PATH's Rotavirus Vaccine Program. "Making rotavirus vaccines available to the children in poor countries who face the greatest risk of dying must be a high priority."

Every child in the world will contract rotavirus at least once before the age of three, regardless of income level or geographic location. Because vaccination is the only way to prevent hospitalizations from severe rotavirus infection in industrialized countries and the mortality it causes in low-resource settings, the World Health Organization (WHO) strongly recommends the inclusion of rotavirus vaccination into the national immunization programs of countries where clinical trials have shown rotavirus vaccines to be safe and effective. In January 2007, the WHO granted "prequalification" to Rotarix(R), allowing it to be purchased through United Nations procurement systems.

Because rotavirus vaccines represent the best hope to save thousands of children's lives in poor countries, PATH's Rotavirus Vaccine Program is working in partnership with Merck and GSK to conduct large-scale clinical trials of their vaccines in Africa and Asia. These data will provide valuable information for developing countries considering the use of rotavirus vaccines to reduce rotavirus mortality.

PATH is an international nonprofit organization that creates sustainable, culturally relevant solutions enabling communities worldwide to break longstanding cycles of poor health. By collaborating with diverse public- and private-sector partners, PATH helps provide appropriate health technologies and vital strategies that change the way people think and act. PATH's work improves global health and well-being. For more information, please visit http://www.path.org.

The PATH Rotavirus Vaccine Program is working with the GAVI Alliance, the World Health Organization, and the US Centers for Disease Control and Prevention to help countries make informed decisions about the use of rotavirus vaccines, and to access and afford the currently licensed vaccines.

Contact: Eileen Quinn, 202-631-9294

equinn@path.org

Deborah Phillips, 206-788-2449

dphillips@path.org


'/>"/>
SOURCE PATH
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. VA Creating Advisory Panel on Rural Health
2. Select Comfort Creates Sleep Number Quality of Life Advisory Board to Improve Lives, Enhance Well-Being
3. ScienceBased Health Appoints Anne L. Coleman, MD, PhD to Scientific Advisory Board
4. Webcast Advisory - The Westaim Corporation Webcast of Conference Call to Discuss 2007 Fourth Quarter Results
5. Former Navy Surgeon General Is Among Three New Accomplished TriWest Advisory Board Members
6. The Advisory Board Company to Present at Upcoming Conferences
7. The Advisory Board Company Reports Fiscal Year 2008 Third Quarter Results
8. Nastech Appoints MDRNA, Inc. Directors Strategic Advisory Board
9. Dr. Warren Jackman Joins CryoCor Scientific Advisory Board
10. OSHA Seeking Nominations for National Advisory Committee on Occupational Safety and Health
11. National Institutes of Health Appoints Timothy C. Birdsall, ND to CAM Advisory Council
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/25/2016)... ... June 25, 2016 , ... Austin residents seeking Mohs surgery ... of Mohs Surgery and to Dr. Russell Peckham for medical and surgical dermatology. , ... for skin cancer. The selective fellowship in Mohs Micrographic Surgery completed by Dr. Dorsey ...
(Date:6/25/2016)... (PRWEB) , ... June 25, 2016 , ... ... athletes and non-athletes recover from injury. Recently, he has implemented orthobiologic procedures as ... City area —Johnson is one of the first doctors to perform the treatment. ...
(Date:6/24/2016)... , ... June 24, 2016 , ... June 19, 2016 ... dangers associated with chronic pain and the benefits of holistic treatments, Serenity Recovery ... are suffering with Sickle Cell Disease. , Sickle Cell Disease (SCD) is a disorder ...
(Date:6/24/2016)... ... June 24, 2016 , ... Comfort Keepers® of San Diego, CA ... the Road To Recovery® program to drive cancer patients to and from their cancer ... ensure the highest quality of life and ongoing independence. Getting to and from ...
(Date:6/24/2016)... ... June 24, 2016 , ... Puradigm® ... Group (TGIG), has initiated cultivation and processing operations at its production facility, and ... Nevada. , Puradigm is the manufacturer of a complete system of proactive air ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... -- Research and Markets has announced the addition ... 2022" report to their offering. ... with kidney failure, it replaces the function of kidneys by ... and thus the treatment helps to keep the patient body,s ... Increasing number of ESRD patients & substantial healthcare ...
(Date:6/23/2016)... 2016  In a startling report released today, National Safety ... lacking a comprehensive, proven plan to eliminate prescription opioid overdoses. ... how states are tackling the worst drug crisis in recorded U.S. ... Kentucky , New Mexico , ... Of the 28 failing states, three – Michigan ...
(Date:6/23/2016)... June 23, 2016 Capricor ... ), a biotechnology company focused on the discovery, ... that patient enrollment in its ongoing randomized HOPE-Duchenne ... exceeded 50% of its 24-patient target. Capricor expects ... third quarter of 2016, and to report top ...
Breaking Medicine Technology: