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:1/18/2017)... Fresno, CA (PRWEB) , ... January 18, 2017 ... ... is pleased to announce that their Vice President of Franchise Development, Paula Turner ... , This award-winning business program, which features the insights of top business leaders ...
(Date:1/18/2017)... ... ... At Hallmark Nameplate, their commitment to quality is what sets them apart. The ... certification is another way they are making constant strides to provide all customers with ... The ISO 13485 Certification is a major accomplishment for Hallmark Nameplate and will allow ...
(Date:1/18/2017)... ... 18, 2017 , ... Michael J. Hennessy Associates, Inc., (MJH), ... for Biosimilars, announced Michael J. Hennessy Associates, Inc. President Michael J. Hennessy, Jr. ... through thought leader interaction in, live video and interactive digital platforms. , In ...
(Date:1/18/2017)... Hills, CA (PRWEB) , ... January 18, 2017 ... ... of dental problems ranging from gum disease to enamel erosion, and those dental ... the Massachusetts Department of Public Health, many pregnant women are failing to get ...
(Date:1/17/2017)... , ... January 17, 2017 , ... Anesthesia Progress ... for dentists to choose the best drug option for each patient. Dentists have several ... and better overall outcomes. , Researchers from the Tokyo Dental College in Tokyo, Japan ...
Breaking Medicine News(10 mins):
(Date:1/19/2017)... ALAMEDA, Calif. , Jan. 18, 2017 /PRNewswire/ ... (MPI) solutions has entered into an agreement with ... for the Momentum MPI imaging system based on ... VivoQuant will be distributed as a complete MPI ... to enable quantitative nanoparticle or cell imaging in ...
(Date:1/18/2017)... , Jan. 18, 2017  EnteroMedics Inc. (NASDAQ: ... devices using neuroblocking technology to treat obesity, metabolic ... pricing of an underwritten public offering of units ... deducting underwriting discounts and commissions and offering expenses ... comprised of Class A Units, priced at a ...
(Date:1/18/2017)... Jan. 18, 2017  Adaptive Sound Technologies, Inc. (ASTI), the ... partnership with Hyatt Place Nashville/Downtown to deliver the best ... sleep therapy machines in over two hundred of its ... important parts of having a great stay is sleeping ... Hyatt Place Nashville/Downtown. "We,re pleased to be able to ...
Breaking Medicine Technology: