Navigation Links
GSK Receives Favorable Recommendation by FDA Advisory Committee for Rotarix(R) (Rotavirus Vaccine, Live, Oral)

If Approved, Rotarix Would be the Only Vaccine Indicated to Prevent Rotavirus Caused by the Five Most Commonly Circulating Types, Offering Completion of the Vaccination by Four Months of Age, with Only Two Doses

GAITHERSBURG, Md. and PHILADELPHIA, Feb. 20 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE: GSK) announced today that the U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) provided a favorable recommendation for the Company's oral rotavirus candidate vaccine, ROTARIX(R) [rotavirus vaccine, live, oral], to prevent rotavirus gastroenteritis in infants. The Committee voted unanimously (12-0) in favor of GSK's data being adequate to support the efficacy of the candidate vaccine. The Committee voted 11-1 in favor of GSK's data being adequate to support the safety of the candidate vaccine.

If approved by the FDA, GSK's candidate vaccine would allow for completion of the rotavirus vaccination series by four months of age and could be integrated into the current vaccine schedule at the two and four month immunization visits. Severe rotavirus diarrhea and dehydration can occur as young as three months of age. Of children under five years of age in the U.S. hospitalized with rotavirus, approximately one in five are younger than six months of age. Rotavirus infects virtually every child in the U.S. by age five and is the leading cause of severe gastroenteritis in infants and young children worldwide.

The candidate vaccine contains a live, weakened form of human rotavirus derived from the most common human rotavirus strain. "If approved, we believe ROTARIX, which was developed to mimic the protective effects of natural infection, would offer an important option in completing rotavirus vaccination by four months of age," said Barbara Howe, M.D., Vice President and Director, North American Vaccine Development, GlaxoSmithKline. "Studies have shown that naturally occurring human rotavirus infection provides significant protection against subsequent moderate to severe rotavirus gastroenteritis regardless of the infecting serotype."

The committee's favorable recommendation, although not binding, will be considered by the FDA in its review of the Biologics License Application (BLA) for the candidate vaccine, which is currently underway.

Clinical data published on two doses of ROTARIX show that protection was sustained through the first two years of life and was highly efficacious against rotavirus hospitalizations (96%) and severe rotavirus gastroenteritis (90%). In addition, the candidate vaccine was effective against rotavirus gastroenteritis of any severity (79%). Specifically, significant protection was demonstrated against severe rotavirus gastroenteritis during two rotavirus seasons caused by types G1 (96%), G2 (86%), G3 (94%), G4 (95%), and G9 (85%), the most commonly circulating rotavirus types in the U.S.

The CDC Advisory Committee on Immunization Practices (ACIP), the American Academy of Pediatrics (AAP), and the American Academy of Family Physicians (AAFP) recommend that infants receive routine vaccination with the rotavirus vaccine currently licensed by the FDA at two, four, and six months of age in order to prevent rotavirus gastroenteritis.


The GSK candidate rotavirus vaccine is an oral live-attenuated human rotavirus vaccine licensed in more than 100 countries around the world. The vaccine was developed to prevent rotavirus gastroenteritis by mimicking the protective effects of natural human rotavirus infection. Naturally occurring human rotavirus infection provides significant protection against subsequent moderate to severe rotavirus gastroenteritis regardless of the infecting serotype(s). Five phase III clinical trials were conducted worldwide to assess the safety and efficacy of GSK's rotavirus candidate vaccine in support of U.S. licensure. The BLA for the GSK rotavirus candidate vaccine is based on one of the largest clinical development plans undertaken by a vaccine manufacturer and includes data from nearly 75,000 infants. The clinical trials conducted in support of U.S. licensure demonstrated efficacy against rotavirus gastroenteritis of any severity due to the five most common currently circulating rotavirus types. The most common solicited adverse reactions in clinical trials were fussiness/irritability, cough/runny nose, fever, loss of appetite, and vomiting.

About Rotavirus

Rotavirus infects virtually every child worldwide by age five and is the leading cause of severe gastroenteritis in infants and young children in the U.S. and worldwide. Severe, dehydrating gastroenteritis can occur as young as three months of age. In the U.S. each year, 2.7 million children younger than five years of age suffer from rotavirus disease, resulting in 410,000 clinic visits and up to 272,000 emergency room visits. In addition, between 55,000 and 70,000 children are hospitalized and 20-60 die each year. In the U.S., the rotavirus season typically begins in the southwest during November- December and spreads to the northeast by April-May.

GlaxoSmithKline: A Leader in Vaccines

GlaxoSmithKline, with U.S. operations in Philadelphia, PA, and Research Triangle Park, NC, is one of the world's leading research-based pharmaceutical and healthcare companies and is committed to improving the quality of human life by enabling people to do more, feel better and live longer.

GSK Biologicals (GSK Bio), one of the world's leading vaccine manufacturers, is headquartered in Rixensart, Belgium, where the majority of GlaxoSmithKline's activities in the field of vaccine research, development and production are conducted.

GSK Bio employs more than 1,500 scientists, who are devoted to discovering new vaccines and developing more cost-effective and convenient combination products to prevent infections that cause serious medical problems worldwide. In 2006, GSK Bio distributed more than 1.1 billion doses of vaccines to 169 countries in both the developed and the developing world - an average of 3 million doses a day. Of those vaccine doses, approximately 136 million were doses of combination pediatric vaccines which protect the world's children from up to six diseases in one vaccine.

Cautionary statement regarding forward-looking statements

Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, the company cautions investors that any forward-looking statements or projections made by the company, including those made in this Announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect the Group's operations are described under 'Risk Factors' in the 'Business Review' in the company's Annual Report on Form 20-F for 2006.


US Media Inquiries Jeff McLaughlin +1 919 483 2839

UK Media Inquiries Alice Hunt +44 20 8047 5502

US Analyst/Investor Inquiries Frank Murdolo +1 215 751 7002

Tom Curry +1 215 751 5419

SOURCE GlaxoSmithKline
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. Kensey Nash Receives FDA 510(k) Clearance for New Safe-Cross(R) Vessel Wall Detection Technology
2. Barr Receives Final Approval for Generic Mirapex(R) Tablets, 0.125mg, 0.25mg, 0.5mg, 1mg & 1.5mg
3. Boehringer Ingelheim Pharmaceuticals, Inc. Receives the NCQA Seal Of Approval
4. Abbott Receives FDA Approval for SIMCOR(R) (Niaspan(R) / simvastatin), a Novel Combination Medicine for Comprehensive Cholesterol Management
5. Receives WEDDLEs 2008 Users Choice Award for Best Job Boards
6. Sanofi-aventis SoloSTAR(R) Insulin Pen for Lantus and Apidra Receives the Prestigious GOOD DESIGN Award
7. AGA Medical Corporation Receives European CE Mark Approval for the AMPLATZER(R) Duct Occluder II
8. CryoLife Receives FDA 510(k) Clearance for SynerGraft(R) Processed Human Pulmonary Heart Valves
9. Ranbaxy Receives Tentative Approval to Manufacture and Market Esomeprazole Magnesium DR Capsules
10. Halogen Receives High Ratings from Bersin & Associates - Company recognized as a market leader, and receives praise for outstanding customer satisfaction
11. Tryton Medical Receives CE Mark Approval for its Side-Branch Stent
Post Your Comments:
(Date:6/23/2016)... Houston Methodist Willowbrook Hospital has signed ... to serve as their official health care provider. ... will provide sponsorship support, athletic training services, and ... volunteers, athletes and families. "We are ... and to bring Houston Methodist quality services and ...
(Date:6/23/2016)... Calif. , June 23, 2016  The Prostate Cancer Foundation ... increasingly precise treatments and faster cures for prostate cancer. Members of the Class ... across 15 countries. Read More About the Class of ... ... ...
(Date:6/23/2016)... SAN FRANCISCO , June 23, 2016   ... it has secured $1 million in debt financing from ... to ramp up automation and to advance its drug ... for its new facility. "SVB has been ... goes beyond the services a traditional bank would provide," ...
(Date:6/23/2016)... , ... June 23, 2016 , ... STACS DNA Inc., ... Leader at the Arkansas State Crime Laboratory, has joined STACS DNA as a Field ... DNA team,” said Jocelyn Tremblay, President and COO of STACS DNA. “In further expanding ...
Breaking Biology Technology:
(Date:6/22/2016)... June 22, 2016   Acuant , ... verification solutions, has partnered with RightCrowd ® ... for Visitor Management, Self-Service Kiosks and Continuous ... that add functional enhancements to existing physical ... and venues with an automated ID verification ...
(Date:6/15/2016)... June 15, 2016 Transparency ... titled "Gesture Recognition Market by Application Market - Global Industry Analysis ... 2024". According to the report, the  global gesture recognition ... 2015 and is estimated to grow at a ... by 2024.  Increasing application of gesture ...
(Date:6/2/2016)... 2, 2016 The Department of Transport ... the 44 million US Dollar project, for the , ... including Personalization, Enrolment, and IT Infrastructure , to ... production and implementation of Identity Management Solutions. Numerous renowned international ... Decatur was selected for the most compliant ...
Breaking Biology News(10 mins):