FDA Approves Rotarix The First Vaccine Licensed To Complete The Rotavirus Immunisation Series By Four Months Of Age

Main Category: Immune System / Vaccines
Also Included In: GastroIntestinal / Gastroenterology;  Regulatory Affairs / Drug Approvals;  Clinical Trials / Drug Trials
Article Date: 21 Apr 2008 - 0:00 PDT

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GlaxoSmithKline (NYSE: GSK) announced that the U.S. Food and Drug Administration (FDA) has approved Rotarix® [Rotavirus Vaccine, live, oral] for the prevention of rotavirus gastroenteritis in infants. Rotarix will offer protection against the most commonly circulating rotavirus types in the U.S. and allow infants to complete the vaccination series by four months of age. The U.S. Centers for Disease Control and Prevention (CDC) currently recommends that children complete the rotavirus immunization series by six months of age. Since rotavirus disproportionately affects young children -- severe rotavirus diarrhea and dehydration can occur as young as three months of age -- Rotarix could help prevent many of the 55,000-70,000 hospitalizations of young children that result from rotavirus in the U.S. each year.

"Among children less than five years of age in the U.S. who are hospitalised due to rotavirus symptoms, approximately one in five is younger than six months of age," said Barbara Howe, M.D., Vice President and Director, North American Vaccine Development, GlaxoSmithKline. "With only two doses, Rotarix allows infants to complete the vaccination series against rotavirus earlier than ever before, which may prevent many of the emergency department visits and hospitalizations that are a burden on families and the healthcare system."

Not only does Rotarix confer protection at an early age, but clinical trials have shown that protection is broad and sustained. Rotarix is indicated for the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) when administered as a two-dose series in infants and children. Clinical data published on the two-dose series 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, Rotarix 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.

"Studies have shown that naturally occurring rotavirus infection protects against subsequent moderate to severe rotavirus gastroenteritis regardless of the infecting serotype," David I. Bernstein, M.D., M.A., Director, Infectious Diseases; Gamble Program at Cincinnati Children's Hospital Medical Center. "Rotarix was developed to mimic natural infection and to protect against rotavirus gastroenteritis without regard to serotype."

The FDA's approval of Rotarix was based on one of the largest clinical development plans undertaken by a vaccine manufacturer and includes data from nearly 75,000 infants. These clinical trials were conducted in the Americas, Europe, Asia and Africa and reflect an ethnically diverse population.

The CDC Advisory Committee on Immunization Practices, the American Academy of Pediatrics, and the American Academy of Family Physicians recommend that infants receive routine rotavirus vaccination in order to prevent rotavirus gastroenteritis. Rotarix will be commercially available in the U.S. in the second half of 2008.

About Rotarix®

Rotarix is an oral live-attenuated human rotavirus vaccine licensed in more than 100 countries around the world. More than 25 million doses of Rotarix have been distributed worldwide. The vaccine was developed for the prevention of 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 Rotarix in support of U.S. licensure. The biological license application for Rotarix 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 most common currently circulating rotavirus types in the U.S. In clinical studies, common adverse events were fussiness/irritability, cough/runny nose, fever, loss of appetite, and vomiting. Rotarix is contraindicated in certain individuals with a history of uncorrected congenital malformation of the gastrointestinal tract.

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 department visits. In addition, between 55,000 and 70,000 children are hospitalised and 20 to 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.

GlaxoSmithKline Biologicals (GSK Biologicals) is a global vaccine company which has shown to be a leader in innovation. The company is active in the fields of vaccine research, development and production with over 30 vaccines approved for marketing and 20 more in development. Headquartered in Belgium, GSK Biologicals has 14 manufacturing sites strategically positioned around the globe. In 2007 GSK Biologicals distributed 1.1 billion doses of vaccines to 169 countries in both developed and the developing world an average of 3 million doses a day.

GSK Biologicals employs over 9,000 people worldwide including more than 1,600 passionate scientists engaged in research aimed at discovering innovative vaccines that contribute to the health and well-being of people of all generations around the world.

Cautionary statement regarding forward-looking statements

Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, 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 GSK' s operations are described under 'Risk Factors' in the 'Business Review' in the company' s Annual Report on Form 20-F for 2007.

GlaxoSmithKline
http://www.gsk.com