FDA To Review GlaxoSmithKline's Application For Rotarix

Armen Hareyan's picture

FDA has accepted for review GlaxoSmithKline's Biologics License Application for Rotarix, an oral candidate vaccine for infants to prevent rotavirus gastroenteritis.

Severe, dehydrating gastroenteritis occurs primarily among children aged three to 35 months. Of children hospitalized with rotavirus, approximately 17 percent are younger than six months old. If approved, the GSK candidate vaccine could offer completion of the rotavirus vaccination series by four months of age. The rotavirus candidate vaccine is a live- attenuated vaccine derived from the most common human rotavirus strain. Published data show that immunity resulting from natural human rotavirus infection provides significant protection against moderate to severe disease, regardless of rotavirus strain.

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. These clinical trials were conducted in the Americas, Europe, Asia and Africa and reflect an ethnically diverse population.


"This vaccine, which is designed to protect in a manner similar to natural human infection, could make a considerable contribution in protecting very young infants from rotavirus disease, a significant burden on families and the healthcare system in the U.S.," said Barbara Howe, M.D., Vice President, North American Vaccine Development, GlaxoSmithKline. "We also believe it is important to immunize infants against rotavirus as early as possible."

The Centers for Disease Control and Prevention's (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 against rotavirus to prevent rotavirus gastroenteritis with the vaccine currently licensed by the FDA at two, four, and six months of age.

The GSK rotavirus candidate vaccine is a live-attenuated oral rotavirus vaccine licensed in 99 countries around the world. The vaccine is designed to prevent rotavirus gastroenteritis by mimicking natural rotavirus infection. Studies have shown that natural rotavirus infection provides significant protection from moderate to severe disease, regardless of rotavirus strain. In the file under review by the FDA, it is proposed that the vaccine would be given in two oral doses beginning at six weeks of age and completed by 24 weeks of age, with a minimum four-week interval between the doses. If approved, the vaccine would typically be administered at the two and four month immunization visits.

Rotavirus infects virtually every child worldwide by age five and is the leading cause of severe acute gastroenteritis in infants and young children in the U.S. and worldwide. Severe diarrhea and dehydration occurs from 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 each year and 20-60 die.