New Rotavirus Vaccine Approved
The US Food and Drug Administration (FDA) has approved the vaccine Rotarix®, a vaccine developed and first tested by Cincinnati Children’s researchers, for the prevention of rotavirus gastroenteritis in infants.
Richard Ward, PhD, a Cincinnati Children’s researcher in the Division of Infectious Diseases, originally isolated the human rotavirus strain in 1988 and with the help of David Bernstein, MD, developed it into a live, orally deliverable vaccine candidate.
Rotarix®, marketed by the GlaxoSmithKline company, was first licensed in Mexico in 2004. Since then, it has been licensed in more than 100 countries, including Brazil, Panama, Thailand and the European Union.
The FDA's US approval was based on one of the largest clinical development plans undertaken by a vaccine manufacturer and includes data from nearly 75,000 infants.
"Rotarix® was created to imitate natural infection and to defend against rotavirus gastroenteritis," says Dr. Bernstein, director of the division of Infectious Diseases at Cincinnati Children's. "Regardless of the infecting serotype, studies show that naturally occurring rotavirus infection protects against moderate to severe rotavirus gastroenteritis."
Rotarix® will be available commercially in the United States in the second half of 2008.
