Rotarix Glaxo Vaccine for Infant Rotavirus Receives Approval From U.S. Food and Drug Administration

Rotarix Glaxo Vaccine for Infant Rotavirus Receives Approval From U.S. Food and Drug Administration

The U.S. Food and Drug Administration approved Rotarix, a GlaxoSmithKline PLC infant vaccine designed to help protect infants from a gastrointestinal illness caused by rotavirus, the company said Thursday.

The approval was expected after an outside panel of medical experts in February backed the vaccine. Glaxo’s vaccine will compete against a similar vaccine, RotaTeq, from Merck & Co.

Rotavirus infection hits most children before age five. Although rotavirus deaths in the U.S. are rare, the infection still causes about 50,000 to 70,000 hospitalizations each year. Rotarix is designed to protect infants against rotavirus during their first two years of life, when the infection’s symptoms are most likely to be severe.

Rotarix and RotaTeq are both oral vaccines. Rotarix would give given at two- and four-months old along with other childhood vaccines that are typically given at the same age. RotaTeq is administered in a three-dose series, typically at two- four- and six-months.

The next step for Rotarix would be a review at a Centers for Disease Control and Prevention vaccine panel this June. If that panel backs the vaccine, which is expected, given FDA’s approval of the vaccine, it would trigger private insurance coverage.

Len Friedland, Glaxo’s clinical director for vaccines, said Rotarix would be widely available during the second half of this year.

Merck’s vaccine has been on the U.S. market since 2006 and federal health officials have been monitoring it for links to a rare bowel problem called intussusception, and Glaxo’s vaccine would also be included in the monitoring program.

A Wyeth vaccine was pulled off the market in 1999 after it was linked to the ailment, which is marked by a twisting or obstruction of the intestine that can be fatal.

So far, 11 clinical studies of Glaxo’s vaccine, involving more than 75,000 children, haven’t shown an increased risk of intussusception, with six cases reported among children receiving the vaccine in clinical studies compared with seven cases seen among patients receiving a placebo, or fake vaccine.

However, during the FDA review of Rotarix, agency officials raised concerns about a higher rate of pneumonia-related deaths and convulsions among vaccinated infants in one of the main studies. The overall death rate from any cause, however, was similar between infants given the vaccine and those in placebo groups.

Glaxo has said it would conduct a post-marketing study of the vaccine to monitor for potential side effects such as pneumonia, convulsions and intussusception.

Rotarix Glaxo Vaccine for Infant Rotavirus Receives Approval From U.S. Food and Drug Administration