FDA Approves New GlaxoSmithKline Vaccine Against Rotavirus
The US FDA announced on April 4, 2008, the approval of Rotarix, the second oral US licensed vaccine for the prevention of rotavirus, an infection that causes gastroenteritis (vomiting and diarrhea) in infants and children.
The US Food and Drug Administration announced on April 4, 2008, the approval of Rotarix, the second oral US licensed vaccine for the prevention of rotavirus, an infection that causes gastroenteritis (vomiting and diarrhea) in infants and children. Rotarix, manufactured by GlaxoSmithKline Biologicals (Rixensart, Belgium), is a liquid and given in a two-dose series to infants from six to 24 weeks of age.
Although the disease is usually self-limiting, rotavirus causes about 2.7 million cases of gastroenteritis in US children each year, about 55,000 to 70,000 of which require hospitalization. Of those, between 20 to 60 cases lead to death. Without vaccination, nearly every child in the United States would likely be infected at least once with rotavirus by age 5. During studies involving more than 24,000 infants, Rotarix was effective in preventing both severe and mild cases of rotavirus-caused gastroenteritis during the first two years of life.
There are many different strains of rotavirus. The vaccine protects against rotavirus gastroenteritis caused by the G1, G3, G4, and G9 strains.
The Solution Lies with SOLBIOTE™: Achieving Sustainability, a Growing Focus in Biopharma
October 28th 2024The nexus between biopharmaceuticals and sustainability is seemingly far apart, however, it is increasingly recognized as an inevitable challenge. It is encouraged to take a sustainable approach to reducing the environmental impact of the production and supply of medicines while improving people's health; delivering the well-being of people and the planet. Yosuke Shimojo (Technical Value Support Section Manager, Nagase Viita) will unveil how SOLBIOTE™, a portfolio of injectable-grade saccharide excipients, would be a key for the biopharmaceutical development and achieving sustainability for a better future of the industry.
