FDA is recommending that healthcare professionals temporarily suspend the use of Rotarix, a vaccine used to prevent rotavirus disease. FDA’s recommendation is a precaution taken while the agency learns more about the situation.

FDA has learned that DNA from porcine circovirus type 1 (PCV1) is present in Rotarix. PCV1 is not known to cause disease in humans. There is no evidence at this time that this finding poses a safety risk. Because available evidence supports the safety of Rotarix, no medical follow-up is needed for patients who have been vaccinated with Rotarix.

There are two licensed vaccines for rotavirus in the United States: RotaTeq and Rotarix. For children who have received one dose of Rotarix, CDC advises that clinicians can complete the series with RotaTeq for the next two doses.

Additional information, including information for healthcare professionals and parents, is provided in the document below.

[03/22/2010 - Update on Rotarix Vaccine¹ - FDA]

    

Important information from the FDA; please disseminate!

Philanthropists Bill Gates and Melinda Gates said Friday they would spend $10 billion to develop and deliver new vaccines over the next decade, highlighting growing concerns that the global recession and competing government priorities will stifle efforts to control diseases in developing countries.

"Hopefully we'll have some breakthroughs," Mr. Gates said in an interview this week, pointing to funding from his foundation aimed at finding a vaccine for malaria.

The money, combined with a call by Mr. Gates for continued investment in vaccines from other donors, comes amid growing worries at the World Health Organization and other health groups that funding shortfalls will stifle the distribution of promising new vaccines and allow diseases like polio to spread in new areas.

Those worries are particularly acute as health officials start rolling out new vaccines that prevent rotavirus, a cause of severe diarrhea, and pneumococcal disease. The new vaccines are fueling concerns in developing countries, many with decrepit primary health care systems, already struggling with how to deliver existing vaccines.

Many African countries, for instance, lack the refrigeration, or "cold chain," needed to keep vaccines fresh while they are being stored and transported.

Amazing. I wonder if Mr. Gates will be remembered more for his impact on technology or his humanitarian efforts?