Saturday, August 1, 2015

FDA reiterates: Rotavirus vaccines are safe despite pig virus

On Sunday, the U.S. Food and Drug Administration sent a notice to pediatricians, family doctors and public health professionals reiterating the agency's decision that both vaccines against rotavirus are safe despite the presence of pig viruses. A study from the Journal of Infectious Diseases released Friday reported that vaccines against the rotavirus had nearly cut in half hospitalizations of children in the U.S. in just two years. Also on Friday, the U.S. Food and Drug Administration reversed course and said that pediatricians and other clinicians should use GlaxoSmithKline's Rotarix vaccine to immunize infants against rotavirus. The agency also reaffirmed its position that Merck & Co.'s RotaTeq vaccine should remain in use.

FDA reiterates: Rotavirus vaccines are safe despite pig virus

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An infant getting a rotavirus vaccination.
An infant getting a rotavirus vaccination.

On Sunday, the U.S. Food and Drug Administration sent a notice to pediatricians, family doctors and public health professionals reiterating the agency’s decision that both vaccines against rotavirus are safe despite the presence of pig viruses.

“Based on a careful evaluation of laboratory results from the manufacturers and its own laboratories, a thorough review of the scientific literature, and input from scientific and public health experts, the agency is revising its recommendation to temporarily suspend use of the Rotarix vaccine,” the FDA said. “FDA has also determined that RotaTeq vaccine should remain in use.”

And the agency added that the benefits of the vaccines that have been shown to prevent hospitalizations for acute diarrhea in American children and hundreds of thousands of deaths in the developing world, out weigh the “theoretical” risk of the pig viruses – PCV1 or PCV2 – found in the vaccines made by Merck & Co. (RotaTeq) and GlaxoSmithKline (Rotarix).

“FDA and the manufacturers will continue to investigate the findings of PCV in rotavirus vaccines and will evaluate information from ongoing testing by FDA and the manufacturers,” the agency stated in its notice on Sunday.

Here is the story by my colleague Marie McCullough on the rotavirus vaccines and pig viruses.

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Check Up covers regional health news and a wide array of healthcare topics from pharmaceutical happenings to patient safety. Read about some of our bloggers here.

Portions of this blog may also be found in the Inquirer's Sunday Health Section.

Michael R. Cohen, R.Ph. President, Institute for Safe Medication Practices
Daniel R. Hoffman, Ph.D. President, Pharmaceutical Business Research Associates
Hooman Noorchashm, M.D., Ph.D. Cardiothoracic surgeon in the Philadelphia area
Amy J. Reed, M.D., Ph.D. Anesthesiologist and Surgical Intensivist in the Philadelphia Area
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