TUESDAY, JUNE 19, 2018

FDA determines rotovirus should not cause vaccine suspension

The Food and Drug Administration, with the help of a panel of experts, has determined that recent findings regarding rotovirus vaccines Rotateq, made by Merck and Co. Pharmaceuticals, and Rotateq, made by GlaxoSmithCline, should not lead to the continued suspension of their use, according to a news release.

Recent findings show that the vaccines, given to infants in U.S., were contaminated with DNA from pig viruses PCV1 and PCV2.

The viruses have led to chronic wasting disease in pigs, which is similar to what the AIDS virus does to humans. But the effects, both long-term and short-term, of PCV1 and PCV2 on humans are not yet known.

On March 22, the FDA's commission asked doctors to suspend use of Rotarix. Additional testing showed that the viruses were also discovered in Rotateq.

The advisory panel at the May 10 meeting stated that the "the benefits of the vaccine trump its risks."

Rotovirus is the leading single cause of diarrhea in infants in and young children and can sometimes lead to death from severe dehydration.

The Coalition for Vaccine Safety described the virus as "benign and treatable" and "rarely fatal," and called on the FDA to reconsider its analysis of the vaccines.

"How can you say the benefits outweigh the risks when you don't know what the risks are?" Mary Holland, a steering committee member, said.