FDA called on to raise vaccine safety testing standards

The National Vaccine Information Center formally called on the U.S. Food and Drug Administration this week to increase its labeling practices and legal vaccine safety testing.

The request was made during a special May 7 hearing of the FDA’s Vaccines & Related Biological Products Advisory Committee, reports.

The hearing was called after fragments of two types of pig viruses were recently found in Merck & Co.'s Rotateq vaccine. One virus is the same one found in GlaxoSmithKline PLC's Rotarix vaccine in March. The FDA, at the time, recommended doctors stop using that vaccine and use Rotateq instead, even though the agency said it didn't think the virus posed any safety risks to humans.

During the May 7 hearing, NVIC called on the FDA to specifically, “recommend use of RotaTeq vaccine be suspended until Merck can guarantee it is free of PCV1 and PCV2 and other adventitious agents.”

The NVIC also called on the FDA to, “institute stronger legal requirements for proof that vaccine cell substrates and other animal products used for production of seed stocks are free from adventitious agent contamination and that vaccines remain clean before being released” and to implement “stricter labeling standards to fully and clearly inform the public using vaccines about residual adventitious agent content of all vaccines,” according to

“The contamination of rotavirus vaccines with animal virus DNA that was not detected pre- or post-licensure is an important wake up call for industry and government,” NVIC co-founder and president Barbara Loe Fisher told “Parents being told by federal officials to give their babies Rotarix and RotaTeq vaccine expect those vaccines and others to be free from adventitious agent contamination.”

NVIC Director of Research and Patient Safety Vicky Debold echoed Fisher’s sentiments and urged the FDA to be transparent in its policies if and when products are found to contain contaminants.

Rotateq was designed to protect infants from a gastrointestinal illness caused by rotavirus and has been administered to millions of infants since it was approved for use in the U.S. in 2006.