During a special meeting of the FDA Vaccines & Related Biological Products Advisory Committee (VRBPAC) held May 7th to discuss new information on contamination of rotavirus vaccines with DNA from two pig viruses, the National Vaccine Information Center (NVIC) called for the FDA to raise legal vaccine safety testing and labeling standards.
“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,” said NVIC Co-Founder and President Barbara Loe Fisher. ”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 called on the FDA to legally require vaccine manufacturers to adhere to binding regulations rather than offering companies non-binding recommendations and to immediately:
- Recommend use of RotaTeq vaccine be suspended until Merck can guarantee it is free of PCV1 and PCV2 and other adventitious agents;
- 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
- Institute stricter labeling standards to fully and clearly inform the public using vaccines about residual adventitious agent content of all vaccines.
NVIC’s Director of Research & Patient Safety, Vicky Debold, PhD, RN, who is also the consumer member of the FDA vaccine advisory committee, urged the FDA to continue to adhere to the precautionary principle and be transparent in its process whenever contaminants are detected in vaccines. “The public has a right to know whatever you learn,” she said.