Skip to content

    Children's Vaccines Health Center

    Font Size
    A
    A
    A

    FDA: Rotavirus Vaccines Safe Despite Pig Virus

    After Millions of Doses, No Harm Seen From Pig Virus in Vaccines for Infants
    By
    WebMD Health News
    Reviewed by Laura J. Martin, MD

    May 14, 2010 - Both rotavirus vaccines given to U.S. infants carry tiny amounts of pig virus or pig virus DNA -- but due to the vaccines' strong safety record, the FDA says doctors should resume their use.

    Last March, the FDA suspended use of GlaxoSmithKline's Rotarix when newly available techniques detected DNA from porcine circovirus type 1 (PCV1) in the vaccine. Further research found whole PCV1 virus in the vaccine -- and showed that DNA from both PCV1 and the related PCV2 were in Merck's RotaTeq vaccine.

    Neither PCV1 nor PCV2 causes disease in humans. Millions of doses of the vaccines have been given to infants with no sign of significant safety problems. Since rotavirus can cause life-threatening diarrhea, and since the risk from the pig viruses is only theoretical, the FDA is lifting its precautionary suspension of Rotarix and encouraging continued use of RotaTeq.

    Meanwhile, the FDA is working with GlaxoSmithKline and Merck to plan follow-up studies. GlaxoSmithKline is redesigning its vaccine to eliminate the pig virus; Merck has not yet announced its plan.

    Children who receive the vaccines do not need follow-up. Pig virus and pig virus DNA was in the vaccine when it was tested in tens of thousands of infants during clinical trials. No safety issues arose.

    Today on WebMD

    Baby getting vaccinated
    Is there a link? Get the facts.
    syringes and graph illustration
    Get a customized vaccine schedule.
     
    baby getting a vaccine
    Know the benefits and the risk
    nurse holding syringe in front of girl
    Should your child have it?
     

    What To Know About The HPV Vaccine
    Article
    24 Kid Illnesses Parents Should Know
    Slideshow
     
    Nausea and Vomiting Remedies Slideshow
    Article
    Managing Immunization Schedules For Kids
    Video
     

    Doctor administering vaccine to toddler
    Video
    gloved hand holding syringe
    Article
     
    infant receiving injection
    Tool
    pills
    Quiz
     

    WebMD Special Sections