FDA Issues Warning Re Rotovirus Vaccine

The Food and Drug Administration issued an advisory today (March 22) to ask healthcare professionals and patients not to use Rotarix, a vaccine that is currently indicated to prevent rotavirus disease. 

The warning came after the FDA was notified by the manufacturer of Rotarix, GlaxoSmithKline that the vaccine was contaminated with an extragenous DNA from porcine circovirus type 1 (PCV1). 

The contamination was first discovered by an independent U.S. academic research team using a novel technique to look for viruses.  Glaxo later confirmed the contamination and alerted the FDA to the incident. Subsequently, the FDA itself also confirmed that the vaccine was tainted with PCV1 DNA. 

On its website, the FDA maintains that there is no evidence to suggest that the presence of this DNA does not pose any risk to vaccine recipients. 

Additionally, The Centers for Disease Control and Prevention issued an official health alert to that the recommended use of the Rotarix vaccine should be suspended until the FDA concludes that it is safe to use the vaccine. 

The FDA says the investigation is ongoing; the agency intends to query an expert panel for their opinion in six weeks  -- at that point, another bulletin will be announced regarding Rotarix. 

The drug regulator recommends that "clinicians temporarily suspend the use of Rotarix for rotavirus immunization." 

Another licensed rotavirus vaccine known as RotaTeq ( Merck) does not contain such a viral DNA, according to the FDA. 

Mainly, rotavirus causes diarrhea and dehydration in young infants.  It is estimated that more than 500,000 infants worldwide die from rotavirus disease. In the United States, the virus causes dozens of deaths and 50,000 to 70,000 hospitalizations each year. 

Rotavirus infects the intestine, resulting in symptoms like fever, upset stomach, vomiting and diarrhea. The illness, which generally occurs during the winter and spring, lasts 3 to 8 days.  

By David Liu and editing by Rachel Stockton