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FDA Calls For Temporary Halt To Using Rotarix Vaccine

 

 

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The `big’ news over the past 24 hours has been the  FDA’s recommendation that the use of GSK’s Rotarix rotavirus vaccine be temporarily suspended after it was discovered to be contaminated with DNA from a (probably harmless to humans) pig virus; Porcine circovirus 1 (PCV1)

 

Clinicians are advised to use Merck’s RotaTeq rotavirus vaccine pending a review of the GSK vaccine.

 

This is a complex story, and one that will take some time to sort out.  All of the facts are not in as yet, and the significance of this find are not at all clear.

 

Rotavirus is one of the leading causes of diarrheal illness in infants and young children, and is believed to cause the deaths of a half million children each year, mostly in developing countries.  

 

The vaccine, which became widely available in 2006, has been credited with a reduction in the incidence of rotavirus disease here in the US and in other countries (see MMWR Reduction in Rotavirus After Vaccine Introduction --- United States, 2000—2009).

 

 

Three pieces of information to help clarify the situation: 

 

First, a report by Maggie Fox of Reuters, one of the best science reporters in the business.

 

Second, the FDA  announcement.

 

And lastly, a referral to Vincent Racaniello’s Virology Blog, where he examines the problem.

 

Glaxo's rotavirus vaccine use suspended - US

12:00am EDT

 

* Merck vaccine not affected

* Suspension is temporary - no evidence of harm

* Rotavirus vaccines have troubled history (Adds WHO, European regulator comment)

 

By Maggie Fox, Health and Science Editor

WASHINGTON, March 22 (Reuters) - Doctors should temporarily stop using GlaxoSmithKline Plc's (GSK.L) (GSK.N) Rotarix vaccine against a diarrhea-causing virus called rotavirus because it is contaminated with an apparently harmless pig virus, regulators and the company said on Monday.

 

Doctors should instead give children Merck and Co Inc's (MRK.N) RotaTeq rotavirus vaccine, which is made using a different method and which shows no evidence of the virus, the U.S. Food and Drug Administration said.

 

The FDA and the company both found DNA from the virus in the vaccine. It is not clear whether whole virus is in the vaccine or just pieces of its DNA.

 

"We do believe the product is safe," FDA Commissioner Dr. Margaret Hamburg told reporters in a telephone briefing. Most children in the United States have been vaccinated with Merck's vaccine, which came onto the market sooner than Rotarix, she said.

(Continue . . .)

 

 

FDA NEWS RELEASE

For Immediate Release: March 22, 2010

Media Inquiries: Shelly Burgess, 301-796-4651; shelly.burgess@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

Components of Extraneous Virus Detected in Rotarix Vaccine; No Known Safety Risk
FDA Recommends Clinicians Temporarily Suspend Use of Vaccine as Agency Learns More

FDA is recommending that healthcare practitioners temporarily suspend use of the Rotarix vaccine for rotavirus immunization in the United States while the agency learns more about components of an extraneous virus detected in the vaccine.  There is no evidence at this time that this finding poses a safety risk.

 

The agency recently became aware that an independent U.S. academic research team, using a novel technique, has found DNA from porcine circovirus 1 (PCV1) in Rotarix, which is manufactured by GlaxoSmithKline.  PCV1 is not known to cause illness in humans or other animals.  In addition, Rotarix has been studied extensively, before and after approval, and found to have an excellent safety record.

(Continue . . . )

 

 

And as a last stop, Vincent Racaniello takes a Virologist’s view of the story in:

 

Porcine circovirus DNA in rotavirus vaccine

Related Post:

FDA
Vaccine
Rotavirus

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