Navigation Links
FDA Asks Docs to Suspend Using Glaxo Rotavirus Vaccine

Rotarix is contaminated with pig virus but poses no known health risk, officials say,,

MONDAY, March 22 (HealthDay News) -- U.S. health officials recommended Monday that doctors temporarily stop using the Rotarix vaccine -- one of two brands available to prevent the diarrhea bug rotavirus -- for children until the source and any potential harm from a contamination of the vaccine has been identified.

Doses of the oral vaccine appear to be contaminated with a benign pig virus, according to officials at the U.S. Food and Drug Administration.

The recommendation comes after independent researchers found porcine circovirus 1 (PCV1) in Rotarix. This virus is not known to cause illness in humans, FDA Commissioner Dr. Margaret Hamburg said during an afternoon teleconference.

"There is no evidence at this time that this material from PCV1 in Rotarix poses any safety risk," Hamburg said. "PCV1 is not known to cause any disease in humans or animals."

Still, vaccines are supposed to be sterile and although Rotarix has a good safety record, finding PCV1 in the vaccine was unexpected, Hamburg said. Rotarix, made by drug giant GlaxoSmithKline, was licensed in 2008.

"While the agency is learning more about the situation, FDA is recommending that clinicians temporarily suspend the use of Rotarix vaccine," Hamburg said.

Rotavirus is a common cause of severe diarrhea among children, hospitalizing approximately 55,000 children each year in the United States. The virus is responsible for more than 600,000 children's deaths each year worldwide. The disease causes vomiting and watery diarrhea for three to eight days, along with fever and abdominal pain, according to the U.S. Centers for Disease Control and Prevention.

Hamburg said that PCV1 may have been present in Rotarix since the vaccine was developed. The contamination was found by independent researchers using new virus-spotting technology, she said.

Follow-up FDA analysis has confirmed the presence of PCV1 in Rotarix, Hamburg added. "FDA is investigating how the PCV1 DNA came to be present in the vaccine," she said.

The other vaccine available to protect against rotavirus is RotaTeq, also delivered by mouth and made by Merck. RotaTeq was licensed by the FDA in 2006 so most children vaccinated in the United States received RotaTeq, Hamburg said.

RotaTeq is made using a different method, she noted. "Preliminary tests on the RotaTeq vaccine by an academic research team and FDA have not shown the presence of PCV1 DNA," Hamburg said.

RotaTeq requires three doses while Rotarix requires two. That means that children who have already gotten one shot of Rotarix should now get two shots of RotaTeq to be fully vaccinated, Hamburg said.

She stressed that the the FDA recommendation applies only to the United States. Other countries where rotavirus is more common and severe may choose to continue recommending Rotarix. "Such a decision would be very understandable," she said.

In several weeks, the FDA is having an expert advisory committee meeting to make additional recommendations on the use of rotavirus vaccines, Hamburg said.

Thomas Breuer, head of global clinical R&D and chief medical officer of biologicals at GlaxoSmithKline, said in a statement that, "no safety issue has been identified by external agencies or GSK. GSK is committed to patient safety and to the highest manufacturing standards for all our vaccines and medicines. We are already working closely and discussing this finding with regulatory agencies around the world."

"GSK is now reviewing how best to replace, in a timely way, the cell bank and virus seeds used as base production material. In the meantime, and in accordance with the regulators, the company will continue to manufacture Rotarix to the existing approved production and quality standards to meet public health needs worldwide," the company added.

More information

For more on rotavirus, head to the U.S. Center for Disease Control and Prevention.

SOURCES: March 22, 2010, press conference with: Margaret Hamburg, M.D., Commissioner, U.S. Food and Drug Administration; March 22, 2010, news release, GlaxoSmithKline

Copyright©2010 ScoutNews,LLC.
All rights reserved

Related medicine news :

1. Anthem Blue Crosss Announcement That It Will Temporarily Suspend a 39% Health Insurance Rate Increase Should Not Deter Immediate Legislative Action
2. Unaware of Laws, Many Parents Not Using Booster Seats for Older Children
3. Tampa Bay Vein Treatment and Cosmetic Dermatology Practice Using New Laser Technology Some Say is the Latest Breakthrough
4. Best Selling, Non Toxic Skin Brightener Does the Job Using Safe, Healthy Ingredients and Introduces New Anti Aging Ingredients
5. Using new approach, Mayo Clinic researchers find level of gene alters risk of Alzheimers disease
6. Family history is strong predictor of obstructive coronary artery disease using CCTA
7. Parrish Medical Center Sees 30 Percent Improvement in Mortality Using Real-Time Clinical Surveillance Solution from Thomson Reuters
8. SDI Reports: Nearly a Third Of Physicians Use Handheld and Smartphone Devices to Access Medical Information - Physicians Most Likely to be Using Apple iPhone
9. Groundbreaking Study Using Ultrasound for the Treatment of Intracerebral and Intraventricular Hemorrhage Stroke Shows Promise
10. Rockland County Landlord Agrees to Settlement With United States to Protect Fair Housing Rights of Tenants With Mental Disabilities
11. Register Online for this Year's Horst Senior Living Conference on April 8 Featuring Keynote Speaker and Senior Housing Expert Jim Moore
Post Your Comments:
(Date:11/27/2015)... ... November 27, 2015 , ... ... progress through sharing, the 2016 Building Better Radiology Marketing Programs meeting ... begin on Sunday, March 6, 2016, at Caesars Palace in Las Vegas with ...
(Date:11/27/2015)... ... November 27, 2015 , ... A simply groundbreaking television series, ... interesting show that delves into an array of issues that are presently affecting Americans. ... from open dialogue, this show is changing the subjects consumers focus on, one episode ...
(Date:11/27/2015)... , ... November 27, 2015 , ... ... an innovative online platform for mental health and wellness consultation, has collaborated with ... partnership will bridge the knowledge gap experienced by parents and bring advice from ...
(Date:11/27/2015)... IL (PRWEB) , ... November 27, 2015 , ... ... of the largest, most successful and prominent nonprofit healthcare organizations in the country. ... governance involvement with various organizations, and helped advance the healthcare industry as a ...
(Date:11/27/2015)... Francisco, California (PRWEB) , ... November 27, 2015 , ... ... Janis Joplin Ann Arbor Michigan boxing style concert posters. This is one of Joplin's ... at the Canterbury House at the University of Michigan in Ann Arbor. The According ...
Breaking Medicine News(10 mins):
(Date:11/27/2015)... DUBLIN , Nov. 27, 2015 Research ... of the "Global Intrauterine Devices Market 2015-2019" ... --> In this report, the author ... intrauterine devices market for 2015-2019. To calculate the market ... of following type of products: Hormonal IUDs and copper ...
(Date:11/26/2015)... november 2015 AAIPharma Services Corp./Cambridge ... investering aan van ten minste $15,8 miljoen ... het mondiale hoofdkantoor in Wilmington, ... in extra kantoorruimte en extra capaciteit voor ... behoeften van de farmaceutische en biotechnologische markten. ...
(Date:11/26/2015)... Research and Markets ( ) has announced ... Outlook to 2019 - Rise in Cardiac Disorders and Growing ... to their offering. Boston ... scientific and others. --> The market ... Boston scientific and others. ...
Breaking Medicine Technology: