Navigation Links
Components of Extraneous Virus Detected in Rotarix Vaccine; No Known Safety Risk
Date:3/22/2010

Follow-up tests by GlaxoSmithKline and FDA scientists confirmed the academic team's findings and confirmed that viral components have been present since the early stages of the vaccine's development, including during clinical studies.  Preliminary testing by both the academic researchers and FDA scientists of another licensed vaccine against rotavirus infection, RotaTeq, has not detected components of PCV1.

"We are making clinicians aware of information recently received by FDA about the Rotarix vaccine," said Dr. Margaret A. Hamburg, Commissioner for Food and Drugs. "There is no evidence at this time that there is a safety concern.  FDA is recommending that clinicians temporarily suspend use of Rotarix until we can learn more about the situation.  We will keep the public and the clinical community updated on our findings."

Rotarix and RotaTeq are given by mouth to young infants to prevent rotavirus disease, which can cause severe diarrhea and dehydration and is estimated to be responsible for the deaths of more than 500,000 infants around the world each year, primarily in low- and middle-income countries.  Before the introduction of a rotavirus vaccine, rotavirus resulted in more than 50,000 hospitalizations and several dozen deaths in the United States each year.  FDA licensed RotaTeq in 2006 and Rotarix in 2008.  M
'/>"/>

SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. HHS Activates Additional Components of National Disaster Medical System to Help U.S. Hospitals Treat Survivors of Earthquake in Haiti
2. Echo Therapeutics Announces Significant Product Development Milestone: The Completion of Next Generation Electronic Components for Its Revolutionary, Patented Symphony(TM) tCGM System
3. Replikins LLC Finds West Nile Virus Replikin Count Has Reached Its Highest Recorded Value
4. Study Confirms Limited Human-To-Human Spread of Avian-Flu Virus in Indonesia in 2006
5. Researchers Identify Virus Possibly Responsible for Declining Honeybee Population Using 454 Sequencing Technology from Roche
6. Anadys Pharmaceuticals Presents Preclinical Results on ANA598, a Non-Nucleoside Inhibitor of the NS5B Polymerase, at the 14th International Symposium on Hepatitis C Virus and Related Viruses
7. CEL-SCI Presents Data for CEL-1000 as a Vaccine Adjuvant with Recombinant Hepatitis B Virus Protein
8. Potent Hepatitis C Virus Inhibitors Show Efficacy and Potential for Once Daily Dosing in Preclinical Studies
9. New Data Published in The Lancet Show GSKs ROTARIX(R) Offers Protection Against the Most Common Circulating Rotavirus Types
10. XTL Biopharmaceuticals Presents Data Regarding its Hepatitis C Virus Small Molecule Program at Hep Dart 2007 - an International Scientific Conference on Viral Hepatitis
11. Researchers Train the Immune System to Deliver Virus That Destroys Cancer in Lab Models
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/17/2015)... , Apr. 16, 2015 Research and Markets ... the "Corporate Reputation of Pharma in 2014 - ... Edition" report to their offering. For ... opinions on the corporate reputation of the pharmaceutical industry ... health with the views of patient organisations representing all ...
(Date:4/17/2015)... TAIPEI , April 17, 2015 TWi ... fully-owned subsidiary, TWi Pharmaceuticals USA , ... in the United States.  It has been in close ... wholesalers and expects to have its own label specialty ... soon in the U.S. pharma market. According ...
(Date:4/16/2015)... A drug commonly taken to prevent seizures in epilepsy may ... according to a study released today that will be presented ... Washington, DC , April 18 to 25, ... experience at some point in their life a condition called ... the eye to the brain gets inflamed," said study author ...
Breaking Medicine Technology:Corporate Reputation of Pharma in 2014 - The Perspective of Mental Health Patient Groups - 1st Edition 2Corporate Reputation of Pharma in 2014 - The Perspective of Mental Health Patient Groups - 1st Edition 3Epilepsy Drug May Preserve Eyesight for People with MS 2
(Date:4/19/2015)... Fla. (PRWEB) April 19, 2015 The ... DO, MPH, MHCM, FACS, as the inaugural winner of ... at its annual meeting, April 18, in Las Vegas, ... Medical Group, vice chairman of the department of surgery ... and Medical Center in Hartford, Connecticut, was instrumental in ...
(Date:4/19/2015)... Carinsurancesavings.biz has released a new blog post explaining how ... have diabetes. , Clients who have diabetes can ... released blog post explains how diabetes influences auto insurance ... cost coverage. , It is now possible to ... website. Clients can visit http://carinsurancesavings.biz for quotes ...
(Date:4/19/2015)... A live auction will be held to sell ... in Brooklyn, NY and other national consignors. Various types of ... exam and much more. , The auction will take ... 9:00am CDT each day. The equipment is at their Chicago ... 60160. Anyone can participate in the auction including those ...
(Date:4/19/2015)... 19, 2015 HealthPostures, LLC , a ... it will exhibit it’s pioneering ergonomics products at the ... Iowa-Illinois Safety Council Professional Development Conference and Expo . ... EZ are used in volume by call centers, educational ... Built to clamp to a desk, the TaskMate Go ...
(Date:4/18/2015)... (PRWEB) April 18, 2015 Carinsurancequotesinfo.com has ... insurance can cover physical injuries caused by a ... excellent financial coverage for a vehicle. A policy can ... by an accident. Drivers should always carry appropriate coverage ... insurance policy can be bought with several important riders ...
Breaking Medicine News(10 mins):Health News:Dr. Scott Ellner named inaugural Roger Schenke Award winner 2Health News:Dr. Scott Ellner named inaugural Roger Schenke Award winner 3Health News:Finding Low Cost Auto Insurance for Diabetic Drivers! 2Health News:Centurion to Sell Surplus Medical Equipment in Online and On-Site Auction 2Health News:HealthPostures' TaskMate Products to be Exhibited at the Wisconsin and Iowa-Illinois Safety Conferences 2Health News:Auto Insurance Plans Can Cover Physical Injuries Caused By An Accident! 2
... Surface Logix Inc. today announced the initiation of a ... secondary Raynaud's disease. SLx-2101 is a novel , long-acting ... associated with vascular dysfunction such as Raynaud's, a vasospastic ... reduction of blood flow to areas such as the ...
... believe that it is easier to get the child admitted to ... ,People depending on private health care find it inadequate. Often they ... their homes. , ,A new survey suggests that many of ... child. This saves thousands of pounds for the family. The research ...
... its first manned mission to Mars, it has taken its first ... you get rid of the body of a dead astronaut on ... be pulled on a critically ill astronaut who is using up ... employ DNA testing to weed out astronauts who might get a ...
... are used to shock the heart back to normal are found ... out of five fails to work after just ten years. On ... default. , The wire or the lead sometimes shocked ... beating abnormally or completely stopped. ,Many a times it ...
... soup before a meal can help cut back on how much ... State study shows . Results show that when participants in the ... they reduced their total calorie intake at lunch by 20 percent, ... ,"This study expands on previous studies about consuming lower-calorie soup as ...
... Indian origin optician who was part of a British charity, made ... in India. ,Premal Patel, who was part of a ... record 850 eye examinations in a day in the Indian city ... sight difficulties in developing countries. ,'The best moment was ...
Cached Medicine News:Health News:Surface Logix Commences Phase 2a Clinical Trial of SLx-2101 in Raynaud's Disease 2Health News:Inadequate Childcare Hits Wales 2Health News:NASA Gets Ready To Address Tough Questions 2Health News:NASA Gets Ready To Address Tough Questions 3Health News:Taking Low-calorie Soup Before Meal Will Help Cut Calories at Meals 2
... The Affinity pacemaker family ... smallest, truly automatic devices. ... combination of advanced technologies ... DR pacemaker incorporates the ...
... pacemaker family offers some ... automatic devices. Featuring the ... advanced technologies ever seen, ... incorporates the exclusive ventricular ...
... The Guidant INSIGNIA ... sophisticated patient-specific, easy-to-use features ... and enhanced patient safety. ... are programmed using the ...
... a small bench top chemistry analyzer that utilizes ... strips with results available within 8 - 15 ... The instrument accepts whole blood samples and is ... card. At the conclusion of testing, results are ...
Medicine Products: