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:6/29/2015)... 2015  PDL BioPharma, Inc. (NASDAQ: PDLI ) ... agreement with CareView Communications, Inc. (OTCQB: CRVW) whereby PDL ... secured debt financing. CareView is an information technology provider ... Under the credit agreement, PDL will provide ... in two tranches of $20 million, based upon the ...
(Date:6/29/2015)... , June 29, 2015  Allergan plc ... intends to release second quarter 2015 financial results ... open of the U.S. financial markets. The Company will ... a.m. Eastern Daylight Time on Thursday, August 6, ... to access the call is U.S./ Canada ...
(Date:6/29/2015)... TARRYTOWN, N.Y. , June 29, 2015 /PRNewswire/ ... today announced that the Proceedings of the ... a paper demonstrating that the Company,s proprietary VelociGene ... the rapid identification and preclinical validation of potential ... and treatment of Middle East Respiratory Syndrome (MERS). ...
Breaking Medicine Technology:PDL BioPharma Announces $40 Million Financing Transaction with CareView Communications 2PDL BioPharma Announces $40 Million Financing Transaction with CareView Communications 3PDL BioPharma Announces $40 Million Financing Transaction with CareView Communications 4Allergan to Host Second Quarter 2015 Earnings Conference Call and Webcast 2Allergan to Host Second Quarter 2015 Earnings Conference Call and Webcast 3Regeneron Rapid Response Platform for Emerging Infectious Diseases Described in Proceedings of the National Academy of Sciences Publication 2Regeneron Rapid Response Platform for Emerging Infectious Diseases Described in Proceedings of the National Academy of Sciences Publication 3Regeneron Rapid Response Platform for Emerging Infectious Diseases Described in Proceedings of the National Academy of Sciences Publication 4Regeneron Rapid Response Platform for Emerging Infectious Diseases Described in Proceedings of the National Academy of Sciences Publication 5
... DURHAM, N.C., May 1, 2012 Heart IT, ... approved zero footprint medical imaging workstation, WebPAX®, announced ... "zero-footprint" medical image viewing technologies. "Zero-footprint" technologies allow ... any computing platform with a standard Internet web ...
... 2012 Amarantus BioSciences, Inc. (OTCBB: AMBS), a ... the treatment of Parkinson,s disease and other nervous ... selected to present in the Emerging Companies Showcase ... Meeting on May 2nd, 2012 in New York ...
Cached Medicine Technology:U.S. Patent Office Issues Sixth Patent Covering 'Zero-Footprint' Medical Image Viewers to Heart Imaging Technologies, LLC 2Amarantus BioSciences to Present at the New York Biotechnology Association (NYBA) 21st Annual Meeting on May 2nd, 2012 2Amarantus BioSciences to Present at the New York Biotechnology Association (NYBA) 21st Annual Meeting on May 2nd, 2012 3
(Date:6/30/2015)... ... 2015 , ... Intellitec Solutions has announced they will be hosting two webinars ... enhanced changes and new procedures involved with updating the cloud version of Dynamics CRM, ... the new user interface and what it will mean for end users, critical items ...
(Date:6/30/2015)... ... June 30, 2015 , ... Healthy ... enhance successful student outcomes. According to Dr. Theo Wubbels (Professor of Education, ... must be able to show “all kinds of behavior when the situation asks ...
(Date:6/30/2015)... ... June 30, 2015 , ... Medflow, the ... a SaaS electronic health records system from the company exclusively dedicated to helping ... 2.0 delivers an intuitive state-of-the-art solution combining modern cloud technology with Medflow’s proven ...
(Date:6/30/2015)... ... 2015 , ... This Fourth of July, Peacock Alley celebrates the ... work, tenacity, perseverance, commitment to quality, honesty and love of friends and family. These ... Gabler's simple love of quilts, Peacock Alley was fully realized and grown while raising ...
(Date:6/30/2015)... , ... June 30, 2015 , ... Curly Hair Solutions™ ... the largest beauty event in the US, featuring products from all over the world. ... Collection. The Collection is a line of hair styling products focused entirely on meeting ...
Breaking Medicine News(10 mins):Health News:Intellitec Solutions to Host Microsoft CRM 2015 Update Webinar 2Health News:Lessons On Leadership - Top 12 Global Teacher Bloggers Reveal the Best Strategies for Building Positive Leadership in Global Classrooms 2Health News:Medflow Launches MEDFLOW 2.0 EHR – The Cloud-Based Ophthalmology EHR 2Health News:Luxury Linen Purveyor Peacock Alley Celebrates the Fourth of July 2Health News:Curly Hair Solutions™ Showcases Entire Curl Keeper™ Collection at Cosmoprof Las Vegas July 12 - 14 2
... , , BURLINGTON, Mass., ... expansion to its product offering with the delivery of ... the integration of the ClearPoint Security Performance Manager (TM) ... The ClearPoint Unified Security Performance and Compliance Manager. The ...
... , , , Flexible ... , NEW YORK, Sept. 14 The American ... Parkinson Foundation (NPF) Young Onset Parkinson Network are co-sponsoring a series ... caregivers. The first conference will be held in Dallas, Texas ...
... ... Snoring and obstructive sleep apnea are serious medical problems. Obstructive sleep ... serious illnesses. Increasingly, specially trained dentists are being called upon to provide ... to wear a CPAP unit. Choosing a sleep-disorders dentist who is qualified ...
... , , , PITTSBURGH, Sept. ... Inc. is prototyping an innovative stroke treatment device designed to speed ... , , Michele Migliuolo, NeuroInterventions President ... a presentation at the 3 Rivers Venture Fair in Pittsburgh on ...
... , WASHINGTON, Sept. 13 Bread for ... citing him as an outstanding individual who has done more to save ... , , "No single person has contributed more ... Rev. David Beckmann, president, Bread for the World. "Norman was truly the ...
... , NAPA, Calif., Sept. 11 Dey L.P., ... today issued an advisory regarding the theft of two different ... and Albuterol Sulfate Inhalation Solution, 0.083%, unit-dose vials. The lots ... of Florida. , , The NDC ...
Cached Medicine News:Health News:ClearPoint Announces Metric Applications Packages for PCI DSS, NERC, Healthcare Compliance and FISMA 2Health News:ClearPoint Announces Metric Applications Packages for PCI DSS, NERC, Healthcare Compliance and FISMA 3Health News:ClearPoint Announces Metric Applications Packages for PCI DSS, NERC, Healthcare Compliance and FISMA 4Health News:APDA/NPF Young Onset Parkinson's Conference Series Kick-Off in Dallas, October 23-24 2Health News:APDA/NPF Young Onset Parkinson's Conference Series Kick-Off in Dallas, October 23-24 3Health News:Snoring Isn't Sexy, LLC Proposes 7 Patient Guidelines for Selecting a Sleep Medicine Dentist 2Health News:Snoring Isn't Sexy, LLC Proposes 7 Patient Guidelines for Selecting a Sleep Medicine Dentist 3Health News:Snoring Isn't Sexy, LLC Proposes 7 Patient Guidelines for Selecting a Sleep Medicine Dentist 4Health News:Rapid-response Technology from NeuroInterventions, Inc. Aims to Quickly Restore Brain's Blood Flow After a Stroke 2Health News:Bread for the World Mourns Passing of Norman Borlaug 2Health News:Dey Issues Advisory 2
... headboxes are the latest ... of portable battery-powered EEG ... robust new mechanical design, ... XLTEK's standard MOBEE24plus and ...
The ACCU-Beam® line of Surgical Microscope Accessories includes digital camera adaptors, beam splitters, objective lenses, fiber optic cables, and fiberoptic retrofits....
The ACCU-Beam® line of Surgical Microscope Accessories includes digital camera adaptors, beam splitters, objective lenses, fiber optic cables, and fiberoptic retrofits....
The ACCU-Beam® line of Surgical Microscope Accessories includes digital camera adaptors, beam splitters, objective lenses, fiber optic cables, and fiberoptic retrofits....
Medicine Products: