Rotarix News and Research

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Vaccination of infants with Rotarix reduces rate of rotavirus infection: Researchers

Vaccination of infants with Rotarix or RotaTeq significantly reduces the rate of severe rotavirus diarrhoea, hospitalizations, medical attention due to rotavirus and severe diarrhoea from all causes. The vaccines are not associated with increased numbers of serious adverse events.

12 May 2010

CVS calls on FDA to suspend use of contaminated rotavirus vaccines

On Friday, the Food and Drug Administration (FDA) convened a panel of experts to review recent findings that rotavirus vaccines given to infants in the U.S., Rotateq, produced by Merck Pharmaceuticals and Rotarix produced by GlaxoSmithKline, are contaminated with DNA from pig viruses PCV1 and PCV2. On March 22nd the FDA Commissioner asked doctors to suspend use of the Rotarix vaccine due to the contamination. Upon additional testing, Rotateq was also found to be contaminated.

10 May 2010

GSK participates in FDA advisory committee's rotavirus vaccine meeting

GlaxoSmithKline today participated in a U.S. Food and Drug Administration (FDA) advisory committee meeting convened to discuss recent findings of porcine circovirus (PCV) in rotavirus vaccines. Although the committee did not issue any formal recommendations, members widely acknowledged that the benefits of vaccinating infants worldwide against rotavirus disease clearly outweigh the theoretical risks associated with the presence of porcine circovirus type 1 (PCV-1) in the vaccines.

10 May 2010

Latest LLMDA technology available to detect viruses, bacteria

Law enforcement authorities seeking to detect bioterrorism attacks, doctors diagnosing diseases and regulatory agencies checking product safety may find a new ally in a Lawrence Livermore National Laboratory detection technology.

6 May 2010

Celldex reports net loss of $6.6 million for first-quarter 2010

Celldex Therapeutics, Inc. today reported financial results for the first quarter ended March 31, 2010. Celldex reported a net loss of $6.6 million, or $0.21 per share, for the first quarter of 2010 compared to a net loss of $7.7 million, or $0.49 per share, for the first quarter of 2009. At March 31, 2010, Celldex reported cash, cash equivalents and marketable securities of $75.4 million, which the Company believes will be sufficient to meet estimated working capital requirements and fund operations into 2012.

4 May 2010

NVIC participates in NVAC-sponsored meeting to discuss the U.S. vaccine safety system

The National Vaccine Information Center participated in a meeting sponsored by the federal National Vaccine Advisory Committee and facilitated by The Keystone Center April 11-13 in Salt Lake City to discuss strengthening the U.S. vaccine safety system.

17 Apr 2010

FDA recommends clinicians temporarily suspend use of Rotarix vaccine

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.

24 Mar 2010

WHO advises continued use of GSK's rotavirus vaccine in developing countries

The WHO on Monday advised developing countries to continue administering GlaxoSmithKline's Rotarix vaccine - which offers protection to children against the diarrhea-causing rotavirus - after the FDA advised doctors in the U.S. to temporarily stop using the vaccine following the discovery that it was "contaminated with an apparently harmless pig virus," Reuters reports

24 Mar 2010

Temporary suspension of Rotarix – a rotavirus vaccine for kids

The US FDA after deliberation has come up with a warning to the nation’s pediatricians to stop giving children a vaccine that prevents diarrhea causing Rotavirus vaccine. There is reportedly a contamination with a harmless pig virus in this vaccine called Rotarix and manufactured by GlaxoSmithKline.

23 Mar 2010

GSK notifies regulatory authorities of the presence of PCV-1 in Rotarix vaccine

GlaxoSmithKline today confirmed that it has notified regulatory authorities of the presence of material from a virus called PCV-1 in its oral rotavirus vaccine, Rotarix™. PCV-1 does not multiply in humans and is not known to cause illness in humans.

23 Mar 2010

Studies in Mexico and Africa demonstrate the effectiveness of rotavirus vaccine

For the first time ever, studies in Mexico and Africa, published today in the New England Journal of Medicine, demonstrate a reduction in diarrheal disease deaths following rotavirus vaccine introduction in Mexico and vaccine efficacy among impoverished populations in Malawi and South Africa.

28 Jan 2010

FDA approves Rotarix

The U.S. Food and Drug Administration has announced the approval of Rotarix, the second oral U.S. licensed vaccine for the prevention of rotavirus, an infection that causes gastroenteritis (vomiting and diarrhea) in infants and children.

4 Apr 2008

US advisory committee recommends approval of Rotarix

The US Advisory Committee on Vaccines and Related Biological Products issued a positive recommendation today on the use of rotavirus vaccines, potentially bringing greater protection to children in the US from this common and sometimes fatal cause of severe diarrhea.

21 Feb 2008

Rotarix accepted for review by FDA

GlaxoSmithKline has announced that the U.S. Food and Drug Administration (FDA) has accepted for review its Biologics License Application (BLA) for Rotarix, an oral candidate vaccine for infants to prevent rotavirus gastroenteritis.

16 Aug 2007