Posts Tagged Guillain-Barré

CDC Reports on Adverse Reactions to Gardasil Vaccine

By CBC News July 7, 2008 | 3:09 PM ET

Almost 8,000 U.S. recipients of the vaccine used to protect against cervical cancer have reported adverse reactions, ranging from pain at the injection site to serious side-effects, says the U.S. Centers for Disease Control and Prevention.

A total of 7,802 people who received Gardasil, made by Merck and Co. Inc., have reported adverse events to the CDC’s Vaccine Adverse Event Reporting System (VAERS) between June 8, 2006, and April 30, 2008. The United States distributed 2.2 million doses of the vaccine in 2006 and 11.3 million in 2007.

Of the people who reported adverse reactions, the most common side-effect was pain at the injection site, according to a recent CDC report.

Seven per cent had serious side-effects – “about half” the average of vaccines overall, according to the report. There were 31 reported cases of Guillain-Barré syndrome (GBS), a neurological condition that results in temporary but often total body paralysis, with 10 cases confirmed. Read the rest of this entry »

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GSK Faces US Delay on Cancer Vaccine

By Andrew Jack in London, FT.com July 1 2008 03:00

GlaxoSmithKline, the UK-based pharmaceutical company, is unlikely to receive US approval for its key cervical cancer vaccine until 2010 at the earliest, under a new timetable it released yesterday.

After requests for fresh information on Cervarix from the Food & Drug Administration in December, GSK said it had decided to await completion of a pivotal clinical trial to be filed with the US regulator during the first half of next year.

Cervarix is a probable blockbuster treatment that is central to the company’s future growth. The cervical cancer vaccine market is expected to be worth more than $1bn a year in sales.

GSK’s timetable change confirms long-standing analysts’ fears of delays for Cervarix, which is competing with a rival vaccine, Gardasil, produced by Merck of the US and already on sale in north America.

GSK filed originally for US approval from the FDA in March 2007, and it has refused to reveal the regulator’s precise concerns other than to say they relate to “safety and efficacy”.

Observers believe the queries focus on the nature of Cervarix’s proprietary adjuvant, a chemical that boosts the immune response to the vaccine. The FDA has not approved a new adjuvant since the 1930s. Read the rest of this entry »

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