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Sanofi pandemic flu vaccine rebuffed by EU agency

H

HenryN

Retired
UPDATE 1-Sanofi pandemic flu vaccine rebuffed by EU agency

Thu Mar 19, 2009 1:22pm EDT
* EMEA concerned about vaccine's effectiveness
* Emerflu would have been used after pandemic declared
(Adds details, background)
LONDON, March 19 (Reuters) - An experimental pandemic flu vaccine from Sanofi-Aventis (SASY.PA: Quote, Profile, Research, Stock Buzz) has been rejected by European regulators because of worries about its effectiveness.
The European Medicines Agency said on Thursday its experts were concerned over the ability of Sanofi's H5N1 shot Emerflu to trigger the production of enough antibodies against the flu virus.
Emerflu was expected to be used in adults to protect against pandemic flu, which many experts fear could be triggered by mutations in the H5N1 strain of virus now circulating in birds. It was only intended for use once a pandemic had been declared. (Reporting by Ben Hirschler; Editing by David Holmes)

http://www.reuters.com/article/rbssHealthcareNews/idUSLJ96033420090319?rpc=401&
 
Re: Sanofi pandemic flu vaccine rebuffed by EU agency

Questions And Answers On Recommendation For The Refusal Of The Marketing Authorisation For Emerflu

Common name:pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) A/Vietnam/1194/2004 (NIBRG-14)


LONDON, March 19, 2009--On 19 March 2009, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Emerflu suspension for injection, intended to be used in adults for prophylaxis of influenza in an officially declared pandemic situation. The company that applied for authorisation is Sanofi Pasteur SA. It may request a re-examination of the opinion within 15 days of receipt of notification of this negative opinion.

some more here: http://www.medadnews.com/News/Index.cfm?articleid=613194
 
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