# 2940
Just a week after being rebuffed by the EU Committee for Medicinal Products for Human Use (CHMP), Sanofi’s Emerflu® has been approved for use in Australia.
EMERFLU®, pandemic influenza vaccine for humans, approved in Australia
Published on 26 March 2009, 00:28 by Insciences
Lyon, France – March 26, 2009 - Sanofi Pasteur, the vaccines division of sanofi-aventis Group (EURONEXT: SAN and NYSE: SNY), announced today that its pandemic influenza vaccine for human use Emerflu®*, has been granted marketing authorization from the Australian Therapeutic Goods Administration (TGA). Emerflu® vaccine is now approved for the prevention of pandemic influenza in Australia upon official declaration of a pandemic.
Emerflu® vaccine is intended to be manufactured and distributed with the identified pandemic strain and used in Australia in accordance with official Australian government guidance.
The Australian approval of Emerflu® vaccine granted today follows the positive recommendation by the Australian Drug Evaluation Committee (ADEC) on February 13 2009, based on a review of results from clinical trials, which began in late 2004 on H5N1 alum-adjuvanted** inactivated influenza vaccine candidates. These trials evaluated the safety and ability of Emerflu® vaccine to elicit a
protective immune response to the H5N1 strains currently identified by global health authorities and experts as a potential source for the next pandemic.
The news out of the EU for Sanofi wasn’t nearly as positive last week when CHMP gave a negative recommendation for the vaccine.
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.
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What were the major concerns that led the CHMP to recommend the refusal of the marketing authorisation?
The CHMP was concerned over the ability of Emerflu to trigger the production of enough antibodies against the flu virus. According to criteria laid down by the CHMP, a mock-up vaccine needs to bring about protective levels of antibodies in at least 70% of people for it to be considered suitable. Because antibody production following Emerflu administration was below this level in the main studies (less than 40% in participants aged below 60 years), the CHMP was concerned that Emerflu was not suitable for use as a mock-up vaccine.
