�With the approval, the U.S. FDA has targeted three new strains of 'flu. Six pharma firms will benefit from the approval, including GlaxoSmithKline, MedImmune (part of AstraZeneca), and Sanofi Pasteur.
The FDA's modification of the strains in the 2008/09 'flu vaccine list is significant, as including three strains rather than updating one or deuce strains has been described as an "unusual occurrence".
Regulators will hope to maintain a higher protective covering rate than in 2007/08, when the vaccine success rate was just 44%. Vaccine makers may experience some difficulties in matching procurement requirements due to the inclusion body of new strains.
U.S. health regulators have provided expanded the range of protection from influenza ('flu) viruses under the country's vaccination schema for 2008/09.
According to the U.S. FDA, 6 vaccines throw been approved:-- CSL Ltd's Afluria
-- GlaxoSmithKline Biologics' (U.K.) Fluarix
-- ID Biomedical Corporation of Quebec's (Canada) Fluval
-- MedImmune Vaccines' FluMist
-- Novartis Vaccines and Diagnostics' (Switzerland) Fluvirin
-- Sanofi Pasteur's (France) Fluzone
The regulatory way has endorsed the passport of the vaccines and Related Biological Products Advisory Committee, with the following new strains of the virus to be included.
-- An A/Brisbane/59/2007 (H1N1)-like virus
-- An A/Brisbane/10/2007 (H3N2)-like virus
-- A B/Florida/4/2006-like virus.
The Centers for Disease Control and Prevention (CDC) has noted that cxl million 'flu vaccine doses were provided in 2007/08. The pharmaceutical firms knotty in the programme have already started ramping up production and indicating shipments. Reuters reports that MedImmune (a unit of U.K. firm AstraZeneca) will manufacture 12 trillion doses of its nasal consonant mist vaccinum, while Sanofi Pasteur has initiated a shipment of 1.3 million doses.
Outlook and ImplicationsThe FDA's approval of three strains in the 'flu inoculation programme is significant apt last year's low protection rate. With some critics calling 2007/08 one of the worst 'flu seasons since 2003/04, the regulator seems to have interpreted a cautious stance in including extra 'flu virus strains. A potential role of drug-resistant MRSA in the level of complication from 'flu infections - particularly in children - is as well being considered, thereby increasing the challenges of ensuring immunity. The CDC has noted that last year, the tribute rate attributed to the vaccines endorsed by the FDA were low. The overall protection rate was 44%, with vaccines unable (at 100%) against the influenza B infection and 58% effectual against the H3N2 straining of influenza A, according to the Washington Post. The regulative agencies are expected to recommend vaccines anticipating the most rife virus strains during the 'flu season. It is clear that last year's experience has increased atmospheric pressure on the CDC and the FDA to act on the 'flu strains affecting the U.S. universe.
The recommendation is dear news for vaccine makers such as Sanofi Pasteur and MedImmune. The latter is 1 of the highest contributors to overall U.S. 'flu vaccine supply, accounting for 40% last year. The French firm is expected to forked its manufacture capacity in the United States in 2009/10, in anticipation of enhanced cater orders from the U.S. government. MedImmune has indicated that the 'flu supply contract is expected to garner a maximum of US$28.4 jillion in revenue. However, the manufacturing of vaccines for the new strains has presented challenges for companies. Manufacturing more than 100 million doses of a 'flu vaccine usually requires a principal time of about eight months, with a potential difference rise in procurement as the wintertime months localise in.
Source - Catarina Walsh
Global Insight, Inc.www.globalinsight.com
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