Sanofi says its H1N1 jab effective after one dose
pharmafile | October 2, 2009 | News story | Sales and Marketing |Â Â Sanofi, h1n1Â
Sanofi Pasteur, the vaccines division of the Sanofi-Aventis Group, has said its swine flu vaccine is effective after a single dose.
The interim analysis of the data from US trials is positive news for the company, as it was previously thought two doses of its vaccine would be necessary.
The finding puts Sanofi on par with GSK and Novartis, which have also both claimed their H1N1 vaccines offer significant protection after one dose, though Sanofi’s vaccine will be available some weeks later than its rivals’.
Wayne Pisano, president and chief executive officer of Sanofi Pasteur, said: “The development of an A(H1N1) vaccine and the efficient execution of clinical trials to evaluate the safety and immunogenicity of this vaccine demonstrate the tremendous achievements that can occur when public and private sectors work collaboratively to address public health challenges.”
Sanofi Pasteur produces approximately 40% of the flu vaccines distributed worldwide and more than 45% of those distributed in the US for the 2008-2009 influenza season.
The company began trials in the US on 6 August to test the immunogenicity and safety of its new H1N1 vaccine in adults of 18 years of age and older, including a group of 65 years of age and older, and in children 6 months of age through 9 years of age.
The results show that a single 15mcg dose of the jab, administered to adults, induces a robust antibody response 21 days post-vaccination that is considered protective.
Final data from these clinical trials, following a second dose of vaccine, will provide additional information to guide recommendations on the optimal dosage, number of doses and schedule.
Sanofi’s vaccine was licensed by the US regulator on September 15 as a ‘monovalent strain change’ to Sanofi Pasteur’s licensed seasonal influenza vaccine. It is yet to be licensed in Europe.
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