Sanofi Pasteur releases data on H1N1 vaccine
SWIFTWATER, Pa. Sanofi Pasteur, the vaccines division of the Sanofi-Aventis Group, on Wednesday announced the final analyses of data from clinical trials of the U.S. licensed influenza A(H1N1) 2009 monovalent vaccine in adults and children.
The data confirm the immunogenicity and safety profile of the vaccine, with no serious vaccine-related adverse events reported during the 42 days of follow-up in the two trials.
“These are extremely important data,” stated Wayne Pisano, president and CEO of Sanofi Pasteur, “because they once again make clear not only the immunogenicity of the influenza A(H1N1) 2009 monovalent vaccine manufactured by Sanofi Pasteur, but also the fact that this vaccine has a safety profile similar to that typically observed with seasonal influenza vaccine in all age groups studied.”
The trials also confirm that one dose of influenza A(H1N1) 2009 monovalent vaccine induces a robust antibody response in adults — but two doses of vaccine are needed to assure a robust antibody response in children 9 years of age and younger. The two-dose regimen for these younger children is similar to the recommendations for seasonal influenza immunization in this age group.
FDA approves generic gastroesophageal reflux disease treatments
PITTSBURGH The Food and Drug Administration has given two companies approval for a generic version of a drug used to treat gastroesophageal reflux disease.
Teva Pharmaceutical Industries and Matrix Labs – the Indian subsidiary of U.S. drug maker Mylan – received approval for manufacturing lansoprazole delayed-release capsules. The drug is a generic version of Tap Pharmaceuticals’ Prevacid DR, which had sales of $2.97 billion during the 12-month period ended June 30, according to IMS Health data.
Both companies said they would begin shipping their versions of the drug immediately. The Matrix version will be sold under the Mylan Pharmaceuticals brand.
FDA approves GSK’s nonadjuvant H1N1 vaccine
PHILADELPHIA GlaxoSmithKline on Tuesday announced that the Food and Drug Administration has approved its unadjuvanted influenza A(H1N1) pandemic vaccine.
The U.S. Department of Health and Human Services has placed an order to fill 7.6 million doses of unadjuvanted H1N1 pandemic vaccine from GSK, which will contribute to the approximately 250 million doses secured by the U.S. government. The vaccine will be produced in multi-dose vials from bulk vaccine manufactured at GSK’s facility in Quebec, Canada. GSK expects to begin shipping vaccine in December and to provide all 7.6 million doses by the end of the year.
An adjuvant is a substance added to a vaccine to improve the immune response, however none of the H1N1 vaccines currently approved in the U.S. contain adjuvants.