Sanofi Pasteur submits supplemental A(H1N1) vaccine application

Sanofi Pasteur has submitted a supplemental application to the Food and Drug Administration (FDA) for the licensure of its A(H1N1) monovalent vaccine.

The submission of the application follows recommendations by the body to evaluate the vaccines under the same regulatory process it uses to approve new viral strains contained in the annual seasonal influenza vaccines.

Commenting on the submission, Wayne Pisano, president and chief executive of Sanofi Pasteur, explained that it is consistent with the company’s commitment to working with public health officials to produce a vaccine to combat the A(H1N1) 2009 virus.

He added: “It is essential that we pursue the vaccine licensure pathway made available to us, while at the same time, continue the important clinical studies of our vaccine.”

Last month, Sanofi Pasteur welcomed the European Medicines Agency Committee for Medicinal Products for Human Use’s confirmation of the safety of the firm’s Lantus (insulin glargine [rDNA] injection) therapy.