US FDA approves vaccines for 2009 H1N1 influenza virus

The US Food and Drug Administration has approved four vaccines against the 2009 H1N1 influenza virus. The vaccines will be distributed nationally after the initial lots become available, which is expected within the next four weeks.

'Today's approval is good news for our nation's response to the 2009 H1N1 influenza virus,' said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. 'This vaccine will help protect individuals from serious illness and death from influenza.'

The vaccines are made by Australia's CSL Limited, US firm MedImmune, Swiss-owned Novartis Vaccines and Diagnostics, and Sanofi Pasteur, part of French drug major Sanofi-Aventis. All four firms manufacture the H1N1 vaccines using the same processes, which have a long record of producing safe seasonal influenza vaccines.

'The H1N1 vaccines approved today undergo the same rigorous FDA manufacturing oversight, product quality testing and lot release procedures that apply to seasonal influenza vaccines,' said Jesse Goodman, FDA acting chief scientist.

The approval was announced by Health and Human Services Secretary Kathleen Sebelius at a hearing that was held by the House Energy and Commerce Committee. The US has spent more than $1 billion to purchase and administer a total of 195 million H1N1 vaccine doses being made by five companies, including UK drugs giant GlaxoSmithKline, the Wall Street Journal reports. Ms. Sebelius said that the agency's officials are still working on that application. About 40 million to 50 million vaccine doses will be available by the middle of next month and will be distributed to each state's health department officials.

Commenting on the approval, Sanofi Pasteur noted that its US licensed Influenza A (H1N1) 2009 Monovalent Vaccine is an inactivated influenza virus vaccine indicated for active immunization of persons six months of age and older against influenza disease caused by pandemic (H1N1) 2009 virus. Sanofi Pasteur provides the only influenza vaccine licensed in the U.S. for populations as young as 6 months of age and older.

"Obtaining FDA licensure of this vaccine for A (H1N1) pandemic response is a key milestone that will enable Sanofi Pasteur to provide a licensed vaccine to the US government to support pandemic immunization efforts," said Wayne Pisano, chief executive of Sanofi Pasteur. "Development and production of an A (H1N1) influenza vaccine remains a high priority for Sanofi Pasteur and we will continue to focus our vaccine production expertise and resources on addressing this public health challenge," he added.