• The U.K. Government will buy 60 million doses of the A (H1N1) adjuvanted influenza vaccine from GlaxoSmithKline PLC and 30 million from Baxter
• The French Government will buy 50 million doses of the A (H1N1) influenza vaccine from GlaxoSmithKline PLC
• The Government of Belgium will buy 12.6 million doses of the A (H1N1) influenza vaccine from GlaxoSmithKline PLC
• The Government of Finland will buy 5.3 million doses of H1N1 antigen from GlaxoSmithKline PLC
• Glaxo will provide 128 million doses of the A (H1N1) adjuvanted influenza vaccine to European countries. The European orders could contribute about $1 billlion to Glaxo sales in 2009.
• The WHO estimates that the pharmaceutical industry can produce from 1 billion to 2 billion doses of H1N1 pandemic vaccine a year.
• The Australian Government ordered 10-million doses of influenza vaccine from Commonwealth Serum Laboratories (CSL).
• HHS Sets Aside $1 Billion Toward Development of Vaccine for the Novel Influenza A (H1N1).
• The U.S. Government will have 60 million vaccine doses by the end of October, 100 million more doses by the end of November and 80 million more doses each month thereafter through March 2010.

Success with adjuvanted vaccines could have implications for the use of resources devoted to development of the next generation of vaccines and for the mechanisms the government uses to accomplish its objectives. Specifically, if adjuvanted vaccines reduced the near-term risk posed by pandemic influenza because they stretched available and planned production capacity, more resources might be made available to support the development of next generation vaccines.

European countries and US took different approaches. European countries are entering into advance supply agreements with manufacturers to provide vaccines in the event of a pandemic; those governments agree to make advance payments to guarantee the supply of vaccine in the event of an influenza pandemic. The current U.S. approach is directly subsidizing vaccine development and additional production capacity.

MedImmune Vaccines Inc. of Gaithersburg, MD received a $32 million firm-fixed-price sole source contract. Sanofi Pasteur received a $12 million firm-fixed-price contract. Both Sanofi Pasteur and MedImmune will benefit from HHS funding of about $1 billion for clinical studies that will take place over the next few months and for commercial-scale production of two potential vaccine ingredients for the pre-pandemic influenza stockpile.

Sanofi Pasteur operates influenza vaccine production facilities in Swiftwater, Pa. and Val de Reuil, France. Production of the new A(H1N1) vaccine for HHS will initially occur in Sanofi Pasteur’s recently licensed influenza vaccine production facility in Swiftwater, Pa. Once ongoing seasonal influenza production concludes in the second facility in Swiftwater, A(H1N1) production can occur in both Swiftwater facilities.

In Swiftwater, Sanofi Pasteur has two licensed influenza production facilities. On May 6, 2009, the FDA licensed Sanofi Pasteur’s new influenza vaccine manufacturing facility in Swiftwater. When operating at full capacity, the new facility will have a capacity of approximately 100 million doses of seasonal influenza vaccine per year. An existing facility in Swiftwater is capable of producing 50 million doses per year and currently is producing vaccine for the 2009/2010 season. In total, the company will have a capacity equivalent to approximately 150 million doses of trivalent seasonal influenza vaccine per year in the United States when both facilities are operating at full capacity.

In Val De Reuil, Sanofi Pasteur is currently producing the trivalent seasonal influenza vaccine for the 2009/2010 season, with the capacity of 120 million doses per year. Sanofi Pasteur’s production facility in Val De Reuil is also capable of producing the new A(H1N1) vaccine.

MedImmune is producing the vaccine against the H1N1 influenza strain known as swine flu, using reverse genetics technology at its facility in the San Francisco area.

The U.S. government is setting aside $1 billion to launch development of an H1N1 swine flu vaccine to immunize 20 million people in key positions in health care, national security and emergency services.

“Preparation and planning are critical to keep Americans safe in the face of a potential pandemic,” Secretary Sebelius said. “Our goal throughout this new H1N1 outbreak has been to stay one step ahead of the virus. An important part of this effort has been our work to develop a potential vaccine because vaccines can help prevent and control influenza virus outbreaks. The actions we are taking today will help us be prepared if a vaccine is needed.”

The following companies will receive funding to produce H1N1 vaccine ingredients:

• Novartis AG – $289 million,
• Sanofi Aventis SA – $191 million,
• GlaxoSmithKline PLC – $181 million,
• Another $150 million will be directed to produce pilot lots of vaccine and to fund the clinical studies.

HHS is also in negotiations with other manufacturers to find more capacity.

With these orders, the pharmaceutical manufacturers will produce a bulk supply of vaccine antigen and adjuvant. Antigen is the active ingredient in a vaccine that causes the human body’s immune system to develop antibodies that help fight an invading virus. Depending on the results of clinical studies, adjuvants could be added to a vaccine to improve the immune system’s response and potentially reduce the amount of antigen necessary for the body to recognize and fight a virus.

Having both antigen and adjuvant on hand provides maximum flexibility in a future immunization program, if a program is recommended. For example, if needed these ingredients could be used in vaccine to help protect health providers and other members of the critical workforce, as recommended by the National Strategy for Pandemic Influenza.

With these funds the pharmaceutical manufacturers will also prepare pilot lots of potential vaccine for use in clinical studies to determine the proper dose for a vaccine, determine if adjuvants are appropriate and ensure a vaccine is safe and effective. The U.S. government will share as much information as possible from the results of these clinical studies with the World Health Organization and the global community so that other countries can benefit from the U.S. efforts to determine dosage, safety and effectiveness.

Update July12, 2009: “There’ll be another $1 billion worth of orders placed to get the bulk ingredients for an H1N1 vaccination.” U.S. Health and Human Services Secretary Kathleen Sebelius announced on July 12.

Global Pandemic Influenza Preparedness Market Forecast 2010-2015 covers market trends and opportunities in addressing pandemic influenza threat.

• Finland and Thailand on May 12 each reported two cases of swine flu in patients recently visiting Mexico.
• Cuba reported its first case on May 11.
• Mexico has reported two more deaths from the A (H1N1) virus, totaling fatalities to 58.
• Three H1N1-related deaths were reported in the United States, one in Costa Rica and one in Canada.
• More swine flu cases have been reported in Europe (Italy, Switzerland, Spain, Portugal, France, Ireland, Britain, the Netherlands, Denmark, Norway, Sweden, Poland, Germany, Austria), Latin America (Guatemala, El Salvador, Panama, Colombia, Argentina, Brazil), Middle East (Israel) and Pacific Rim (Japan, South Korea, China, Australia and New Zealand)

A (H1N1) Influenza Status Report as of May13, 2009