Federal Government Awards Sanofi Pasteur $100M Avian Flu Vaccine Contract
The federal government has awarded Sanofi Pasteur a $100 million contract to supply an experimental avian flu vaccine for the Strategic National Stockpile, the Philadelphia Inquirer reports.
According to Sanofi-Aventis, the parent company of Sanofi Pasteur, the contract calls for the company to manufacture the vaccine at a Pennsylvania facility for the 2008-2009 flu season. In addition, the federal government will pay Sanofi Pasteur additional fees to store, formulate and fill the vaccine (Loyd, Philadelphia Inquirer, 9/16).
Federal health officials in August announced that the vaccine for the H5N1 avian flu strain -- which has spread among birds in Asia and Russia and has infected more than 100 humans -- prompted an effective immune response in clinical trials on healthy human volunteers. Additional trials of the vaccine will continue to determine the most effective dosage of the vaccine, the number of injections required to receive protection and whether the addition of other ingredients could improve the potency of lower dosages (California Healthline, 8/9).
The federal government had previously purchased some doses of the vaccine for trials, but the new contract marks the first effort to develop a national stockpile in the event of an avian flu outbreak, HHS spokesperson Bill Hall said (Rockoff, Baltimore Sun, 9/16). The federal government plans to purchase a supply of the vaccine for 20 million residents in the event of an avian flu outbreak, as well as a supply of antiviral medications for 20 million additional residents.
In a statement, HHS Secretary Mike Leavitt said that the federal government has purchased 84,300 doses of the antiviral medication Relenza, manufactured by GlaxoSmithKline, for $2.8 million (Philadelphia Inquirer, 9/16). In addition, the federal government has stockpiled a supply of the antiviral medication Tamiflu for 4.3 million residents and plans to purchase additional doses (Neergaard, Associated Press, 9/15).
Hall said that, because the most effective dosage of the Sanofi Pasteur avian flu vaccine remains undetermined, the estimate of the number of doses available under the $100 million contract ranges from two million to 20 million (Baltimore Sun, 9/16). Trials indicate that a "very large dose of the vaccine would be recommended by health officials," the Wall Street Journal reports (Zhang, Wall Street Journal, 9/16).
Hall also said that the vaccine might not provide full protection because the H5N1 avian flu strain might mutate. However, federal health officials hope that the vaccine will provide at least some protection. The purchase of the vaccine is "an insurance policy," Hall said (Baltimore Sun, 9/16).
However, Jeffrey Levi, senior policy adviser at the Trust for America's Health, said, "It's a step in the right direction, but a fraction of the investments the country is going to need to make to be fully prepared for a pandemic," adding, "The problem is that the administration has to ask for more money" (Wall Street Journal, 9/16).
In related news, international and federal health officials on Thursday warned that nations must take action to prepare for a potential avian flu outbreak.
Robert Webster, a researcher at St. Jude's Children's Research Hospital in Memphis, Tenn., said at a briefing on Capitol Hill that a future avian flu outbreak is certain. He added, "The only thing (the H5N1 virus) doesn't know how to do is transmit from me to you." Webster recommended that the U.S. begin to stockpile vaccines and antiviral medications because the process could take years (CQ HealthBeat, 9/15).
Meanwhile, World Health Organization Director-General Lee Jong-wook told attendees at a U.N. meeting, "Human influenza is coming, ... and no government, no leaders can afford to be caught off-guard." According to Reuters/Boston Globe, Jong-wook made the statement after President Bush on Wednesday announced to the U.N. the formation of the International Partnership on Avian and Pandemic Influenza, a program under which nations and international organizations would combine resources and expertise to fight avian flu.
Andrew Natsios, head of the U.S. Agency for International Development, said, "The consequences for the global economy could be massive. Without international and national responses, we will not stop the disease."
Paula Dobriansky, undersecretary of state for democracy and global affairs, said that the U.S. should hold a meeting of senior officials in Washington, D.C., to discuss the issue (Eckert, Reuters/Boston Globe, 9/16).