FDA predicts more vaccine production than last year
Shipments suspended after reports of hoarding
Don’t expect a repeat of last year’s shortage of influenza vaccine this winter. Do expect, however, to hear more about preparing for a possible avian flu pandemic.
The FDA announced in October that it expects "significantly" more flu vaccine to be produced for the 2005-2006 influenza than was available last year. Four manufacturers are distributing influenza vaccine this year: Sanofi Pasteur, MedImmune Vaccines, GlaxoSmithKline Biologicals, and Chiron Corp. The FDA says it does not know the exact number of doses that will be distributed because Chiron had lowered its projections.
Much of the attention, though, has already shifted to planning for a possible pandemic caused by the H5N1 avian influenza virus. Millions of wild birds and poultry have been culled or killed. The virus remains primarily an animal disease for now and most cases have been reported in Asia and Europe; however, H5N1 has infected 125 people and killed 64, according to statistics published Nov. 9 by the World Health Organization (WHO). The cases of bird flu infection in humans have primarily been attributed to contact with infected poultry or contaminated surfaces. Health officials, however, are concerned that virus strains could mutate to become transmissible between humans.
At a November meeting in Geneva, the WHO said the world is taking the threat of an influenza pandemic seriously. The goal of the meeting was to work toward a global consensus for controlling the disease in animals while simultaneously preparing for a potential human pandemic, the organization says.
Because such a human-transmissible virus strain would be new, it may be resistant to existing antiviral medications. Four different influenza antiviral medications (amantadine, rimantadine, oseltamivir phosphate, and zanamivir) are currently approved by the FDA for the treatment and/or prevention of influenza, according to the Centers for Disease Control and Prevention (CDC) in Atlanta. The four usually work against influenza A viruses. However, H5N1 viruses identified in humans in Asia in 2004 and 2005 have been resistant to amantadine and rimantadine, the CDC says.
Media coverage of the bird flu has prompted concern about H5N1 among the public. News agencies are reporting that demand for zanamivir (Relenza) and particularly oseltamivir phosphate (Tamiflu) has risen, fueling fears that some patients, and even health officials and organizations, are trying to stockpile the drugs. In response, oseltamivir manufacturer Roche Holding AG announced in October that it had temporarily suspended shipments of oseltamivir to private buyers in the United States and Canada to ensure that enough of the antiviral drug would be available for patients with seasonal influenza. Roche also stopped supplying oseltamivir to private doctors and pharmacies in Hong Kong, saying it would only fill orders for government stockpiles, according to Reuters.
Infectious disease societies in the United States are urging the public not to panic, while also asking that federal policy-makers and local health care institutions have sufficient stockpiles to treat sick people and maintain the health care system in the event of a pandemic. On that end, the Senate approved nearly $8 billion in late October to stockpile vaccines and other drugs.
The Department of Health and Human Services (HHS) has announced plans to buy enough H5N1 influenza vaccine for 20 million people and enough influenza antivirals for another 20 million people. These supplies will be placed in the nation’s Strategic National Stockpile where they will be available for use in the event of an influenza pandemic. At time of publication, HHS had awarded a $100 million contract to Sanofi Pasteur and a $62.5 million contract to Chiron to manufacture an avian influenza vaccine. In addition, the FDA announced in October that it had formed a Rapid Response Team to work in partnership with HHS, the CDC, the National Institutes of Health, and industry, to "ensure every necessary measure is taken to provide an adequate and timely supply" of antiviral drugs to treat avian flu, should it emerge in the United States.
The agency anticipates that oseltamivir production can be in full gear within 12 months.
Roche also announced in early November that it will increase its own production capacity by the end of 2006 so that it can produce 300 million treatments of oseltamivir annually. This is a 10-fold increase over the capacity in 2004.
Bush plan will cost billions
Also in November, President Bush announced a $7.1 billion plan to guard against pandemic influenza. The request includes $6.7 billion in additional 2006 appropriations for HHS.
Approximately $4.7 billion would go toward investments in creating vaccine production capacity and stockpiles, $1.4 billion to stockpile antiviral drugs, and $555 for surveillance, public health infrastructure, and communications, including $100 million for state and local preparedness.
Some groups criticized Bush’s plan, saying that preparedness for a pandemic would take too long. The plan also largely bypasses international institutions, including the World Health Organization and the Global Fund to Fight AIDS, Tuberculosis and Malaria, which have expertise in supporting the development of health systems, says the Global AIDS Alliance in Washington, DC.
The Infectious Diseases Society of America in Alexandria, VA, however, applauds the president for giving the issue the attention it warrants. "The president’s strategy provides an initial framework with strong potential. Success will require a long-term commitment and coordinated effort from the state and local government, the medical profession, business, and the American people."
Dont expect a repeat of last years shortage of influenza vaccine this winter. Do expect, however, to hear more about preparing for a possible avian flu pandemic.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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