Bird Flu: Science and Policy

[DewDiligence]

European Regulators Approve Glaxo's Bird-Flu Vaccine

http://online.wsj.com/article/SB120362217503883593.html

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By JEANNE WHALEN
February 21, 2008 3:41 p.m.

European regulators have given preliminary approval to a vaccine designed for use in advance of a bird-flu pandemic to help people build immunity against the lethal H5N1 virus.

The vaccine, made by GlaxoSmithKline PLC, is the first vaccine designed to be used before an outbreak occurs. The European Medicines Agency recommended Thursday that the vaccine be approved for sale; the European Commission must still give final approval. A Glaxo spokesman said the company plans to submit the vaccine for U.S. Food and Drug Administration approval by the end of this year.

In a statement, Glaxo said that a "number of national governments" have expressed interest in stockpiling the vaccine, called Prepandrix. The Glaxo spokesman declined to comment on whether the shot would be sold directly to consumers.

The H5N1 virus has been circulating for several years, killing thousands of birds and hundreds of people, but has not yet mutated into a strain that could be easily passed from person to person. If that does happen, it would spark a pandemic.

Prepandrix is designed to raise immunity against several strains of the H5N1 virus. If a pandemic were to happen, vaccine makers would attempt to isolate the strain causing the outbreak and make a more precise vaccine to protect people against it.

A number of other companies are developing bird-flu vaccines, including Sanofi-Aventis SA, Novartis AG, CSL Ltd. of Australia and Baxter International Inc., of Deerfield, Ill.

Last year, the FDA approved a Sanofi vaccine that targets an early strain of H5N1 but has some drawbacks: it showed limited efficacy in clinical tests and must be taken in two large doses. Public health officials worry that vaccines requiring large doses of the active ingredient, or antigen, aren't practical because there is limited manufacturing capacity worldwide. The U.S. government has stockpiled doses of the Sanofi vaccine until more advanced shots are available.

Glaxo's vaccine, Prepandrix, contains an extra ingredient known as an adjuvant, which allows a low level of active ingredient to be used in each shot.
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