U.S. News

European Agency Backs Glaxo Bird-Flu Shot


A first-generation experimental bird flu vaccine for use in humans from GlaxoSmithKline has won outline support from European regulators.

The European Medicines Agency said on Friday it had recommended granting a license to Daronrix, a "mock-up" vaccine that could be used as the base for producing a shot to protect people in the event of a pandemic triggered by bird flu.

Daronrix is the first vaccine to have been given such endorsement.

It would be used once a pandemic had officially been declared by the World Health Organisation or the European Union, but it marks just one approach in vaccine preparations.

Glaxo, like several of its rivals, is also working on a second-generation vaccine against the H5N1 virus strain that causes bird flu and it said it planned to submit this product for regulatory approval within the next few weeks.

This second vaccine could potentially be used as part of a pre-pandemic vaccination campaign, helping to prepare the human immune system in advance of a pandemic.

The newer vaccine -- which Glaxo has already sold to some governments -- also has the added benefit of needing very little antigen to produce a strong immune response, allowing for production of large quantities for mass vaccination.