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EU Grants Marketing License for Pre-Pandemic Flu Vaccine

By Matthew Watson, May 23, 2008

On May 19, 2008, the Associated Press (AP) reported that GlaxoSmithKline (GSK) has been granted a marketing license by the European Commission to begin distributing the first “pre-pandemic” influenza vaccine to hit the European market.¹ GSK was granted the license after a positive opinion was written on February 21, 2008, by the Committee for Medicinal Products for Human Use (CHMP).² CHMP is a branch of the European Medicines Agency, which is equivalent to the U.S. Food and Drug Administration. The Biosecurity Briefing first reported on this issue on March 7, 2008, following the CHMP’s positive opinion.³

According to an article in the journal PLoS One, on May 20, 2008, the vaccine, Prepandrix, was developed to provide human immunity to the H5N1 influenza virus. Prepandrix is a vaccine coupled with an adjuvant (an immune system enhancer), and it has been shown in clinical trials to induce an immune response against three recently circulating strains of H5N1.⁴ The vaccine is currently indicated for persons between the ages of 18 and 60, and is well tolerated within that age group. Prepandrix has also been shown to be effective at reducing mortality due to H5N1 infection by nearly 96% in preclinical trials, according to a GSK news release on May 19.⁵

GSK intends to donate 50 million doses of Prepandrix to the World Health Organization’s (WHO) pharmaceutical stockpile, which would enhance access among populations of developing nations.⁵ With two doses required per person (an immunization and a booster), this donation would provide coverage for up to 25 million individuals.

In related H5N1 news, the AP reported on Wednesday, May 22, that Bangladesh confirmed its first human case.⁶ The Directorate General of Health Services indicated in a statement that a child had been infected with the virus in January, and the diagnosis has been confirmed by the U.S. Centers for Disease Control and Prevention (CDC). 

References

1. EU approves Glaxo bird flu vaccine. Associated Press. May 19, 2008. http://www.cnn.com/2008/BUSINESS/05/19/glaxo.vaccine.ap/index.html?eref=rss_latest. Accessed May 19, 2008.
2. European Medicines Agency, Committee for Medicinal Products for Human Use. Summary of positive opinion for Prepandrix. February 21, 2008. http://www.emea.europa.eu/pdfs/human/opinion/Prepandrix_6273608en.pdf. Accessed May 20, 2008.
3. Cantu M. First pre-pandemic flu vaccine recommended for EU-wide marketing license. Biosecurity Briefing. March 7, 2008. http://www.upmc-biosecurity.org/website/biosecurity_briefing/archive/international_biosecurity/2008-03-07-1stprepanfluvaceulicense.html. Accessed May 23, 2008.
4. Leroux-Roels I, Bernhard R, Gerard P, Drame M, Hanon E, Leroux-Roel G. Broad clade 2 cross-reactive immunity induced by an adjuvanted clade 1 rH5N1 pandemic influenza vaccine. PLoS One. 2008;3(2). http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0001665. Accessed May 20, 2008.
5. First pre-pandemic vaccine approved to help protect against pandemic influenza [news release]. London, UK: GlaxoSmithKlein; May 19, 2008. http://www.gsk.com/media/pressreleases/2008/2008_pressrelease_10048.htm. Accessed May 20, 2008. 
6. Bangladesh reports 1st human case of H5N1 bird flu. Associated Press. May 22, 2008. http://ap.google.com/article/ALeqM5gF9z7Pq5i1-tejcQFEIQo8hO9sZAD90QN6QO1. Accessed May 22, 2008.