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Biosecurity Briefing
First Pre-Pandemic Flu Vaccine Recommended for EU-Wide Marketing License By Michelle Cantu, March 7, 2008 On February 21, 2008, the European Medicines Agency (EMEA), the equivalent of the U.S. Food and Drug Administration (FDA), announced in a press release that it recommends “the authorization of... [Europe's] first ‘pre-pandemic vaccine’ for humans against influenza caused by the H5N1 virus.” This recommendation was then sent to the European Commission which has yet to authorize the sale of the vaccine.1 The vaccine, Prepandrix, is an H5N1 adjuvanted pre-pandemic vaccine manufactured by GlaxoSmithKline (GSK) plc, and has been approved for licensure by EMEA. The press release described Prepandrix as having the potential to “trigger an immune response against the H5N1 strain of influenza virus before or during an officially declared influenza pandemic.”1 According to a GlaxoSmithKline press release issued February 21, prior to EMEA’s approval of Prepandrix, GSK received a Positive Opinion from Europe’s Committed for Medicinal Products for Human Use (CHMP), which is an important regulatory step and one that is critical in obtaining an EU-wide marketing license. To reach this milestone, the vaccine was evaluated for safety, reactogenicity, immunogenicity, and cross-protection.2 On February 27, 2008, vaccine clinical findings were published in an online study in PLoS One. The most important finding of the study was the ability of an H5N1 inactivated vaccine, with adjuvant, to induce neutralizing antibodies against three recently circulating strains in clinical trials. The authors noted that “These results are encouraging, as they demonstrate that a vaccine based on an existing H5N1 strain could potentially protect against a range of different emerging H5N1 strains.”3 In related H5N1 news, the World Health Organization (WHO) reported that the cumulative number of confirmed human cases of H5N1 is currently 369, with most recent cases occurring in Vietnam and Egypt.4 To date, H5N1 has not mutated into a strain that is transmissible from person to person. However, there is recognition of the threat of a pandemic. In the GSK press release, Jean Stephenne, president and general manager of GSK Biologicals (the vaccine division of GSK), reported that, “A number of national governments have expressed significant interest in stockpiling our candidate pre-pandemic vaccine, which further highlights the important role pre-pandemic vaccination could play in comprehensive pandemic preparedness plans…”2 References
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