Pandemic Preparedness Picks Up Pace with First Flu Vaccine Approval

The FDA’s (Rockville, MD, www.fda.gov) first approval in the United States of a vaccine for humans against the H5N1 influenza virus marks an important step forward in protecting the public against a pandemic influenza outbreak. The vaccine, produced by Sanofi Pasteur, the vaccine division of Sanofi-Aventis (Paris, France, www.sanofi-aventis.com) could be used in the event the H5N1 avian virus were to develop the capability to spread from human to human, resulting in the rapid spread of the disease. Should such an influenza pandemic emerge, the vaccine may provide early limited protection in the months before a vaccine tailored to the pandemic strain of the virus could be developed and produced.

Sanofi Pasteur will not sell the vaccine commercially. Instead, the vaccine has been purchased by the US federal government for inclusion in the US Strategic National Stockpile for distribution by public health officials if needed.

Other Flu Vaccine Developments
The H5N1 influenza vaccine’s immunization consists of two intramuscular injections, given approximately one month apart. Meanwhile, several other manufacturers across the globe are gearing up to develop a next generation of influenza vaccines for enhanced immune responses at lower doses, using technologies intended to boost the immune response. Recently, Baxter International, Inc. (Deerfield, IL, www.baxter.com), announced final Phase 1 and 2 data for its adjuvant-free investigational pandemic H5N1 influenza vaccine and plans to initiate a Phase 3 clinical trial of the candidate vaccine in Europe to confirm the study results.

The Dutch biotechnology company Crucell N.V. (Leiden, The Netherlands, www.crucell.com) has received a European Commission-funded grant toward the development of a pandemic influenza vaccine. The €1.7 million grant, which was awarded to a consortium of nine leading universities and companies working in the field of influenza research, will finance preclinical and clinical testing of H5N1 vaccines. Also, Crucell has completed an influenza alliance with ADImmune Corporation (Taichung, Taiwan, www.adimmune.com). Under the terms of the deal, ADImmune will use Crucell’s virosome technology to produce a virosomal adjuvanted influenza vaccine for specified markets.

In another vaccine alliance, Eden Biodesign Ltd. (Liverpool, UK, www.edenbiodesign.com) has been selected by ImmBio (Cambridge, UK, www.immbio.com), a biotechnology company developing next generation anti-infective vaccines, to provide a range of development and manufacturing services for its leading influenza vaccine programme. This project targets both seasonal and pandemic flu.

California-based Vical Incorporated (San Diego, CA, www.vical.com) has presented new data from a recently completed study in mice showing hat a seasonal influenza vaccine formulated with the company’s Vaxfectin adjuvant generated up to 60­-fold higher antibody responses than an unformulated vaccine at the same dose. The formulation of Sanofi Pasteur's Fluzone commercial vaccine with Vaxfectin also allowed a nearly 10-fold reduction in vaccine dose while generating equivalent or better antibody responses compared with unformulated vaccine, even at the lowest doses tested. Vical is developing its own Vaxfectin-formulated DNA vaccine designed to protect against emerging strains of influenza virus that have the potential to cause a pandemic.