Is pharma ready this time?

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Pharma and biotech companies are competing to have enough vaccine on hand for the next swine flu (H1N1) outbreak. They missed the one last winter and spring, and their response has uniformly been: We'll be ready next time.

Traditional vaccine technology requires one chicken egg per dose, so you can't start to get ready until you identify the strain of the causative virus. That means you are apt to be forever lagging one outbreak behind, keeping your fingers crossed that the vaccine will still work.

The earliest a vaccine will be ready is October, but since the virus evolves so rapidly that it is a constantly moving target. Hence no one can be sure that the vaccine will still “recognize” the virus. And if it doesn't, it won't work.
The  Department of Health and Human Services  has made a billion dollar commitment to have enough vaccine on hand for the next outbreak, which the experts are predicting will come this fall or winter. Out of this fund it has given MedImmune a $90 million contract to prepare enough of its FluMist vaccine to cope with the demand.

Last flu season there was so much hoarding of Tamiflu and Relenza, two antiviral drugs, that when MM&M columnist Marc Siegel, MD, took a box of Tamiflu samples to a TV studio for demonstration purposes, he discovered when he left that someone—presumably one of the producers—had taken most of them.

Meanwhile, several biotech companies, making an end run around the traditional egg technology; starting from scratch, they can't be sure they will be ready either.

If you want to place a bet as to who will win this race, there is one contender: Antigen Express.

Douglas Powell, PhD, director of immunobiology at Antigen Express, a subsidiary of Generex Biotechnology, told MM&M  that the consensus at a symposium on swine flu and other novel flu pandemics he had attended was that the H1N1 virus would continue to evolve, and that therefore companies using traditional egg cell technology would have a hard time keeping up with the demand, not only for the swine flu pandemic but for any future flu outbreak.

By contrast, he claims, that his company uses fourth-generation synthetic peptide technology that permits more rapid development, beginning with a swine flu vaccine. That, he goes on, “has so far eluded all major companies, despite HHS funding.” The reason, he explains, is that their technology has not evolved since the first generation of live virus vaccines against smallpox.

Second-generation vaccines utilize “killed” viruses that have been chemically inactivated—such as today's seasonal flu vaccines.

Third-generation vaccines use recombinant proteins that are expressed in yeast or insect cells.

The fourth generation of vaccines, which his company is exploring for swine flu, use peptides to stimulate T-helper cells. These vaccines have the advantage that they are not virus-specific; because T-helper cells are basic to the immune response, once you solve the scientific challenge you have a vaccine that works equally well not only H1N1, but any future evolving flu epidemics. Also, they can be synthesized rapidly and in large quantities, so we will not only have lapped the swine flu virus, but be ready for whatever flu epidemic comes next.

Warren Ross is editor at large of MM&M

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