Americans come up with first swine flu vaccine:

http://www.news-medical.net/news/20090624/Americans-come-up-with-first-swine-flu-vaccine.aspx

24. June 2009 06:25

It has been reported in the United States that an American company has produced the first vaccine against influenza A H1N1 (swine flu).

The company based in Connecticut, Protein Sciences Corporation, won a $35-million government contract to develop an influenza vaccine using insect cell technology and Protein Sciences's director Dan Adams says the first batch of about 100,000 doses were produced last week and the manufacture of the vaccine continues.

The U.S. Department of Health and Human Services awarded the initial $35-million contract to Protein Sciences, which could be extended for another five years to reach $147 million.

According to Health Secretary Kathleen Sebelius insect cell technology has advanced in recent years to a point where it could help meet a surge in demand for U.S. based vaccines for seasonal and pandemic flu.

Swine flu, which emerged in Mexico in April, has been declared a pandemic by the World Health Organization which says swine flu has to date killed 231 people worldwide and infected more than 52,000 people in 100 countries.

The rapid spread of the new influenza strain prompted scientists around the world to race to develop a seed strain which is a necessary first step in developing a vaccine using either chicken eggs or mammalian cells.

Experts have warned that the virus could very well mutate during the southern hemisphere's flu season before returning north in a more lethal form in the autumn - this was the case in the deadly 1918 flu pandemic, which killed an estimated 20 to 50 million people around the world.

The process used by Protein Sciences produces the flu vaccine by infecting caterpillar cells with a baculovirus carrying the gene for hemagluttinin, a molecule that sticks out of the surface of the influenza virus and scientists say by using this method, vaccine candidates, clinical investigational lots, and commercial-scale vaccine production may be produced faster than by using traditional vaccine production methods.

Mr Adams says the method does not need a seed strain in order to develop a vaccine - they apparently worked with the genetic code from a dead virus sent from the Centers for Disease Control and Prevention (CDC) which means the vaccine manufacturing process is much quicker and is also safer as the caterpillars have no association with man or other animals, denying any chance for their cells to learn how to propagate human viruses.

The government grant means if the company's new insect-cell technology proves to be safe and effective, Protein Sciences will have to increase its manufacturing capability to provide a finished vaccine within 12 weeks of pandemic onset and would also have to produce at least 50 million doses of flu vaccine within six months of pandemic onset.

Adams says that should not be a problem because manufacturing a vaccine using insect cells can be easily and rapidly scaled up because it does not require the same specialized factories required to produce vaccine using egg or mammalian cells.

With emergency approval from the Food and Drug Administration (FDA) the new vaccine could be immediately available.

Swiss company Novartis, which was also awarded a U.S. government to the tune of $289 million to develop a vaccine against (A)H1N1 flu, announced two weeks ago that it was on the brink of beginning pre-clinical trials - tests in vitro and on animals - on its first batch of swine flu vaccine.

French company Sanofi-Pasteur also hopes to have doses of swine flu vaccine ready for clinical trials within weeks - Taiwan's Adimmune Corporation says it expects to complete clinical trials on its A(H1N1) influenza vaccine around September.

The award of the contract to the Protein Sciences Corporation caused a certain amount of concern because the company was reportedly on the brink of bankruptcy and liquidation, with creditors claiming they were owed $11.7 million.

Critics have questioned the government's judgment in entrusting such vital research to a financially strapped company but officials say thorough financial audits of Protein Sciences were carried out before the grant was awarded.