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A new swine flu vaccine was approved yesterday by the United States’ Food and Drug Administration (FDA). This is the first long-anticipated step, as the government looks to start mass vaccinations next month.

The vaccine is made by CSL Ltd. of Australia, Switzerland’s Novartis, France’s Sanofi-Pasteur and the U.S.-based Medimmune.

The bulk of the vaccines should start arriving on October 15, and it should be available at approximately 90,000 locations in the U.S. The Government has ordered 195 million doses, and will order more if needed.

After trading at a 52-week high of US$7.79 on Tuesday (September 1), Novavax Inc.’s shares relapsed yesterday, plunging to to 10.68% by the close of trading. Shares of the vaccine-maker took a hit after Oppenheimer Holdings Inc. cut its rating on Novavax stock to “perform” from “outperform”.

Prior to this unpleasant report, Novavax had been receiving positive attention for the successful mid-stage testing of its seasonal vaccine which uses virus-like particles to induce immune responses against three strains of viruses, including the H1N1 or “Swine Flu” virus.

The World Health Organization has said that vaccine manufacturers are on track to start delivering the first batches of Swine Flu vaccine some time next month (September). Several drug manufacturers have reportedly started testing their vaccines on humans, and early safety results should be available by next month, thus clearing the way for its use.

Drug regulators in the U.S. and Europe have a fasttrack drug approval process that will make the vaccine available even before extensive safety tests are completed. The World Health Organization does expect to see reports of side effects once vaccine distribution starts, and is recommending that the first vaccine recipients be health-care workers.

Swiss drugmaker Novartis has reportedly begun to test its swine flu vaccine on humans. These are said to be the company’s first swine flu tests on humans, and it will test the vaccine’s safety and whether one or two shots are necessary.

Novartis’ swine flu vaccine is being tested in a yearlong trial of 6,000 people of all age groups and drawn from the following countries – Germany, Britain, and the United States. Novartis has said also that their swine flu vaccine will likely be on the market before the trial finishes. Novartis expects to start shipping their swine flu vaccine in the last quarter of 2009, and will reportedly continue the deliveries next year.

Half of Novartis’ swine flu vaccines that are being tested now were grown in chicken eggs (the traditional way of making flu vaccines), while the other half use a new cell-based technology.

The Novartis swine flu vaccines being tested in Europe have an adjuvant (an ingredient used to boost the body’s immune response), while in the United States, Novartis will be testing vaccines both with and without adjuvants.

Once Novartis receives preliminary data from this swine flu vaccine trial, they will submit this information to drug regulators including the European Medicines Agency. European and U.S. regulators have a fast-track process for approving swine flu vaccine – in order to ensure that it is available before the traditional flu season starts in the fall. The swine flu virus is expected to surge at that time.

With Swine Flu confirmed as an official pandemic, the race is now on among drug companies to produce a Swine Flu vaccine.

GlaxoSmithKline said recently that it would be ready to begin large-scale vaccine production within a few weeks. Sanofi-Aventis also said recently that it had started working on its own version.

Meanwhile, Swiss pharma giant Novartis announced on Friday (June 12) that it had created an experimental vaccine that has not been tested in people. Novartis’ vaccine was reportedly made via a cell-based technology that may prove faster than the traditional way of making vaccines (i.e. through the use of chicken eggs).

The World Health Organization (WHO) has estimated that approximately 2.4 billion does of pandemic vaccine could be available in about a year.

As swine flu cases now top 6,600 worldwide, vaccine makers and other experts met yesterday at the World Health Organization (WHO) to discuss the tough decisions that must be made quickly in order to fight the evolving swine flu virus.

Pharmaceutical companies are said to be ready to begin making a swine flu vaccine — but there are concerns, especially given that the virus may mutate, so many questions abound: For e.g. how much of the swine flu vaccine should be produced? How will it be distributed? Who should get it? etc.

The group’s recommendations will be passed on to WHO Director-General Margaret Chan, who is expected to issue advice to vaccine manufacturers and the World Health Assembly next week.