Swine flu: GlaxoSmithKline will donate 50 million vaccine doses to poor nations

The U.S. may worry about having enough H1N1 vaccine to protect its population from swine flu, but at least it's getting precious doses. Many developing countries, which can't afford the sometimes expensive medication, don't have any at all.

That may change soon. The U.K.'s GlaxoSmithKline (GSK) said Tuesday it will donate 50 million doses of its H1N1 influenza vaccine to developing countries most in need through the World Health Organization. Initial shipments will start by the end of November with shipments to be completed by May 2010, the WHO said. GlaxoSmithKline's move comes as several other pharmaceuticals have pledged similar measures.

"We welcome this very generous donation by GlaxoSmithKline, which will go to protect the health of the world's poorest people. This is a real gesture of global solidarity towards those who would not be otherwise able to have access to the vaccine," said Dr. Margaret Chan, the WHO's Director-General, who has in the past called for "international solidarity to provide fair and equitable access to pandemic influenza vaccines for all countries."

In its statement, the WHO added it has a list of 95 developing countries that are eligible to receive donated vaccines, and it aims to secure enough vaccines to cover 10% of the population of these countries. The WHO hopes to secure about 200 million doses.

In addition to Glaxo, the WHO says of the 25 companies making the vaccine, France's Sanofi-Aventis (SNY) will give a total of 100 million doses, while MedImmune and CSL will donate 3 million doses each. The WHO is hoping Novartis (NVS) will also donate soon.

Will Promises Be Kept?

Also, a number of countries promised to donate doses out of the stock they purchased for themselves, according to an interview with Marie-Paule Kieny, head of WHO's Initiative for Vaccine Research. The U.S. has promised to donate 10% of its own vaccine purchases and deliver in early December. Australia committed to giving vaccines by November.

Other countries, such as France and the U.K. may also donate. The donated vaccines coming shortly should inoculate up to 2% of the population in these countries.

But these are still just promises. For example, the U.S. originally said it would donate 10% of the vaccine it ordered for its citizens after it had received 40 million doses. But the country modified that plan after President Obama declared the H1N1 epidemic a national emergency.

The White House said the donations would begin only after the needs of the most at-risk population in the U.S. are met. The U.S. isn't the only one that is altering its intentions to donate vaccines. Other nations that promised such donations have done the same.

Questions About Equitable Distribution

There are other complications, too, that come with the donations. The WHO is requiring certain conditions be met by nations that want the donated vaccines. One is to hold the vaccine manufacturers harmless in case of adverse events, because the WHO cannot bear that responsibility.

Meanwhile, in the U.S. there has been outrage over how the vaccine has been distributed. Causing concern was the fact that Wall Street firms or Guantanamo detainees got the vaccines. In Canada, too, there have been cases of queue jumping, not to mention vaccination of Taliban detainees in Afghanistan causing anger. In Europe, though, most swine flu shots are by invitation only.

Until solidarity and equitable distribution at home isn't met, it's perhaps too much to expect a global equitable system of vaccine delivery.

Expanding the Use of Vaccines

While countries scramble to distribute the vaccine, researchers are rushing to build better defenses against H1N1 -- and other ills. A recent vaccine confab in Washington, D.C., featured a variety of different new vaccine technologies. Attracting attention was the keynote speaker of 7th Annual Vaccines: "All Things Considered" conference, Daniel Zimmerman of Cel-Sci Corp. (CVM), whose work involves both H1N1 influenza and inflammatory diseases.

Cel-Sci's LEAPS (for Ligand Epitope Antigen Presentation System) technology allows scientists to direct an immune response against specific disease epitopes (an area on the antigen that a compound stimulates to get a desired result) without producing certain proteins that could produce potentially harmful inflammatory reaction.

A Cel-Sci study showed that immunization with a LEAPS immunogen for herpes simplex virus activates a protective immune response against the virus in mice, while a LEAPS immunogen for treatment of rheumatoid arthritis reduces the production of pro-inflammatories to block the progression of disease in mice. The company on Monday presented data from a study it conducted in collaboration with Northeastern Ohio Universities College of Medicine and Pharmacy on its LEAPS vaccine technology.

What's promising, researchers say, is the LEAPS immunogen's ability to activate the desired immune response without generating pro-inflammatory responses, which should make for inherently safe vaccines.

Cel-Sci, of course, is also trying its hand in LEAPS-H1N1 treatment. CEO Geert Kersten said: "We feel that this new data is encouraging and supportive of our H1N1 treatment for hospitalized patients" where inflammatory reactions can contribute to patients' deaths. In fact, the U.S. Food and Drug Administration has been so impressed with the work that back in September, it gave the company an expedited approval to go ahead with human clinical trials for H1N1. On Friday, Cel-Sci announced it was ready to begin with the trials at The Johns Hopkins Bayview Medical Center.

Beyond Infectious Diseases

Many other companies were set to present reports at the conference, including Immunovaccine, a small vaccine development company in Halifax, Nova Scotia, which is investigating a therapeutic vaccine against ovarian, breast and prostate cancer. Another was Advaxis, which has developed what it calls Listeria technology. This approach uses bioengineered bacteria to activate the immune system to treat cancer, infectious diseases or allergic syndromes. It has been used against several cancers and has been able to consistently demonstrate therapeutic responses resulting in complete tumor regression.

From private companies such as EpiVax, VaxArt and VaxDesign to the buzzing Novavax (NVAX) and Vical (VICL), vaccines seem all the rage. Researchers are looking into not just traditional vaccines for infectious diseases such as flu, AIDS, malaria and so on, but also for noninfectious diseases such as cancer and allergies. Another burgeoning field is therapeutic vaccines, which are administered after the patient becomes sick. They're being investigated in wide areas from cancer to smoking and cocaine addiction.

With pharmaceutical companies facing increasing challenges because of drugs losing patent protection, increasing generic competition and not-so-promising new-drug pipelines, vaccines could offer the next growth opportunities. Just this last quarter, vaccine sales lifted revenues at GlaxoSmithKline, AstraZeneca (AZN) and Sanofi Aventis. Novartis and Merck (MRK) are also set to get a boost from the swine flu pandemic. It's no wonder then that drugmakers are buying or making investments in this business. This trend will likely continue.

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