From PRO-MED:

Health officials raised the alarm about a strain of swine flu that is resistant to the Tamiflu treatment as the virus claimed more lives on Tuesday [4 Aug 2009], with Viet Nam reporting its first fatal case. India and South Africa both reported their first deadly cases of the A(H1N1) virus late Monday [3 Aug 2009]. Maria Teresa Cerqueira, head of the Pan-American Health Organization office in La Jolla, California, said a Tamiflu-resistant mutation of A(H1N1) [the Influenza pandemic (H1N1) 2009 virus] had been found around the US-Mexico border in El Paso and close to McAllen, Texas. Experts had gathered in La Jolla, California, on Monday to discuss responses to the outbreak, and warned that resistant strains were likely emerging because of overuse of antivirals like Tamiflu.

“In the United States Tamiflu is sold with a prescription, but in Mexico and Canada it is sold freely and taken at the first sneeze. Then, when it is really needed, it doesn’t work,” said Cerqueira late Monday. Cases of A(H1N1) that were resistant to the anti-viral medicine have now been found in the United States, Canada, Denmark, Hong Kong and Japan.

As the northern hemisphere autumn approaches, and with it the onset of seasonal flu, the WHO is working with drug companies to ensure vaccines to cope both with H1N1 and seasonal flu will be available. World Health Organization spokeswoman Fadela Chaib said the agency hoped to give an update on its vaccine plans later this week. Leading flu vaccine makers include Sanofi-Aventis, Novartis , Baxter, GlaxoSmithKline and Solvay.

Novartis has started human testing of H1N1 swine flu vaccine candidates while Sanofi-Aventis, the world leader in flu shots, will commence within days, company officials said on Tuesday [4 Aug 2009]. The launch of clinical trials is a key part of a widening program of work being undertaken by big pharmaceutical companies as they prepare for mass vaccination from next month. GlaxoSmithKline, the other “big three” flu vaccine supplier, said it would initiate clinical studies later this month. Health care officials are relying on a vaccine to contain the spread of disease, providing a potential sales windfall for those companies that are able to deliver quickly and in large volume.

Australia’s CSL has so far been the fastest commercial operator, after starting its first clinical trials in Australia two weeks ago. Now others are catching up.

“We started a little over a week ago,” Novartis spokesman Eric Althoff said by telephone from Basel.

Benoit Rungeard, product communications director for Sanofi Pasteur, the vaccines division of the French drugmaker, told Reuters his company would start “in the coming days or next week.”

Althoff said Swiss-based Novartis was conducting its clinical trials in a number of countries, including the United States, Britain and Germany, and was testing both single and booster, or repeat, doses of vaccines. Novartis, in common with other manufacturers, will also compare vaccines with and without adjuvants — ingredients that boost the
immune system response. AstraZeneca, whose MedImmune unit makes smaller amounts of a flu vaccine that is sprayed into the nose rather than injected, said it would start clinical trials in the United States around Aug 17.

Meanwhile, a Taiwanese biotech company on Tuesday [4 Aug 2009] started mass production of a swine flu vaccine before even completing clinical trials, in a bid to get a jump before the start of the winter flu season. Adimmune Corp, the island’s only human vaccine manufacturer, said it was starting production at its plant in central Taichung. The company is due to deliver 5 million doses of A(H1N1) influenza vaccine before the end of October, according to the purchase contract it has signed with the government, said deputy CEO and president Ignatius Wei.

The company says it has completed some animal trials of the vaccine, but will only begin human trials in September, sparking criticism about the risks of manufacturing an
as-yet unproven product. But Huang Li-min, a doctor at National Taiwan University Hospital who will oversee the human trials, says Adimmune is taking a calculated risk.

“They have to do so … they are racing against time,” Huang told Agence France Presse, referring to the upcoming start of flu season. “There may be a risk for the company, but the risk is
small to an experienced company,” he said.