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H1N1 (Swine Flu): TAMIFLU EXTENSION AND VACCINE DELAY OFFICIAL

This is good news for anyone who has invested in Tamiflu…it is now officially recognized that the drug when kept at proper conditions has a shelf life of 7 years rather than 5.  However, the only entity that can legally grant that are the individual governments.  If I had any outdated Tamiflu I would hang onto it…a little efficacy is better than none at all.

TAMIFLU SHELF-LIFE EXTENSION UP TO COUNTRIES: WHO

Tamiflu, known generically as oseltamivir, is the frontline antiviral being used against the H1N1 virus, commonly known as swine flu, which is causing an influenza pandemic.

Capsules kept in government stockpiles worldwide or currently on the market carry a five-year expiry date.

Tamiflu must be taken in the first 24-48 hours to be effective
Tamiflu must be taken in the first 24-48 hours to be effective against influenza

Two-Year Extension?

The World Health Organization said on Tuesday it was up to national regulatory authorities to decide whether to extend the shelf life of the flu drug Tamiflu by two years, as recommended by Swiss drug maker Roche. The United States, Canada, Australia, Hong Kong and the European Union’s drug watchdog have extended Tamiflu’s shelf life to 7 years from 5 after company data showed the active ingredient’s longer stability, a Roche spokeswoman said.

The WHO says most people infected with H1N1 have mild symptoms and Tamiflu should be given only to flu sufferers at high risk including pregnant women or those with complications such as pneumonia. The European Medicines Agency has said it is acceptable to apply the extension to current stocks of the drug during a flu pandemic, a decision followed last month by Switzerland.

“We are working with health authorities to also extend the shelf life in other markets because it makes sense,” Roche spokeswoman Claudia Schmitt told Reuters.

Roche was providing its stability data to governments to help them extend the shelf life of their stockpiles, she said. “Governments have had stockpiles since the bird flu time,” she added, referring to the H5N1 avian flu strain which erupted in 2003 and also responds to treatment with the antiviral.  The drug manufacturer has donated about 10.65 million treatment courses to the WHO for distribution and use in the poorest countries. The first donation to the U.N. agency was made in 2004 and the second in May as H1N1 spread more widely.

http://www.reuters.com/article/healthNews/idUSTRE57H25720090818

VACCINE DELAY – 120 MILLION IS NOW 45 MILLION DOSES

The U.S. Department of Health and Human Services has long predicted it would have 120 million doses on hand by Oct. 15, but now expects just 45 million by that date because of the packaging delays.  U.S. health officials acknowledged this week that capacity issues in the manufacturers fill lines would slow the rollout of the vaccine and began hunting for factories that can get more of the liquid into vials quicker.

The same issue is occurring in Canada as well. The Public Health Agency of Canada said Tuesday that it would take some time to get all Canadians vaccinated regardless of how quickly GSK was able to deliver the vaccine. In Canada, GSK will begin producing vaccine in November, or possibly late October, and it will be Christmas before every Canadian who wants a shot can get one.

One Billion Ordered

Northern Hemisphere countries have so far ordered more than one billion doses from several drug companies, the World Health Organization said yesterday. It takes two weeks for the vaccine to be considered fully effective. And many people will require more than one shot. Which means it will be February or even March before the vaccine is protecting most who are inoculated.

Local Health Departments will decide how and who will be giving the H1N1 vaccine when it becomes available.
In the US local Health Departments will decide how and who will be giving the H1N1 vaccine when it becomes available.

Drug makers around the world have said the virus strain is producing about 30 per cent of the yield of the normal flu virus. John Treanor, a vaccine expert at the University of Rochester in New York, said even November could be too late for the vaccinations to start. “It depends on when the swine flu comes back – and that is extremely unpredictable,” Dr. Treanor said. It could return with the regular flu season in December. Or it could reappear in September, he said.

“The experience in the U.S. last summer, or early spring, seemed to be that a lot of the flu activity at least started in schools and it went away when school was over. So, if you follow that logic, you might be concerned that the next wave of this would start up when kids go back to school very shortly,” Dr. Treanor said.

“And that makes the vaccine delay a little bit more important because it would mean, at least in the beginning, your first response to any upsurge in activity will not include the vaccine because it would not be available.”

http://www.theglobeandmail.com/news/national/logjam-in-vaccine-packaging-to-delay-h1n1-flu-shots/article1256528/

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