US seeks to fast-track flu vaccine

US officials should help drug companies speed the supply of swine flu drugs and vaccines, making at least some shots available…

US officials should help drug companies speed the supply of swine flu drugs and vaccines, making at least some shots available by mid-September instead of mid-October, White House science advisers said today.

They also urged the US Food and Drug Administration to quickly decide on new, intravenous formulations of flu drugs, including current drugs such as Roche AG's Tamiflu and GlaxoSmithKline's Relenza but also BioCryst Pharmaceuticals' experimental drug peramivir, lifting its shares 13 per cent to $11.38 in midday trading on Nasdaq.

The President's Council of Advisors on Science and Technology said the department of health and Human Services should tell manufacturers to begin to "fill and finish" H1N1 flu vaccines right away - putting them into vials for shipment.

"Such a decision would need to be taken almost immediately," the group said in a report.

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Most experts believe people will need two doses of the vaccine, delivered at least two weeks apart, to
 develop full immunity to the new H1N1 flu.

Last week the US Department of Health and Human Services said only 45 million doses of the new H1N1 vaccine would be on hand in mid-October, instead of 120 million previously forecast, with 20 million a week due after that.

HHS plans to eventually vaccinate at least 160 million people by December, with pregnant women, healthcare workers, children and young adults at the front of the line.

Five companies make swine flu vaccine for the U.S. market -- AstraZeneca's MedImmune unit, CSL Ltd, GlaxoSmithKline Plc, Novartis AG and Sanofi-Aventis SA.

The Council also recommended a quicker decision on intravenous versions of flu drugs. People who are seriously ill can only be given drugs intravenously.

Tamiflu, a pill known generically as oseltamivir, is made by Roche under license from Gilead Sciences. Relenza, which is inhaled, is known generically as zanamivir and is made by Glaxo under license from Biota.

Drugmakers are working on intravenous formulations of both and BioCryst is working to perfect peramivir, which is designed to be given intravenously.

The advisers said the US Centers for Disease Control and Prevention should strengthen guidelines on when these drugs should be given. Tamiflu and Relenza can treat and prevent all types of influenza A if given soon enough but the World Health Organization says they should be saved only for people who are at high risk of serious complications or death.

And the panel said the government should take advantage of the pandemic to improve flu surveillance.

Currently only a fraction of people with flu-like symptoms ever get a flu test and statistics on flu are extrapolated. For instance, the CDC and WHO both have stopped counting actual H1N1 infections, saying only that more than a million people have likely been infected in the United States alone.

Pandemic H1N1 is circulating widely and experts expect it to worsen in the northern hemisphere's autumn as schools get under way. The council's report says the virus, although moderate, poses a serious health threat to the United States because it is likely to infect so many people.

Reuters