Friday, July 24, 2009

US: 160M doses of swine flu vaccine due in Oct.

http://news.yahoo.com/s/ap/20090724/ap_on_go_ca_st_pe/us_med_swine_flu_vaccine

Greed kills and big Pharma is willing to accept that risk, since it's only your life they are gambling with

The U.S. may have as many as 160 million doses of swine flu vaccine available sometime in October, even though manufacturers worldwide are having serious trouble brewing shots, federal health officials said Thursday.

The Food and Drug Administration may formally approve much of that vaccine before studies required to prove how well it works are completed, treating the new inoculations just like the recipe change that regular winter flu vaccine undergoes each year.

That doesn't mean mass vaccinations would start before key information from studies of thousands of volunteers is in, U.S. officials stressed Thursday. Most of those studies start next month to determine if people will need one shot or two for good protection and how high a dose should be in each shot. The earliest results should start arriving in September and October.

But the FDA told its scientific advisers it could finish the red tape of licensing much of that vaccine well before the use-it-or-not decision is made — because it's brewed exactly the same as regular winter flu vaccine, merely using the new swine influenza virus, part of the common H1N1 influenza family, as the chief ingredient. Companies just have to take the normal steps required for each year's regular winter flu vaccine, such as proving the inoculations are manufactured appropriately.

Taking the same path now will save some important time because "the virus is ahead of us," said FDA vaccine chief Dr. Norman Baylor. This "is not a rubber stamp. We do need to review some data to give us some comfort that that vaccine will provide some benefit