FDA to speed new flu vaccines to market (2 for 1 marketing)

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Highlights: They even allow for the possibility of one day vaccinating people against a potential future pandemic strain at the same time they get their regular winter flu shot. "If that particular strain were to become the pandemic, at least we would not be naive to that strain. You could have that strategy," said Dr. Norman Baylor, head of FDA's vaccine office. But rather than focus on any one strategy, the draft guidelines spell out different approaches to approval. "What we really want to do is get manufacturers really ramped up, and bring on new manufacturers, so we can meet that target of making sure we have the capacity to make enough influenza vaccine ... for everyone who needs it," Baylor said. In the case of a previously approved flu vaccine, manufacturers could tweak the vaccine for use against a new flu strain without having to

seek a new license from the FDA, according to the draft documents. Additionally, a manufacturer could receive "accelerated approval" for a new flu vaccine by performing studies showing that recipients experienced a surge in protective immune-system cells. http://www.cnn.com/2006/HEALTH/conditions/03/03/birdflu.fda.ap/

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This sounds to me like a proposal to give vaccine manufacturers a go-ahead to bring their products to market, without them having to provide adequate assurances of the safety of their products. Aasa <redhead60707@...> wrote: Highlights: They even allow for the possibility of one day vaccinating people against a potential future pandemic strain at the same time they get their regular winter flu shot. "If that particular strain were to become the pandemic, at least we would not be naive to that strain. You could have that strategy," said Dr. Norman Baylor, head of FDA's vaccine office. But rather than focus on any one strategy, the draft guidelines spell out different approaches to approval. "What we

really want to do is get manufacturers really ramped up, and bring on new manufacturers, so we can meet that target of making sure we have the capacity to make enough influenza vaccine ... for everyone who needs it," Baylor said. In the case of a previously approved flu vaccine, manufacturers could tweak the vaccine for use against a new flu strain without having to seek a new license from the FDA, according to the draft documents. Additionally, a manufacturer could receive "accelerated approval" for a new flu vaccine by performing studies showing that recipients experienced a surge in protective immune-system cells. http://www.cnn.com/2006/HEALTH/conditions/03/03/birdflu.fda.ap/ Brings words and photos together (easily) withPhotoMail

- it's free and works with .