Vaccine

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At lecture at Newton-Wellesley Hospital in MA, Dr. Michael Young indicated that phase III of clinical trials has been completed on vaccine study and results are very promising. There are still several more years of testing required, but it may be available sooner than we anticipated. I sure hope so!

[This message has been edited by kstreeter (edited September 20, 2002).]

[This message has been edited by kstreeter (edited September 20, 2002).]

On Sep 21, 2002

If you look at Tanox's website ([url]http://www.tanox.com[/url]), it shows that they are at the end of Phase II trials. If you check the news releases on the website, the last one (a positive one)regarding the vaccine was on May 1.

Judy

On Sep 21, 2002

Hmmm...perhaps that is because the data has not been published yet???

On Sep 24, 2002

The trials are being conducted on children 12 and over, therefore, when it is FDA approved, it will be approved only for children 12 and over. I have been told that that doesn't mean that we can't find an allergist who will prescribe it for our children anyway, but obviously health insurance won't cover it.

On Sep 24, 2002

Look at the link that Ethan's Mother posted. It says they have reached the primary endpoint for Phase II testing. It's also good news about being on the fast track. Wonder when they will start Phase III? They may need additional subjects for a Phase III trial, and didn't they have difficulty enrolling subjects for Phase II?

Judy

On Sep 24, 2002

About the insurance, my daughter`s allergist has already said we are the first ones he will call when it is approved (YEAH!) and she is only 7. He said probably insurance may not cover it at first, but I could write a letter and request "compassionate use", due to the severity of my daughter`s pa. We have not gone into the specifics of what the letter should say, since it is not yet time to do it. Can someone explain to me what the thing is about the six months in the press release posted by Ethan`s mother? Does this mean our allergists will be able to prescribe it in six months? Maybe I am being overly optimistic.

On Sep 26, 2002

I am a pharmaceutical rep, and sometimes the FDA's timelines and "red tape" can be quite confusing. After reading several media reports, I contacted Tanox. They stated that Phase II trials have been completed. After Phase III trials have been completed, then the FDA will guarantee a review the drug within 6 months of application. Since this drug is a "life-altering" medication, the FDA has applied a fast-track designation. Only those drugs that offer drastic improvements in the quality of life receive this designation. Hopefully, the phase III trial will end early if endpoints are met sooner than expected. If that is the case, then the product might be available earlier. As for a pediatric indication, that would take additional studies and time. If the product is successful, most allergists would prescribe the injection. Most insurance companies will probably not cover the product in the beginning. It is supposed to be quite costly.

[This message has been edited by docd3122 (edited September 26, 2002).]

On Sep 26, 2002

Any indication when Phase III trials will begin?

Judy

On Sep 26, 2002

How costly is "quite costly"? Any idea of the dollar amount and is the injection monthly?

On Sep 30, 2002

My allergist stated that most insurance companies would not cover the product after the launch. He felt injections could cost 5$50-$100 a piece. Injections are to be given every 3-4 weeks. Since Phase III trials have not been completed, pricing is variable. Novartis, the company marketing the product will have their managed care reps working with insurance companies. It's in their best interest to make sure this product is adequately covered by these companies to increase sales. I see great incentive for them to cover these injections. Think of the billions of dollars are spent each year on emergency/daily treatments and medications. They would be fools not to cover this injection. But, I'm a bit biased with two PA children........

On Sep 30, 2002

Did you say $50 to $100 each? That would be great; I thought it would be more like $1000 each. If I could buy some safety for my child, and some peace of mind for roughly $1200 a year, it is well worth it. I realize it is not a small amount of money, but at least it is do-able if we cut some corners elsewhere.

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