Vaccine

Posted on: Fri, 09/20/2002 - 12:58pm
Anonymous's picture
Anonymous (not verified)

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

Posted on: Sat, 09/21/2002 - 5:11am
JudyH's picture
Offline
Joined: 03/07/2002 - 09:00

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

Posted on: Sat, 09/21/2002 - 11:52am
Anonymous's picture
Anonymous (not verified)

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

Posted on: Tue, 09/24/2002 - 12:25am
Heather2's picture
Offline
Joined: 09/25/2001 - 09:00

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.

Posted on: Tue, 09/24/2002 - 2:39am
JudyH's picture
Offline
Joined: 03/07/2002 - 09:00

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

Posted on: Tue, 09/24/2002 - 5:22am
Carefulmom's picture
Offline
Joined: 01/03/2002 - 09:00

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.

Posted on: Thu, 09/26/2002 - 1:31am
docd3122's picture
Offline
Joined: 01/16/2001 - 09:00

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).]

Posted on: Thu, 09/26/2002 - 4:05am
JudyH's picture
Offline
Joined: 03/07/2002 - 09:00

Any indication when Phase III trials will begin?
Judy

Posted on: Thu, 09/26/2002 - 5:00am
Carefulmom's picture
Offline
Joined: 01/03/2002 - 09:00

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

Posted on: Mon, 09/30/2002 - 1:36am
docd3122's picture
Offline
Joined: 01/16/2001 - 09:00

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........

Posted on: Mon, 09/30/2002 - 9:01am
Carefulmom's picture
Offline
Joined: 01/03/2002 - 09:00

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.

More Community Posts

Peanut Free and Nut Free Community

create a new community post
Latest Post by penelope Mon, 10/14/2019 - 12:56pm
Comments: 0
Latest Post by penelope Mon, 10/14/2019 - 12:52pm
Comments: 1
Latest Post by Italia38 Tue, 10/08/2019 - 12:19pm
Comments: 3
Latest Post by Italia38 Tue, 10/08/2019 - 12:18pm
Comments: 1
Latest Post by penelope Mon, 10/07/2019 - 7:19pm
Comments: 2
Latest Post by penelope Mon, 10/07/2019 - 7:16pm
Comments: 10
Latest Post by penelope Mon, 10/07/2019 - 7:13pm
Comments: 13
Latest Post by penelope Mon, 10/07/2019 - 7:10pm
Comments: 9
Latest Post by mom2two Mon, 09/16/2019 - 1:03pm
Comments: 18
Latest Post by desmond Mon, 09/16/2019 - 1:00pm
Comments: 1
Latest Post by desmond Mon, 09/16/2019 - 12:58pm
Comments: 19
Latest Post by TeddyCan Mon, 09/09/2019 - 4:32pm
Comments: 10
Latest Post by DTurner Mon, 09/09/2019 - 4:31pm
Comments: 5
Latest Post by B.M.18 Mon, 09/09/2019 - 4:30pm
Comments: 3
Latest Post by abolitionist146 Mon, 09/09/2019 - 4:28pm
Comments: 2
Latest Post by nutfreenyc Mon, 09/09/2019 - 4:19pm
Comments: 4
Latest Post by AllergicTeen2 Mon, 09/09/2019 - 4:18pm
Comments: 2
Latest Post by PeanutAllergy.com Fri, 09/06/2019 - 1:52pm
Comments: 1

More Articles

You might have wondered if small amounts of an ingredient can be added to a food product without being declared on the food’s label. The FDA...

Is it possible to eat your way to a food allergy cure? Scientists think it’s...

There are many reasons why you may want to substitute almond flour for wheat flour in recipes. Of course, if you have a...

Not all oils are created equal. Some oils are high in saturated fats or in trans-fatty acids – not good for general health. Some are partially...

It may never be safe to begin feeding peanut butter to your baby or toddler if you have peanut allergies in your family. If either parent or one...

More Articles

More Articles

What is a peanut allergy? It is a reaction that occurs in the body after eating peanuts or peanut...

For those with severe food allergies, flying can be a stressful process. Here are...

Approximately one out of 13 children under age 18 are allergic to at least one food, though many of them will outgrow their allergy by the age of...

Fact 1: Over a third of food allergy reactions happen after the first known oral...

The reason why some people are affected by allergies while others are not begins in their genes. Allergies are passed down from generation to...

Here’s a tip that might someday save your life, or that of a loved one: two to four times a year, review the proper way to use your epinephrine...

Lactose intolerance is the inability to process lactose, a sugar found in milk, caused by the lack of a needed enzyme. Those with lactose...

Food Allergen Labeling and Consumer Protection Act (FALCPA)

An important part of peanut allergy awareness was enacted on January 1, 2006...

Tomato allergies are very rare. They are a "type 1 allergy," which means a contact allergy. When a person with this type of allergy touches a...

Milk allergies are becoming more common, especially in babies and small children. There is some confusion about what is an allergic reaction and...

Recognizing food allergy in babies or toddlers is not always easy, but there are specific risk factors and signs that parents and other caregivers...

Burlap bags are often used to store and ship coffee beans, potatoes, rice, seeds, nuts, and peanuts. They can be one of the disguised...

People with pollen allergies need to stay away from some foods. If you have allergic rhinitis in the spring or fall, you may not realize that you...

Of course, everyone knows that if you have a peanut allergy that you should avoid peanuts, peanut butter, peanut butter cookies and foods that...

Eating at a nut-free lunch table in school is a safety precaution that causes some students to feel isolated from their peers. Unfortunately,...