North American Vaccine Message Board

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Biotech / Medical : North American Vaccine

NVX 1.410

-6.6%

Nov 3 3:59 PM EST

Public Reply Prvt Reply Mark as Last Read File

Previous 10 Next 10 Previous Next

To: andy harrison who wrote (47)	11/1/1996 9:10:00 AM
From: andy harrison	of 82

Let me respond point by point to Sturza's latest attack on NVX,Letter F.253-10/31/96. First of all the Advisory Panel recommended approval of NVX for shots 1-4 in a program of all accellular vaccinations. This is the same recommendation that Connaught received. No one can get 5th. shot approval for an all accellular regimen, for the simple reason that the children in Sweden are not old enough to have received the 5th. shot and no data exits. The Panel also gave NVX a recommendation to use the vaccine for the 5th. booster shot after 4 whole cell shots. The only question on using the vaccine was for the 4th. booster shot after 3 whole cell shots, as only 42 children had received the shot.The data to support the use of this shot will be available to the FDA by the end of November, in plenty of time for early FDA approval. There was no recommendation for the new 2000 child test. There is absolutely no reason to believe that the FDA and CDC will change the USA immunization schedule of 2,4,6, 12-18 months and 6 years. Why would they recommend Connaught for 1-4 shot approval and SKB for 1-3 and no on shot 4 if they intended to change the schedule??? Both Connaught and SKB tested on the European schedule and had the same questions about bridging data, and they were resolved in the same manner as with NVX. The efficacy of the vaccine ranged from a minimum of 71% to 86% depending on the test protocal and the definition of Pertussis. NVX used the stricker WHO defintition of Pertussis. Connaught and SKB use the product FHA in their vaccines and could not use the stricker definition. In addition, NVX had a nurse visit each child in its vaccination program to discover Pertussis, while Connaught and SKB used self reporting by the children's family. All cases of severe side effects were shown by NVX to be non-vaccine related and the panel accepted this as factually correct. If you want an independent review of these points, you should read BIOWORLD Today from 10.31.96 and a highlight from 10.30.96. Or the article in the Washington Post from 10.30.96. Mark Harrison

Report TOU Violation

Share This Post

Public Reply Prvt Reply Mark as Last Read File

Previous 10 Next 10 Previous Next