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[Nienke]

On the website of the European Medicines Agency, the European Union drug regulator, it says that the Baxter's swine flu jab Celvapan has not been tested: http://www.emea.europa.eu/humandocs/PDFs/E...-h982pu06en.pdf

From page 2:
<Posology and method of administration
This pandemic influenza vaccine H1N1 has been authorised based on data obtained with a version containing H5N1 antigen supplemented with data obtained with the vaccine containing H1N1 antigen. The Clinical Particulars section will be updated in accordance with emerging additional data.
There is currently no clinical experience with Celvapan (H1N1) in adults, elderly, children or adolescents.
The decision to use Celvapan (H1N1) in each age group defined below should take into account the extent of the clinical data available with a version of the vaccine containing H5N1 antigen and the disease characteristics of the current influenza pandemic.
The dose recommendations are based on the safety and immunogenicity data available on the administration of vaccine containing 7.5μg HA derived from A/Vietnam/1203/2004 (H5N1) at day 0 and 21 to adults, including the elderly.>

Also beware of possible false positives after the jab. From page 4:
<Following influenza vaccination, false positive serology test results may be obtained by the ELISA method for antibody to human immunodeficiency virus-1 (HIV-1), hepatitis C virus, and especially, HTLV-1. >

[Sheryl]

Sorry but no, that is not what it says.

What is says is that in order to expedite its availability, results of tests with what are termed "mock up" vaccines would be used while results from tests with the exact vaccione were ongoing. Some such tests had already been completed at the time this report was written and they are decsribed on page 5 of the link:

"• Clinical Trials with Celvapan (H1N1)
Limited preliminary safety data after the first dose from clinical trials in adults aged over 18 years (N=387) and children aged from 9 to 17 years (N=101), 3 to 8 years (N=24) and 6 to 35 months (N=21) investigating two different dose levels (3.75μg or 7.5μg) of Celvapan H1N1v suggest a comparable safety profile with that reported for the H5N1 mock-up vaccine formulation"

Since the above was written much larger trials have been completed, with the exact vaccine, and considerable post-marketing surveillance data is also now available.

The use of data from "mock up vaccines" is standard practice in pandemic situations. It does not replace clinical testing of the actual antigen, it just allows the approval process to proceed more quickly, because in a pandemic situation if the vaccine is not gotten out there fairly early on it is of little use.