"No clinical experience" with Celvapan swine flu jab, admits Baxter

"No clinical experience" with Celvapan swine flu jab, admits Baxter

Thursday, 19 November 2009 10:43





Baxter's swine flu jab Celvapan has not been tested according to the "Summary of product characteristics" on the website of the European Medcines Agency, the European Union drug regulator.

http://www.emea.europa.eu/humandocs/PDFs/EPAR/celvapan/spc/emea-spc-h982pu06en.pdf



„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," says the document under the Section Clinical Particulars 4.2 page 2



„No data are available in children or adolescents. However, should vaccination be considered necessary, the experience with similarly constructed vaccines suggests that dosing in accordance with the adult dose may be appropriate.



„There are currently no data available on the use of Celvapan in pregnancy.



„Data from pregnant women vaccinated with different inactivated non-adjuvanted seasonal vaccines do not suggest malformations or fetal or neonatal toxicity.“



The document says under the section "Pharmacological Properties" that the vaccine has been authorised under special regulations applying to "Exceptional Circumstances." Under these emergency regulations, pandemic vaccines do not need to be tested for safety or efficacy before they are given to people.

Similar pandemic vaccines, Pandemrix and Focetria are classified as bioweapons by EU and US regulators.

Baxter's Celvapan is being used in Austria, Ireland and Germany, among other countries.

Two doctors who took the jab in Austria, including one who allegedly did it publicly to prove the jab was harmless, are said to have come down with high fever soon afterwards.

Both had to sign consent forms waiving their right to claim compensation from Baxter in the event of the jab causing damage.

More extracts from the document show






4.8 Undesirable effects

•UClinical trials with H5N1 mock-up vaccine



In clinical trials with the mock-up vaccine using an H5N1 vaccine strain (see section 5.1) in 606 subjects (326 between 18 and 59 years old, and 280 aged 60 and above), the following adverse reactions were assessed as at least possibly related by the investigator. Most of the reactions were mild in nature, of short duration and qualitatively similar to those induced by influenza vaccines. There were fewer reactions after the second dose of the vaccine compared with the first dose. The most frequently occurring adverse reaction was injection site pain, which was usually mild.

Adverse reactions from clinical trials with the mock-up vaccine are listed below (see section 5.1 for more information on mock-up vaccines).

Adverse reactions are listed according to the following frequency.

Very common (≥1/10)

Common (≥1/100 to <1/10)

Uncommon (≥1/1,000 to <1/100)

Rare (≥1/10,000 to <1/1,000)

Very rare (<1/10,000)

Not known (cannot be estimated from the available data)

Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.