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23 November 2009
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Nederlandstalig
This article is part of the series Swine Flu.
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Vaccination advice given to pregnant women based on 'practically no scientific data'

By Daan de Wit
Translated by Ben Kearney

The vaccines Pandemrix and Focetria have been chosen to fight the Swine Flu in The Netherlands, vaccines with so-called adjuvants. On what basis was the decision made to vaccinate pregnant Dutch women with these specific drugs? The answer from the National Health Council is clear - though not reassuring - namely 'that there is practically no scientific data on the use of the adjuvants (agents that stimulate the immune system) used in the vaccines during pregnancy'.

The manufacturers of the drugs have also gone on the record. In the Pandemrix insert it states: 'At this time there is no available data concerning the use of Pandemrix in pregnant women'. And the same statement can be found in the insert for Focetria. Yet the Dutch National Health Council still advises giving vaccinations with adjuvants to women who are more than 13 weeks pregnant. This policy differs from that of other countries. 'In France the government is recommending a vaccine without adjuvants for pregnant women. The Canadian government has ordered vaccines free of adjuvants for pregnant women. In Switzerland, a vaccine containing adjuvants didn't earn the green light for use on women who are expecting', reports the Belgian paper De Standaard.

How did the Dutch National Health Council arrive at their advice for vaccinating pregnant women? The council writes that this occured in cooperation with 'the Center for Infectious Disease Control under the National Institute for Public Health and the Environment on the basis of expert consultation on November 4, 2009'. While offering the advice to vaccinate after the first trimester (13 weeks) of pregnancy, the experts - who thus must work with 'practically no scientific data' - also note: 'This lack of data is of particular import during the first trimester, the most vulnerable phase for the fetus, when the organs are developing. This means two things. First, that the setting of a limit at 13 weeks is based on the vulnerability of the fetus. On grieppandemie.nl the argument is employed that women who are in the last stage of pregnancy have decreased lung capacity and are therefore more vulnerable to the flu because of the breathing problems this can cause. The second and most important conclusion to be drawn from the advice of experts not to vaccinate prior to 13 weeks but to go ahead and vaccinate after that period, is that their advice is based on 'almost no scientific data' on the safety of the vaccine.

In Belgium the choice has also been limited to vaccines with additives. Because of this, four Belgian mothers are bringing charges against the Belgian government. According to these women, there has been no serious study done on the potential effects of a vaccine containing the adjuvant squalene on pregnant women. This is confirmed by the description of Focetria, published on September 24, 2009: 'To date, there have been no clinical trials designed to evaluate the tolerability and safety of MF59-adjuvanted vaccines in pregnant women'. MF59 consists largely of squaleen, according to the same document. The mothers are also ignoring the constructive advice of the French-speaking union for gynecologists and midwives in Belgium. They point out that this organization is sponsored by GlaxoSmithKline, the maker of the vaccine available in Belgium.

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