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EU Panel Warns of Fever in Children After GSK Pandemrix

Posted by Jane Akre
Friday, December 04, 2009 1:04 PM EST
Category: Protecting Your Family
Tags: Swine Flu, Centers for Disease Control and Prevention, H1N1, Influenza, Public Health

Pandemrix causes fever in children in clinical trials after second dose reports EU.

Children Risk High Fever After GSK Pandemrix

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IMAGE SOURCE: GSK Web site

The European Medicines Agency is warning that young children may experience a fever after the second dose of a swine flu vaccine made by GlaxoSmithKline, Pandemrix.

In a press release issued Friday, the EU regulatory agency that looks for adverse events, is recommending that that warning be put into the product label. The second dose is the one thought to increase the immune response against the H1N1 virus.

The children affected in an ongoing clinical trial by GSK were six months to three years and the fever reported was 38 celsius (100.4 fahrenheit) after the second dose of Pandemrix, compared to the first.

Children also experienced soreness at the injection site and drowsiness, irritability and a loss of appetite after the second shot.

European regulators recommend children receive two doses of swine flu vaccine. Glaxo says one dose may be enough.

GSK’s vaccine contains an adjuvant, a chemical that boost the immune response. It is sold in Europe and Canada. The U.S. version of Glaxo’s vaccine is sold without the adjuvant.

GlaxoSmithKline last month warned that one batch of its Canadian-made swine flu vaccine had the potential to trigger life-threatening side effect such as anaphylactic shock.

Pandemrix contains a flu strain called A/California/7/2009 (H1N1) v-like strain (X-179A).

In a press briefing today, the world Health Organization reports that more than 150 million swine flu doses has been distributed to more than 40 countries with no evidence of side effects. #


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