The most common adverse reactions in the clinical trial included injection site reactions, flu-like symptoms, nausea, headache and elevations in liver enzymes (serum transaminases).

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Other safety issues in the trials included injection site reactions and flu-like symptoms.

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The most common adverse reactions in patients treated with KYNAMRO that led to treatment discontinuation and occurred at a rate greater than placebo were: injection site reactions (5.0%), alanine aminotransferase (ALT) increased (3.4%), flu-like symptoms (2.7%), aspartate aminotransferase (AST) increased (2.3%), and liver function test abnormal (1.5%).

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That drug has not only liver side effects, but also must be injected and can cause painful injection-site reactions.

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Side effects have been limited to nausea and mild skin reactions to the injection.

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The most severe reactions require the use of an injection of epinephrine to subside, which is why many people with food allergies carry auto-injectors for emergencies.

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At most, a child may experience mild reactions to the vaccine, including swelling at the injection site, itching, low-grade fever or restlessness, Martin said.

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The global pharmaceutical company added that the vast majority of suspected adverse reactions have related either to the symptoms of recognised side-effects or were due to the injection process and not the vaccine itself.

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