EMA takes issue with BMJ article on Pandemrix vaccine

RAPS

27 September 2018 - A recent article in the BMJ suggested that one pandemic flu vaccine was less safe than others, though the EMA said Wednesday that the comparisons are “not scientifically valid.”

The BMJ article, titled “Pandemrix vaccine: why was the public not told of early warning signs?” suggests that GlaxoSmithKline’s Pandemrix vaccine was less safe than other pandemic flu vaccines based on a comparison of the number of suspected adverse reactions reports received.

“EMA’s view is that this comparison is not scientifically valid and the BMJ article’s consequent conclusions are flawed and misleading to its readers and the wider public,” the agency said.

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Michael Wonder

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Michael Wonder

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Europe , Regulation , Vaccine , Safety