HPV Vaccine Safety Review

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Dear European Medicines Agency,

Under the right of access to documents in the EU treaties, as developed in Regulation 1049/2001, I am requesting documents which contain the following information:

I am informed by the UK MHRA that the paper 'Current Safety Concerns with Human Papillomavirus Vaccine: A Cluster Analysis of Reports in VigiBase' was recently evaluated via the European Medicines Agency (EMA) as part of the routine periodic safety update report for Gardasil/Gardasil 9. It was concluded that the publication does not raise any new safety concerns. Please provide evidence used in this review and advise where I can obtain a copy of the review report.

Yours faithfully,

Steve Hinks

PF-15, Agencia Europea de Medicamentos

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Best regards,
The European Medicines Agency

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