EMA to again place HPV vaccines under its safety lens

While the European Medicines Agency said it "does not question that the benefits of HPV vaccines outweigh their risks," on Monday it announced a safety review of the shots that have thus far failed to live up to expectations partly due to safety concerns and a sex-related stigma.

The safety watchdog said it'll analyze available data with a focus on rare reports of complex regional pain syndrome--a chronic pain condition affecting the limbs--and postural orthostatic tachycardia syndrome, in which the heart rate increases abnormally after sitting or standing up. Intended to prevent cervical cancer and other conditions associated with human papillomavirus, HPV vaccines have been administered to more than 70 million people worldwide.

After some initial estimates on the vaccines pegged sales between $4 billion and $10 billion annually, the reality has put those expectations in check.

Merck's ($MRK) Gardasil, marketed in Europe since 2006, reeled in $1.83 billion in sales 2013 before falling to $1.73 billion last year. Just last month, the European Commission approved its successor, Gardasil 9, expected to generate $1.9 billion in peak sales, though much of that at the expense of Gardasil. Merck and Sanofi Pasteur will market the shot in Europe under the joint venture Sanofi Pasteur MSD, which was cleared along with the approval to begin pricing and reimbursement negotiations with EU countries. The FDA approved the follow-up in December.

GlaxoSmithKline's ($GSK) Cervarix has had its European marketing approval since 2007 and pulled in worldwide sales of £118 million (about $183 million) last year, 26% less than 2013.

For years, Merck and GSK have worked to increase uptake by fending off safety concerns and an unfounded perception that HPV vaccines would lead to increased promiscuity.

In its review, EMA's safety watchdogs will seek to clarify the frequency of the conditions after vaccination and to identify any causal link. There are no recommendation changes for the vaccines while the study is underway.

- here's the release

Special Report: The top 5 vaccine makers by 2013 revenue - Merck - GlaxoSmithKline

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