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EMA review clears GSK and Sanofi Pasteur MSD HPV vaccines

Concludes Cervarix andGardasil don’t cause CRPS or POTS

GSK and Sanofi Pasteur MSD's cervical cancer vaccines have been cleared by the EMA's pharmacovigilance committee, after it found no link between the two products and potentially serious side effects.

The regulator's Pharmacovigilance Risk Assessment Committee (PRAC) ruled out a connection between Cervarix and Gardasil and complex regional pain syndrome (CRPS) or postural orthostatic tachycardia syndrome (POTS).

Commenting on the PRAC's findings Sanofi Pasteur MSD UK, which manufactures Gardasil, said: “We welcome this rigorous, scientifically based evaluation of the safety profile these vaccines that has included published research, clinical trial data, adverse event reports and input from leading experts and patient groups.”

CRPS is a chronic pain syndrome affecting a limb, while POTS is a condition where the heart rate increases abnormally on sitting or standing up, together with symptoms such as dizziness, fainting and weakness, and also headaches, nausea and fatigue.

The review found no evidence that the overall rates of these syndromes in vaccinated girls were different from expected rates in these age groups, even taking into account possible underreporting.

However, the EMA's Pharmacovigiliance Risk Assessment Committee (PRAC) noted that certain symptoms of CRPS and POTS might overlap with chronic fatigue syndrome.

It is estimated that in the general population around 150 girls and young women per million between the ages of 10 and 19 develop CRPS every year, and at least 150 girls and young women per million may develop POTS each year.

The review recognised that over 80 million girls and women worldwide have now received these vaccines, and in some European countries they have been given to up to 90% of the recommended age group.

Article by
Nikhil Patel

9th November 2015

From: Regulatory



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