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Papillomavirus vaccine: no risks to the unborn child

The data available at the beginning of 2012 on women exposed to papillomavirus vaccines during the first three months of pregnancy do not give cause for concern. In the light of the global data available, severe adverse effects in women are rare.

Papillomavirus 6,11,16,18 (Gardasil°) and 16,18 (Cervarix°) vaccines are expected to prevent cervical cancers caused by the papillomavirus, without there yet being evidence of efficacy on a large scale. They are authorised for vaccinating girls from the age of 9.

They are non-live vaccines. As a precaution, it is better to avoid inoculating pregnant women with these vaccines. But it does happen that women are exposed to them shortly before becoming pregnant or during a pregnancy of which they are unaware.

The evidence from female rats does not show any risk of fetal malformation from the two papillomavirus vaccines.

For the papillomavirus 6, 11, 16 and 18, vaccine, the clinical trials and the  Pregnancy Register for Gardasil° have shown no difference in the number of malformations between children born live who have been exposed to the papillomavirus vaccine (more than 1200 children monitored), and children born live who had not been exposed. For papillomavirus 16, 18, virus, the scant evidence shows a percentage of malformations akin to that of the non-vaccinated group.

Overall, this evidence does not give cause for concern.

It also appears, in the light of global data available at the end of 2011, that adverse effects of papillomavirus vaccines on women are rare.

©Prescrire 1 June 2012

"HPV vaccines and pregnancy: the situation in early 2012" Prescrire Int 2012; 21 (128): 154-157. (Pdf, subscribers only).

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