MedicalResearch.com Interview with:
Senior Investigator, M.Sc.,Dr.Med.Sci.
Department of Epidemiology Research
Division of National Health Surveillance & Research
MedicalResearch.com: What is the background for this study?
Response: HPV vaccination targeting girls and young women has been introduced in many countries throughout the world. HPV vaccines are not recommended for use in pregnancy, but given the target group, inadvertent exposure will occur in early unrecognized pregnancies. However, data on the safety of HPV vaccination in pregnancy is lacking.
MedicalResearch.com: What are the main findings?
Response: From a source-population of more than 580,000 pregnancies we identified up to 1774 (the exact number depending on the specific outcome under study) pregnancies with inadvertent HPV vaccine exposure. We found no support for a adverse effect on the unborn baby of HPV vaccination in pregnancy. The potential adverse effects evaluated in our study included spontaneous abortion, stillbirth, major birth defects, small for gestational age, low birth weight and preterm birth.
MedicalResearch.com: What should readers take away from your report?
Response: The study provides important information for the medical doctor who encounters this situation in clinical practice and provides reassurance for the young women who are inadvertently vaccinated early in pregnancy.
The aim of our study was not to evaluate the benefits/risks of HPV vaccination in pregnancy, and HPV vaccines should still not be administered in pregnancy.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: Hopefully other researchers will contribute with similar studies of this important issue. Although our study is the largest to date, inadvertent exposure in early pregnancy is still rare, which limits the statistical certainty of the results, especially for the rarer outcomes.
For vaccines not indicated for use in pregnancy, but inadvertently administered, studies such as ours is the only way to evaluate the safety of this exposure.
The study was funded by the Novo Nordisk Foundation and the Danish Medical Research Council.
MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.
Nikolai M. Scheller, M.D., Björn Pasternak, M.D., Ph.D., Ditte Mølgaard-Nielsen, M.Sc., Henrik Svanström, Ph.D., and Anders Hviid, Dr.Med.Sci.
N Engl J Med 2017; 376:1223-1233
March 30, 2017 DOI: 10.1056/NEJMoa1612296
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