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HPV vaccination during pregnancy has no adverse consequences

The analysis also showed no increased risk of spontaneous abortion, premature birth, low birth weight, stillbirth or having a child who is small for gestational age.

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New evidence from a Danish nationwide study suggests that Sanofi Pasteur’s quadrivalent human papillomavirus vaccine (HPV), marketed as Gardasil is not dangerous in the unusual case if it is accidentally given during early pregnancy.

Under the 1,665 women who are exposed to the Gardasil vaccine during the pregnancy, there was no increased risk of having a child with a serious congenital abnormality, compared to 6,660 women not exposed during pregnancy.

The analysis also showed no increased risk of spontaneous abortion, premature birth, low birth weight, stillbirth or having a child who is small for gestational age.

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“For our research, little was known about the safety of the HPV-vaccination in pregnancy,” co-author Dr. Otherwise, Hviid told Reuters Health in an e-mail. “The lesson is that for young women who are inadvertently vaccinated early in pregnancy, there is no need to worry; our results support that this exposure has an adverse effect on the unborn baby.”

And for now, “HPV vaccine not be administered during pregnancy,” said Hviid, senior researcher at the department of epidemiology research at the Statens Serum institut in Copenhagen.

“The study does not cover all bases, but what is it the general says, is very positive news,” said Dr. Robert Burk of the Albert Einstein College of Medicine in New York told Reuters Health in a telephone interview. “As far as they can measure in a large population, there seems to be no major demonstrable adverse effect of the HPV vaccine. It is a kind of what we anticipated, but the news is as good as your going to get a vaccine.”

Merck manufactures the vaccine in the United States.

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The study did not look at the safety of the bivalent version of the vaccine that relates to less strains of HPV.

More than 72 million women and girls worldwide have received HPV vaccines, which are designed to protect against cervical cancer and other cancers. The vaccine is recommended for women ages 9 to 26, but not during the pregnancy.

However, women who are pregnant but don’t realize that it is sometimes vaccinated.

“That is not unusual,” said Burk, a professor in the microbiology, immunology, epidemiology and the health of the population, which was not involved in the study. “You are immunizing women in their reproductive window when a good chunk of women to get pregnant.”

A previous analysis that combined data from two studies reported an increased spontaneous abortion in women who become pregnant within 90 days after vaccination with the HPV bivalent vaccine, but other research has called that into question.

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The new study, reported in the New England Journal of Medicine, looked at all pregnant women in Denmark, the use of several different national registers. The data for the years 2006 to 2013.

Cases of spontaneous abortion in the first six weeks of the pregnancy were not included, the authors write, because many cases of spontaneous abortion during the first weeks of pregnancy may go unnoticed.

Although the raw data did suggest an increased risk of low birth weight, premature birth and major congenital anomalies, vaccinated women were also more likely to be smokers, unmarried and have both lower income and lower levels of education, making them at higher risk for these outcomes in the first place.

As soon as the research team adjusted for these factors, they found no significant difference in risk for women who have the vaccine during pregnancy.

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