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Influenza Vaccine Safe for Pregnant Women, Study


Influenza Vaccine Safe for Pregnant Women, Study

(ePharmaNews) – A study found that an infant’s in utero exposure to the influenza A(H1N1) vaccine that his/her mother received did not significantly increase the risk of major birth defects, preterm birth, or fetal growth restrictions. While in another study, researchers found a small increased risk in adults of the nervous system disorder, Guillain-Barre syndrome, during the 4 to 8 weeks after vaccination, according to 2 studies in the July 11 issue of JAMA.

The influenza A(H1N1) epidemic in 2009 increased the risk of diseases and death in pregnant women as well as similar risks in the embryo.  The influenza vaccine might be a solution to protect both mother and baby from serious complications; thus it is significant to finally prove that this vaccine is safe for pregnant women.

“Pregnant women were among the main target groups prioritized for vaccination against influenza A(H1N1)pdm09, and an estimated 2.4 million women were vaccinated during pregnancy in the United States alone. However, assessment of the fetal safety of H1N1 vaccination in pregnancy has been limited to a few pharmacovigilance reports and descriptive cohort studies,” said Björn Pasternak, M.D., Ph.D., of the Statens Serum Institut, Copenhagen, Denmark.

The study included all live-born singleton infants in Denmark delivered between November 2, 2009, and September 30, 2010. It compared infants who were exposed to the vaccine and those who were not. Following exclusions, a group of 53,432 live-born infants was identified with 6,989 (13.1 percent) exposed to the vaccine during pregnancy.

Nearly similar rates of preterm birth and major birth defects were seen in infants who were exposed to the vaccine during pregnancy and those who were not. The results were also similar even when the researchers identified whether the time of exposure was in the first trimester of pregnancy or in the last two trimesters.

“Taking gestational age into account, there was no increased risk of small size for gestational age associated with vaccination in the first (25 [7.6 percent] exposed vs. 31 [9.4 percent] unexposed) or the second or third trimester (641 [9.7 percent] exposed vs. 657 [9.9 percent] unexposed),” the researchers wrote.

“In conclusion, this nationwide cohort study in Denmark found no significant associations between exposure to an AS03-adjuvanted influenza A(H1N1)pdm09 vaccine in pregnancy and risk of adverse fetal outcomes including major birth defects, preterm birth, and growth restriction. Although the data provide robust evidence of safety with respect to outcomes associated with second- or third-trimester exposure, results from analyses of first-trimester exposure should be viewed as preliminary and need confirmation. Further research also needs to address risk of specific birth defects as well as effectiveness of H1N1 vaccination in pregnancy.”


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Prepared by: Basel AlJunaidy


Source :

ePharmaNews






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