tetano
Editor, Senior Moderator
Vaccine. 2012 May 4. [Epub ahead of print]
A(H1N1)v2009: A controlled observational prospective cohort study on vaccine safety in pregnancy.
Oppermann M, Fritzsche J, Weber-Schoendorfer C, Keller-Stanislawski B, Allignol A, Meister R, Schaefer C.
Source
Institute for Clinical Teratology and Drug Risk Assessment in Pregnancy, Charit? - Universit?tsmedizin Berlin, Germany.
Abstract
BACKGROUND:
A(H1N1)v2009 influenza vaccination of pregnant women was a challenge for health care providers, as little safety data were available.
METHODS:
We prospectively followed the pregnancies of women who were vaccinated at any time during pregnancy or ≤4 weeks prior to conception and compared these outcomes to a control cohort matched by the estimated date of birth. Primary endpoints: rate of spontaneous abortion and major malformations. Secondary endpoints: preeclampsia, gestational age at birth, and birth weight.
RESULTS:
Pregnancy outcome of 323 women immunized with adjuvanted or non-adjuvanted A(H1N1)v2009 influenza vaccines from 2009-09-28 to 2010-03-31 were compared to 1329 control subjects. The risk for spontaneous abortions (HR 0.89; 95% CI 0.36-2.19) and the rate of major malformations (all trimesters: OR 0.87; 95% CI 0.38-1.77; preconception and first trimester exposure: OR 0.79; 95% CI 0.13-2.64) did not vary between the two cohorts. Furthermore, there was no increase in preeclampsia, prematurity, and intrauterine growth retardation in the vaccinated cohort.
CONCLUSION:
The results of our study do not indicate a risk for the pregnant woman and the developing embryo/fetus after H1N1 vaccination. We provide and apply methods novel in observational studies on pregnancy outcome, especially if a single dose exposure is investigated.
Copyright ? 2012. Published by Elsevier Ltd.
PMID:
22564554
[PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/22564554
A(H1N1)v2009: A controlled observational prospective cohort study on vaccine safety in pregnancy.
Oppermann M, Fritzsche J, Weber-Schoendorfer C, Keller-Stanislawski B, Allignol A, Meister R, Schaefer C.
Source
Institute for Clinical Teratology and Drug Risk Assessment in Pregnancy, Charit? - Universit?tsmedizin Berlin, Germany.
Abstract
BACKGROUND:
A(H1N1)v2009 influenza vaccination of pregnant women was a challenge for health care providers, as little safety data were available.
METHODS:
We prospectively followed the pregnancies of women who were vaccinated at any time during pregnancy or ≤4 weeks prior to conception and compared these outcomes to a control cohort matched by the estimated date of birth. Primary endpoints: rate of spontaneous abortion and major malformations. Secondary endpoints: preeclampsia, gestational age at birth, and birth weight.
RESULTS:
Pregnancy outcome of 323 women immunized with adjuvanted or non-adjuvanted A(H1N1)v2009 influenza vaccines from 2009-09-28 to 2010-03-31 were compared to 1329 control subjects. The risk for spontaneous abortions (HR 0.89; 95% CI 0.36-2.19) and the rate of major malformations (all trimesters: OR 0.87; 95% CI 0.38-1.77; preconception and first trimester exposure: OR 0.79; 95% CI 0.13-2.64) did not vary between the two cohorts. Furthermore, there was no increase in preeclampsia, prematurity, and intrauterine growth retardation in the vaccinated cohort.
CONCLUSION:
The results of our study do not indicate a risk for the pregnant woman and the developing embryo/fetus after H1N1 vaccination. We provide and apply methods novel in observational studies on pregnancy outcome, especially if a single dose exposure is investigated.
Copyright ? 2012. Published by Elsevier Ltd.
PMID:
22564554
[PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/22564554