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BEDREHELSE-Bedre helse og livskvalitet

Safety of Covid-19 vaccination in pregnancy

Alternative title: Sikker COVID-19 vaksinering under svangerskapet

Awarded: NOK 12.0 mill.

In this project we will study the safety of Covid-19 vaccination during pregnancy. We will study pregnancy outcomes, short term effects on the women and fetus, and potential effects in children of mothers who were vaccinated during pregnancy. It is difficult to predict how the current COVID-19 pandemic will progress. Mutations continuously alter the virus’ ability to spread and potentially the severity of infections. The available evidence points to increased risk of severe disease, complications and hospitalizations in pregnant women with COVID-19 infection. COVID-19 infection during pregnancy is also associated with increased risk of a range of adverse pregnancy outcomes. Vaccination during pregnancy will protect pregnant women from COVID-19 infections. As IgG antibodies are actively transferred through the placenta to the fetus, it is also likely that maternal vaccinations during pregnancy protect infants from COVID-19 infection the first months of life. The current COVID-19 vaccines have not been tested in pregnant women, and thus, safety data and effectiveness data of these vaccines during pregnancy is limited. It is difficult for pregnant women and care-givers to make decisions about COVID-19 vaccination and follow-up studies of vaccinations during pregnancy are important to support decisions. New evidence regarding vaccine safety and effectiveness is crucial for keeping the population’s trust and adherence to vaccine programs. Very few countries can address population risks related to safety of vaccination in pregnancy. The robust population-based Norwegian registries provide a unique opportunity. Our international team has broad expertise in using population-based data to study infections and vaccinations in pregnancy. Vaccinations is happening right now, and pregnant women are recommended vaccine. We will provide new and crucial knowledge for public health management, clinical practice and will guide the scientific community on further research needs.

It is difficult to predict how the current COVID-19 pandemic will progress, and what its final impact will be. Mutations continuously alter the virus’ ability to spread and the potentially the severity of infections, making it difficult to predict changes in risk groups, and whether the current vaccines will remain effective. Reassuring the general population regarding vaccine safety and effectiveness is crucial for keeping the trust and adherence to vaccine programs. Although data on COVID-19 infection during pregnancy is still limited, the available evidence points to increased risk of severe disease, complications and hospitalizations in pregnant women with COVID-19 infection. COVID-19 infection during pregnancy is also associated with increased risk of a range of adverse pregnancy outcomes. Vaccination during pregnancy will protect pregnant women from COVID-19 infections. There are also potential benefits to the child after birth of maternal vaccination during pregnancy as IgG antibodies are actively transferred through the placenta to the fetus. It is likely that maternal vaccinations during or pregnancy protect infants from COVID-19 infection The current COVID-19 vaccines have not been tested or approved for use in pregnant women, and thus, safety and effectiveness of these vaccines during pregnancy is unknown. Currently, it is difficult for pregnant women and care givers to make decisions about COVID-19 vaccination as empirical data to support decisions is lacking. Very few countries can address population risks related to safety of vaccination in pregnancy. With national linked Norwegian registry data our international team will study the safety of COVID-19 vaccination during pregnancy, addressing pregnancy outcomes, short term effects on the women and fetus, and longer term effects in children born after maternal pregnancy vaccination. Our team has broad expertise in using population-based data to study infections in pregnancy.

Funding scheme:

BEDREHELSE-Bedre helse og livskvalitet