The French health authority ANSM is launching a study to assess the safety of Covid-19 vaccines in pregnancy. The Covacpreg study is part of the enhanced vaccine surveillance system set up by the ANSM and the regional pharmacovigilance centers (CRPV), who are responsible for monitoring the adverse effects of Covid-19 vaccines. The Covapreg study will follow the course of post-vaccination pregnancies until the birth of the child. With the aim to enrich scientific knowledge on the Covid-19 vaccines in pregnancy.
Starting 3 April this year, pregnant women in France (from the 2nd trimester) have been given priority for access to vaccination with an mRNA vaccine (Comirnaty from Pfizer BioNtech and Moderna laboratories), in particular if they present with risk pathology or if they are susceptible to be in contact with infected people in their professional capacity.
Although studies to date have not shown any adverse consequences for the course of pregnancy from Covid-19 vaccines, the data needs to be consolidated. This is why the information collected during this study will be of great help in increasing knowledge about Covid-19 vaccines and their possible adverse effects in pregnant women. Participation in this study of pregnant women vaccinated against Covid-19 is on a voluntary basis and does not modify the medical monitoring of their pregnancy.
How will the study proceed?
After registration, participants will be contacted by phone or email, by the clinical research associate (ARC) of the CRPV in Lyon or Toulouse in order to answer a questionnaire (approximately 15 minutes in duration): approximately 1 month after the date of vaccination (after the 1st dose and/or after the 2nd dose): to determine the medical history, any medication taken, previous pregnancies, any adverse effects after vaccination, etc. Note: Women vaccinated at the start of pregnancy will also be asked to answer a questionnaire after the 2nd trimester ultrasound. After the due date: to know the progress of the pregnancy and their newborn.
There’s more information on the site, but I hope that what I have provided constitutes a helpful summary.
ANSM stands for L’Agence nationale de sécurité du médicament et des produits de santé (The National Agency for the Safety of Medicines and Health Products).
By David Lewis, Novartis