Follow-up of Covid-19 Vaccinated Pregnant and/or Breastfeeding Women in Tunisia

• Published in: Drug safety 2022-10, Vol.45 (10), p.1231-1231
• Main Authors: Zgolli, F, Lakhoua, G, Aouinti, I, Daldoul, M, Alaya, N, Daghfous, R, Kastalli, S, Aidli, S E
• Format: Article
• Language: English
• Subjects: Asthenia; Breast feeding; Breastfeeding & lactation; Childbirth & labor; Chills; Coronaviruses; COVID-19 vaccines; Data collection; Fever; Headache; Immunization; Jaundice; Miscarriage; mRNA; Neonates; Pain; Phototherapy; Pregnancy; Telephone calls; Vaccines; Womens health
• ISSN: 0114-5916; 1179-1942

Introduction: Initially, vaccination against Covid-19 was not recommended during pregnancy due to the lack of data. With the benefit of hindsight, it has become recommended. This decision followed the reassuring results from pregnant women who voluntarily or inadvertently received Covid-19 vaccines, especially with mRNA vaccines [1]. In Tunisia, from May 2021, pregnant women have been prioritized in the national vaccination program with the recommendation of the messenger RNA platform. Objective: To follow-up Covid-19 vaccinated pregnant and/or breastfeeding women in Tunisia. Methods: We have started a pilot study (from September 2021 to April 2022) for monitoring pregnant and/or breastfeeding women. Data collection was carried out via telephone calls. We excluded women who were unreachable after two phone calls. The data collected concerned the course as well as the outcome of the pregnancy and the health status of newborns. In addition, women were asked about the possible occurrence of adverse effects following immunization. Results: Our study included 1253 women. Seventeen percent of them were previously infected with Covid-19. The vaccination schedule was complete (two doses) in 83% of cases. Pfizer-BioNTech vaccine (PBV) was used in 73% of cases (11% of cases in the first trimester, 42% in the second trimester and 19% in the third trimester) and Moderna vaccine in 26%. Coronavac vaccine was used in 1% of cases. Vaccination was performed during pregnancy in 74 % of cases and breastfeeding in 11% of cases. Fifteen percent of women received the first dose during pregnancy and the second dose after childbirth. Reported adverse events following vaccination were: pain at the injection site in 47%, fever in 23%, soreness in 15%, asthenia in 6%, headache in 5%, hot flashes in 3% and chills in 1% of cases. Pregnancy and breastfeeding outcomes were favourable in 1246 women (99.4% of cases). Forty-seven percent of women delivered at term without incident and newborns were apparently in good health. One case of spontaneous miscarriage was reported in a woman with a history of spontaneous abortion and Covid-19 infection two weeks after receiving the first dose of PBV. Six cases of neonatal jaundice were also reported with PBV with good evolution with phototherapy. Conclusion: Our study confirms the data in the literature concerning the safety of Covid-19 vaccines on pregnant and/or breastfeeding women.