Safety and efficacy of inactivated COVID-19 vaccines in women vaccinated during the first trimester of pregnancy
Objectives: This study aimed to investigate the safety of the inactivated COVID-19 vaccines in early pregnant women in view of their adverse-effect profile and associated maternal-fetal complications, as well as to evaluate their immunogenicity. Methods: In this prospective observational cohort stud...
| Main Authors: | , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2023-05-01
|
| Series: | International Journal of Infectious Diseases |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S1201971223000942 |
| _version_ | 1797850491370078208 |
|---|---|
| author | Yan Ma Zhenli Shan Yicun Gu Yiying Huang |
| author_facet | Yan Ma Zhenli Shan Yicun Gu Yiying Huang |
| author_sort | Yan Ma |
| collection | DOAJ |
| description | Objectives: This study aimed to investigate the safety of the inactivated COVID-19 vaccines in early pregnant women in view of their adverse-effect profile and associated maternal-fetal complications, as well as to evaluate their immunogenicity. Methods: In this prospective observational cohort study, 232 women in their first trimester or those in the periconception period who inadvertently received two doses of inactivated COVID-19 vaccine between January 21, 2021, and January 14, 2022 were analyzed. Meanwhile, 735 unvaccinated early pregnancy women were also included in the study at a case-to-control ratio of 1:3. Results: The vaccination group did not have an increased miscarriage rate compared with that of the control group (P = 0.918). Furthermore, the birth defect rates in the vaccine group and control group were 0.83% and 1.0%, respectively. Vaccination did not increase the risk of small for gestational age, gestational diabetes mellitus, preterm, or hypertensive disorders of pregnancy (P >0.01). Within 12 weeks after the second dose, the inactivated vaccine effectively produced neutralizing antibody (NAb) against SARS-CoV-2. The NAb levels in the paired umbilical cord serum and maternal serum samples during delivery were negative in both groups. The T-cell subset remained within the normal range in both groups. Conclusion: Therefore, our study proves that inactivated COVID-19 vaccines are safe for mothers and fetuses and also effective in producing NAb against SARS-CoV-2. |
| first_indexed | 2024-04-09T19:01:03Z |
| format | Article |
| id | doaj.art-32e30de7518a46589c4f300276bdc8fc |
| institution | Directory Open Access Journal |
| issn | 1201-9712 |
| language | English |
| last_indexed | 2024-04-09T19:01:03Z |
| publishDate | 2023-05-01 |
| publisher | Elsevier |
| record_format | Article |
| series | International Journal of Infectious Diseases |
| spelling | doaj.art-32e30de7518a46589c4f300276bdc8fc2023-04-08T05:10:47ZengElsevierInternational Journal of Infectious Diseases1201-97122023-05-01130196202Safety and efficacy of inactivated COVID-19 vaccines in women vaccinated during the first trimester of pregnancyYan Ma0Zhenli Shan1Yicun Gu2Yiying Huang3Shanghai Key Laboratory of Maternal Fetal Medicine, Shanghai Institute of Maternal-Fetal Medicine and Gynecologic Oncology, Shanghai First Maternity and Infant Hospital, School of Medicine, Tongji University, Shanghai, ChinaShanghai Key Laboratory of Maternal Fetal Medicine, Shanghai Institute of Maternal-Fetal Medicine and Gynecologic Oncology, Shanghai First Maternity and Infant Hospital, School of Medicine, Tongji University, Shanghai, ChinaShanghai Key Laboratory of Maternal Fetal Medicine, Shanghai Institute of Maternal-Fetal Medicine and Gynecologic Oncology, Shanghai First Maternity and Infant Hospital, School of Medicine, Tongji University, Shanghai, ChinaCorresponding author.; Shanghai Key Laboratory of Maternal Fetal Medicine, Shanghai Institute of Maternal-Fetal Medicine and Gynecologic Oncology, Shanghai First Maternity and Infant Hospital, School of Medicine, Tongji University, Shanghai, ChinaObjectives: This study aimed to investigate the safety of the inactivated COVID-19 vaccines in early pregnant women in view of their adverse-effect profile and associated maternal-fetal complications, as well as to evaluate their immunogenicity. Methods: In this prospective observational cohort study, 232 women in their first trimester or those in the periconception period who inadvertently received two doses of inactivated COVID-19 vaccine between January 21, 2021, and January 14, 2022 were analyzed. Meanwhile, 735 unvaccinated early pregnancy women were also included in the study at a case-to-control ratio of 1:3. Results: The vaccination group did not have an increased miscarriage rate compared with that of the control group (P = 0.918). Furthermore, the birth defect rates in the vaccine group and control group were 0.83% and 1.0%, respectively. Vaccination did not increase the risk of small for gestational age, gestational diabetes mellitus, preterm, or hypertensive disorders of pregnancy (P >0.01). Within 12 weeks after the second dose, the inactivated vaccine effectively produced neutralizing antibody (NAb) against SARS-CoV-2. The NAb levels in the paired umbilical cord serum and maternal serum samples during delivery were negative in both groups. The T-cell subset remained within the normal range in both groups. Conclusion: Therefore, our study proves that inactivated COVID-19 vaccines are safe for mothers and fetuses and also effective in producing NAb against SARS-CoV-2.http://www.sciencedirect.com/science/article/pii/S1201971223000942Inactivated COVID-19 vaccinePregnancy complicationsFirst trimesterNeutralizing antibodyCord blood |
| spellingShingle | Yan Ma Zhenli Shan Yicun Gu Yiying Huang Safety and efficacy of inactivated COVID-19 vaccines in women vaccinated during the first trimester of pregnancy International Journal of Infectious Diseases Inactivated COVID-19 vaccine Pregnancy complications First trimester Neutralizing antibody Cord blood |
| title | Safety and efficacy of inactivated COVID-19 vaccines in women vaccinated during the first trimester of pregnancy |
| title_full | Safety and efficacy of inactivated COVID-19 vaccines in women vaccinated during the first trimester of pregnancy |
| title_fullStr | Safety and efficacy of inactivated COVID-19 vaccines in women vaccinated during the first trimester of pregnancy |
| title_full_unstemmed | Safety and efficacy of inactivated COVID-19 vaccines in women vaccinated during the first trimester of pregnancy |
| title_short | Safety and efficacy of inactivated COVID-19 vaccines in women vaccinated during the first trimester of pregnancy |
| title_sort | safety and efficacy of inactivated covid 19 vaccines in women vaccinated during the first trimester of pregnancy |
| topic | Inactivated COVID-19 vaccine Pregnancy complications First trimester Neutralizing antibody Cord blood |
| url | http://www.sciencedirect.com/science/article/pii/S1201971223000942 |
| work_keys_str_mv | AT yanma safetyandefficacyofinactivatedcovid19vaccinesinwomenvaccinatedduringthefirsttrimesterofpregnancy AT zhenlishan safetyandefficacyofinactivatedcovid19vaccinesinwomenvaccinatedduringthefirsttrimesterofpregnancy AT yicungu safetyandefficacyofinactivatedcovid19vaccinesinwomenvaccinatedduringthefirsttrimesterofpregnancy AT yiyinghuang safetyandefficacyofinactivatedcovid19vaccinesinwomenvaccinatedduringthefirsttrimesterofpregnancy |