No observable influence of COVID-19 inactivated vaccines on pregnancy and birth outcomes in the first trimester of gestation

ABSTRACT

Background

While studies have demonstrated that certain COVID-19 vaccines administered during pregnancy did not affect neonatal or maternal outcomes significantly, the safety of inactivated SARS-CoV-2 vaccines in China, given during the first trimester, remains to be fully elucidated.

Method

A retrospective cohort study was conducted involving female participants who gave birth from January to October 2021. The study compared pregnancy, delivery, and neonatal outcomes between subjects who received one or two doses of the inactivated COVID-19 vaccines during their first trimester and unvaccinated control subjects.

Results

A total of 2658 pregnant women was recruited. Among them, 2358 (88.7%) reported ongoing pregnancies; 326 (13.8%) of these were vaccinated. Additionally, 277 (10.4%) experienced spontaneous miscarriages between 6 to 20 gestational weeks; 40 (14.4%) of these were vaccinated, yielding an odds ratio of 0.67–1.36 (95% confidence interval) for COVID-19 vaccination. The comparison of neonatal complications, including an Apgar score less than 7, preterm birth, low birth weight, and newborn respiratory complications, between unvaccinated and vaccinated participants revealed no statistical significance.

Conclusion

The administration of COVID-19 inactivated vaccines during the first trimester of pregnancy is not associated with adverse pregnancy or neonatal outcomes, providing a substantial ground for pertinent health education.

KEYWORDS:

• First trimester
• COVID-19 inactivated vaccine
• birth outcome
• pregnancy
• birth defect

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or material discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or mending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contribution statement

All authors have made a significant contribution to the work reported; Ting Du performed the research, and wrote the paper. Qiuxia Qu and Yawen Zhang analyzed the data. Qin Huang reviewed the manuscript. Ting Du and Qin Huang designed and conceptualized the study and confirmed the authenticity of the raw data. All authors have read and approved the final manuscript.All agree to take responsibility and be accountable for the contents of the article and to share responsibility to resolve any questions raised about the accuracy or integrity of the published work.

Data availability statement

The datasets that support the findings of this study are managed by Suzhou Municipal Health Commission and can be requested from the corresponding author upon reasonable request.

Additional information

Funding

This paper was funded by the First Affiliated Hospital of Soochow University.