Safety of the BBIBP-CorV COVID-19 Vaccine in Relation to Adverse Clinical Outcomes in Newborns: A Prospective Cohort Study

Reyilaimu Muhetaier,1 Luhan Zhang,2 Guifeng Ding,2 Kai Wang,3 Xiaoqin Li2 1School of Public Health, Xinjiang Medical University, Urumqi, 830017, People’s Republic of China; 2Xinjiang Clinical Medical Research Center for Perinatal Diseases, Maternal and Child Health Hospital of Urumqi, Urumqi, 830000, People’s Republic of China; 3School of Medical Engineering and Technology, Xinjiang Medical University, Urumqi, 830017, People’s Republic of ChinaCorrespondence: Kai Wang, School of Medical Engineering and Technology, Xinjiang Medical University, Urumqi, 830017, People’s Republic of China, Email [email protected]: Objective: The aim of this study is to evaluate the safety of preconception inoculation with an inactivated SARS-CoV-2 vaccine with respect to adverse birth outcomes in newborns, to elucidate the potential association between inactivated COVID-19 vaccination and birth outcomes, and to provide scientific evidence to inform future vaccine policy development.Methods: In this study, a prospective cohort design is adopted, including913 mother–infant pairs among 2243 pregnant and postpartum women who delivered between January 2023 and May 31, 2023, at You’ai Hospital and the Maternal and Child Health Hospital in Urumqi. On the basis of the number of preconception doses of an inactivated SARS-CoV-2 vaccine, Poisson regression models were used to analyse the safety of preconception vaccination in terms of adverse birth outcomes in newborns.Results: Among 913 participants, 13.8% were unvaccinated (n=126), while 1-, 2-, and 3-dose BBIBP-CorV recipients accounted for 2.4% (n=22), 17.9% (n=163), and 65.9% (n=602), respectively. Stratified analysis revealed no increased risk of adverse neonatal outcomes in any vaccinated group vs unvaccinated group (1-dose: RR 1.07 [0.67– 1.71]; 2-dose: 1.02 [0.80– 1.31]; 3-dose: 1.03 [0.84– 1.26]). Sensitivity analysis confirmed that there were no significant differences.Conclusion: This study provides substantial evidence that prepregnancy BBIBP-CorV vaccination poses no safety concerns for neonatal outcomes. Clinically, these findings suggest that obstetricians should recommend COVID-19 vaccination during preconception counselling as a protective measure for future pregnancies. Public health implications include (1) supporting the integration of inactivated vaccines into prepregnancy health care programs to enhance immunity before gestation and (2) informing national policies to accelerate vaccine coverage among women of childbearing age, thereby reducing maternal–foetal risks in potential pandemics.Keywords: SARS-CoV-2, inactivated COVID-19 vaccine, neonatal, vaccine safety, vaccine safety evaluation