Evidence map›Paper›PMID 36924838›Full record

Observational studyInternational journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases2023

Safety and efficacy of inactivated COVID-19 vaccines in women vaccinated during the first trimester of pregnancy.

Yan Ma, Zhenli Shan, Yicun Gu, Yiying Huang

Open access · goldAbstract readObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
3.8field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 13 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Review
  5. The Effectiveness and Influence of COVID-19 Vaccination on Perinatal Individuals and Their Newborns: An Updated Meta-Analysis.The Canadian journal of infectious diseases & medical microbiology = Journal canadien des maladies infectieuses et de la microbiologie medicale · 2025
    Review
  6. Review
  7. Article
  8. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors at 1 institution in 1 country.

Yan MaShanghai 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, China.
Zhenli ShanShanghai 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, China.
Yicun GuShanghai 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, China.
Yiying HuangShanghai 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, China. Electronic address: huangyiyingcovid@163.com.
Shanghai First Maternity and Infant Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThis 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.

methodsIn 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.

resultsThe 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.

conclusionTherefore, our study proves that inactivated COVID-19 vaccines are safe for mothers and fetuses and also effective in producing NAb against SARS-CoV-2.

Indexed as

COVID-19COVID-19 VaccinesAntibodies, NeutralizingAntibodies, ViralFemaleHumansInfant, NewbornPregnancyPregnancy Trimester, FirstProspective StudiesSARS-CoV-2VaccinationVaccines, InactivatedAntibodies, NeutralizingAntibodies, ViralCOVID-19 VaccinesVaccines, InactivatedCord bloodFirst trimesterInactivated COVID-19 vaccineNeutralizing antibodyPregnancy complications

Identifiers

PMID36924838
PMCPMC10014124
OpenAlexW4324135385

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.