Clinical and Histopathological Evaluation of the Sinopharm COVID-19 Vaccine's Effects on Newborns and Placenta in Pregnant Women
Sameh Fawzy Elsonbaty1*, Mohammad Chand Jamali2*, Maxime Merheb1,
Hend Mohamed Ahmed Hamed1, Mohammed Abdalhamied M. Abushohada1,
Tarig Mohamed Fadl Elmula 2, Adham Elsonbaty3
1Department of Health & Laboratory Sciences,
College of Medical and Health Sciences, Liwa University, Abu Dhabi, UAE.
2Department of Health & Laboratory Sciences,
College of Medical and Health Sciences, Liwa University, Al Ain, Abu Dhabi, UAE.
3Faculty of Medicine, October 6 University, Egypt.
*Corresponding Author E-mail: sameh.elsonbaty@lu.ac.ae, mjamali68@gmail.com, maxime.merheb@lu.ac.ae, hend.ahmad@lu.ac.ae, mohammed.abushohada@lu.ac.ae, tarig.fadlalla@lu.ac.ae ,samsonbaty@gmail.com
ABSTRACT:
The COVID-19 pandemic presents significant medical challenges, including unclear perinatal issues. Infection can occur at any stage of pregnancy, potentially leading to in utero transmission. Most studies indicate no significant clinical impact on fetal malformations or neonatal death from fetal infection. This study evaluates the importance of vaccinating pregnant women against COVID-19 and the potential for in utero transmission, correlating these factors with pathological findings in placental tissues and newborns. It examines how placental changes may contribute to neonatal symptoms and how vaccination reduces complications for both mothers and neonates. The study involves a retrospective clinicopathological analysis of 50 placental autopsies from non-vaccinated pregnant women aged 25-30 years infected with COVID-19 during the 2nd or 3rd trimester, compared to 50 autopsies from vaccinated women (with the Sinopharm vaccine) in the same age range and trimesters. Findings suggest that COVID-19 infection in non-vaccinated mothers leads to placental issues like placentitis and vessel obstruction, causing decreased perfusion, placental insufficiency, and perinatal problems such as fetal hypoxia. Vaccinated mothers showed minimal or no such complications. The study highlights the intimate relationship between neonatal complications and intrauterine COVID-19 infection, suggesting that including the COVID-19 vaccine in premarital vaccination programs could prevent these issues, benefiting both mothers and neonates.
KEYWORDS: Covid 19, Optimization, Pathological effects, Placenta.
1. INTRODUCTION:
Previous studies of infected mothers with covid 19 who had either mild, moderate, or non-existent symptoms had indicated that transplacental infections were either absent or were rare1,2. Most studies indicated that there is no excess perinatal mortality occurring in the neonates of mothers with covid 19, but some neonatal complications have been recorded3,4.
Stillbirths occur with TORCH (Toxoplasma, rubella, cytomegalovirus, herpes) but it is not a common complication with covid 19. So, we expect that some pathological changes may be related to placental involvement that may cause neonatal symptoms5. To understand the cause(s) of fetal and neonatal complications following maternal infection with COVID-19, we analyzed 100 cases (50 vaccinated and 50 non-vaccinated mothers who were exposed to COVID-19 infection) with histological placental examination to detect pathological changes that may be present in placenta and may cause the neonatal symptoms and the difference between vaccinated and non-vaccinated mothers)6,7.
The inclusion criteria included 50 vaccinated women and 50 non-vaccinated women with a positive test for covid 19 during 2nd and 3rd trimester of pregnancy using polymerase chain reaction (PCR) before delivery. The two groups of Women between 25-30 years old, healthy, with a BMI between 25-35 (The average BMI during pregnancy).
The exclusion criteria included Women with Diabetes, hypertension or any chronic disease or Women with a history of having previous neonates with any complication or unexplained neonatal mortality.
Vaccination (before pregnancy) is one of the widely used methods to prevent COVID-19 infection, advanced clinical experiments constantly develop different vaccines. The rapid development of science and technology enabled the improvement and rapid development of different vaccinations8,9. Faster studies after COVID-19 appearance enable the control of the pandemic. Previous Pandemics as cholera as there were late development of preventive measures caused millions of deaths in the 19th century. vaccination indicated that no symptoms or excess perinatal mortality are occurring in the neonates of mothers receiving the COVID-19 vaccine, but some neonatal complications have been recorded in non-vaccinated mothers. stillbirth occurs with TORCH (Toxoplasma, rubella, cytomegalovirus, herpes) but it is not a common complication with covid-19.
So, we try to detect pathological changes that may be related to placental involvement causing neonatal symptoms following maternal infection with COVID-19. This unique improvement in vaccination development technology rendered vaccination has numerous superiorities over other control measures, especially with mass production with low cost, non-invasive applications, safety, and efficacy10.
In this context, the objective of our study is to evaluate how vaccination development to covid-19 and availability causes low complications in mothers and neonates.
2. METHODS:
2.1 Study population:
To understand the causes of fetal and neonatal complications, we correlate clinical findings in 10 neonates of 50 non-vaccinated mothers, who had no systemic diseases or other infections during pregnancy but were infected with the COVID-19 virus during the 2nd and 3rd trimesters, with the histological findings in placental autopsies to detect any pathological changes that may be present and cause the neonatal symptoms. This was compared to 50 vaccinated mothers whose showed no or minimal symptoms after proved infected by PCR test to both mother during pregnancy and neonate after pregnancy.
2.2 Samples preparation:
After Delivery either normal vaginal Delivery or Caesarean section, placenta samples were obtained, washed, then specimen were taken and subsequently stored until examined. For Light Microscopy, the placenta specimens were immediately fixed in 10% formalin solution, washed and dehydrated in ascending grades of alcohol (70%, 90%, and 100%). This was followed by clearing overnight in xylene. Embedding was performed, paraffin blocks were obtained, and 5-6 ΅m thick serial sections were cut and mounted on microscope slides. Specimens were stained with Hematoxylin and Eosin and examined under a light microscope.
2.3 Statistical Analysis:
A morphometric study was conducted to measure the mean area percent of positive findings. Data was obtained using the Leica Qwin 500 C LTD image analyzer computer system (Cambridge, UK), at the Histology Department October 6 university. The measurements were done in 10 random nonoverlapping fields per section, using the binary mode, at a magnification of x400. Results were considered significant when the P value was < 0.05.
Excel spreadsheet was used for analysis of quantitative data of pathological changes in placenta including, Villous trophoblastic necrosis, chronic histiocytic intervillositis and massive perivillous fibrin deposition. Percentages and frequencies related to pathological changes are presented using tables and bar diagrams.
3. RESULTS:
We detected that there are abnormalities in 10 placentae of non-vaccinated mothers among 50 infected mothers during pregnancy with confirmed COVID-19 infection in the 2nd and 3rd trimester compared with the absence of such lesions in vaccinated mothers.
The major pathology lesions that were present as seen by the naked eye were necrosis (Figure 1) and these destructive lesions were associated with covid 19 maternal infection during pregnancy.
Histological examination of the placentae showing thrombosis of blood vessels of the placentae in some cases with severe Covid 19 infection. These placental abnormalities affect the placental function, dependent on the severity of maternal infection. Including peri-villous fibrin deposition (Figure 1(C)) Villous degeneration, histiocytic inter-villosities and trophoblast necrosis (Figure 1(D)).
Placental pathology has been useful in understanding how maternal infection can affect the fetus and the adverse neonatal outcomes with covid infections during pregnancy as shown in Table1 and Table 2.
Figure 1: (A) Necrosis in the placenta of non-vaccinated mothers; (B) Placenta showing blood vessels obstruction as a destructive lesion associated with covid 19 infection of the mother; (C) peri-villous fibrin deposition; (D) Villous degeneration (Red arrow), histiocytic inter-villositis (Green arrow) and trophoblast necrosis (Blue arrow).
Table 1: (cases 1-6). Showing mild to moderate infection with covid 19 in mothers during 2nd and 3rd trimester, and its effects on the placenta and newborn.
|
Case |
1 |
2 |
3 |
4 |
5 |
6 |
|
Maternal age/year |
25 |
27 |
30 |
27 |
27 |
26 |
|
Gestational age / week |
40 |
39 |
38 |
38 |
37 |
38 |
|
Maternal PCR |
+ve |
+ve |
+ve |
+ve |
+ve |
+ve |
|
Trimester infection |
2nd |
3rd |
2nd |
2nd |
3rd |
3rd |
|
Inf. Severity |
mild |
Mild |
Mod. |
Mod. |
mild |
Mod. |
|
Placenta wt./gm |
470 |
484 |
473 |
414 |
502 |
480 |
|
Newborn Nasopharyngeal swab |
-ve |
-ve |
-ve |
-ve |
-ve |
-ve |
|
symptoms of the newborn |
Fever, cough |
Fever, cough |
Fever, cough |
Fever, cough |
Fever, cough |
Fever, cough |
Table 2: (cases 7-10). Showing severe infection with covid 19 in mothers during 2nd and 3rd trimester, and its effects on the placenta and newborn.
|
Case |
7 |
8 |
9 |
10 |
|
Maternal age/year |
30 |
28 |
27 |
30 |
|
Gestational age / w |
36 |
37 |
38 |
38 |
|
Maternal PCR |
+ve |
+ve |
+ve |
+ve |
|
Trimester infection |
2nd |
2nd |
3rd |
2nd |
|
Inf. Severity |
Sev. |
Sev. |
Sev. |
Sev. |
|
Placenta wt. /gm |
460 |
487 |
502 |
470 |
|
Newborn Nasopharyngeal swab |
-ve |
-ve |
-ve |
-ve |
|
symptoms of the newborn |
Fever, cough, tachypnea, Vomiting. |
tachypnea, Fever, cough |
Low birth weight, Fever, cough |
Fever, cough, tachypnea, Vomiting. |
DISCUSSION:
There were many arguments about vaccination and its role at the beginning of its use, with both non-medical and medical personnel having doubts about the effects of the vaccine due to insufficient evidence of its efficacy11,12. The pathological changes detected in the placenta after infection, caused by thrombosis of the placenta (Figure (B)), affect placental perfusion, resulting in placental insufficiency and consequently health problems in neonates.
The Maternal infections with COVID-19 viruses resulted in placental pathology with no transmission to the fetus, but the pathological changes that occur in the placenta may cause neonatal complications13,14. We expect that the Placental changes may be the cause of mal perfusion that results in placental insufficiency and consequently health problems in the neonates or even stillbirth15,16.
Examining a series of placentae is important to detect significant patterns of pathological findings, regardless of the infection condition of the neonate. Furthermore, examination of the pathological changes in the placenta is a critically important tool for the determination of the cause of complications in neonates or perinatal mortality17,18.
A major concern regarding the COVID-19 infection was the possible similarity of the COVID-19 virus complications with TORCH viruses and the importance of including the COVID-19 test in the routine viral screening with pregnancy and to include the COVID-19 vaccine in the compulsory vaccination program to mothers before pregnancy19.
Various pathological changes in the placenta including,20 Villous trophoblastic necrosis, chronic histiocytic inter-villositis, and massive perivillous fibrin deposition that possibly affect the circulation in the placenta and consequently affect the newborn as shown in Figure 2.
With vaccinated mothers these changes in the placenta and the neonatal symptoms are less likely to occur12, this denotes the importance of adding the COVID-19 vaccine (inactivated Covid 19 virus) as a compulsory vaccine in the premarital vaccination program)21,22.
Figure 2: Showing various pathological changes in placenta including, Villous trophoblastic necrosis, chronic histiocytic intervillositis and massive perivillous fibrin deposition.
CONCLUSION:
The COVID-19 infection during pregnancy is a major risk factor for perinatal and postnatal morbidity when correlated with the pathological findings detected after examination of a series of placentae as we detect significant patterns of pathological findings, regardless of the infection condition of the neonate23. The routine COVID-19 viral screening with pregnancy and vaccination before pregnancy is important to prevent placental pathology and the importance of follow-up of pregnant mothers with covid 19 infection24. The Importance of full vaccination of married women before pregnancy as a routine vaccination to prevent virus effects on the mother, neonate, and placentae25,26. The limitation of this study is using only Sinopharm vaccine, it is better to compare Sinopharm with other vaccines. In addition, another limitation is that we did not include long term follow-up of babies to detect late complications.
ETHICS APPROVAL, CONSENT TO PARTICIPATE, CONSENT FOR PUBLICATION:
This study was approved by the Ethics Committee of 6th October Hospital-Giza-Egypt (2020-15), and all procedures performed herein involving human participants were in accordance with the Helsinki Declaration. Written informed consents for research and publication were obtained from all patients.
AVAILABILITY OF DATA AND MATERIAL:
The data that support the findings of this study are available upon request
DECLARATION OF COMPETING INTEREST:
The authors declare that there is no conflict of interest regarding the publication of this paper.
AUTHOR CONTRIBUTION STATEMENT:
Samer Fawzi Elsonbaty: Collecting samples- Histological section- Gross and Microscopic examination, Writing, review and editing, Conceptualization.
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Received on 20.04.2025 Revised on 06.08.2025 Accepted on 16.10.2025 Published on 13.01.2026 Available online from January 17, 2026 Research J. Pharmacy and Technology. 2026;19(1):372-376. DOI: 10.52711/0974-360X.2026.00054 © RJPT All right reserved
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