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COVID-19 vaccine and non-syndromic orofacial clefts in five arab countries. A case-control study

  • Rana A. Alamoudi,
  • Heba Jafar Sabbagh,
  • Mohammad Zeinalddin,
  • Ola B. Al-Batayneh,
  • Taimoor Al Bulushi,
  • Mamdouh A. AboulHassan,
  • Mohamed Koraitim,
  • Lateefa Alkharafi,
  • Buthaina Almuqbali,
  • Sultan Musaad Alghamdi,
  • Dania Bahdila,
  • Shaimaa Mohsen Refahee,
  • Maryam Quritum,
  • Fatemah Fahad Taqi,
  • Bader Albassam,
  • Mariam Ayed,
  • Alia Embaireeg,
  • Raqiya Alnahdi,
  • Mona Talal AlSharif,
  • Aziza Johar Aljohar,
  • Fatma Dawood Abdulhameed,
  • Najla Sulaiman Alrejaye,
  • P S Viswapurna,
  • Tamara Al Halasa,
  • Osama Adel Basri,
  • Mohammed A. Bataineh,
  • Maha El Tantawi

摘要

Objectives

Risk factors for non-syndromic orofacial cleft (NSOFCs) include genetic profile and environmental exposure to medication and illnesses during pregnancy. We assessed the association between the COVID-19 vaccination and the incidence of NSOFC across five Middle Eastern countries.

Materials and methods

This multi-country, hospital-based, case-control study included infants with NSOFCs whose first 3 intrauterine months coincided with the time when pregnant women were allowed to receive COVID-19 vaccination in the countries participating in the study. Newborns with NSOFCs were examined for cleft type and their parents were interviewed for maternal exposures and COVID-19 vaccination. Controls were newborns matched to cases in gender and setting.

Results

The study recruited 977 (348 children with NSOFCs and 629 controls). Maternal use of nicotine (Adjusted Odds Ratio (AOR): 2.437; P = 0.044) and family history of NSOFC (AOR: 11.059; P < 0.001) increased significantly the AOR of having a child with NSOFC. On the other hand, COVID-19 vaccine administration to pregnant mothers have significantly decreased the AOR of having a child with NSOFC (AOR: 0.337; P = 0.006).

Conclusion

This study suggests that COVID-19 vaccination is not related to NSOFC and might protect against having a child affected with such a congenital anomaly.

Clinical relevance

The finding of this study is important for healthcare providers for considering COVID-19 vaccination for pregnant woman. Clear communication and education about the potential risks and benefits would be crucial for informed decision-making. The study’s results would directly impact pregnant individuals, as they would need accurate information to make informed decisions about their health and the health of their infants.