Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

Safety and Immunogenicity of COVID-19 BBIBP-CorV Vaccine in Children 3-12 Years Old

Khaled Greish
* ORCID logo ,
Abdulla Alawadhi
,
Ahmed Jaradat
,
Amer Almarabheh
,
Marwa AlMadhi
,
Jaleela Jawad
,
Basma Alsaffar
,
Ejlal Alalawi
,
Adel Al-Sayyad
,
Afaf Merza
,
Batool Alalawi
,
Donia Qayed
,
Ahmed Humaidan
,
Manaf Al-Qahtani
* ORCID logo
Version 1 : Received: 13 March 2022 / Approved: 16 March 2022 / Online: 16 March 2022 (15:24:51 CET)

A peer-reviewed article of this Preprint also exists.

Greish, K.; Alawadhi, A.; Jaradat, A.; Almarabheh, A.; AlMadhi, M.; Jawad, J.; Alsaffar, B.; Alalawi, E.; Alsayyad, A.; Merza, A.; Alalawi, B.; Qayed, D.; Humaidan, A.; Al Qahtani, M. Safety and Immunogenicity of COVID-19 BBIBP-CorV Vaccine in Children 3–12 Years Old. Vaccines 2022, 10, 586. Greish, K.; Alawadhi, A.; Jaradat, A.; Almarabheh, A.; AlMadhi, M.; Jawad, J.; Alsaffar, B.; Alalawi, E.; Alsayyad, A.; Merza, A.; Alalawi, B.; Qayed, D.; Humaidan, A.; Al Qahtani, M. Safety and Immunogenicity of COVID-19 BBIBP-CorV Vaccine in Children 3–12 Years Old. Vaccines 2022, 10, 586.

Abstract

Background and Objectives: In the current Covid-19 pandemic, children below the age of 12 could manifest Covid-19 symptoms and serve as a reservoir for the virus in the community. The present study was conducted to evaluate the reactogenicity, and immunogenicity of BBIBP-CorV, prior to involving this age group in the vaccination program in the kingdom of Bahrain. Subjects and Methods: The study included 582 children from 3 to 12 years old of Bahraini and non-Bahraini nationality, all of which contributed to the reactogenicity study. Of those, 401 contributed to the immunogenicity study. All children received 2 doses of BBIBP-CorV inactivated virus 3 weeks apart. To assess reactogenicity, children were followed up for 5 weeks to evaluate any vaccine-related adverse events (AE). To assess immunogenicity, blood was collected on day 0 and day 35 to assess antibody titer against S, N, and neutralizing antibody. Results: Of the 582 participants, (45.4%) were female, (54.61%) were male, with 49% in 9-12 age group. Of the 401 children contributing to the immunogenicity study, 274 (68.3%) had no prior exposure to Covid-19. The overall incidence of AE was 27.7%. No significant difference was found among different age groups. The most frequent AE was local (at the injection site) and occurred in 16% of children, followed by fever in 9.3%. No serious adverse events were reported. The Seroconversion rate was 100% among children with no prior exposure to Covid-19. Children with previous Covid-19 exposure had higher averages of anti-S (2379 U/ml compared to 409.1), anti-N (177.6 U/ml compared to 30.9) and neutralizing antibody (93.7 U/ml compared to 77.1) than children with no prior exposure at day 35. Conclusions: Two doses of COVID-19 BBIBP-CorV on the subjects aged between 3 to 12 has good safety and tolerance and can induce an effective immune response and neutralizing antibody titer.

Keywords

COVID-19; BBIBP-CorV; children 3-12 years old; the anti-spike; Anti-nucleocapsid; Neutralizing antibody

Subject

Medicine and Pharmacology, Epidemiology and Infectious Diseases

Copyright: This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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