Different Safety Pattern of an Inactivated SARS-CoV-2 Vaccine (CoronaVac) According to Age Group in a Pediatric Population from 3 to 17 Years Old, in an Open-Label Study in Chile

During the COVID-19 pandemic, the importance of vaccinating children against SARS-CoV-2 was rapidly established. This study describes the safety of CoronaVac in children and adolescents between 3- and 17-years-old in a multicenter study in Chile with two vaccine doses in a 4-week interval. For all participants, immediate adverse events (AEs), serious AEs (SAEs), and AEs of special interest (AESIs) were registered throughout the study. In the safety subgroup, AEs were recorded 28 days after each dose. COVID-19 surveillance was performed throughout the study. A total of 1139 individuals received the first and 1102 the second dose of CoronaVac; 835 were in the safety subgroup. The first dose showed the highest number of AEs: up to 22.2% of participants reported any local and 17.1% systemic AE. AEs were more frequent in adolescents after the first dose, were transient, and mainly mild. Pain at the inoculation site was the most frequent AE for all ages. Fever was the most frequent systemic AE for 3-5 years old and headache in 6-17 years old. No SAEs or AESIs related to vaccination occurred. Most of the COVID-19 cases were mild and managed as outpatients. CoronaVac was safe and well tolerated in children and adolescents, with different safety patterns according to age.

References

Jara A, Undurraga E, Flores J, Zubizarreta J, Gonzalez C, Pizarro A . Effectiveness of an inactivated SARS-CoV-2 vaccine in children and adolescents: a large-scale observational study. Lancet Reg Health Am. 2023; 21:100487. PMC: 10117174. DOI: 10.1016/j.lana.2023.100487. View

Ling R, Ramanathan K, Tan F, Tai B, Somani J, Fisher D . Myopericarditis following COVID-19 vaccination and non-COVID-19 vaccination: a systematic review and meta-analysis. Lancet Respir Med. 2022; 10(7):679-688. PMC: 9000914. DOI: 10.1016/S2213-2600(22)00059-5. View

Wood N, Lopez L, Glover C, Leeb A, Cashman P, Deng L . Short term adverse event profile of COVID-19 mRNA vaccines in children aged 5-15 years in Australia. Lancet Reg Health West Pac. 2023; 31:100684. PMC: 9854254. DOI: 10.1016/j.lanwpc.2023.100684. View

Jara A, Undurraga E, Zubizarreta J, Gonzalez C, Acevedo J, Pizarro A . Effectiveness of CoronaVac in children 3-5 years of age during the SARS-CoV-2 Omicron outbreak in Chile. Nat Med. 2022; 28(7):1377-1380. PMC: 9307483. DOI: 10.1038/s41591-022-01874-4. View

Hause A, Baggs J, Marquez P, Myers T, Gee J, Su J . COVID-19 Vaccine Safety in Children Aged 5-11 Years - United States, November 3-December 19, 2021. MMWR Morb Mortal Wkly Rep. 2021; 70(5152):1755-1760. PMC: 8736274. DOI: 10.15585/mmwr.mm705152a1. View

Kyriakidis N, Lopez-Cortes A, Gonzalez E, Grimaldos A, Prado E . SARS-CoV-2 vaccines strategies: a comprehensive review of phase 3 candidates. NPJ Vaccines. 2021; 6(1):28. PMC: 7900244. DOI: 10.1038/s41541-021-00292-w. View

Sadeghi S, Kalantari Y, Shokri S, Fallahpour M, Nafissi N, Goodarzi A . Immunologic response, Efficacy, and Safety of Vaccines against COVID-19 Infection in Healthy and immunosuppressed Children and Adolescents Aged 2 - 21 years old: A Systematic Review and Meta-analysis. J Clin Virol. 2022; 153:105196. PMC: 9162782. DOI: 10.1016/j.jcv.2022.105196. View

Schleiss M, John C, Permar S . Children are the key to the Endgame: A case for routine pediatric COVID vaccination. Vaccine. 2021; 39(38):5333-5336. PMC: 8358829. DOI: 10.1016/j.vaccine.2021.08.005. View

Chen L, Cai X, Zhao T, Han B, Xie M, Cui J . Safety of Global SARS-CoV-2 Vaccines, a Meta-Analysis. Vaccines (Basel). 2022; 10(4). PMC: 9030038. DOI: 10.3390/vaccines10040596. View

10.

Zhang Y, Zeng G, Pan H, Li C, Hu Y, Chu K . Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine in healthy adults aged 18-59 years: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial. Lancet Infect Dis. 2020; 21(2):181-192. PMC: 7832443. DOI: 10.1016/S1473-3099(20)30843-4. View

11.

Abarca K, Iturriaga C, Urzua M, Le Corre N, Pineda A, Fernandez C . Safety and Non-Inferiority Evaluation of Two Immunization Schedules with an Inactivated SARS-CoV-2 Vaccine in Adults: A Randomized Clinical Trial. Vaccines (Basel). 2022; 10(7). PMC: 9323976. DOI: 10.3390/vaccines10071082. View

12.

Booth A, Reed A, Ponzo S, Yassaee A, Aral M, Plans D . Population risk factors for severe disease and mortality in COVID-19: A global systematic review and meta-analysis. PLoS One. 2021; 16(3):e0247461. PMC: 7932512. DOI: 10.1371/journal.pone.0247461. View

13.

Zhu F, Jin P, Zhu T, Wang W, Ye H, Pan H . Safety and Immunogenicity of a Recombinant Adenovirus Type-5-Vectored Coronavirus Disease 2019 (COVID-19) Vaccine With a Homologous Prime-Boost Regimen in Healthy Participants Aged ≥6 Years: A Randomized, Double-Blind, Placebo-Controlled, Phase 2b.... Clin Infect Dis. 2021; 75(1):e783-e791. PMC: 8522421. DOI: 10.1093/cid/ciab845. View

14.

Frenck Jr R, Klein N, Kitchin N, Gurtman A, Absalon J, Lockhart S . Safety, Immunogenicity, and Efficacy of the BNT162b2 Covid-19 Vaccine in Adolescents. N Engl J Med. 2021; 385(3):239-250. PMC: 8174030. DOI: 10.1056/NEJMoa2107456. View

15.

Soto J, Melo-Gonzalez F, Gutierrez-Vera C, Schultz B, Berrios-Rojas R, Rivera-Perez D . Inactivated Vaccine-Induced SARS-CoV-2 Variant-Specific Immunity in Children. mBio. 2022; 13(6):e0131122. PMC: 9765711. DOI: 10.1128/mbio.01311-22. View

16.

Creech C, Anderson E, Berthaud V, Yildirim I, Atz A, Melendez Baez I . Evaluation of mRNA-1273 Covid-19 Vaccine in Children 6 to 11 Years of Age. N Engl J Med. 2022; 386(21):2011-2023. PMC: 9127699. DOI: 10.1056/NEJMoa2203315. View

17.

Klok F, Pai M, Huisman M, Makris M . Vaccine-induced immune thrombotic thrombocytopenia. Lancet Haematol. 2021; 9(1):e73-e80. PMC: 8585488. DOI: 10.1016/S2352-3026(21)00306-9. View

18.

Gao Q, Bao L, Mao H, Wang L, Xu K, Yang M . Development of an inactivated vaccine candidate for SARS-CoV-2. Science. 2020; 369(6499):77-81. PMC: 7202686. DOI: 10.1126/science.abc1932. View

19.

Buonsenso D, Perramon A, Catala M, Torres J, Camacho-Moreno G, Rojas-Solano M . Multisystem Inflammatory Syndrome in Children in Western Countries? Decreasing Incidence as the Pandemic Progresses?: An Observational Multicenter International Cross-sectional Study. Pediatr Infect Dis J. 2022; 41(12):989-993. PMC: 9645445. DOI: 10.1097/INF.0000000000003713. View

20.

Wu Z, Hu Y, Xu M, Chen Z, Yang W, Jiang Z . Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine (CoronaVac) in healthy adults aged 60 years and older: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial. Lancet Infect Dis. 2021; 21(6):803-812. PMC: 7906628. DOI: 10.1016/S1473-3099(20)30987-7. View