Safety and immunogenicity of the ChAdOx1 nCoV-19 (AZD1222) vaccine in children aged 6–17 years: a preliminary report of COV006, a phase 2 single-blind, randomised, controlled trial

Li, Grace; Cappuccini, Federica; Marchevsky, N; Aley, Parvinder K.; Aley, Robert; Anslow, Rachel; Bibi, Sagida; Cathie, Katrina; Clutterbuck, Elizabeth A.; Faust, Saul N; Feng, Shuo; Heath, Paul T.; Kerridge, Simon; Lelliott, Alice; Mujadidi, Yama F; Ng, Khuen Foong; Rhead, Sarah; Roberts, Hannah; Robinson, Hannah; Roderick, Marion; Singh, Nisha; Smith, David J.; Snape, Matthew D; Song, Rinn; Tang, Karly; Yao, Andy; Liu, Xinxue; Lambe, Teresa; Pollard, Andrew J.; Aboagye, Jeremy; Ambihapathy, W; Jf, Baker; Beales, ER; Boon, Adrianus C. M.; Brampton, R; Branch, NM; Cooper, Rachel; Cornish, EL; Cuevas-Asturias, S; Danos, Z; Davies, Sophie; George, Liza; Drury, Ruth; Flaxman, Amy; Fowler, Jamie; Galiza, Eva; Godfrey, Leila; Haskell, L; Hillson, Kushalinii; Hultin, CL; Koleva, Stanislava; Lees, Emily A.; Mabbett, Reece; Muller, Jilly; Munro, APS; Oliver, AL; Owens, Daniel R; Pearce, JP; Rajan, Matthew; Ratcliffe, Helen; Rowbotham, I; Salter, S; Sanders, Helen; Sapuan, SS; Sharpe, Hannah; Sheehan, Emma; Sutton, Natalina; Thaygaraja, G; Thomson-Hill, S; Ulaszewska, Marta; Woods, Danielle; Team, Bristol Clinical Research Nurse

doi:10.1016/s0140-6736(22)00770-x

Cited by 33 publications

(26 citation statements)

References 35 publications

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“…For comparison, the US reports 75% of mRNA-based SARS-CoV-2 vaccine recipients experience local adverse reactions, and 69% systemic adverse reactions in the 7 days following vaccination; similar to this study, the most frequently reported reactions were injection site pain, fatigue, headache and myalgia 18. Clinical trials of the Pfizer, Moderna, AstraZeneca, Sinopharm and CoronaVac vaccines in healthy children and adolescents also show similar results; predominantly mild to moderate reactogenic AEs in the first few days following vaccination and few reports of serious AEs related to the vaccine 19–25. The WHO has determined the Pfizer and Moderna vaccines safe for use in children and adolescents, and now recommends children with existing health conditions be prioritised for vaccination.…”

Section: Discussionsupporting

confidence: 78%

“…18 Clinical trials of the Pfizer, Moderna, AstraZeneca, Sinopharm and Coro-naVac vaccines in healthy children and adolescents also show similar results; predominantly mild to moderate reactogenic AEs in the first few days following vaccination and few reports of serious AEs related to the vaccine. [19][20][21][22][23][24][25] The WHO has determined the Pfizer and Moderna vaccines safe for use in children and adolescents, and now recommends children with existing health conditions be prioritised for vaccination.…”

Section: Discussionmentioning

confidence: 99%

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SARS-CoV-2 vaccine safety in adolescents with inflammatory rheumatic and musculoskeletal diseases and adults with juvenile idiopathic arthritis: data from the EULAR COVAX physician-reported registry

et al. 2022

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BackgroundThere is a lack of data on SARS-CoV-2 vaccination safety in children and young people (CYP) with rheumatic and musculoskeletal diseases (RMDs). Current vaccination guidance is based on data from adults with RMDs or CYP without RMDs.ObjectivesTo describe the safety of SARS-COV-2 vaccination in adolescents with inflammatory RMDs and adults with juvenile idiopathic arthritis (JIA).MethodsWe described patient characteristics, flares and adverse events (AEs) in adolescent cases under 18 with inflammatory RMDs and adult cases aged 18 or above with JIA submitted to the European Alliance of Associations for Rheumatology COVAX registry.ResultsA total of 110 cases were reported to the registry. Thirty-six adolescent cases were reported from four countries, most with JIA (42%). Over half (56%) reported early reactogenic-like AEs. One mild polyarthralgia flare and one serious AE of special interest (malaise) were reported. No CYP reported SARS-CoV-2 infection postvaccination.Seventy-four adult JIA cases were reported from 11 countries. Almost two-thirds (62%) reported early reactogenic-like AEs and two flares were reported (mild polyarthralgia and moderate uveitis). No serious AEs of special interest were reported among adults with JIA. Three female patients aged 20–30 years were diagnosed with SARS-CoV-2 postvaccination; all fully recovered.ConclusionsThis is an important contribution to research on SARS-CoV-2 vaccine safety in adolescents with RMDs and adults with JIA. It is important to note the low frequency of disease flares, serious AEs and SARS-CoV-2 reinfection seen in both populations, although the dataset is limited by its size.

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Section: Discussionsupporting

confidence: 78%

Section: Discussionmentioning

confidence: 99%

SARS-CoV-2 vaccine safety in adolescents with inflammatory rheumatic and musculoskeletal diseases and adults with juvenile idiopathic arthritis: data from the EULAR COVAX physician-reported registry

et al. 2022

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“…Survivors, especially women and girls, are often subject to stigma, isolation, and spousal or communal rejection-dynamics that can be exacerbated by preconflict patriarchy. [8][9][10] Similarly, sexual violence can involve the emasculation of male community leaders. 9 It is also associated with an increased lifetime risk of other types of gender-based violence, particularly intimate partner violence.…”

Section: Prevention Of Conflict-related Sexual Violence In Ukraine An...mentioning

confidence: 99%

“…9 It is also associated with an increased lifetime risk of other types of gender-based violence, particularly intimate partner violence. 9,10 Conflict-related sexual violence can have transgenerational impacts. In the context of ethnic cleansing, rape may be committed to eradicate ethnic groups through insemination and reproduction, causing long-term social disruption.…”

Section: Prevention Of Conflict-related Sexual Violence In Ukraine An...mentioning

confidence: 99%

“…paediatric COVID-19 and multisystem inflammatory syndrome. [7][8][9] In The Lancet, Grace Li and colleagues 10 present promising findings that help improve our understanding of COVID-19 vaccines for paediatric populations worldwide, paving the way for better access globally to safe and efficacious COVID-19 vaccines. In a phase 1/2 trial, the researchers assessed the tolerability and immunogenicity of AstraZeneca's ChAdOx1 nCoV-19 vaccine (n=211) compared with a control vaccine (n=51) among healthy children aged 6-11 years and adolescents aged 12-17 years from the UK (129 [49%] of 262 participants were girls and 236 [90%] were White).…”

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confidence: 99%

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Increasing children's global access to COVID-19 vaccines

Patel

2022

The Lancet

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Humoral and cellular immunity of two‐dose inactivated COVID‐19 vaccination in Chinese children: A prospective cohort study

Gan

Zeng

et al. 2022

Journal of Medical Virology

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Children are the high‐risk group for COVID‐19, and in need of vaccination. However, humoral and cellular immune responses of COVID‐19 vaccine remain unclear in vaccinated children. To establish the rational immunization strategy of inactivated COVID‐19 vaccine for children, the immunogenicity of either one dose or two doses of the vaccine in children was evaluated. A prospective cohort study of 322 children receiving inactivated COVID‐19 vaccine was established in China. The baseline was conducted after 28 days of the first dose, and the follow‐up was conducted after 28 days of the second dose. The median titers of receptor binding domain (RBD)‐IgG, and neutralizing antibody (NAb) against prototype strain and Omicron variant after the second dose increased significantly compared to those after the first dose (first dose: 70.0, [interquartile range, 30.0–151.0] vs. second dose: 1261.0 [636.0–2060.0] for RBD‐IgG; 2.5 [2.5–18.6] vs. 252.0 [138.6–462.1] for NAb against prototype strain; 2.5 [2.5–2.5] vs. 15.0 [7.8–26.5] for NAb against Omicron variant, all p < 0.05). The flow cytometry results showed that the first dose elicited SARS‐CoV‐2 specific cellular immunity, while the second dose strengthened SARS‐CoV‐2 specific IL‐2+ or TNF‐α+ monofunctional, IFN‐γ+TNF‐α+ bifunctional, and IFN‐γ−IL‐2+TNF‐α+ multifunctional CD4+ T cell responses (p < 0.05). Moreover, SARS‐CoV‐2 specific memory T cells were generated after the first vaccination, including the central memory T cells and effector memory T cells. The present findings provide scientific evidence for the vaccination strategy of the inactive vaccines among children against COVID‐19 pandemic.

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Safety and immunogenicity of the ChAdOx1 nCoV-19 (AZD1222) vaccine in children aged 6–17 years: a preliminary report of COV006, a phase 2 single-blind, randomised, controlled trial

Cited by 33 publications

References 35 publications

SARS-CoV-2 vaccine safety in adolescents with inflammatory rheumatic and musculoskeletal diseases and adults with juvenile idiopathic arthritis: data from the EULAR COVAX physician-reported registry

SARS-CoV-2 vaccine safety in adolescents with inflammatory rheumatic and musculoskeletal diseases and adults with juvenile idiopathic arthritis: data from the EULAR COVAX physician-reported registry

Increasing children's global access to COVID-19 vaccines

Humoral and cellular immunity of two‐dose inactivated COVID‐19 vaccination in Chinese children: A prospective cohort study

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