Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Children

Summary

This is a Phase 1/2/3 study in healthy children. Dependent upon safety and/or immunogenicity data generated during the course of this study, and the resulting assessment of benefit-risk, the safety, tolerability, and immunogenicity of BNT162b2 in participants \<6 months of age may subsequently be evaluated.

Timeline

Start

2021-03-24

Primary completion

2023-10-04

Completion

2023-12-08

Outcome

Sources disagree · no verdict is set; each source's reading is shown below

registry Geometric mean ratio 0.61 (95% CI 0.53 to 0.70) reads as mixed primary results NCT04816643 ↗

paper a ratio meeting the prespecified immunogenicity success criterion (lower bound of two-sided 95% CI, >0.67; geometric mean ratio point estimate, ≥0.8). reads as mixed primary results PMID 34752019 ↗

paper Immunobridging success criteria for the geometric mean ratio and seroresponse at 1 month after dose 3 were met in both age groups. reads as mixed primary results PMID 36791162 ↗

release “In participants aged 12-15 years old, BNT162b2 demonstrated 100% efficacy” reads as met primary endpoint biontech.com ↗

Publications

• Pather S, Charpentier N, van den Ouweland F, Rizzi R, Finlayson A, Salisch N, Muik A, Lindemann C, Khanim R, Abduljawad S, Smith ER, Gurwith M, Chen RT; Benefit-Risk Assessment of VAccines by TechnolOgy Working Group (BRAVATO; ex-V3SWG). A Brighton Collaboration standardized template with key considerations for a benefit-risk assessment for the Comirnaty COVID-19 mRNA vaccine. Vaccine. 2024 Sep 17;42(22):126165. doi: 10.1016/j.vaccine.2024.126165. Epub 2024 Aug 27.
• Simoes EAF, Klein NP, Sabharwal C, Gurtman A, Kitchin N, Ukkonen B, Korbal P, Zou J, Xie X, Sarwar UN, Xu X, Lockhart S, Cunliffe L, Lu C, Ma H, Swanson KA, Koury K, Shi PY, Cooper D, Tureci Ӧ, Jansen KU, Sahin U, Gruber WC. Immunogenicity and Safety of a Third COVID-19 BNT162b2 mRNA Vaccine Dose in 5- to 11-Year Olds. J Pediatric Infect Dis Soc. 2023 Apr 28;12(4):234-238. doi: 10.1093/jpids/piad015.
• Munoz FM, Sher LD, Sabharwal C, Gurtman A, Xu X, Kitchin N, Lockhart S, Riesenberg R, Sexter JM, Czajka H, Paulsen GC, Maldonado Y, Walter EB, Talaat KR, Englund JA, Sarwar UN, Hansen C, Iwamoto M, Webber C, Cunliffe L, Ukkonen B, Martinez SN, Pahud BA, Munjal I, Domachowske JB, Swanson KA, Ma H, Koury K, Mather S, Lu C, Zou J, Xie X, Shi PY, Cooper D, Tureci O, Sahin U, Jansen KU, Gruber WC; C4591007 Clinical Trial Group. Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age. N Engl J Med. 2023 Feb 16;388(7):621-634. doi: 10.1056/NEJMoa2211031.
• Walter EB, Talaat KR, Sabharwal C, Gurtman A, Lockhart S, Paulsen GC, Barnett ED, Munoz FM, Maldonado Y, Pahud BA, Domachowske JB, Simoes EAF, Sarwar UN, Kitchin N, Cunliffe L, Rojo P, Kuchar E, Ramet M, Munjal I, Perez JL, Frenck RW Jr, Lagkadinou E, Swanson KA, Ma H, Xu X, Koury K, Mather S, Belanger TJ, Cooper D, Tureci O, Dormitzer PR, Sahin U, Jansen KU, Gruber WC; C4591007 Clinical Trial Group. Evaluation of the BNT162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age. N Engl J Med. 2022 Jan 6;386(1):35-46. doi: 10.1056/NEJMoa2116298. Epub 2021 Nov 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	BNT162b2	Messenger RNA (mRNA)	3 ug	—
Subject	BNT162b2	Messenger RNA (mRNA)	10 ug	—
Subject	BNT162b2	Messenger RNA (mRNA)	20 ug	—
Subject	BNT162b2	Messenger RNA (mRNA)	30 ug	—

Indications