Covid-19 Living Data

Trial NCT04816643
Publication Walter E, N Engl J Med, 2021
Dates: 2021-06-07 to 2021-06-19
Funding: Private (BioNTech and Pfizer)
Conflict of interest: Yes

Methods
	RCT
	Location : Multicenter / United States, Spain, Finland, Poland Follow-up duration (months): 2.5
	10 mcg BNT162b2 (n = 1528) Placebo (n = 757)
Inclusion criteria	Children 5 to 11 years of age; no or stable preexisting conditions (i.e., disease not requiring a significant change in therapy or hospitalization for worsening disease in the 6 weeks before enrollment)
Exclusion criteria	Receipt of COVID-19 preventative treatments; history of multisystem inflammatory syndrome in children (MIS-C) or of severe adverse reaction with a vaccine or any component of the study intervention; immunodeficiency, autoimmune disease, or conditions associated with prolonged bleeding; receiving immunosuppressive therapy (including cytotoxic agents and systemic glucocorticoids)
Interventions
	Intervention 2 IM doses of BNT162b2 10 mcg, 21 days apart
	Control 2 IM doses of saline placebo, 21 days apart
Participants
	Randomized 2285 participants
	Characteristics of participants Type of participants: Children N=2285 1182 males Children: 2285 Pregnant women: 0 Immunocompromized patients: 0 Mean age: Age range: 5-11
	Description of participants Children aged 5-11 years with or without stable co-morbidities with no history of COVID-19 in 81 centres in the USA, Spain, Finland, and Poland
Primary outcome
	In the register Percentage of participants in Phase 2/3 reporting local reaction [ Time Frame: for 7 days after Dose 1 and Dose 2 ] Pain or tenderness at the injection site, redness and swelling as reported on electronic diaries. Percentage of participants in Phase 2/3 reporting systemic events [ Time Frame: for 7 days after Dose 1 and Dose 2 ] Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, new or worsened joint pain, decreased appetite, drowsiness, and irritability as reported on electronic diaries Percentage of participants in Phase 2/3 reporting adverse events [ Time Frame: from Dose 1 through 1 month after the last dose ] As elicited by investigational site staff Percentage of participants in Phase 2/3 reporting serious adverse events [ Time Frame: from Dose 1 through 6 months after the last dose ] As elicited by investigational site staff Ph 2/3 selected-dose participants, immunobridging of SARS-CoV-2 serum neutralizing titers after 2 doses in participants ≥5 to <12 years to the geometric mean of SARS-CoV-2 serum neutralizing titers in participants 16 to 25 years in the C4591001 study [ Time Frame: 1 month after the second dose ] As measured at the central laboratory Ph 2/3 selected-dose participants, immunobridging of SARS-CoV-2 serum neutralizing titers after 2 doses in participants ≥2 to <5 years to the geometric mean of SARS-CoV-2 serum neutralizing titers in participants 16 to 25 years in the C4591001 study [ Time Frame: 1 month after the second dose ] As measured at the central laboratory Ph 2/3 selected-dose participants, immunobridging of SARS-CoV-2 serum neutralizing titers after 2 doses in participants ≥6 months to <2 years to the geometric mean of SARS-CoV-2 serum neutralizing titers in participants 16 to 25 years in C4591001 study [ Time Frame: 1 month after the second dose ] As measured at the central laboratory In Phase 2/3 selected-dose participants, the difference in percentages of participants with seroresponse in participants ≥5 to <12 years of age and participants 16 to 25 years of age from Phase 2/3 of the C4591001 study [ Time Frame: 1 month after the second dose ] As measured at the central laboratory In Phase 2/3 selected-dose participants, the difference in percentages of participants with seroresponse in participants ≥2 to <5 years of age and participants 16 to 25 years of age from Phase 2/3 of the C4591001 study [ Time Frame: 1 month after the second dose ] As measured at the central laboratory In Phase 2/3 selected-dose participants, the difference in percentages of participants with seroresponse in participants ≥6 months to <2 years of age and participants 16 to 25 years of age from Phase 2/3 of the C4591001 [ Time Frame: 1 month after the second dose ] As measured at the central laboratory
	In the report NR
Variants description
	Variants Delta
	Description *
Documents avalaible	Protocol Yes. In English Statistical plan Yes Data-sharing stated: Yes, from June 15, 2023 Data accessibility: Upon request, and subject to certain criteria, conditions and exceptions (see https://www.pfizer.com/science/clinical-trials/trialdata-and-results for more information), Pfizer will provide access to individual de-identified participant data from Pfizer-sponsored global interventional clinical studies conducted for medicines, vaccines and medical devices (1) for indications that have been approved in the US and/or EU or (2) in programs that have been terminated (i.e., development for all indications has been discontinued). Pfizer will also consider requests for the protocol, data dictionary, and statistical analysis plan. Data may be requested from Pfizer trials 24 months after study completion. The de-identified participant data will be made available to researchers whose proposals meet the research criteria and other conditions, and for which an exception does not apply, via a secure portal. To gain access, data requestors must enter into a data access agreement with Pfizer. Corresponding author: Dr. Gurtman, Alejandra.Gurtman@pfizer.com
Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review	Variant delta: Some concerns
General comment	In addition to the published article, the study registry and protocol were used in data extraction and risk of bias assessment. The target sample size specified in the registry was achieved. There were no important differences between protocol/registry and published report in population, procedures, interventions or outcomes. We report data from phase 2/3 investigating two 10 mcg doses of the BNT162b2 vaccine in 5-11 year olds with medium follow-up of 2.3 months and data cut-off on September 9, 2021. Participants will be followed for a total of 2 years after receipt of the first dose. Data on phase 1 were also reported in the article but not extracted because phase 1 was not randomised.