Trial NCT04368728
Publication Polack F, N Engl J Med, 2020
Dates: 27/07/2020 to 14/11/2020
Funding: Private (BioNTech and Pfizer)
Conflict of interest: Yes
Methods | |
RCT | |
Location :
Multicenter / Argentina, Brazil, Germany, South Africa, Turkey, USA Follow-up duration (months): 2.43 | |
• 30 mcg BNT162b2 (n = 21720) • Placebo (n = 21728) |
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Inclusion criteria |
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Exclusion criteria |
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Interventions | |
Intervention
2 IM doses of 30-mcg BNT162b1 per dose on days 1, 21 |
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Control
2 IM doses of 0.5 mL normal saline per dose on days 1 and 21 | |
Participants | |
Randomized 43548 participants | |
Characteristics of participants Type of participants: Healthy volunteers N=43548 19075 males Pregnant women: 0 Mean age: Age range: 16-89 | |
Description of participants Healthy SARS-CoV-2 DNA negative adults in multiple centres in Argentina, Brazil, Germany, South Africa, Turkey, and the USA | |
Primary outcome | |
In the register Percentage of participants in Phase 2/3 reporting adverse events [ Time Frame: From dose 1 through 6 months after the last dose ]; Percentage of participants in Phase 2/3 reporting serious adverse events [ Time Frame: From dose 1 through 6 months after the last dose ]; Confirmed COVID-19 in Phase 2/3 participants without evidence of infection before vaccination [ Time Frame: From 7 days after the second dose of study intervention to the end of the study, up to 2 years ] ; Confirmed COVID-19 in Phase 2/3 participants with and without evidence of infection before vaccination [ Time Frame: From 7 days after the second dose of study intervention to the end of the study, up to 2 years ] | |
In the report Safety: The primary end points of this trial were solicited, specific local or systemic adverse events and use of antipyretic or pain medication within 7 days after the receipt of each dose … and unsolicited adverse events … through 1 month after the second dose and unsolicited serious adverse events through 6 months after the second dose. Efficacy: The first primary end point was the efficacy of BNT162b2 against confirmed Covid-19 with onset at least 7 days after the second dose in participants who had been without serologic or virologic evidence of SARS-CoV-2 infection up to 7 days after the second dose. | |
Documents available |
Protocol Yes. In English Statistical plan Yes Data-sharing stated:
Yes, Upon request, and subject to review |
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 |
Some concerns |
General comment |
In addition to the published paper, the study registry, protocol, and statistical analysis plan were used in data extraction and risk of bias assessment. The reported results are from Phase 3 of a Phase 1/2/3 ongoing trial (NCT04368728). There were few differences between the published article and the trial registry in population, procedures, interventions and outcomes. We extracted the n randomized to be the number of randomized participants injected with vaccine or placebo after exclusions of 99 participants who underwent randomization but were not vaccinated and 1 participant who did not sign the informed consent document, as well well as 13 participants who underwent randomization after the cutoff. 37,086 participants were randomized for efficacy with a median follow up of 2 months but only 36,523 were analyzed and the reason for exclusions were unclear. Safety outcomes were assessed on the population who received 1 dose irrespective of follow up time (up to 14 weeks). Safety monitoring will continue for 2 years after administration of the second dose of vaccine. |