Covid-19 Living Data

Trial NCT04955626
Publication Moreira E D, N Engl J Med, 2022
Dates: 2021-07-01 to 2021-08-10
Funding: Private (BioNTech and Pfizer)
Conflict of interest: Yes

Methods
	RCT
	Location : Multicenter / Brazil, South Africa, USA Follow-up duration (months): 3.2
	BNT162b2 booster (n = 5088) Placebo booster (n = 5048)
Inclusion criteria	At least 16 years of age had previously received two doses of the BNT162b2 vaccine administered 19 to 42 days apart in the ongoing pivotal trial had received the second vaccine dose at least 175 days (approximately 6 months) earlier healthy participants with pre-existing stable disease could be included, including those with chronic stable HIV, hepatitis C virus, or hepatitis B virus infection
Exclusion criteria	Previous clinical or virologic COVID-19 diagnosis receipt of COVID-19 preventative treatments history of severe adverse reaction with a vaccine or any component of the study intervention immunodeficiency, autoimmune disease, or conditions associated with prolonged bleeding
Interventions
	Intervention 1 IM 30 mcg BNT162b2 booster, at least 175 days after primary BNT162b2 2-dose series
	Control 1 IM saline placebo booster, at least 175 days after primary BNT162b2 2-dose series
Participants
	Randomized 10,136 participants
	Characteristics of participants Type of participants: Adults and adolescents N=10,136 4975 males Children: 0 Pregnant women: 0 Immunocompromized patients: 0 Mean age: Age range: 16-86
	Description of participants Adults and adolescents (from age of 16 years) that had received two doses BNT162b2 in a previous trial at least 6 months previously and had no history of COVID-19 at 123 sites in Brazil, South Africa, and the USA
Primary outcome
	In the register 1) Confirmed COVID-19 incidence in participants without evidence of past SARS-CoV-2 infection [ Time Frame: from 7 days after the booster dose through the blinded follow-up period, which may be from 2 to 12 months ]; 2) Confirmed COVID-19 incidence in participants with and without evidence of past SARS-CoV-2 infection [ Time Frame: from 7 days after the booster dose through the blinded follow-up period, which may be from 2 to 12 months ]; 3) Percentage of participants reporting adverse events [ Time Frame: from the booster dose to 1 month after the booster dose ]; 4) Percentage of participants reporting serious adverse events [ Time Frame: from the booster dose to 6 months after the booster dose ]
	In the report 1) Incidence of adverse events and serious adverse events; 2) Effectiveness of the BNT162b2 vaccine against laboratory-confirmed Covid-19 beginning at least 7 days after the administration of dose 3
Documents available	Protocol Yes. In English Statistical plan Yes Data-sharing stated: Yes Data accessibility: Upon request through the following website: https://www.pfizer.com/science/clinical-trials/trialdata-and-results Corresponding author: Dr. Dychter, samuel.dychter@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	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 is no change from the trial registration in the intervention and control interventions. Primary outcomes were reported as presented in the registry.