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Bnt162b2

Manufactured by Johnson & Johnson

BNT162b2 is a nucleic acid-based vaccine candidate developed by Pfizer and BioNTech. It is designed to elicit an immune response against the SARS-CoV-2 virus.

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4 protocols using bnt162b2

1

COVID-19 Vaccine Effectiveness Protocol

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A standardized data extraction form was developed and two investigators (PS and AES) worked independently to extract study details. The following information was extracted: year of study publication, country and time frame, type of vaccine; mRNA-1273 (Moderna); BNT162b2 (Pfizer-BioNTech); Ad26.COV2.S (Janssen), inferential statistical test estimates (vaccine effectiveness or efficacy and its 95% confidence intervals), follow-up time after full vaccination (2-doses for mRNA-127 and BNT162b2 and 1 dose for Ad26.COV2.S), study-level descriptive statistics (mean (SD)/ median (IQR) age in years, proportion (%) female, male and obese), follow-up time (days), and definitions of symptomatic, and severe COVID-19. Authors were contacted for missing or incomplete information. The risk of bias of the included RCTs was evaluated with the Cochrane Collaboration’s Risk of Bias 2 tool (Additional file 1: Table S3) [8 ]. Methodological quality for nonrandomized observational studies was assessed with the Newcastle–Ottawa Scale (NOS) [9 ]. Based on the NOS criteria, we assigned a maximum of 4 stars for selection, 2 stars for comparability, and 3 stars for exposure and outcome assessment. Studies with fewer than 5 stars were considered low quality; 5 to 7 stars, moderate quality; and more than 7 stars, high quality.
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2

Booster Dose Effectiveness in Brazil

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We conducted a matched test-negative case-control study between September 6, 2021, and April 22, 2022, in Brazil. The national Covid-19 vaccination campaign started on January 17, 2021, and the administration of booster doses began for the general population on September 6, 2021. The primary series used in Brazil were homologous schemes of Sinovac CoronaVac (two doses), Oxford-AstraZeneca ChAdOx1 nCoV-19 (two doses), Pfizer BNT162b2 (two doses), Janssen Ad26.COV2.S (single dose), and heterologous combinations of the above products in periods of vaccine shortage. All four vaccine products were administered as a homologous or heterologous booster dose. There was no differential recommendation for which vaccine to be administered, except a suggestion for BNT162b2 if available. The booster vaccination followed an age-prioritization scheme. The interval between second and booster doses was initially six months and was subsequently shortened to four months during November 2021 in some states and nationally on December 20, 2021. The proportion of individuals with a primary series of CoronaVac who received a booster dose of Ad26.COV2.S or ChAdOx1 nCoV-19 was small; therefore we limited our analysis to booster doses of CoronaVac and BNT162b2.
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3

SARS-CoV-2 Vaccine Response in HSCT Patients

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A single-center, retrospective review of electronic medical record (EMR) data was conducted among HSCT recipients who received SARS-CoV-2 vaccinations between January 2020 and August 2022 at Brigham and Women's Hospital and Dana-Farber Cancer Institute in Boston, Massachusetts. Patients were included if they were ≥18 years old and had received ≥1 dose of BNT162b2 (Pfizer-BioNTech), mRNA-1273 (Moderna), or Ad26.COV2.S (Janssen) vaccine and had been tested at least once for anti-S IgG. Vaccines were administered intramuscularly according to their respective Emergency Use Authorizations (EUAs): BNT162b2 (30 mcg in 0.3 mL for all doses), mRNA-1273 (100 mcg in 0.5 mL for primary series, 50 mcg in 0.25 mL for booster doses), Ad26.COV2.S (5 × 1010 viral particles in 0.5 mL for all doses). All vaccines consisted of the monovalent ancestral SARS-CoV-2 spike sequence as the study period ended before the availability of bivalent variant-containing boosters. The anti-S IgG measurements occurred between January 28, 2021, and August 25, 2022. Patients were censored as of the date of SARS-CoV-2 monoclonal antibody (mAb) therapy or positive test for SARS-CoV-2 infection. Those who had anti-S IgG assays only before transplant or who relapsed and received an alternate treatment were excluded.
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4

IMID Patient Vaccine Response Cohort

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The T2B! cohort consists of IMID patients on and not on ISP treatment, and healthy controls. Participants were vaccinated either through the national vaccination campaign or as part of the ongoing study with one or two doses of any of the four different vaccines available in the Netherlands during 2021; BNT162b2 (Pfizer/BioNTech), CX-024414 (Moderna), ChAdOx1nCoV-19 (AstraZeneca) or Ad.26.COV2.S (Janssen) as primary immunization and CX-024414 or BNT162b2 as additional vaccinations (i.e. a third and/or booster vaccinations). In this cohort, primary immunizations ranged from March 1st, 2021 to December 10th, 2021, while additional vaccinations ranged from September 27th, 2021 to July 6th, 2022.
For this substudy, we selected IMID patients who received at least one vaccination as part of primary immunization, and who at least completed the survey at baseline and at 60 days follow-up after start of primary immunization.
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