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41 protocols using ad26 cov2 s

1

COVID-19 Vaccination Protocols and Dosages

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The administered vaccines were nucleoside-modified mRNA vaccines BNT162b2 (BioNTech/Pfizer) and mRNA-1273 (Moderna) and viral vector vaccines such as ChAdOx1-S (AstraZeneca) and Ad26.COV2.S (Johnson & Johnson). The vaccines were delivered intramuscularly. The dosage for BNT162b2 in the primary vaccination cycle and the booster vaccination was 30 µg/0.3 mL for each dose. As for mRNA-1273, a dosage of 100 µg/0.5 mL in the primary vaccination cycle and a dosage of 50 µg/0.5 mL for the booster vaccination were used, respectively. In regard to ChAdOx1-S and Ad26.COV2.S, respective dosages of 2.5 × 108 Inf.U (infectious units)/0.5 mL and 8.92 log10 Inf.U/0.5 mL were used. These dosages were the ones used in the general population.
Due to reports of thromboembolic events linked to viral vector vaccines (Ad26.COV2.S by Johnson & Johnson and ChAdOx1-S by AstraZeneca), in April 2021, the Ministry of Health of Italy recommended these vaccines to people aged 60 or older. Thus, most patients either received nucleoside-modified mRNA vaccines or were administered a viral vector vaccine as the first dose and a nucleoside-modified mRNA vaccine as a second dose and booster dose.
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2

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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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

Immunocompromised COVID-19 Vaccine Response

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Immunocompromised individuals were eligible if they had any of the following: solid organ transplantation (SOT), hematological malignancy, solid cancer undergoing systemic or radiation therapy within the prior 12 months, autoimmune or chronic inflammatory disease undergoing therapy within the prior 12 months, and human immunodeficiency virus (HIV). For the control arm, we enrolled nonimmunocompromised HCWs. Participants with a known history of COVID-19 were excluded. Prior COVID-19 was ascertained by participant (immunocompromised patient or HCW) self-report, then confirmed by manual chart review for positive SARS-CoV-2 polymerase chain reaction (PCR) results within the UPMC EMR, conducted by either the PI (G.H.) or the study coordinators. All participants were required to have completed vaccination with 2 doses of a messenger RNA (mRNA) vaccine (mRNA-1273 [Moderna] or BNT162b2 [Pfizer]) or the adenovirus vaccine ChAdOx1 nCoV-19 (AstraZeneca), or a single dose of the adenovirus vaccine Ad26.COV2.S (Johnson & Johnson) at least 14 days before testing.
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5

VITT Characterization After COVID-19 Vaccines

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The study was performed in two Italian centers: Azienda Ospedaliera Universitaria Careggi in Florence and Fondazione Policlinico Universitario Agostino Gemelli IRCCS in Rome.
We tested 5 patients from Rome (4 M/1 F; median age 42 (33–67)) and 8 patients from Florence (2 M/6 F, median age 71 (41–78)) who developed a clinical VITT picture with both the Vaxzevria (AstraZeneca) and Ad26.COV2S (Johnson & Johnson) vaccines. The clinical and demographic characteristics of the study population are reported in Table 1.
Samples were collected before intravenous immunoglobulin (IvIg) or anticoagulant administration in 8 patients and during IvIg therapy in 5 patients.
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6

Immunogenicity of mRNA COVID-19 Vaccines in IBD

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IBD patients and healthy controls received the mRNA vaccines mRNA-1273 (Moderna, Cambridge, MA, USA) or BNT162b2 (BioNTech, Mainz, Germany; Pfizer, New York, NY, USA), both of which have been licensed in the European Union. Patients and controls vaccinated with the adenovirus vector-based vaccines Ad26.CoV2.S (Johnson & Johnson, Janssen Pharmaceutica, Beerse, Belgium) and/or ChAdOx1 (AstraZeneca, Cambridge, United Kingdom) were excluded from study [14 (link),15 (link),16 (link),17 (link)].
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7

SARS-CoV-2 and PCV13 Vaccine Administration Protocol

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SARS-CoV-2 vaccines were obtained from commercial supply and administered per the package insert, with product selection based on availability of BNT162b2 (Pfizer-BioNTech),10 (link) mRNA-1273 (Moderna),11 (link) or Ad26.COV2.S (Johnson & Johnson).9 (link) PCV13 (Wyeth) was obtained from commercial supply and administered per the package insert (supplemental Methods). SARS-CoV-2 and PCV13 vaccinations were not performed concurrently.
Patients without detectable spike protein antibody after vaccination (RBD immunoassay) were offered an additional dose of mRNA-1273 or BNT162b2 from investigational product surplus from a multicenter trial (#NCT04761822; supplemental Methods).
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8

Vaccine Uptake During SARS-CoV-2 Rollout

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Our outcome was vaccine uptake, defined as second dose of any vaccine against SARS-CoV-2 infection which was offered as part of the vaccine rollout in Denmark: BNT162b2 (Pfizer BioNTech), mRNA-1273 (Moderna), Ad26.COV2.S (Johnson & Johnson), or ChAdOx1 (AstraZeneca). For the Johnson & Johnson vaccine, only one dose was required and, thus, the first dose was used as outcome in these cases. The rollout of SARS-CoV-2 vaccination was targeted according to the Danish Health Authority's specification of 12 target groups.15
The vaccine data were retrieved from the Danish Vaccination Register30 containing individual-level information on the dates for and type of vaccines given. These data were provided through the Danish Health Data Authority.
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9

Herpes Zoster Risk After COVID-19 Vaccination

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Individuals who received any dose of a COVID-19 vaccine with emergency use authorization from the US Food and Drug Administration (BNT162b2 [Pfizer-BioNTech], mRNA-1273 [Moderna], or Ad26.COV2.S [Johnson & Johnson]) from December 11, 2020, through June 30, 2021, were eligible to be included in the study. Eligible participants were further required to be continuously enrolled in both medical and pharmacy coverage from 270 days before the date of first recorded COVID-19 vaccine dose (index date) through July 31, 2021, to allow for determination of baseline characteristics and herpes zoster cases after vaccination. Individuals with vaccination records inconsistent with guidance from the Centers for Disease Control and Prevention (CDC) at the time of the study (eg, excess doses, receipt of a vaccine before the vaccine’s date of emergency use authorization, or receipt of a vaccine before age eligibility) were excluded. COVID-19 vaccines were identified by the presence of a CPT or HCPCS code in the medical claims database or by an 11-digit NDC or drug name text search in the pharmacy claims database (eTable 1 in the Supplement). Individuals with a previous diagnosis of herpes zoster (identified by ICD-10 code B02.xx) in the 270 days before the index date were excluded.
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10

SARS-CoV-2 Vaccine Efficacy Assessment

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Vaccinated individuals in the cohort received a vaccine against SARS-CoV-2 in Denmark (approved by the European Medicines Agency) and were followed up from the date of vaccination with the first dose (with BNT162b2, mRNA-1273, ChAdOx1 nCoV-19 (AstraZeneca), or Ad26.COV2.S (Johnson and Johnson)). Only estimates for individuals vaccinated with BNT162b2 or mRNA-1273 are presented in the main analysis. Estimates for individuals vaccinated with ChAdOx1 nCoV-19 or Ad26.COV2.S are presented in the supplemental materials, because these vaccines were withdrawn from the national mass vaccination programme and rarely used. The main risk window of interest was the 28 days after vaccination, which included day 0, the day of vaccination. If study participants received a second dose, they re-entered a 28 day risk window.
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