Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine through 6 Months

New England Journal of Medicine, Год журнала: 2021, Номер 385(19), С. 1761 - 1773

Опубликована: Сен. 15, 2021

BNT162b2 is a lipid nanoparticle-formulated, nucleoside-modified RNA vaccine encoding prefusion-stabilized, membrane-anchored severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) full-length spike protein. highly efficacious against disease 2019 (Covid-19) and currently approved, conditionally or authorized for emergency use worldwide. At the time of initial authorization, data beyond months after vaccination were unavailable.In an ongoing, placebo-controlled, observer-blinded, multinational, pivotal efficacy trial, we randomly assigned 44,165 participants 16 years age older 2264 12 to 15 receive two 30-μg doses, at 21 days apart, placebo. The trial end points laboratory-confirmed Covid-19 safety, which both evaluated through 6 vaccination.BNT162b2 continued be safe have acceptable adverse-event profile. Few had adverse events leading withdrawal from trial. Vaccine was 91.3% (95% confidence interval [CI], 89.0 93.2) follow-up among without evidence previous SARS-CoV-2 infection who could evaluated. There gradual decline in efficacy. 86 100% seen across countries populations with diverse ages, sexes, race ethnic groups, risk factors SARS-CoV-2. 96.7% CI, 80.3 99.9). In South Africa, where variant concern B.1.351 (or beta) predominant, 53.5 100) observed.Through despite efficacy, favorable safety profile preventing Covid-19. (Funded by BioNTech Pfizer; ClinicalTrials.gov number, NCT04368728.).

Язык: Английский

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Comparing COVID-19 vaccines for their characteristics, efficacy and effectiveness against SARS-CoV-2 and variants of concern: a narrative review

Clinical Microbiology and Infection, Год журнала: 2021, Номер 28(2), С. 202 - 221

Опубликована: Окт. 27, 2021

Язык: Английский

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Efficacy of the mRNA-1273 SARS-CoV-2 Vaccine at Completion of Blinded Phase

New England Journal of Medicine, Год журнала: 2021, Номер 385(19), С. 1774 - 1785

Опубликована: Сен. 22, 2021

At interim analysis in a phase 3, observer-blinded, placebo-controlled clinical trial, the mRNA-1273 vaccine showed 94.1% efficacy preventing coronavirus disease 2019 (Covid-19). After emergency use of was authorized, protocol amended to include an open-label phase. Final analyses and safety data from blinded trial are reported.

Язык: Английский

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Evaluation of the BNT162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age

New England Journal of Medicine, Год журнала: 2021, Номер 386(1), С. 35 - 46

Опубликована: Ноя. 9, 2021

Safe, effective vaccines against coronavirus disease 2019 (Covid-19) are urgently needed in children younger than 12 years of age.A phase 1, dose-finding study and an ongoing 2-3 randomized trial being conducted to investigate the safety, immunogenicity, efficacy two doses BNT162b2 vaccine administered 21 days apart 6 months 11 age. We present results for 5-to-11-year-old children. In trial, participants were randomly assigned a 2:1 ratio receive either at dose level identified during open-label 1 or placebo. Immune responses month after second immunologically bridged those 16-to-25-year-olds from pivotal 30-μg BNT162b2. Vaccine Covid-19 7 more was assessed.During study, total 48 5 age received 10 μg, 20 30 μg (16 each level). On basis reactogenicity selected further study. 2268 (1517 children) placebo (751 children). At data cutoff, median follow-up 2.3 months. 5-to-11-year-olds, as other groups, had favorable safety profile. No vaccine-related serious adverse events noted. One dose, geometric mean severe acute respiratory syndrome 2 (SARS-CoV-2) neutralizing titers 5-to-11-year-olds 1.04 (95% confidence interval [CI], 0.93 1.18), meeting prespecified immunogenicity success criterion (lower bound two-sided 95% CI, >0.67; point estimate, ≥0.8). with onset reported three recipients 16 (vaccine efficacy, 90.7%; 67.7 98.3).A vaccination regimen consisting 10-μg found be safe, immunogenic, efficacious (Funded by BioNTech Pfizer; ClinicalTrials.gov number, NCT04816643.).

Язык: Английский

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Safety and Efficacy of a Third Dose of BNT162b2 Covid-19 Vaccine

New England Journal of Medicine, Год журнала: 2022, Номер 386(20), С. 1910 - 1921

Опубликована: Март 23, 2022

Active immunization with the BNT162b2 vaccine (Pfizer–BioNTech) has been a critical mitigation tool against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection during disease 2019 (Covid-19) pandemic. In light of reports waning protection occurring 6 months after primary two-dose series, data are needed on safety and efficacy offering third (booster) dose in persons 16 years age or older.

Язык: Английский

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Low-dose mRNA-1273 COVID-19 vaccine generates durable memory enhanced by cross-reactive T cells

Science, Год журнала: 2021, Номер 374(6566)

Опубликована: Сен. 14, 2021

A smaller-dose jab does the job Low-dose messenger RNA (mRNA) vaccines potentially allow health providers to administer more doses from a limited vaccine supply and can be less reactogenic. Whether low-dose COVID-19 mRNA generate immune responses comparable currently approved remains an open question, however. Mateus et al . report results of clinical trial comparing patients who received 25-μg mRNA-1273 (Moderna) 100-μg vaccinees severe acute respiratory syndrome coronavirus 2–infected individuals. The Moderna generated long-lived T cell immunity that was equivalent between younger older could enhanced by presence cross-reactive cells. Moreover, antibody induced were natural infection about half as strong those seen with high-dose vaccination. —STS

Язык: Английский

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Effectiveness of BNT162b2 (Pfizer-BioNTech) mRNA Vaccination Against Multisystem Inflammatory Syndrome in Children Among Persons Aged 12–18 Years — United States, July–December 2021

MMWR Morbidity and Mortality Weekly Report, Год журнала: 2022, Номер 71(2), С. 52 - 58

Опубликована: Янв. 7, 2022

Multisystem inflammatory syndrome in children (MIS-C) is a severe postinfectious hyperinflammatory condition, which generally occurs 2-6 weeks after typically mild or asymptomatic infection with SARS-CoV-2, the virus that causes COVID-19 (1-3). In United States, BNT162b2 (Pfizer-BioNTech) vaccine currently authorized for use and adolescents aged 5-15 years under an Emergency Use Authorization fully licensed by Food Drug Administration persons ≥16 (4). Prelicensure randomized trials ≥5 documented high efficacy immunogenicity (5),§ real-world studies 12-18 demonstrated effectiveness (VE) against (6). Recent evidence suggests vaccination associated lower MIS-C incidence among (7); however, VE of 2-dose Pfizer-BioNTech regimen has not been evaluated. The 2 doses received ≥28 days before hospital admission preventing was assessed using test-negative case-control design¶ hospitalized patients at 24 pediatric hospitals 20 states** during July 1-December 9, 2021, period when most could be temporally linked to SARS-CoV-2 B.1.617.2 (Delta) variant predominance. Patients (case-patients) two groups controls matched case-patients were evaluated: had least one COVID-19-like symptom negative reverse transcription-polymerase chain reaction (RT-PCR) antigen-based assay results, syndrome-negative without illness. Among 102 181 controls, estimated 91% (95% CI = 78%-97%). All 38 requiring life support unvaccinated. Receipt level protection years, highlighting importance all eligible children.

Язык: Английский

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Efficacy and safety of COVID-19 vaccines

Cochrane library, Год журнала: 2022, Номер 2023(3)

Опубликована: Дек. 7, 2022

Язык: Английский

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Risk Factors for Severe COVID-19 in Children

PEDIATRICS, Год журнала: 2021, Номер 149(1)

Опубликована: Окт. 22, 2021

OBJECTIVES Describe population-based rates and risk factors for pediatric severe coronavirus disease 2019 (COVID-19) (ie, ICU admission, invasive mechanical ventilation, or death). METHODS During March 2020 to May 2021, the COVID-19–Associated Hospitalization Surveillance Network identified 3106 children hospitalized with laboratory-confirmed acute respiratory syndrome 2 infection in 14 states. Among 2293 primarily admitted COVID-19, multivariable generalized estimating equations generated adjusted ratios (aRRs) 95% confidence intervals (CIs) of associations between demographic medical characteristics abstracted from patient electronic records COVID-19. We calculated age-adjusted cumulative COVID-19 among all children. RESULTS Approximately 30% had COVID-19; 0.5% died during hospitalization. aged <2 years, chronic lung (aRR: 2.2; CI: 1.1–4.3), neurologic disorders 2.0; 1.5‒2.6), cardiovascular 1.7; 1.2‒2.3), prematurity 1.6; 1.1‒2.2), airway abnormality 1.1‒2.2) were associated 17 feeding tube dependence 1.5‒2.5), diabetes mellitus 1.9; 1.6‒2.3) obesity 1.2; 1.0‒1.4) Severe occurred 12.0 per 100 000 overall was highest infants, Hispanic children, non-Hispanic Black CONCLUSIONS Results identify at potentially higher who may benefit prevention efforts, including vaccination. Rates establish a baseline monitoring changes illness severity after increased availability vaccines emergence new variants.

Язык: Английский

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SARS-CoV-2 vaccine effectiveness against infection, symptomatic and severe COVID-19: a systematic review and meta-analysis

BMC Infectious Diseases, Год журнала: 2022, Номер 22(1)

Опубликована: Май 7, 2022

Abstract Background The temporal evolution of SARS-CoV-2 vaccine efficacy and effectiveness (VE) against infection, symptomatic, severe COVID-19 is incompletely defined. VE could be dependent on age, types, variants the virus, geographic region. We aimed to conduct a systematic review meta-analysis duration symptomatic COVID-19. Methods MEDLINE, Scopus, Cochrane Central Register Controlled Trials, Database Systematic Reviews, World Health Organization Global Literature Coronavirus Disease, CoronaCentral databases were searched studies selected. Independent reviewers selected randomized controlled trials cohort with outcome interest. extracted data, assessed risk bias. Meta-analysis was performed DerSimonian-Laird random-effects model Hartung-Knapp-Sidik-Jonkman variance correction. GRADE (Grading Recommendations, Assessment, Development Evaluation) approach used assess certainty (quality) evidence. Primary outcomes included as function time Results Eighteen representing nearly 7 million individuals. all infections declined from 83% in first month after completion original vaccination series 22% at 5 months or longer. Similarly, 94% 64% by fourth month. for ages high overall, level being 90% (95% CI, 87–92%) five longer fully vaccinated. lower individuals ≥ 65 years those who received Ad26.COV2.S. Conclusions infection waned over but protection remained These data can inform public health decisions around need booster vaccination.

Язык: Английский

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