Evidence map›Paper›PMID 35753841›Full record

ArticleVaccine2022

A Brighton Collaboration standardized template with key considerations for a benefit/risk assessment for the Moderna COVID-19 Vaccine (mRNA-1273).

Brett Leav, Walter Straus, Phil White, Alison Leav, Tashawnee Gaines, Grace Maggiacomo, Denny Kim, Emily R Smith, Marc Gurwith, Robert T Chen and 1 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Vaccine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Brett LeavModerna, Inc., Cambridge, MA, USA.
Walter StrausModerna, Inc., Cambridge, MA, USA.
Phil WhiteModerna, Inc., Cambridge, MA, USA.
Alison LeavModerna, Inc., Cambridge, MA, USA.
Tashawnee GainesModerna, Inc., Cambridge, MA, USA.
Grace MaggiacomoModerna, Inc., Cambridge, MA, USA.
Denny KimBrighton Collaboration, a program of the Task Force for Global Health, Decatur, GA, USA.
Emily R SmithBrighton Collaboration, a program of the Task Force for Global Health, Decatur, GA, USA. Electronic address: bc-coordinator@taskforce.org.
Marc GurwithBrighton Collaboration, a program of the Task Force for Global Health, Decatur, GA, USA.
Robert T ChenBrighton Collaboration, a program of the Task Force for Global Health, Decatur, GA, USA.
Benefit-Risk Assessment of VAccines by TechnolOgy Working Group BRAVATO ex-V3SWG

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The Brighton Collaboration Benefit-Risk Assessment of VAccines by TechnolOgy (BRAVATO) Working Group has prepared standardized templates to describe the key considerations for the benefit-risk assessment of several vaccine platform technologies, including nucleic acid (RNA and DNA) vaccines. This paper uses the BRAVATO template to review the features of a vaccine employing a proprietary mRNA vaccine platform to develop Moderna COVID-19 Vaccine (mRNA-1273); a highly effective vaccine to prevent coronavirus disease 2019 (Covid-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). In response to the pandemic the first in human studies began in March 2020 and the pivotal, placebo-controlled phase 3 efficacy study in over 30,000 adults began in July 2020. Based on demonstration of efficacy and safety at the time of interim analysis in November 2020 and at the time of trial unblinding in March 2021, the mRNA-1273 received Emergency Use Authorization in December 2020 and full FDA approval in January 2022.

Indexed as

COVID-19Viral Vaccines2019-nCoV Vaccine mRNA-1273AdultHumansmRNA VaccinesRisk AssessmentSARS-CoV-2Vaccines, Synthetic2019-nCoV Vaccine mRNA-1273mRNA VaccinesVaccines, SyntheticViral VaccinesBenefit/RiskCOVID-19mRNASafetySARS-CoV-2Vaccine

Identifiers

PMID35753841
PMCPMC9181264

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.