Evidence map›Paper›PMID 33125914›Full record

ReviewThe Lancet. Infectious diseases2021

What defines an efficacious COVID-19 vaccine? A review of the challenges assessing the clinical efficacy of vaccines against SARS-CoV-2.

Susanne H Hodgson, Kushal Mansatta, Garry Mallett, Victoria Harris, Katherine R W Emary, Andrew J Pollard

2 registry-linked trialsOpen access · bronzeAbstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in The Lancet. Infectious diseases, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 352 papers, 12 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
352citing papers in PubMed, 12 pooled it
15.1field-weighted citation impact, top 1% of its field
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.

NCT04741386 completednot on this map

The Immune-response and Safety of COVID-19 Vaccination in Patients With Chronic Kidney Disease, on Dialysis, or Living With a Kidney Transplant - A Prospective, Controlled, Multicenter Cohort Study by the RECOVAC Consortium

Typeobservational_patient_registrySponsorUniversity Medical Center GroningenRan2021 to 2022Enrolled854ConditionsCovid19, Chronic Kidney DiseasesArmsSARS-CoV-2 vaccination
NCT04841785 completednot on this map

The RECOVAC LESS CoV-2 Study - Long Term Efficacy and Safety of SARS-CoV-2 Vaccination in Patients in Patients With Chronic Kidney Disease Stage G4-G5, on Dialysis or After Kidney Transplantation

TypeobservationalSponsorUniversity Medical Center GroningenRan2021 to 2023Enrolled4,868ConditionsCovid19, SARS-CoV Infection, Chronic Kidney DiseasesArmsmailer-based finger-prick
3 · Its place in the literature

Who cites it

352 citing papers in PubMed, 12 syntheses or guidelines pooled it, 664 citations in OpenAlex.

  1. Pooled it
  2. Globally approved vaccines for COVID-19: a systematic review.Brazilian journal of microbiology : [publication of the Brazilian Society for Microbiology] · 2025
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  10. Immunogenicity and Safety of the COVID-19 Vaccines Compared With Control in Healthy Adults: A Qualitative and Systematic Review.Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research · 2022
    Pooled it
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  13. Trial
  14. Serological reactivity of inactivated SARS-CoV-2 vaccine based on an S-RBD neutralizing antibody assay.International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases · 2022
    Trial
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292 more citing papers are in PubMed but not listed here.

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

6 authors at 3 institutions in 1 country.

Susanne H HodgsonThe Jenner Institute, University of Oxford, Oxford, UK. Electronic address: susanne.hodgson@ndm.ox.ac.uk.
Kushal MansattaUniversity of Oxford Clinical Medical School, Medical Sciences Division, University of Oxford, Oxford, UK.
Garry MallettUniversity of Oxford Clinical Medical School, Medical Sciences Division, University of Oxford, Oxford, UK.
Victoria HarrisNuffield Department of Primary Care Health Sciences, Radcliffe Primary Care Building, Radcliffe Observatory Quarter, Oxford, UK.
Katherine R W EmaryOxford Vaccine Group, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.
Andrew J PollardOxford Vaccine Group, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.
Oxford BioMedica (United Kingdom) · GBUniversity of Oxford · GBJenner Institute · GB

Funding

Medical Research Council MC_PC_19055
6 · The paper itself

Abstract

The novel coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has caused more than 1 million deaths in the first 6 months of the pandemic and huge economic and social upheaval internationally. An efficacious vaccine is essential to prevent further morbidity and mortality. Although some countries might deploy COVID-19 vaccines on the strength of safety and immunogenicity data alone, the goal of vaccine development is to gain direct evidence of vaccine efficacy in protecting humans against SARS-CoV-2 infection and COVID-19 so that manufacture of efficacious vaccines can be selectively upscaled. A candidate vaccine against SARS-CoV-2 might act against infection, disease, or transmission, and a vaccine capable of reducing any of these elements could contribute to disease control. However, the most important efficacy endpoint, protection against severe disease and death, is difficult to assess in phase 3 clinical trials. In this Review, we explore the challenges in assessing the efficacy of candidate SARS-CoV-2 vaccines, discuss the caveats needed to interpret reported efficacy endpoints, and provide insight into answering the seemingly simple question, "Does this COVID-19 vaccine work?"

Indexed as

Clinical Trials as TopicCOVID-19COVID-19 VaccinesHumansImmunogenicity, VaccineOutcome Assessment, Health CareResearch DesignSARS-CoV-2Treatment OutcomeVaccinationCOVID-19 Vaccines

Identifiers

PMID33125914
PMCPMC7837315
OpenAlexW3088489318

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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.