Evidence map›Paper›PMID 37391580›Full record

ReviewNPJ vaccines2023

Availability and use of Standards in vaccine development.

Michael Selorm Avumegah, Giada Mattiuzzo, Anna Särnefält, Mark Page, Karen Makar, Janet Lathey, June Kim, Solomon Abebe Yimer, Danielle Craig, Ivana Knezevic and 3 more

Abstract readReview
In one paragraph

Review in NPJ vaccines, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing 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

7 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
  4. Article
  5. Article
  6. Article
  7. Review
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

13 authors.

Michael Selorm AvumegahCoalition for Epidemic Preparedness Innovations (CEPI), Oslo, Norway. selorm.avumegah@cepi.net.ORCID http://orcid.org/0000-0003-2325-2238
Giada MattiuzzoMedicines and Healthcare products Regulatory Agency (MHRA), Potters Bar, UK.ORCID http://orcid.org/0000-0001-9475-1590
Anna SärnefältCoalition for Epidemic Preparedness Innovations (CEPI), Oslo, Norway.ORCID http://orcid.org/0000-0003-0421-9061
Mark PageMedicines and Healthcare products Regulatory Agency (MHRA), Potters Bar, UK.
Karen MakarBill & Melinda Gates Foundation (BMGF), Seattle, USA.
Janet LatheyNational Institute of Allergy and Infectious Diseases (NIAID), Bethesda, USA.
June KimCoalition for Epidemic Preparedness Innovations (CEPI), Oslo, Norway.
Solomon Abebe YimerCoalition for Epidemic Preparedness Innovations (CEPI), Oslo, Norway.
Danielle CraigCoalition for Epidemic Preparedness Innovations (CEPI), Oslo, Norway.ORCID http://orcid.org/0009-0005-8961-8564
Ivana KnezevicWorld Health Organization (WHO), Geneva, Switzerland.ORCID http://orcid.org/0000-0002-6441-7601
Valentina BernasconiCoalition for Epidemic Preparedness Innovations (CEPI), Oslo, Norway.
Paul A KristiansenCoalition for Epidemic Preparedness Innovations (CEPI), Oslo, Norway.
Ingrid KromannCoalition for Epidemic Preparedness Innovations (CEPI), Oslo, Norway.

Funding

World Health Organization 001
6 · The paper itself

Abstract

Reference materials are critical in assay development for calibrating and assessing their suitability. The devasting nature of the COVID-19 pandemic and subsequent proliferation of vaccine platforms and technologies has meant that there is even a greater need for standards for immunoassay development, which are critical to assess and compare vaccines' responses. Equally important are the standards needed to control the vaccine manufacturing processes. Standardized vaccine characterization assays throughout process development are essential for a successful Chemistry, Manufacturing and Controls (CMC) strategy. In this perspective paper, we advocate for reference material incorporation into assays and their calibration to International Standards from preclinical vaccine development through control testing and provide insight into why this is necessary. We also provide information on the availability of WHO international antibody standards for CEPI-priority pathogens.

Identifiers

PMID37391580
PMCPMC10313826

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.