Evidence map›Paper›PMID 40625176›Full record

ReviewHuman vaccines & immunotherapeutics2025

A second-generation, self-amplifying COVID-19 Vaccine: World's first approval and distribution in the Japanese market with vaccine hesitancy.

Toshio Naito

Abstract readReview
In one paragraph

Review in Human vaccines & immunotherapeutics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Review
  2. Review
  3. 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

1 author.

Toshio NaitoDepartment of General Medicine, Faculty of Medicine, Juntendo University, Tokyo, Japan.ORCID 0000-0003-1646-9930

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The mRNA vaccine is a milestone in immunotherapeutics, as symbolized by the 2023 Nobel Prize for Physiology or Medicine awarded to Drs. Karikó and Weissman. Whereas the conventional, "first-generation" mRNA vaccine was globally distributed to hundreds of millions of people to decrease COVID-19 prevalence, further advanced constructs have been pursued by researchers and pharmaceutical manufacturers. The key feature of the "second-generation" mRNA vaccine is a self-amplifying replicon that may allow a low dose to ensure durable immunogenicity. In clinical trials, ARCT-154 indeed showed effectiveness (magnitude, persistence, and breadth) superior to conventional mRNA vaccines, with similar or less frequent adverse responses, and acquired its world's first approval in November 2023 in Japan (brand name: KOSTAIVE manufactured by Meiji Seika Pharma, Tokyo, Japan) to prevent COVID-19 infection. Real-world distribution of KOSTAIVE was started in October 2024, and researchers are collecting data on its effectiveness and safety despite nonscientific, but persistent, antivaccine skepticism.

Indexed as

COVID-19COVID-19 VaccinesVaccination HesitancyClinical Trials as TopicDrug ApprovalHumansJapanVaccines, SyntheticCOVID-19 VaccinesVaccines, SyntheticCOVID-19efficacyimmunotherapeuticsJapanmRNA vaccine

Identifiers

PMID40625176
PMCPMC12239764

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.