Evidence map›Paper›PMID 37824453›Full record

ArticlePloS one2023

Safety profile of inactivated COVID-19 in healthy adults aged ≥ 18 years: A passive surveillance in Indonesia.

Nastiti Kaswandani, Bernie Endyarni Medise, Elcha Leonard, Hindra Irawan Satari, Julitasari Sundoro, Sri Rezeki Harun Hadinegoro, Ade Putra, Putra Fajar Angkasa

Open access · goldAbstract read
In one paragraph

Article in PloS one, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.4field-weighted citation impact, top 39% 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.

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

1 citing paper in PubMed, 2 citations in OpenAlex.

  1. 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

8 authors at 1 institution in 1 country.

Nastiti KaswandaniFaculty of Medicine, Department of Child Health, University of Indonesia, Central Jakarta, DKI Jakarta, Indonesia.
Bernie Endyarni MediseFaculty of Medicine, Department of Child Health, University of Indonesia, Central Jakarta, DKI Jakarta, Indonesia.ORCID 0000-0001-7494-7238
Elcha LeonardNational Adverse Events Following Immunization (NC AEFI) of Indonesia, Central Jakarta, DKI Jakarta, Indonesia.ORCID 0000-0002-6171-1768
Hindra Irawan SatariFaculty of Medicine, Department of Child Health, University of Indonesia, Central Jakarta, DKI Jakarta, Indonesia.
Julitasari SundoroNational Adverse Events Following Immunization (NC AEFI) of Indonesia, Central Jakarta, DKI Jakarta, Indonesia.
Sri Rezeki Harun HadinegoroFaculty of Medicine, Department of Child Health, University of Indonesia, Central Jakarta, DKI Jakarta, Indonesia.
Ade PutraNational Adverse Events Following Immunization (NC AEFI) of Indonesia, Central Jakarta, DKI Jakarta, Indonesia.ORCID 0000-0002-6524-0086
Putra Fajar AngkasaNational Adverse Events Following Immunization (NC AEFI) of Indonesia, Central Jakarta, DKI Jakarta, Indonesia.
University of Indonesia · ID

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Coronavirus Disease 2019 (COVID-19) vaccination in Indonesia has shown effectiveness in reducing the morbidity and mortality of Covid-19. The study aims to evaluate the incidence rate and severity of Adverse Events Following Immunization (AEFI) of inactivated SARS-CoV-2 vaccine during the first quarter of 2021 until the second quarter of 2022 in Indonesia. More than two hundred million Sinovac/CoronaVac were given from January 13th, 2021, until June 30th, 2022. Data for this study were collected manually and electronically from the national vaccine safety website managed by the National Committee (NC) of AEFI Indonesia and the Ministry of Health Indonesia. The total number of injections observed in the study was 264,311,992 doses consisting of 142,449,795 (first dose), 121,613,324 (second dose), and 248,873 (booster dose). Of the injections given, 301 subjects with Serious AEFIs (SAE) and 10.261 subjects with non-serious AEFIs (AE) reported, with a majority of SAE and AEs found in the first dose. Most of the SAEs were classified as coincidental events by the NC AEFI (IR 0.8/1 million doses on first dose injection; 0.31 on second dose injection). ISRR (immunization stress-related response) is in the second rank of SAEs reported (0.59 IR/1 million doses on the first dose; 0.14 on the second dose). The incidence rate of SAEs and AEs, both in the variable of age, sex, and symptoms per 1 million dose injections in Indonesia, was very rare according to WHO guidelines. Most SAEs were classified as coincidences or unrelated to the vaccine. The result showed that the Sinovac/CoronaVac in Indonesia is safe.

Indexed as

COVID-19COVID-19 VaccinesAdultHumansIndonesiaSARS-CoV-2VaccinesVaccines, InactivatedCOVID-19 Vaccinessinovac COVID-19 vaccineVaccinesVaccines, Inactivated

Identifiers

PMID37824453
PMCPMC10569643
OpenAlexW4387581269

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.