Evidence map›Paper›PMID 37346082›Full record

ArticleVaccine: X2023

Safety profile of inactivated COVID-19 vaccine in indonesian adults.

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

Open access · goldAbstract read
In one paragraph

Article in Vaccine: X, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
0.6field-weighted citation impact, top 35% 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

0 citing papers in PubMed, 3 citations in OpenAlex.

No citing paper in PubMed yet.

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.

Hindra Irawan SatariNational Committee of Adverse Event Following Immunization (NC-AEFI) Indonesia, Central Jakarta, Indonesia.
Nastiti KaswandaniNational Committee of Adverse Event Following Immunization (NC-AEFI) Indonesia, Central Jakarta, Indonesia.
Bernie Endyarni MediseNational Committee of Adverse Event Following Immunization (NC-AEFI) Indonesia, Central Jakarta, Indonesia.
Julitasari SundoroNational Committee of Adverse Event Following Immunization (NC-AEFI) Indonesia, Central Jakarta, Indonesia.
Sri Rezeki HadinegoroNational Committee of Adverse Event Following Immunization (NC-AEFI) Indonesia, Central Jakarta, Indonesia.
Elcha LeonardNational Committee of Adverse Event Following Immunization (NC-AEFI) Indonesia, Central Jakarta, Indonesia.
Ade PutraNational Committee of Adverse Event Following Immunization (NC-AEFI) Indonesia, Central Jakarta, Indonesia.
Putra Fajar AngkasaNational Committee of Adverse Event Following Immunization (NC-AEFI) Indonesia, Central Jakarta, Indonesia.
University of Indonesia · ID

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Vaccines are urgently needed to handle the morbidity and mortality of the COVID-19 pandemic in Indonesia. The inactivated vaccine is widely used in Indonesia's national immunization program due to its eligibility of stock, easier to transport, and considered to be more established than newer platforms. In this study, we aimed to evaluate the safety profile of the inactivated vaccine and analyze the safety profile between adults and the elderly. Methods: A prospective analytical study was conducted to evaluate the safety profile of inactivated COVID-19 vaccine among healthy adults aged ≥ 18 years from September 2nd to December 28th, 2021, at ten primary health centers from 5 districts in Jakarta, Indonesia. The participants were instructed to record the symptoms after inactivated COVID-19 vaccine injection in the diary card for 28 days. Chi-square tests were carried out to analyze the relationship between the adverse event following immunization (AEFI) in adults and elderly groups. Results: Four of 1113 participants were not included in this study due to the lack of follow-up. Out of 1109 participants, there were 1044 adults (18-59 years) and 65 elderly (>59 years). There were no serious AEFI cases reported. Most AEFI cases were mild to moderate and resolved after several days of injection. Local pain, myalgia and fatigue were the most frequent adverse events reported. We found that there was no correlation between the adults and elderly age group with the incidence of AEFI (p = 0.924) for local reactions (p = 0.181) and most of the systemic reactions (p = 0.629). However, there is an increased risk of fever in the elderly group compared to the adult group (OR 4.046, 95 % CI 1.794-9.124, p = 0.003) following immunization. Conclusions: Our study demonstrated that the inactivated COVID-19 vaccine is safe, considering that all symptoms experienced were mild to moderate and resolved entirely.

Indexed as

AEFICOVID-19Inactivated vaccine

Identifiers

PMID37346082
PMCPMC10257516
OpenAlexW4380201718

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.