Evidence map›Paper›PMID 37133805›Full record

Observational studyDrug safety2023

Long-Term Safety Analysis of the ChAdOx1-nCoV-19 Corona Virus Vaccine: Results from a Prospective Observational Study in Priority Vaccinated Groups in North India.

Upinder Kaur, Zeba Fatima, Kalika Maheshwari, Vikas Sahni, Amol Dehade, Anju Kl, Ashish Kumar Yadav, Sangeeta Kansal, Vaibhav Jaisawal, Sankha Shubhra Chakrabarti

Open access · hybridAbstract readObservational Study
In one paragraph

Observational study in Drug safety, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
3.5field-weighted citation impact, top 7% 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

11 citing papers in PubMed, 18 citations in OpenAlex.

  1. Article
  2. Review
  3. Observational
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. 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

10 authors at 1 institution in 1 country.

Upinder KaurDepartment of Pharmacology, Institute of Medical Sciences, Banaras Hindu University, Varanasi, UP, India.
Zeba FatimaInstitute of Medical Sciences, Banaras Hindu University, Varanasi, UP, India.
Kalika MaheshwariInstitute of Medical Sciences, Banaras Hindu University, Varanasi, UP, India.
Vikas SahniInstitute of Medical Sciences, Banaras Hindu University, Varanasi, UP, India.
Amol DehadeDepartment of Pharmacology, Institute of Medical Sciences, Banaras Hindu University, Varanasi, UP, India.
Anju KlDepartment of Kaumarbhritya-Balroga (Ayurvedic Paediatrics), Institute of Medical Sciences, Banaras Hindu University, Varanasi, UP, India.
Ashish Kumar YadavCenter for Biostatistics, Institute of Medical Sciences, Banaras Hindu University, Varanasi, UP, India.
Sangeeta KansalDepartment of Community Medicine, Institute of Medical Sciences, Banaras Hindu University, Varanasi, UP, 221005, India. sangeetakansalbhu@gmail.com.
Vaibhav JaisawalDepartment of Kaumarbhritya-Balroga (Ayurvedic Paediatrics), Institute of Medical Sciences, Banaras Hindu University, Varanasi, UP, 221005, India. drvaibhav29@gmail.com.
Sankha Shubhra ChakrabartiDepartment of Geriatric Medicine, Institute of Medical Sciences, Banaras Hindu University, Varanasi, UP, 221005, India. sankha.chakrabarti1@bhu.ac.in.ORCID 0000-0001-7737-0016
Institute of Medical Sciences · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionVarious vaccines for protection against COVID-19 were provided emergency approval in late 2020 to early 2021. There is a scarcity of long-term safety data for many of these.

objectiveThe main aim of this study is to provide the one-year safety results of the ChAdOx1-nCoV-19/AZD1222 vaccine and determine the risk factors of adverse events of special interest (AESIs) and persistent AESIs.

methodsThis was a prospective observational study conducted from February 2021 to April 2022 in a tertiary hospital in North India and its two associated centers. Health care workers, other frontline workers, and the elderly vaccinated with the ChAdOx1-nCoV-19 vaccine constituted the study population. Individuals were contacted telephonically at pre-decided intervals for one year and health issues of significant concern were recorded. Atypical adverse events developing after a booster dose of the COVID-19 vaccine were assessed. Regression analysis was conducted to determine risk factors of AESI occurrence and determinants of AESIs persisting for at least one month at the time of final telephonic contact.

resultsOf 1650 individuals enrolled, 1520 could be assessed at one-year post-vaccination. COVID-19 occurred in 44.1% of participants. Dengue occurred in 8% of participants. The majority of the AESIs belonged to the MedDRA

conclusionNearly half of the ChAdOx1-nCoV-19 vaccine recipients developed COVID-19 over one year. Vigilance is warranted for AESIs such as musculoskeletal disorders. Females, individuals with hypothyroidism, diabetes, and pre-vaccination history of COVID-19 are at higher risk of adverse events. Vaccines received after natural SARS-CoV-2 infection may increase the risk of persistence of adverse events. Sex and endocrinal differences and timing of the COVID-19 vaccine with respect to natural infection should be explored as determinants of AESIs in the future. Pathogenetic mechanisms of vaccine-related adverse events should be investigated along with comparisons with an unvaccinated arm to delineate the overall safety profile of COVID-19 vaccines.

Indexed as

COVID-19HypothyroidismMusculoskeletal DiseasesAgedChAdOx1 nCoV-19COVID-19 VaccinesFemaleHumansIndiaSARS-CoV-2VaccinationChAdOx1 nCoV-19COVID-19 Vaccines

Identifiers

PMID37133805
PMCPMC10155654
OpenAlexW4367834356

What OpenQuestion holds

Textmetadata
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.