Evidence map›Paper›PMID 36030299›Full record

Observational studyDrug safety2022

A Prospective Observational Study on BBV152 Coronavirus Vaccine Use in Adolescents and Comparison with Adults: Interim Results of the First Real-World Safety Analysis.

Upinder Kaur, Anju K L, Mayank Chauhan, Aditi Joshi, Agniva Das, Sangeeta Kansal, Vaibhav Jaisawal, Kishor Patwardhan, Sankha Shubhra Chakrabarti

Open access · hybridAbstract readObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in Drug safety, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
1.2field-weighted citation impact, top 20% 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

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 12 citations in OpenAlex.

  1. Pooled it
  2. AEFI Pattern among Adolescent COVID-19 Vaccine and Perception Regarding Vaccination among Adolescents: A Mixed-Methods Study.Indian journal of community medicine : official publication of Indian Association of Preventive & Social Medicine · 2025
    Article
  3. Article
  4. Article
  5. Review
  6. Article
  7. Observational
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

9 authors at 1 institution in 1 country.

Upinder KaurDepartment of Pharmacology, Institute of Medical Sciences, Banaras Hindu University, Varanasi, UP, India.
Anju K LDepartment of Kaumarbhritya/Balroga (Ayurveda-Paediatrics), Institute of Medical Sciences, Banaras Hindu University, Varanasi, UP, 221005, India.
Mayank ChauhanDepartment of Kriya Sharir (Ayurveda-Physiology), Institute of Medical Sciences, Banaras Hindu University, Varanasi, UP, 221005, India.
Aditi JoshiInstitute of Medical Sciences, Banaras Hindu University, Varanasi, UP, India.
Agniva DasDepartment of Pharmacology, Institute of Medical Sciences, Banaras Hindu University, Varanasi, UP, India.
Sangeeta KansalDepartment of Community Medicine, Institute of Medical Sciences, Banaras Hindu University, Varanasi, UP, India.
Vaibhav JaisawalDepartment of Kaumarbhritya/Balroga (Ayurveda-Paediatrics), Institute of Medical Sciences, Banaras Hindu University, Varanasi, UP, 221005, India. drvaibhav29@gmail.com.
Kishor PatwardhanDepartment of Kriya Sharir (Ayurveda-Physiology), Institute of Medical Sciences, Banaras Hindu University, Varanasi, UP, 221005, India. kpatwardhan@bhu.ac.in.
Sankha Shubhra ChakrabartiDepartment of Geriatric Medicine, Institute of Medical Sciences, Banaras Hindu University, Varanasi, UP, 221005, India. sankha.chakrabarti1@bhu.ac.in.ORCID http://orcid.org/0000-0001-7737-0016
Institute of Medical Sciences · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe BBV152 coronavirus disease 2019 (COVID-19) vaccine (COVAXIN) has recently been approved for adolescents.

objectiveWe provide the first real-world safety data of COVAXIN use in adolescents and compare with adults.

methodsA prospective observational study was initiated in January 2022. Enrolled adolescents and adults were contacted by telephone after 14 days of receiving the BBV152 vaccine. The primary outcome was vaccine safety assessed as rate of adverse events following immunization (AEFIs). Severity grading of AEFIs was done using the Food and Drug Administration (FDA) scale. Interim results are presented.

resultsA total of 698 adolescents and 326 adults were enrolled. AEFIs after the first dose developed in 243 out of 670 adolescents (36.3%), with 21% reporting only local AEFIs and 15.2% reporting systemic AEFIs. Among 340 adolescents who had received the second dose of vaccine, 129 (37.9%) developed AEFIs, with only local involvement in 20.3% and systemic involvement in 17.6%. Injection site pain and fever were the common AEFIs. The majority of AEFIs were mild-moderate. Nearly 0.9% of adolescents receiving the first dose reported severe AEFIs. Atypical AEFIs were observed in 0.6-0.9% of adolescents. The majority of the AEFIs resolved in 1-2 days. AEFIs were persistent in > 2% of adolescents at day 14 after the second dose, and also in 3.7% of adults overall at follow-up. No difference was observed in AEFI incidence and patterns between adolescents and adults. Regression analysis showed females and those with a history of allergy to be, respectively, at 1.6 times and 3 times increased risk of AEFIs among adolescents.

conclusionsCOVAXIN carries an overall favorable short-term safety profile in adolescents. The observed AEFI rates in adolescents are much lower than that reported with mRNA vaccines, but head-head comparisons in the same population are required to generate relative vaccine safety data. Female adolescents and those with a history of allergy need watchfulness for severe and persistent AEFIs. With some AEFIs persisting at 14 days, a longer follow-up is recommended to strengthen the safety data of COVAXIN.

Indexed as

CoronavirusCOVID-19COVID-19 VaccinesHypersensitivityVaccinesAdolescentAdultAdverse Drug Reaction Reporting SystemsFemaleHumansVaccinationCOVID-19 VaccinesVaccines

Identifiers

PMID36030299
PMCPMC9419918
OpenAlexW4293348896

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.