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ORIGINAL ARTICLE Table of Contents  
Ahead of print publication
A study on safety and clinical efficacy of COVID-19 vaccines among adults in South India: A cross-sectional study


1 Department of Community Medicine, Kempegowda Institute of Medical Sciences, Bangalore, Karnataka, India
2 Department of Medical Intern, Kempegowda Institute of Medical Sciences, Bangalore, Karnataka, India
3 Scientist D (Medical), ICMR-National Centre for Disease Informatics and Research, Bangalore, Karnataka, India
4 Department of Community Medicine, Akash Institute of Medical Sciences and Research Centre, Bangalore, Karnataka, India

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Date of Submission16-Jun-2022
Date of Decision24-Jul-2022
Date of Acceptance08-Aug-2022
Date of Web Publication06-Oct-2022
 

  Abstract 


Introduction: COVID-19 virus caused a pandemic in 2020. Since vaccine was the only modality to combat the pandemic, the development of vaccine was fast tracked and made available within 1 year of detecting the virus. Objective: The objective of this study was to assess the safety and clinical efficacy of the COVID-19 vaccines. Materials and Methods: This was a cross-sectional study conducted between June 2021 and September 2021 in Bengaluru using digital data capture. Data pertaining to sociodemographic profile, details of the vaccine administered, adverse events developing within 7 days of vaccine administration, and breakthrough infection were collected. Descriptive statistics such as frequencies, percentages, and mean and standard deviation were used. Inferential statistics such as the Chi-square test were used to test association. Results: The study involved 103 study participants. Totally 100 (97.08) participants had taken Covishield and 3 (2.92) had taken Covaxin. Only 3 (2.9%) study participants had breakthrough infections and all these three participants had taken Covishield. Ninety-four (91.26%) of study participants had taken at least one dose of COVID-19 vaccine. A total of 62 (60.19%) participants had one or the other adverse reaction following vaccination. Only 3 (2.9%) study participants had breakthrough infections and all these three participants had taken Covishield. Conclusion: The given COVID-19 vaccines are safe and clinically efficacious with no statistically significant difference between the COVID-19 vaccine type and adverse reaction or with the incidence of breakthrough infection.

Keywords: Breakthrough, COVID-19, efficacy, safety, vaccine


How to cite this URL:
Anwith HS, Mariyam D, Madhusudan M, Chethana R, Lakshmi H. A study on safety and clinical efficacy of COVID-19 vaccines among adults in South India: A cross-sectional study. Apollo Med [Epub ahead of print] [cited 2022 Nov 28]. Available from: https://apollomedicine.org/preprintarticle.asp?id=357994





  Introduction Top


Coronavirus belonging to the family Coronaviridae is known to cause severe acute respiratory syndrome (SARS) in mammals.[1] The coronavirus is known to cause outbreaks by its ability of mutation with most recent pandemic in 2019 which was named COVID-19.[2] The World Health Organization (WHO) declared a global emergency over the novel coronavirus outbreak in Wuhan, a city located in China's Hubei province on January 30, 2020.[3] COVID-19 was declared a pandemic on March 11, 2020, by the WHO.[4] The first case of COVID-19 was reported in India on January 27, 2020, in Kerala.[5] Thereafter the virus caused devastating consequences with huge mortality and morbidity hampering normal life in the whole of the country and worldwide.

Very little was known regarding the virus and the disease but there was no definitive treatment available through various drugs and biologicals were tried for the treatment. Wearing a mask, following social distancing, handwashing, and hand sanitization were the only modalities available for disease prevention.[6],[7]

The development of vaccine was the only way to protect the people and combat the pandemic. Hence, the vaccine development was fast tracked and vaccines were provided emergency use authorization within 1 year of detection of the first case.[8],[9] This was a unique development since the development of any vaccine involved many years and was subjected to multiple phases of clinical trials and not all vaccines get emergency use authorization. The Government of India constituted the National Expert Group on Vaccine Administration for COVID-19 to provide all guidelines pertaining to COVID vaccine administration in India.[10] The Central Drugs Standard Control Organization approved the two COVID-19 vaccines Covishield developed by Serum Institute of India and Covaxin developed by Bharat Biotech for restricted emergency use in the country on January 3, 2021.[11] However, the Covaxin vaccine was permitted to be used only under the clinical trial mode.

COVID-19 vaccine was first commissioned to be used on health-care workers but there was a lot of vaccine hesitancy among the health-care workers which were seen in one out of 10 medical students according to the study done in India among medical students with representation from all the states.[12]

The Covishield vaccine is an adenovirus vector-based vaccine AZD1222 which was developed from Oxford–AstraZeneca and manufactured by Serum Institute of India.[13] Covaxin was the first indigenously developed COVID-19 vaccine by Bharat Biotech which is an inactivated whole-virus vaccine developed on Vero cells.[14]

Hence, this study was taken up after 6 months, the vaccines were commissioned to be used and also approved to be used on all individuals aged >18 years with an objective to assess the safety and clinical efficacy of the indigenous vaccines.


  Materials and Methods Top


This was a cross-sectional study conducted between June 2021 and September 2021. Informed consent was obtained from all the study participants and confidentiality was maintained. The selection of the study participants was by snowball technique using purposive sampling. The estimated sample size was 103 study participants. Participants not consenting to the study were excluded from the study. Data were collected digitally using Google Forms which had pretested and semi-structured questions. Data pertaining to sociodemographic profile, type of vaccine administered, and details of the adverse events developing within 7 days of vaccine administration. Data regarding breakthrough infection were also collected. A vaccine breakthrough infection is defined as the detection of SARS-CoV-2 RNA or antigen in a respiratory specimen collected from a person ≥14 days after receipt of all recommended doses of an approved COVID-19 vaccine.

Data containing Excel sheets were downloaded from the Google Forms database and analyzed using OpenEpi software.[15]

Descriptive statistics such as frequencies, percentages, and mean and standard deviation were used. Inferential statistics such as the Chi-square test were used to test association.


  Results Top


The study involved 103 study participants, of which 34 (33%) were males and 69 (67%) were females. The mean age of the study participants was 29.4 years with standard deviation of 12.6 years. The range with respect to age was 18–80 years.

Out of the 103 study participants 100 (97.09%) participants had taken Covishield vaccine and 3(2.91%) participants had taken Covaxin [Table 1].
Table 1: Distribution of study participants based on the number of doses of COVID vaccine taken

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The majority of the study participants were unemployed 68 (66%) and 35 (34%) were employed. Seventy-seven (74.8%) study participants had completed their graduation and none of the study participants were illiterates.

A total of 62 (60.19%) participants had one or the other adverse reaction following vaccination [Table 2] and [Table 3]; however, there was no statistically significant association between the type of vaccine administered and the development of adverse reaction. The most common adverse reaction seen was pain at the injection site which was 48 (46.6%) followed by body pain 43 (41.74%). All the reactions were mild and self-limiting or relived on symptomatic medication. None of the participants were hospitalized for suffering adverse reactions [Table 3].
Table 2: Association between the vaccine administered and development of adverse reaction

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Table 3: Distribution of the study participants based on adverse reactions suffered

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Only 3 (2.9%) study participants had breakthrough infection and all these three participants had taken Covishield. However, there was no statistically significant association between the type of vaccine administered and breakthrough infection [Table 4].
Table 4: Distribution of the study participants based on breakthrough infections

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  Discussion Top


The study involved 103 participants which included health-care workers, general public, and frontline workers. The majority (67%) of the study participants was females and the majority was unemployed. This was similar to the observation made during a multicentric clinical trial during the development of Covishield vaccine.[16]

During the study, it was seen that 60.19% of the participants experienced one or the other adverse reaction which is almost similar to the findings of phase 2/3 trial wherein 74.2% of participants experienced the reaction.[16] None of the study participants in the present study had serious adverse reaction but 2.32% of the study participants experienced serious adverse reactions during the clinical trial. Similar observation was made in a study done in Hubballi, Karnataka, wherein none of the participants had serious adverse reaction and most common adverse reaction was pain at the injection site, fever, and headache.[17]

Only 2.9% of participants who were fully vaccinated had breakthrough infection but according to the study done among health-care workers in Bengaluru, the incidence of breakthrough infections was 14.5%.[18] There was no statistically significant association between the type of vaccine and breakthrough infection similar to the abovementioned study. According to a study done in Hubballi, Karnataka, the rate of breakthrough infections was 1.25%, and breakthrough infections were seen more in recipients of Covishield compared to Covaxin which is a similar observation as our study.[17]

This study has certain limitations as the responses were collected using digital data collection using Google Forms by snowball sampling which could be a source for potential biases. Due to the sampling technique followed the findings cannot be generalized to the entire health worker community or the general population of the Karnataka state/India. Nevertheless, the study provides useful insight about the safety and clinical efficacy of the COVID-19 vaccines used in India and may help in allaying vaccine hesitancy.


  Conclusion Top


The given COVID-19 vaccines are safe and clinically efficacious with no statistically significant difference between the COVID-19 vaccine type and adverse reaction or with the incidence of breakthrough infection. Similar multicenter studies involving a larger population have to be conducted to generalize the study results.

Acknowledgment

We sincerely thank all the study participants for their valuable time & co-operation.

Conflicts of interest

There are no conflicts of interest.

Patient consent

Informed consent was obtained from all the study participants.

Funding

Nil.

Author's contribution

  • Huluvadi Shivalingaiah Anwith –conception of the idea
  • Deena Mariyam – data collection
  • Madhusudan M – initial article draft
  • Chethana Ramegowda – statistical analysis
  • Lakshmi Hulugappa – critical revision of the article and final approval of the version to be published.




 
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Correspondence Address:
Hulugappa Lakshmi,
Department of Community Medicine, Akash Institute of Medical Sciences and Research Centre, Bengaluru, Karnataka
India
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/am.am_92_22




 
 
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  [Table 1], [Table 2], [Table 3], [Table 4]



 

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