A Retrospective observational survey of adverse events following immunization comparing tolerability of covishield and covaxin vaccines in the real world

Research Article

  • Porus Rajpurohit Eris Lifesciences Ltd. Ahmedabad, Gujarat. India. 380015 https://orcid.org/0000-0003-3495-098X
  • Manoj Suva Eris Lifesciences Ltd. Ahmedabad, Gujarat. India. 380015
  • Hardik Rajpurohit Govt. of Rajasthan, Primary Health Centre, Jaitpur, Pali, Rajasthan, India 306421
  • Yogesh Singh Dr. Sarvepalli Radhakrishnan Rajasthan Ayurveda University, Jodhpur, Rajasthan. 342037
  • Praveen Boda Alcon Laboratories India Pvt. Ltd. Bangalore, India. 560048.
Keywords: Vaccine, COVID-19, COVAXIN, COVISHIELD, Adverse event following immunization

Abstract

The COVID-19 vaccination drive is on a boost in India. On 16-January-2021 India has successfully driven the biggest vaccination drive for 300 million priority groups against the coronavirus disease (COVID-19) and rolled out the world's largest vaccination drive to vaccinate around. People were confused about which vaccination to choose and many were unaware of how these two vaccines differ from one other, while the government was working hard to build confidence and encourage people to come forward to take the made-in-India Covid-19 vaccine (COVAXIN and COVISHIELD). However, the result of the first phase and second phase vaccination drive clearly shows that both the Indian vaccines are effective and safe. Since, both the Indian vaccines have received Emergency Use Authorization  (EUA) by Drugs Controller General of India (DCGI) in India, the regulatory agency and the manufacturers are keeping a close watch and monitoring on the Adverse event reported following immunization (AEFI) and to allow quick identification and action of any new safety information. A retrospective observational cohort survey was conducted on 75 fully vaccinated volunteers. The data was collected and analyzed. The percentage of The AEFI experienced with COVISHIELD vs COVAXIN during 1st does was 92.45 % vs 77.27 % and with 2nd dose 86.79 % vs 72.72 % respectively. However, no SAE was reported during the survey and almost 20 % of subjects were aware of the AEFI reporting but because of negligence, didn't report. Fever was the most common AEFI experienced in both vaccines. Only 6.66 % of volunteers got an infection with COVID-19 post-vaccination.

Author Biographies

Porus Rajpurohit, Eris Lifesciences Ltd. Ahmedabad, Gujarat. India. 380015

Pharmacovigilance Officer, Department of Pharmacovigilance and Regulatory affairs

Manoj Suva, Eris Lifesciences Ltd. Ahmedabad, Gujarat. India. 380015

Manager, Department of Medical Affairs

Hardik Rajpurohit, Govt. of Rajasthan, Primary Health Centre, Jaitpur, Pali, Rajasthan, India 306421

Medical Officer, Department of Medical, Health & Family Welfare

Yogesh Singh, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurveda University, Jodhpur, Rajasthan. 342037

M.D. Scholar, PG Department of Dravyaguna

Praveen Boda, Alcon Laboratories India Pvt. Ltd. Bangalore, India. 560048.

Senior Patient Safety Specialist, Department of Global device vigilance operations and Regulatory affairs.

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Published
2021-09-01
How to Cite
1.
Rajpurohit P, Suva M, Rajpurohit H, Singh Y, Boda P. A Retrospective observational survey of adverse events following immunization comparing tolerability of covishield and covaxin vaccines in the real world . jpadr [Internet]. 2021Sep.1 [cited 2021Oct.16];2(3):21-6. Available from: https://jpadr.com/index.php/jpadr/article/view/43