Abstract
In India, up until December 2021, Covishield and Covaxin vaccines against COVID-19 were being used for mass vaccination programs. In view of the urgency of fighting the ongoing pandemic, many vaccines have been granted emergency use approval while phase 2/3 clinical trials were still underway. Even for vaccines that have completed phase 3 trials, safety data may not be comprehensive. This retrospective observational study was conducted at a designated Regional Training Centre for Pharmacovigilance cum Adverse Drug Reaction Monitoring Centre (AMC) under the Pharmacovigilance Programme of India. The data sources were stimulated spontaneous reports of Adverse Events Following Immunization (AEFI) due to the COVID-19 vaccines from 10 January to 31 December 2021. A total of 51,010 COVID vaccine doses were administered during the study period. There were 330 AEFI reported (AEFI rate: 0.65%). Six AEFI were serious events among which three were Adverse Events of Special Interest. The majority of the AEFI were systemic, reported after the first dose, and with an onset between 1 and 24 h after vaccination. On comparing Covishield and Covaxin, there were no statistically significant differences in the AEFI reported with either vaccine in terms of gender, seriousness, lag period, duration, recovery, causality, treatment received for AEFI, presence of co-morbidity, or history of COVID-19 infection. Overall, the rates of AEFI was uncommon, and serious AEFI were rare with both Covishield and Covaxin, with a higher rate after the first dose. Whether immunological tolerance or allayed anxiety was responsible for the lower AEFI risk with the second dose remains to be investigated.
Subject
Pharmacology (medical),Infectious Diseases,Drug Discovery,Pharmacology,Immunology
Reference20 articles.
1. Pan American Health Organization (2022, September 30). Pharmacovigilance for COVID-19 Vaccines. Available online: https://covid-19pharmacovigilance.paho.org.
2. Effectiveness and safety of SARS-CoV-2 vaccine in real-world studies: A systematic review and meta-analysis;Liu;Infect. Dis. Poverty,2021
3. (2022, September 20). Fact Sheet for Vaccine Recipient Approved for Restricted Use in Emergency Situation of ChAdOx1 nCoV-19 Corona Virus Vaccine (Recombinant) Covishield™ in Prevention of COVID-19 Disease in Individuals 18 Years of Age and Older, Available online: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NzI2MA.
4. (2022, September 30). COVAXIN - India’s First Indigenous Covid-19 Vaccine | Bharat Biotech. Available online: https://www.bharatbiotech.com/covaxin.html.
5. (2022, September 30). Fact Sheet for Vaccine Recipients and Caregivers, Available online: https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/en/biotechver.pdf.
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