Rahat Kumar*, Narinder Singh, Jaswinder Singh, Vikram Bhandari
Department of Pharmacology, SGRDIMSAR, Amritsar, Punjab, India
*Address for Corresponding Author
Rahat Kumar, Professor,
Department of Pharmacology, SGRDIMSAR, Amritsar, Punjab, India
Abstract
COVID-19 infection is still an ongoing pandemic and it emerged in December 2019, in Wuhan, China. The research indicate that coronavirus is a beta-coronavirus belonging to the subtypes as SARS virus leading to the pandemic and life-threatening infection. There is no antiviral available for this infection so vaccination is the best method for providing immunity against this virus. Objective: To generate the pharmacovigilance data of Covishield vaccine in subjects given both doses of this vaccine. Methods: This was an observational, retrospective, non-interventional, passive surveillance safety study with no formal sample size. The study was based on spontaneous reporting of ADEs following Covishield vaccination in subjects with consent for vaccination. The Covishield vaccination was given at medical institute Sri Guru Ram Das Institute of Medical Sciences and Research (SGRDIMSAR), Amritsar, Punjab, India in dosage of 0.5 ml and with a gap of 12 to 16 weeks. The subjects were informed to report solicited and unsolicited ADEs within 7 days from vaccination by personal interaction, telephonic reporting, and even by reporting at pharmacovigilance cell, SGRDIMSAR. The solicited and unsolicited reactions after vaccination till 7 days were noted on the proforma designed as per the literature provided by the Serum Institute of India, Pune, Maharashtra, India. Results: The results indicate that 1364 and 1340 subjects were given first and second doses of Covishield vaccine, the most common age group being >50 years. After first dose, out of the total 1119 ADEs, 1078 (96.3%) were solicited and 41 (3.6%) were unsolicited ADEs while 559 (97.2%) were solicited while 16 (2.7%) were unsolicited ADEs after second dose and most common ADEs reported was pain and fever at injection site. The severity of ADEs after second dose was much lesser in terms of percentage in comparison to first dose and There was no serious ADEs leading to death, prolonged hospitalization, any event requiring hospitalization or visit to emergency department of the hospital. Conclusion: The results of this study indicate that Covishield is safe and effective vaccine. The ADEs after second dose are lesser in comparison to first dose and similarly in high-risk patients the vaccine was found to be tolerated effectively.
Keywords: Coronavirus, SARS-CoV-2, Covishield, Pharmacovigilance
