Oxford-AstraZeneca Covid-19 vaccine gets ICMR nod to begin trials at KEM, Nair hospitals
Mumbai: The Oxford University-Astra Zeneca Covid-19 vaccine, Covishield will undergo Phase 2 and Phase 3 clinical trials by August-end at two civic-run hospitals in Mumbai — King Edward Memorial (KEM), Parel, and BYL Nair Hospitals, Mumbai Central.
Preliminaries of conducting trial have begun in these two hospitals after the Indian Council for Medical Research (ICMR) showed a green flag to these two hospitals from Mumbai out of a total of 10 medical institutes that have been selected for the pan-India vaccine trial.
This came after British-Swedish multinational biopharmaceutical company AstraZeneca reached a licensing agreement with the Pune-based Serum Institute of India (SII) to supply one billion doses of the University of Oxford's potential Covid-19 vaccine, AZD1222, for low-and-middle-income countries, with a commitment to provide 400 million before the end of 2020.
The Oxford-AstraZeneca vaccine has been named as Covidshield in India.
As per Dr. Hemant Deshmukh, Dean of KEM, Phase 1 of the trial was completed in July in the UK, which has received a promising response. Presently, phase 2, and 3 trials of the vaccine will be conducted. After the completion of the phase 2 trial, reports will be submitted to the Data Safety Monitoring Board, then to the Central Drugs Standard Control Organization (CDSCO) for stage 3 of the trial.
Phase II/III trial's purpose is to see if a vaccine made from the weakened virus that causes the common cold in chimps can protect from COVID. A total of 17 institutions in India to participate in the trial to be conducted by the Serum Institute of India, Pune. Further, the size of the sample would be 1,600 people — 400 for immune response study and 1,200 to gauge safety.
Elaborating on the details of the selection criteria of volunteers, anyone between the age of 18 to 99 years is eligible to participate. Both males and females and permitted to take part in the trial. Further, the participant should be a healthy adult as determined by medical history and most importantly informed consent is a must. Besides, he/she must be a resident of the study area for ease of sample collection, visits. Moreover, women of childbearing potential must have a negative urine pregnancy test within 24 hours before vaccine administration.
However, a person with acute illness with or without fever at the time of vaccine administration or with a history of lab-conﬁrmed Covid-19 in household or work contact cannot participate in the trial. Further, participants who have developed antibodies for SARS-CoV-2 with a history of severe allergic reactions after previous vaccinations are also excluded from participating. Those who have conﬁrmed or suspected conditions with impaired/altered functions of the immune system are also not permitted to be a part of the trial.
As per a recent TOI report, interested and eligible participants can contact;
- Mumbai — King Edward Memorial Hospital (022-24133767, 24174420); BYL Nair Hospital (022-23027644, 45 (direct))
- Pune — BJ Medical College, Bharati Vidyapeeth, Jehangir Hospital
- Wardha — Jawaharlal Nehru Medical College
- Nagpur — Mahatma Gandhi Institute of Medical Science
Commenting on the same, Suresh Kakani, Additional Commissioner, Brihanmumbai Municipal Corporation (BMC) told HT, "It is a proud moment for us as Mumbai is the only city where civic-run hospitals have been given permission to run the trial. In other cities, only government-run hospitals have been granted the opportunity."