On Wednesday, two male volunteers at Pune’s Bharati Hospital became the first to get injected as phase 2/3 clinical trials of the Oxford-AstraZeneca COVID-19 vaccine candidate have begun in India.One of the volunteers is a 48-year-old gynaecologist, working at a private hospital in Pune, who had volunteered 10 years ago in clinical trials for a vaccine against the H1N1 (swine flu) virus.The other, which is also the first volunteer, is injected with the candidate named Covishield in India. ...
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On Wednesday, two male volunteers at Pune’s Bharati Hospital became the first to get injected as phase 2/3 clinical trials of the Oxford-AstraZeneca COVID-19 vaccine candidate have begun in India.
One of the volunteers is a 48-year-old gynaecologist, working at a private hospital in Pune, who had volunteered 10 years ago in clinical trials for a vaccine against the H1N1 (swine flu) virus.
The other, which is also the first volunteer, is injected with the candidate named Covishield in India. He is a 32-year-old doctoral candidate in statistics working for a private company in the Pune city. A total number of 1,600 volunteers are going to be a part of this study at several trial sites. The Drug Controller General of India (DCGI), which is the national drug regulator, on 3rd August had allowed Pune-based Serum Institute of India, which is the world’s largest manufacturer of vaccines, to conduct the phase 2 and 3 human clinical trials of the vaccine candidate in India.
The vaccine candidate, ChAdOx1 nCoV-19 or AZD1222, is undergoing advanced human clinical trials already in South Africa, Brazil and the United Kingdom. Oxford University researchers had declared last month that the candidate had caused a dual immune response in phase 1 and 2 human clinical trials against the coronavirus and also had shown an “accepted safety profile”.
The 48-year-old gynaecologist told The Indian Express that her then 11-year-old daughter had participated in a clinical trial during the H1N1 pandemic and, now 10 years later, they have enlisted support as volunteers for the Covishield vaccine trial.
The 32-year-old volunteer belongs to a family of farmers, and has studied in Aurangabad, said that partaking in the trial is his contribution to defeat the coronavirus that has claimed millions of lives worldwide. With a well-attended media event, the 32-year-old volunteer received his shot at 1.35 pm and the second volunteer was injected after 15 minutes, at 1.50 pm.
Dr Sanjay Lalwani, Medical Director of Bharati Vidyapeeth Medical College and Hospital, said that on Tuesday 5 volunteers were screened and RT-PCR and antibody tests were also conducted. Three volunteers out of the five tested positive for antibodies against coronavirus that means they might have had the infection at certain point, and hence cannot participate in the trial.
Many clinical trial sites have seen a lot of volunteers for the study trial. All the four sites in Pune have seen almost 250-300 volunteers. On Wednesday, those who got enrolled for screening at Bharati Hospital were the 48-year-old gynaecologist’s, his 47-year-old wife and daughter, who is a 22-year-old student of engineering.
The gynaecologist said that he had seen many doctors and healthcare staff had got infected with the virus, and he felt good about being a part of the trial for the producing vaccine. He further said that he is aware that he might have got a placebo instead of the vaccine, but he is mentally prepared for that. He has seen many people trying to sell immunity-boosters in this pandemic. He strongly feels that a vaccine could be the solution.
He said that his wife and daughter would also get their shots on Thursday if they manage to clear the tests for the virus and antibodies. It will be the 1st clinical trial for his wife and the 3rd for their daughter. His daughter had earlier participated in a trial for cervical cancer vaccine.
The vaccine candidate is developed by the Jenner Institute at Oxford University from a weakened version of a common cold virus, also known as adenovirus from chimpanzees. It has been modified hence cannot grow in humans. Serum Institute had a tie up with British-Swedish pharmaceutical firm AstraZeneca to manufacture a billion doses of the vaccine for low-income countries.
Executive director of Bharati Vidyapeeth’s health sciences section, Dr Asmita Jagtap, said that the institution is involved in more than 50 clinical trials for the last 15 years. They get several calls from people who want to enlist as volunteers.
Dr Jitendra Oswal, deputy medical director of Bharati Hospital, also said that 100 volunteers will participate at some sites. They will enlist 25 trial participants at their site.
On Wednesday, KEM Hospital and Research Centre at Vadu, approximately 20 km from Pune, also started screening volunteers. 5 people will be administered shots on Thursday at this trial site, if they test negative for COVID-19. Jehangir Hospital and Sassoon General Hospital, are the other two trial sites in Pune and still waiting for their doses of the candidate.
Source: The Indian Express
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