Two male volunteers were injected at Oxford-AstraZeneca as Phase 2/3 clinical trials at Bharti Hospital, Pune. COVID-19 The vaccine candidate debuted in India on Wednesday.
One of the volunteers was a 48-year-old gynecologist at a private hospital in Pune, who also volunteered 10 years ago for clinical trials for a vaccine against the H1N1 (swine flu) virus.
The second – the first volunteer is injected with a candidate named Covishield in India – figures include a 32-year-old doctoral candidate who works for a private company in the city.
A total of 1,600 volunteers will be part of the study at several testing sites. Drug Controller General of India (DCGI), the national drug regulator, on August 3 to make the Pune-based Serum Institute of India, the world’s largest vaccine, to conduct 2/3 human clinical trials of the vaccine in India. Was allowed. .
The vaccine candidate, ChAdOx1 nCoV-19 or AZD1222, is already undergoing advanced human clinical trials in Brazil, South Africa and the United Kingdom. Researchers at Oxford University announced last month that the candidate had initiated a dual immune response in human immunological testing in Phase 1 and Phase 2 Coronavirus Causes Kovid-19, and an “Approved Security Profile” was shown.
“My (then) 11-year-old daughter participated in a clinical trial during H1N1 Universal epidemic And, 10 years later, we have pledged our support as volunteers to test the covicill vaccine, “the 48-year-old gynecologist told The Indian Express.
The 32-year-old, who belongs to a family of farmers, and who has studied in Aurangabad, said: “Participating in the trial is my contribution to the beating of the virus that has claimed millions of lives globally.”
In a well-attended media event, the 32-year-old received his shot at 1.35 pm. The second volunteer was injected 15 minutes later, at 1.50 pm.
“On Tuesday, five volunteers were screened and RT-PCR and antibody tests were performed. Three volunteers tested positive for antibodies against Kovid-19, meaning they may have an infection at some point, and therefore, they cannot participate in the trial, “Dr. Sanjay Lalwani, Medical Director of Bharti Vidyapeeth Medical College and Hospital, said. .
Crowds of volunteers have been seen for the study in most clinical trial sites. Each of the four sites in Pune has 250–300 volunteers. The 48-year-old gynecologist’s 47-year-old wife and her daughter, now a 22-year-old engineering student, were among those who admitted for screening at Bharti Hospital on Wednesday evening.
Hospital officials said the CEO of a well-known firm and his family along with his driver were also investigated.
The gynecologist said that he had seen many doctors and health workers get infected with the virus, and felt good about being part of the test for the vaccine.
“I am not feeling excited about participating in this test, because I have seen some people die due to complications related to the disease. Science is the only way to fight this virus, ”he said.
“I know I can get a placebo instead of a vaccine, and I’m mentally prepared for it. I have seen many people trying to sell immune-boosters in times of epidemics. This is not correct, and I strongly feel that a vaccine may be the solution. “
The gynecologist said that his wife and daughter would get their shots on Thursday if they approved the testing for the virus and antibodies. This will be the first clinical trial for his wife and the third for his daughter. “She (daughter) has previously participated in a test for a vaccine for the cervix Cancer. “
The vaccine candidate has been developed by the Jenner Institute at Oxford University from a weaker version of a common cold virus (known as adenovirus) modified from chimpanzees so that it cannot develop in humans. The Serum Institute has tied up with British-Swedish pharmaceutical firm AstraZeneca to produce one billion doses of the vaccine for low-income countries.
Executive Director of Health Sciences Section of Bharti Vidyapeeth, Dr. Asmita Jagtap said that the institution had been involved in more than 50 clinical trials in the last 15 years. “We are getting many calls from people wanting to be recruited as volunteers,” she said.
Deputy Medical Director of Bharti Hospital, Dr. Jitendra Oswal said that 100 volunteers will participate at some sites. “We will list 25 trial participants on our site,” he said.
On Wednesday, KEM Hospital and Research Center in Vadu, about 20 km from Pune, also started screening volunteers. Shots will be given to five people on Thursday at this test site, provided they test negative for Kovid-19.
The other two testing sites at Jahangir Hospital and Sassoon General Hospital, Pune, were waiting for the candidate’s dose on Wednesday.
There is more optimism and enthusiasm going on at the test sites – at Bharti Hospital, security officer Mallika Sache said: “India will be freed from February (vaccine will make India independent again).”