Serum Institute starts human trials of Oxford University's Covid-19 Vaccine
By Jahanbee Gupta
A total of 25 volunteers will be enrolled at Pune’s Bharati Vidyapeeth Medical College and Hospital. The hospital had screened five volunteers on Tuesday to administer the vaccine as a part of the Phase 2 trial. Three volunteers were found with positive antibodies. Dr. Sanjay Lalwani, medical director of the hospital, said that he got clearance to start screening volunteers yesterday after the clearance they got the investigational product from Serum Institute.
The first five are called the volunteers of the team who do their physical examination and a physician certified that they are healthy. They also explained the benefits and losses of being a part of the trial to them and got their consent.
Volunteer their RT-PCR test and an antibody test to check for any past infection.
In the test three of them came positive for antibodies, so they could not be part of the study. The other two were given the vaccine. Besides, they have screened 10 more volunteers today (Wednesday).
The Drug Controller General of India, the country’s apex regulator for clinical trials, gave its nod on 2 August to start Phase 2 and Phase 3 trials of the vaccine at 17 selected trial sites across India. The Oxford candidate, ‘Covidshield,’ is among the frontrunners to develop an effective vaccine against Covid-19. Swedish- British pharma company has agreed to tie up with Serum Institute, for the Oxford company. By 2021 the company will manufacture a billion doses for low and middle-class people.