By Raju Vernekar
Pune/Maharashtra, August 27:
The much-awaited trial of Phase II clinical trial of the Oxford Covid-19 vaccine, being manufactured by the city-based Serum Institute of India (SII), began at a medical college and hospital here on Wednesday.
On August 3, the Drug Controller General of India (DCGI) had given the go-ahead to SII for conducting phase-2 and -3 human clinical trials of the vaccine candidate in the country.
Two male volunteers were administered the vaccine at Bharti Vidyapeeth’s Medical College and Hospital. Doctors at the hospital administered the first shot of the ‘Covishield’ vaccine to a 32-year-old man after his reports of COVID-19 and antibodies tests came out negative, Medical Director of Bharti Vidyapeeth’s Medical College, Hospital and Research Centre, Dr Sanjay Lalwani, said. Another 48-year-old male volunteer was also given the vaccine, he added.
While the 32 year-old volunteer works for a private company, the other one is associated with the healthcare sector. Before administering the vaccine, doctors checked their temperature, blood pressure and heart beats. Five volunteers had enrolled themselves for the trial after the doses were received from the SII. “The COVID-19 and antibodies tests were conducted on all the five volunteers. Of them, the reports of three volunteers’ antibodies test came out positive. So they became ineligible for the trial,” Dr Lalwani said.
Two of them, who were administered the vaccines are being monitored. They will be given another dose after 28 days. In all 25 candidates will given the vaccine in the next seven days.
The trial sites include four in Pune (Bharati hospital, KEM Hospital and Research Centre, Jehangir Hospital and BJ Medical College), AIIMS in Delhi, Rajendra Memorial Research Institute of Medical Sciences in Patna (Bihar), Post Graduate Institute of Medical Education and Research (PGIMER) in Chandigarh, among others.
SII has selected 17 sites in India to conduct the Phase II trial of Oxford COVID-19 vaccine. A total of 1,600 candidates will be enrolled for trials in phases II and III. In phase II, approximately 100 participants will be enrolled and vaccinated across various sites. This is mainly to assess the vaccine’s safety and its side-effects. The vaccine doses have to be administered within seven days of enrolment, and this safety cohort will be followed for a week. There will be a temporary halt, when the data safety monitoring board will assess the results. After 10 days, the phase III part of the study will begin, which will include 1,500 trial participants.
Volunteers above 18 years have to provide an informed consent to participate in the trial. Once the vaccine is administered the trial participant will be monitored for the next half hour and then sent home. There will be a follow-up for the next six months. Initial screening visits will include nasopharyngeal swab tests and blood samples will be taken to rule out coronavirus infection in the participants. Social distancing will be practised.
According to the Clinical Trials Registry-India, “Covishield” will be administered as a two-dose schedule — 0.5 ml dose intramuscularly on Day 1 and Day 29. Placebo will be administered as a two-dose schedule on Day 1 and 29 – 0.5 ml dose intramuscularly.
SII, the world’s largest vaccine maker, has signed an agreement to manufacture the potential vaccine developed by the Jenner Institute of Oxford University in collaboration with British-Swedish pharma company “AstraZeneca” to produce 1 billion doses of the vaccine for India and low-and-middle income countries.
The COVID-19 vaccine candidate developed by the Jenner Institute, a part of the Nuffield Department of Medicine at the University of Oxford, showed a positive result in its initial trial. The COVID-19 vaccine produced a dual immune response in people aged 18 to 55. The vaccine will be launched under the brand name “Covishield” in India.
The Bill & Melinda Gates Foundation has already announced that they will provide at-risk funding of $150 million to support SII’ two promising vaccines by “University of Oxford” and “Novavax”. Under this agreement, SII can charge a maximum of $3 per dose for the two COVID-19 vaccines. The vaccine maker will get the funding from the Gates Foundation through international vaccine alliance “GAVI”.
Oxford-AstraZeneca vaccine in India was reported to be ready in 73 days. However, SII later refuted such claims and said that the vaccine will only be commercialised after proper trials are conducted. Two more vaccines – Bharat Biotech’s Covaxin, and Zydus Caldia’s Zy-CoV-D are also under trials in the country.
