Oxford vaccine trial: Vital health parameters of the two volunteers, who have been administered the Oxford COVID-19 vaccine candidate at a medical college in Pune, are normal, news agency Press Trust of India reported, citing a senior official of the hospital. The phase II clinical trial of the Oxford COVID vaccine started in India on Wednesday at a Pune hospital.
One of the volunteers was a 48-year-old gynecologist at a private hospital in Pune who had also volunteered 10 years ago for clinical trials for a vaccine against the H1N1 (swine flu) virus. The other — the first volunteer to be injected with the candidate that has been named Covishield in India — is a 32-year-old doctoral candidate in statistics who works for a private company in the city.
“Since yesterday, our medical team is in touch with the two volunteers and both are fine. They do not have any pain, fever, injection-side reaction, or systemic illness post-vaccination,” the medical college and hospital’s deputy medical director Dr. Jitendra Oswal said.
After the vaccine was administered, both the volunteers were observed for 30 minutes and later allowed to go home, he said, adding that the hospital’s medical team is conducting follow-ups with the volunteers.
“They have been given all the necessary emergency numbers (to contact in case of need) and our medical team is also conducting follow-ups with them,” he added. The vaccine dose will be repeated on both the volunteers after one month, the hospital’s medical director Dr. Sanjay Lalwani said on Wednesday. He said in all, 25 candidates will be given the vaccine in the next seven days. Dr. Sonali Palkar, in-charge of the medical college’s research cell, said four to five persons were screened on Wednesday and a decision to administer the vaccine to them as part of the clinical trial is subject to their Covid-19 and antibody test reports.
A total of 1,600 volunteers will be part of the study at multiple trial sites. The Drug Controller General of India (DCGI), the national drug regulator, had on August 3 allowed Pune-based Serum Institute of India, the world’s largest manufacturer of vaccines, to conduct phase 2/3 human clinical trials of the vaccine candidate in India.
The vaccine candidate, ChAdOx1 nCoV-19 or AZD1222, is already undergoing advanced human clinical trials in Brazil, South Africa, and the United Kingdom. Oxford University researchers announced last month that the candidate had triggered a dual immune response in phase 1 and phase 2 human clinical trials against the coronavirus that causes Covid-19, and had shown an “accepted safety profile”.