6 volunteers opt out of AstraZeneca-Oxford vaccine's trial in Mumbai

Amid the government’s plan to issue emergency use authorisation for COVID vaccines, six volunteers have opted out of the clinical trials of the Oxford-AstraZeneca candidate being conducted at the King Edward Memorial (KEM) hospital in Parel, Mumbai.

Also read: India may issue emergency use licence for COVID vaccines in 4 weeks

The first dose was administered to 101 people at KEM in October, but six of them did a no show for the second dose. According to hospital authorities, since it is voluntary, no one can be coerced into participating in the trials.

However, according to reports, the situation was different at the BYL Nair Hospital, another centre where the trials are being conducted. For the first dose, 148 volunteers had turned up. All of them came for the second dose too, hospital authorities said. The vaccine candidate requires two doses to be effective. The volunteer responses are monitored after the second dose is given.

Also read: India’s COVID-19 recovery more than 90%, highest in world: Health Ministry

In November, the vaccine candidate was in news after a 40-year-old business consultant from Chennai withdrew from the trial after being administered the first dose, complaining that he suffered from serious neurological and psychological symptoms. He had volunteered for the third phase of the vaccine trial, being conducted by Serum Institute of India, at the Sri Ramachandra Medical College Hospital. He has filed a lawsuit against Serum Institute demanding a compensation of ₹5 crore along with immediate suspension of the testing, manufacturing, and distribution of the vaccine.

Union Health Secretary Rajesh Bhushan has that said nine vaccines, at present, are at different stages of development, including Covishied being developed by AstraZeneca-Oxford, Bharat Biotech’s Covaxin, Sputnik V from Russia, ZyCOV-D and another being developed by Aurobindo Pharma.

Hyderabad-based Bharat Biotech, Pune-based SII, and the Indian leg of US pharma major Pfizer are looking to get early emergency use licence from the Drugs Controller General of India (DCGI).

16 other centres have been listed with the Clinical Trials Registry, India, for the trials being conducted for Covishield. As of now, except for KEM Hospital, no other Centre has reported anyone opting out of the trials.