The government today said it had found no reason to stop the Oxford vaccine trials in India after reviewing a Chennai volunteer's allegation of serious adverse effects, including memory loss and change in behavior.
The Adar Poonawalla-led Serum Institute of India (SII) also said the vaccine was "safe and immunogenic" and the Data and Safety Monitoring Board and the Ethics Committee had "independently cleared" the trials after examining the complaint.
''After initial causality assessment, findings did not necessitate stoppage of the Serum trials. SII vaccine trials have entered Phase 3. After reviewing all documents, SII has been given permission to conduct Phase 3 trials. Bharat Biotech also has been allowed to conduct Phase 3 trials," said Rajesh Bhushan, Health Secretary.
The 40-year-old marketing professional was a volunteer for the third phase of the Covid vaccine trial and was administered a dose on October 1.
The wife of the volunteer said since he received a trial dose, he had lost an American project and had found it difficult to do simple tasks. The family has claimed Rs 5 crore as compensation from the vaccine maker, but she denied any motive, financial or otherwise.
"Our primary demand was to bring this to the notice of people. This vaccine is being called the option for India. We can't stay quiet. We could have sold our silence, we could have just sent a notice and gained something... But our hearts wouldn't let us do that," the woman told NDTV on phone from Chennai.
She described her husband as a well-informed, creative person. "His ability to write, present things in a creative manner were his plus points. Now he is unable to do his work," she said.
"Even after two weeks, simple things like online payments... he asks me to do. He got a good project during the pandemic; it was an American project that started on October 1. Apparently he has lost that. Because of his condition the clients have moved back. They wanted their work to be done quickly."
The couple said it was hugely worrying that the trials continued even after their complaint.
"Our question was, why didn't they halt the trial when such an adverse reaction was seen? At least until they were 100 per cent sure? How could they administer vaccine again to volunteers before informing them," she said.
The Health Ministry said trial subjects always signed a consent form and most of the trials were multi-site, conducted across various hospitals and states with an ethics committee at each site. "This committee is independent of the government and of the vaccine manufacturer. Whenever in the course of a clinical trial, any adverse event happens, the institutional ethics committee takes note of it and within a period of 30 days gives its report to the Drugs Controller General of India," said the health Secretary.
Serum has called the volunteer's allegations "malicious and misconceived".
"The COVISHIELD vaccine is safe and immunogenic. The incident with the Chennai volunteer though highly unfortunate was in no way induced by the vaccine and Serum Institute of India is sympathetic with the volunteer's medical condition," Serum Institute said in its statement.
The Serum Institute and Bharat Biotech are expected to apply for authorisation this month. British regulators are also looking at trial results of the Oxford vaccine. Once the drugs are cleared, they can be administered -- first to health care providers - possibly from January onwards.