The Serum Institute of India (SII) has said the vaccine was “safe and immunogenic”
New Delhi:
The government said today that it has found no reason to stop trials of the Oxford vaccine in India after reviewing a Chennai volunteer’s claim of serious adverse effects, including memory loss and behavior change.
The Serum Institute of India (SII) led by Adar Poonawalla also said that the vaccine was “safe and immunogenic” and that the Safety and Data Monitoring Board and Ethics Committee had “independently authorized” the trials after examining the complaint.
” After the initial causality assessment, the findings did not require discontinuation of the serum assays. IBS vaccine trials have entered Phase 3. After reviewing all the documents, IBS has been given permission to conduct Phase 3 trials. Bharat Biotech has also been allowed to conduct Phase 3 trials, “he said. Rajesh Bhushan, Secretary of Health.
The 40-year-old marketer volunteered for the third phase of the Covid vaccine trial and was given a dose on October 1.
The volunteer’s wife said that since receiving a test dose, he had missed an American project and found it difficult to perform simple tasks. The family has claimed 5 million rupees as compensation from the vaccine manufacturer, but she denied any motive, financial or otherwise.
“Our main demand was that people find out about this. This vaccine is being called the option for India. We cannot remain silent. We could have sold our silence, we could have sent a warning and won something … But our hearts wouldn’t let us do that, “the woman told NDTV by phone from Chennai.
She described her husband as a creative and informed person. “His ability to write, to present things creatively were his plus points. Now he can’t do his job,” he 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 lost it. Due to his condition the clients They have moved. They wanted their work done quickly. “
The couple said it was very worrying that the trials were continuing even after their complaint.
“Our question was, why didn’t they stop the trial when such an adverse reaction was seen? At least until they were 100 percent sure? How could they re-administer the vaccine to the volunteers before informing them,” he said .
The Health Ministry said that the trial subjects always signed a consent form and that most of the trials were multi-site, conducted in various hospitals and states with an ethics committee at each site. “This committee is independent from the government and the vaccine manufacturer. Whenever an adverse event occurs during a clinical trial, the institutional ethics committee takes note of it and within 30 days delivers its report to the Controller of Drugs General of India, ”said the Secretary of Health.
Serum has called the volunteer’s accusations “malicious and ill-conceived.”
“The COVISHIELD vaccine is safe and immunogenic. The incident with the Chennai volunteer, although very unfortunate, was not induced in any way by the vaccine and the Serum Institute of India is sympathetic to the medical condition of the volunteer,” said Serum Institute in its release.
The Serum Institute and Bharat Biotech are expected to apply for authorization this month. British regulators are also looking at the results of the Oxford vaccine trials. Once the drugs are authorized, they can be administered first to healthcare providers, possibly starting in January.
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