The initial findings did not require stopping trials of the Oxford Covid-19 vaccine, he said.
“Every time a clinical trial begins, subjects are expected to sign a prior informed consent form. This is a worldwide practice, it occurs in all countries. The form informs the subject about possible adverse events that may occur in case one decides to participate in the trial, “said the official. during a briefing with journalists in New Delhi.
The Serum Institute of India, the world’s largest vaccine maker, on Tuesday denied allegations that a COVID-19 trial volunteer suffered serious side effects from a vaccine developed by AstraZeneca and the University of Oxford, saying the vaccine is safe and secure. immunogenic.
“We want to assure everyone that the vaccine will not be released for mass use unless it is shown to be immunogenic and safe,” he blogged.
Last week, a volunteer in Chennai claimed to have suffered severe neurological and psychological symptoms after receiving the experimental injection and sued the company along with others and sought compensation from ₹5 crore.
“The incident with the Chennai volunteer, while very unfortunate, was in no way vaccine-induced and the Serum Institute of India is sympathetic to the volunteer’s medical condition,” the Pune-based institute said.
Serum is conducting AstraZeneca vaccine trials in India as part of a manufacturing agreement.
“Given the complexities and misnomer names on vaccination and immunization, the legal notice was sent (to the volunteer) to safeguard the reputation of the company that is being unfairly maligned,” Serum said.
He said that all necessary regulatory and ethical processes and guidelines were followed diligently and strictly.
“Adverse events occur with drugs or vaccines or any other health intervention. It is the role of the regulator after collecting all the data to determine or refute whether there is a causal link between the event and the intervention,” said the Director General of the ICMR , Balram Bhargava.
“The Data Safety Monitoring Board also monitors clinical trials on a day-to-day basis and watches for adverse events and reports them. The Controller General of Medicines analyzes all reports and finds out if there is a one-to-one correlation between the adverse event and vaccination: Secretary of Health, “added Bhushan.
“Adverse events occur with drugs, vaccines or any other health intervention. It is the role of the regulator after collecting all the data to determine or refute whether there is a causal link between the event and the intervention,” added Bhargava.
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