Updated: December 2, 2020 7:52:43 am
At the Serum Institute of India on Monday. (Photo: Reuters)
UNDERLINING THAT several controls have been put in place to track adverse reactions reported in clinical trials for the Covid vaccine candidate being developed by the Serum Institute of India (SII), the Center said Tuesday that its initial evaluation “did not require discontinuation” after from a trial in Chennai The participant sought compensation of Rs 5 million from the Pune company for suffering a “serious adverse reaction”.
In its first public comments on the notice, the government also said that it has no role to play in such claims filed anywhere in the country. “ICMR has no role in supporting or not supporting a legal claim filed anywhere in the country,” said Union Health Secretary Rajesh Bhushan.
ICMR chief Dr Balram Bhargava said that the initial assessment carried out by the regulator based on documents sent to him by independent supervisory bodies “did not require the interruption of these trials.”
ICMR and SII are the Indian vaccine partners being developed by the University of Oxford and AstraZeneca. On Sunday, the SII had said the trial participant’s allegation was “malicious”, that his medical condition was unrelated to the vaccine trial, and that he would seek damages of Rs 100 million.
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“What is important to remember is that adverse events occur with medications, vaccines or any other health intervention. The role of the regulator, after collecting all the data, is to determine or disprove whether there is a causal link between the event and the intervention. So that causal link, whether it needs to be determined or disproved, needs to be done by the DCGI (Comptroller General of Drugs of India) … This is done purely on a scientific basis and the evaluation is done with criteria based In objectivity, ”said Bhargava. .
The Secretary of Health said that the first of several measures implemented to monitor the trial is the “prior informed consent form” that lists possible adverse events, which a subject must sign. “This is a global practice … without the subject’s signature, he or she cannot participate in a clinical trial,” Bhushan said.
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“Second, these vaccine trials are multi-center and multi-site; subjects receive the vaccine under medical care, are monitored and observed. Each site has an institutional ethics committee, which is independent from sponsors and the government. Whenever there is an adverse event, the ethics committee takes note of it and gives its findings… to the regulator within 30 days, ”he said.
Bhushan said the Data Security and Monitoring Board (DSMB), “which is independent from the government and the vaccine manufacturer” and is made up of experts in knowledge of the domain, “also monitors the clinical trial on a day-to-day basis.” “They also report such adverse events. They can also recommend whether they decide to temporarily stop the trial or conduct an investigation, ”he said.
“Four … the rules state that whenever there is an adverse event, the Chief Investigator must fill out a Form-5 and the report is submitted to the regulator,” he said. The ethics committee and DSMB also review the report to find out “if there is a one-to-one correlation between the adverse event and vaccination. Only after the regulator examines all these reports submitted by different bodies, does it give the green light to the trials, “he said.
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“In the present case, the Serum Institute’s phase 2/3 and phase 3 vaccine trial permit has been granted based on the examination of these documents … The adverse event referred to in the case of the vaccine developed by Oxford-Serum occurred in October. All these five processes, don’t assume, have not been met, ”said Bhushan.
When asked if the government supports SII’s move to claim Rs 100 million in damages, the Health Secretary said: “Under normal circumstances, vaccine development generally takes 8 to 10 years. But given the size and impact of the pandemic, we are trying to break that timeline 16-18 months … when you have this context, there is a possibility that commercial interest will dictate certain strategic actions on the part of commercial entities. . The governments of the time had nothing to do with it. “
Bhushan also said that guidelines for states on how to communicate with the public about the need for a vaccine and “vaccine safety” will be issued soon.
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