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Union Health Secretary Rajesh Bhushan (PTI)
Union Health Secretary Rajesh Bhushan (PTI)

Adverse event won't affect Covid vaccine's timeline in any manner: Govt

  • 'Initial findings did not necessitate stopping Oxford Covid-19 vaccine trials,' says Union Health Secretary
  • Serum Institute of India on Tuesday denied allegations that a Covid-19 trial volunteer suffered serious side effects from a vaccine developed by AstraZeneca and Oxford University

New Delhi: Adverse event will not affect the timeline in any manner whatsoever, said Rajesh Bhushan, Secretary, Health Ministry on Tuesday when asked about the recent adverse event reported during the Serum Institute of India's coronavirus vaccine trial.

Initial findings did not necessitate stopping Oxford Covid-19 vaccine trials, he said.

"Whenever clinical trial starts, subjects are expected to sign prior informed consent form. This is global practice, it happens across all countries. Form tells subject about possible adverse events that may happen in case one decides to participate in trial," the official said during a briefing with reporters in New Delhi.

Serum Institute of India, the world's largest vaccine manufacturer, on Tuesday denied allegations that a COVID-19 trial volunteer suffered serious side effects from a vaccine developed by AstraZeneca and Oxford University, saying that the vaccine is safe and immunogenic.

"We would want to assure everyone that the vaccine won't be released for mass use unless it is proven immunogenic, and safe," it said in a blog.

Last week, a volunteer in Chennai claimed to have suffered serious neurological and psychological symptoms after taking the experimental shot and has sued the company along with others and a sought compensation of 5 crore.

"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," the Pune-based institute said.

Serum is conducting trials of AstraZeneca's vaccine in India as part of a manufacturing agreement.

"Taking into consideration the complexities and existing misnomers about vaccination and immunisation; the legal notice was sent (to the volunteer) therefore to safeguard the reputation of the company which is being unfairly maligned," Serum said.

It said all the requisite regulatory and ethical processes and guidelines were followed diligently and strictly.

"Adverse events do occur with drugs or vaccines or any other health intervention. It is the role of the regulator after collating all data to ascertain or refute whether there is a causal link between the event and intervention," said ICMR Director-General Balram Bhargava

"Data Safety Monitoring Board also monitors clinical trial from day to day basis and keep an eye on adverse events and report it. Drug Controller General analyses all reports and finds out whether there's a one-to-one co-relation between adverse event and vaccination: Health Secretary," Bhushan added.

"Adverse events do occur with drugs or vaccines or any other health intervention. It is the role of the regulator after collating all data to ascertain or refute whether there is a causal link between the event and intervention," added Bhargava.

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