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COVID-19 vaccine | Participant of Covishield trial sends legal notice to SII, seeks Rs 5 crore compensation

The participant received the vaccine on October 1 and on October 11, he started experiencing severe headaches and was not able to respond to questions, said the notice to Serum Institute of India

November 28, 2020 / 02:40 PM IST
Representative image

Representative image

Vaccine major Serum Institute of India (SII) has been issued a legal notice by a participant in the trials of its COVID-19 vaccine candidate, Covishield.

A law firm representing the participant has claimed that the volunteer suffered a serious adverse event after being administered the under-trial vaccine shot. In its notice to the vaccine maker, it also alleged that despite this, SII made no public disclosure about it.

In the notice, which has also been sent to the drug regulatory authority, the firm has demanded financial compensation of Rs 5 crore from the Pune-based vaccine manufacturer, reported The Economic Times.

The publication claims to have reviewed a copy of the legal notice. Moneycontrol couldn't independently verify it.

SII has partnered with global pharma giant AstraZeneca and the Oxford University for COVID-19 vaccine - Covishield.

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COVID-19 Vaccine

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A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.

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There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.

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Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.

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According to the report, the participant (40) from Tamil Nadu was a part of phase 3 trials conducted at Sri Ramachandra Institute of Higher Education and Research, Chennai.

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In the notice, it was stated that the participant was “assured” that the vaccine had been found to be “safe”, and the study was to further confirm the safety and immune response of Covishield in Indian adults, said the report.

Also, the notice said the suffering of the participant was not even remotely close to what was cited in the participant information sheet.

The participant received the vaccine on October 1 and on October 11, he started experiencing severe headaches and was not able to respond to questions, said the notice. The participant suffered “acute neuro encephalopathy”, it alleged.

“The client was therefore led to believe that taking the Covishield test vaccine was safe and risks associated… would hardly lead to any serious side effect, leave alone severe adverse effect,” said the notice.

For the latest updates of PM Modi's visit to vaccine manufacturing facilities, click here

The legal notice was sent on November 21, said the report, adding that R Rajaram, advocate for the complainant, was waiting for SII's response. “We will file a writ petition in court next week,” the publication quoted Rajaram as saying.

Copies of the legal notice have also been sent to the Chief Executive of AstraZeneca, UK, Chief Investigator of the Oxford trials and Vice-Chancellor of Sri Ramachandra Institute, the report said.

SR Ramakrishnan, Principal Investigator at Sri Ramachandra Institute, said an extensive investigation was carried out and they don’t think the adverse event was related to the vaccine, said the report.

The report was submitted to the Data and Safety Monitoring Board, SII, and the drug regulator within the stipulated time, Ramakrishna was quoted as saying. He further said the trials were not halted as they did not receive any such direction either from the sponsor or the drug regulator.

Follow our full coverage on COVID-19 here.
Moneycontrol News
first published: Nov 28, 2020 02:40 pm

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