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Coronavirus vaccine: Is the Oxford vaccine safe? All you need to know about the 'adverse' side-effects reported by a volunteer in India

TIMESOFINDIA.COM | Last updated on - Nov 30, 2020, 16:02 IST
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Indian volunteer reports 'adverse' side-effects with the Oxford vaccine jab

As we reach closer to securing a COVID-19 vaccine, the emergence of strange side-effects and certain complications have marred the trials and are also contributing to vaccine hesitancy.

While no vaccine is truly a 100% side-effect free, there are some symptoms and signs post inoculations doctors want to warn us and prepare us for. Severalvolunteers, part of the global COVID-19 vaccine trials have also spoken up about their experiences.

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How safe and effective is the Oxford vaccine for use?

Closer home, one of the most exciting trials which is in the last stages of testing is Oxford-Astrazeneca vaccine. Marketed under the name, 'Covisheild', early observation studies peg that the vaccine carries at least a 70% efficacy rate.

At the same time, the vaccine has also been found to showcase certain side-effects in preliminary trials, which, unfortunately, also temporarily 'halted' the testing in the past months.

Now, an Indian volunteer, a participant who was part of the trial has filed a defamation suit against Serum Institute of India, Pune, which is conducting the trials.

Here's all you need to know about the same

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Volunteer demands compensation, complains side-effects

Vaccine trials for the Oxford vaccine shot, currently in phase III testing are going on at selected centres across the country. One such volunteer, a Chennai-based man, who was part of the trials filed a lawsuit, demanding Rs. 5 crores as compensation, complaining of suffering from serious, 'adverse' side-effects after receiving the dose of the vaccine.

According to reports, the participant was administered the jab at Sri Ramachandra Institute of Higher Education and Research (SRIHER), Chennai, in the first week of October.

While the man has fully recovered and feels no lingering problems, the adverse side-effects, which he claims to have never experienced or alerted by officials before have made him file for compensation.

The 40-year-old man, who belongs to the 'healthy' group has also demanded the trials be brought to a complete halt, any manufacturing and distribution to be stopped, warning other volunteers to be careful about the damages.

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What side-effects are being reported?

The volunteer reports suffering from serious neurological and psychological deficits post receiving the experimental vaccine jab.

While the case is under contention, this is strangely not the first time that neurological complications have been reported.

A few months back, a participant in the UK trials developed strange, unknown neurological deficits which brought the trials to an immediate halt and enquiries were ordered. However, it was later cleared up that the medical issues were unrelated to the vaccine dose being given to the woman participant.

Another volunteer, a 28-year-old man reportedly died due to mysterious complications during the vaccine trials. While the man belonged to the placebo group, his death also sparked rumours that one must be averse to the negative developments with any vaccine.

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Do the claims hold true?

The vaccine makers, on their part, have asserted that the vaccine does not inhibit any side-effects out of the normal range, and any which the volunteers could experience are only 'reactogenic' in nature.

Serum Institute of India, meanwhile, has also refuted the claims and filed an Rs. 100 crore defamation suit against the volunteer, citing 'wrong' charges to defame the company.

Terming the claims to be 'fake', SII has also said that regulatory authorities know about the working of the serious vaccine.

A preliminary assessment is done by the Indian Council of Medical Research officials also found that there is no apparent link between the adverse effects reported by the volunteer and the Serum vaccine's working.

A senior SII official also said that there is no truth to the claims.

"The principal investigator at the clinical site has already cleared this long time ago. In fact, this 40-year-old volunteer has recovered fully. These allegations are post-meditated. The volunteer is trying to extort something from the world-renowned company. The allegations are all garbage,"

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How safe is the Oxford-Astrazeneca shot?

The safety and complete efficacy profile of the vaccine can also be analyzed once the vaccine trials get wrapped up. However, initial findings have suggested that the vaccine delivers no 'unusual' side-effects, which could harm a person who receives the vaccine shot.

Not only is the Oxford vaccine one of the best-suited ones for our country, but studies have also observed that not only does the vaccine work well across different age-groups, it also delivers sufficient immunity and spikes up antibody count, much like what is expected of the vaccine.

More than 30,000 volunteers, across 4 countries are part of the trial right now. The vaccine trials being conducted in India are at par with the global ones. Only routine side-effects such as temporary fever, chills, muscle pain have been reported. Thus, terming the Covishield vaccine 'unsafe' at this point would be an anomaly.

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What happens when side-effects are discovered in between trials?

Like it happened in recent cases, investigations are thoroughly launched to look into any claims and medical breaches discovered in the trials. However, it should be noted that most volunteers who sign up for the trials are already informed of any side-effects they could probably experience as part of the trials since they make use of experimented doses of medicine. Volunteers, in some trials, are also given the authority to leave the trial midway if they experience some unpleasant or altering problems.

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