EMA issues ‘warning’ about new ‘serious’ side effect of the AstraZeneca Covid vaccine

The speed and success of the Covid vaccination campaign across the rich world has been breathtaking. Legitimate ethical concerns have been raised around the uneven distribution but plunging death rates in developed countries is a testament to both scientific ingenuity and efficient public health policy. However, the effects of the vaccines must be monitored, even though getting vaccinated is a no brainer for the vast majority of the population.

PRAC has been keeping GBS under close monitoring and in September 2021 assessed additional data requested from the marketing authorisation holder and the results from a scientific literature review.

GBS is a serious nerve inflammation, which may cause temporary loss of feeling and movement (paralysis) and difficulty breathing.

It is important to put the risk into perspective.

A total of 833 cases of GBS had been reported with the AstraZeneca vaccine worldwide by 31 July 2021, while around 592 million doses of AstraZeneca vaccine had been given to people worldwide by 25 July 2021.

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Reported cases concern suspected side effects, i.e. medical events that have been observed after vaccination, but which are not necessarily related to or caused by the vaccine.

The EMA concluded: “Based on the assessment of these data and taking into account neurological expert advice, PRAC concluded that a causal relationship between Vaxzevria [AstraZeneca vaccine] and GBS is considered at least a reasonable possibility.”

According to the NHS, GBS mainly affects the feet, hands and limbs, causing problems such as numbness, weakness and pain.

“It can be treated and most people will eventually make a full recovery, although it can occasionally be life-threatening and some people are left with long-term problems,” warns the health body.

COVID-19 vaccines have to go through several stages of clinical trials before they can be approved for use.

Clinical trials are where a vaccine or medicine is tested on volunteers to make sure it works and is safe.

All vaccines used in the UK must be approved by the independent Medicines and Healthcare products Regulatory Agency (MHRA).

The MHRA makes sure the vaccines meet strict international standards for safety, quality and effectiveness. Once a vaccine is approved, it’s closely monitored to continue to make sure it is safe and effective.

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