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NEW: EMA recognises neurological disorder as very rare side effect of AstraZeneca vaccine

A new safety report from the European Medicines Agency (EMA) has recognised the neurological disorder Guillain-Barre syndrome as a “very rare” side effect of the AstraZeneca  Covid-19 vaccine.

The EMA report issued Wednesday said that it was including “a warning to raise awareness of cases of Guillain-Barré syndrome (GBS) reported following vaccination” in the product information of Vaxzevria (the Astra Zeneca vaccine).

“GBS is a serious nerve inflammation, which may cause temporary loss of feeling and movement (paralysis) and difficulty breathing,” it said but added that the frequency category allocated to the possible side effect was ‘very rare’.

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) said it had been “keeping GBS under close monitoring” and that a total of 833 cases of GBS had been reported with the AstraZeneca jab worldwide by 31 July 2021,  while around 592 million doses of Vaxzevria had been given to people by 25 July.

“Based on the assessment of these data and taking into account neurological expert advice, PRAC concluded that a causal relationship between Vaxzevria and GBS is considered at least a reasonable possibility,” they said.

The safety authority noted that the equally rare risk of blood clots had been added to the AstraZeneca vaccine product information earlier this year.

” A total of 1,503 cases had been reported worldwide as of 31 July 2021, while around 592 million doses of Vaxzevria had been given to people worldwide by 25 July 2021. 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. Close monitoring and risk characterisation of TTS will continue as part of the MSSR and PSUR processes for Vaxzevria,” they said.

Other side-effects noted are flu-like symptoms, with the EMA reporting that: “pain in the extremity (legs and arms), abdominal (stomach) pain and influenza-like symptoms (such as high temperature, sore throat, runny nose, cough and chills) were added as side effects to the product information of Vaxzevria, following the outcome of the Committee for Medicinal Products for Human Use (CHMP) of June 20211

Despite the additions to the side effect list, the EMA stressed that the benefits of getting the vaccine still far outweigh the risks

 

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