The Medicines Surveillance Risk Assessment Committee PRAC of the European Medicines Agency (EMA) has decided to include a warning in the product information for AstraZeneca’s COVID-19 vaccine Vaxzevria. This has resulted from the current safety report from the Paul Ehrlich Institute (PEI) dated 15 July 2021. Guillain-Barré syndrome (GBS) is an acute inflammation of the peripheral nervous system and the nerve roots (polyradiculoneuritis) resulting in ascending paralysis. Symptoms regress in most cases, according to the PEI. However, some patients experience a longer course of the disorder, residual neurological symptoms or relevant permanent damage. Death can also occur. A rare subtype of GBS is Miller-Fisher syndrome (MFS). Movement coordination disorders (ataxia), eye muscle paralysis and the loss or weakening of the muscle reflexes are characteristic of this form of GBS. By 30 June 2021, 51 cases of GBS and 3 cases of MFS following vaccination with Vaxzevria had been reported to the PEI. The onset of first symptoms averaged 14.6 days after vaccination. The vaccinated persons affected were 30 women and 24 men between the ages of 32 and 93. After the administration of Vaxzevria, more cases of Guillain-Barré syndrome have been reported in Germany than would be expected by chance based on the number of people vaccinated. According to the PEI, this indicates a risk indication. Intensive medical treatment was necessary for six of the victims. In two cases the outcome was fatal. The United States Food and Drug Administration (FDA) had previously warned of an increased risk of Guillain-Barré syndrome for those vaccinated with the COVID-19 vaccine from US manufacturer Johnson & Johnson.
The FDA recommends seeing a doctor if vaccinated persons experience any of the following:
● Feelings of weakness or tingling, especially in the legs and arms, that worsen and spread to other areas of the body
● Difficulty walking
● Problems with facial movements, speaking, chewing, or swallowing
● Double vision or inability to move your eyes
● Difficulty controlling your bladder or bowel movements