Amsterdam: Guillain-Barre Syndrome (GBS), a neurological disease, has been classified as an “extremely uncommon” adverse effect of the AstraZeneca Covid vaccination, also known as Covishield in India, by the European Medicines Agency.
GBS is a severe nerve inflammation that can result in temporary paralysis (loss of feeling and movement) as well as breathing difficulties.
In a fresh report released on Wednesday, the European Medicines Agency (EMA) stated that a causal link between the AstraZeneca vaccination and GBS was “considered at least a plausible probability.”
As a result, the condition should be “added as a side effect to the product details.”
“The frequency category allocated is ‘very rare’ (that is, occurring in less than 1 in 10,000 persons), which is the category of the lowest frequency foreseen in EU product information,” the EMA said in the update.
The incidence of the side effect remains extremely rare, with only 833 cases reported worldwide from about 592 million administered doses of the adenovirus-based AstraZeneca vaccine, as of July 25.
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 regulatory body said.
The EMA further recommended that patients must talk to their healthcare professionals before taking AstraZeneca vaccine, if they previously had GBS after being given the vaccine.
It added that people should seek immediate medical attention if they develop weakness and paralysis in the extremities that can progress to the chest and face.
A study, published in the peer-reviewed medical journal Annals of Neurology in June, described an unusual variant of Guillain-Barre syndrome characterised by prominent facial weakness in seven cases from a regional medical center in Kerala, India. The cases occurred within two weeks of the first dose of vaccination.
“Six out of the seven patients progressed to areflexic quadriplegia and required mechanical ventilatory support,” said Boby Varkey Maramattom, from the Department of Neurology, Aster Medcity, Kochi, Kerala.
“The frequency of GBS was 1.4 to 10 fold higher than that expected in this period for a population of this magnitude. In addition, the frequency of bilateral facial weakness, which typically occurs in less than 20 percent of GBS cases, suggests a pattern associated with the vaccination,” he added.
While the advantages of immunisation far exceed the danger of this very uncommon side effect, the researchers cautioned that doctors should be aware of the possibility of this unusual neurological condition after receiving Covid-19 vaccinations.
Johnson & Johnson’s Covid vaccine, which was created using the same technology as AstraZeneca, was recently approved for GBS. The EMA has also included discomfort in the legs and arms, as well as stomach pain and influenza-like symptoms, as adverse effects of the AstraZeneca vaccination in the product description.