AstraZeneca’s Covid vaccine may trigger a nerve disorder in ‘very rare’ cases, the EU’s vaccine watchdog has said.
The European Medicines Agency said today 833 cases of Guillain-Barre syndrome had been reported worldwide out of 592million doses dished out.
It said the overall risk of suffering the syndrome after being vaccinated with AstraZeneca was less than one in 10,000.
Guillain-Barre sees the immune system go haywire and start to attack nerve cells, triggering symptoms including muscle pain, numbness and pins and needles.
Most people who suffer the condition make a full recovery, but one in five can be left with long-term problems such as difficulty walking and one in 20 die.
The EMA said they considered it ‘at least a reasonable possibility’ that Guillain-Barre is a side effect of the Oxford-made jab.
The regulator has already listed the condition to the single-shot dose Johnson and Johnson vaccine, which uses the same technology as the Oxford-designed jab.
Britain’s medical regulator does not officially recognise the syndrome as a side effect of AstraZeneca’s vaccine, but says it has recorded 393 cases after vaccination and it is keeping a close eye on the condition.
It is not clear how many of these led to long-term complications, but three patients have died from the condition.
What is Guillain-Barre syndrome?
Guillain-Barre syndrome is a very rare condition that can be sparked by viral infections.
It is thought to be triggered when the immune system misfires and starts attacking the body’s own nerve cells.
Symptoms of the condition include numbness, pins and needles, muscle weakness and problems with balance and co-ordination.
The NHS says they tend to start in the hands and feet before spreading up the arms and legs.
They should get worse over the first few days, they said, before starting to improve.
Most people who suffer Guillain-Barre syndrome make a full recovery, but around one in five are left with longer term problems and one in 20 die.
Treatments include painkillers and blood transfusions to help bring the condition under control.
The Medicines and Healthcare products Regulatory Agency (MHRA) added there have been 44 suspected cases following administration of the Pfizer jab, and one death.
There have also been three cases after inoculation with the Moderna jab.
Official figures show Britain has dished out more than 48.7million AstraZeneca doses, 38.9million Pfizer shots and 2.2million Moderna jabs.
The MHRA says it has not been able to ‘confirm or rule out’ whether the jab could trigger the condition.
Its chief Dr June Raine said they would ‘continue to review’ cases of the conditon following vaccination.
It is another blow for the AstraZeneca jab which was the workhorse of Britain’s vaccination drive, after it was linked to very rare blood clots.
The UK’s vaccine advisers have recommended under-40s receive an alternative jab to this shot because of concerns over the condition.
The EMA and the MHRA have stressed that the benefits of vaccination still outweigh the risks of the potential side effect.
But the EMA ‘considered at least a reasonable possibility’ that the AstraZeneca jab could trigger the syndrome in ‘very rare’ cases.
‘Guillain-Barre syndrome should therefore be added to the product information as a side effect of Vaxzevria,’ they said.
Vaxzevria is the name for the AstraZeneca jab in Europe.
They added: ‘The frequency category allocated is “very rare” (i.e. occuring in less than one in 10,000 persons), which is the category of the lowest frequency foreseen in EU product information.’
Dr Raine, the MHRA chief executive, said: ‘The MHRA will continue to review cases of Guillain-Barré Syndrome reported following vaccination with Covid vaccines to assess the possible increased risk of Guillain-Barré Syndrome associated with Covid vaccines, with independent advice from its Vaccine Benefit-Risk Working Group.
‘Anyone who experiences weakness and paralysis in the extremities, possibly spreading to the chest and face, within four to six weeks following vaccination should seek urgent medical attention.
‘We encourage anyone who believes they have experienced a side effect to a Covid vaccine to report it via Coronavirus Yellow Card scheme.
‘The benefits of vaccination continue to outweigh the risks for the majority of people.’
The MHRA says online the condition has been known to be associated with infections with Covid as well as other infectious diseases.
They add that underlying or undiagnosed illness can also lead to suspected cases of the condition.
Their website adds: ‘The MHRA has been closely monitoring and assessing cases of Guillain-Barre syndrome reported following administration of the Covid vaccines.
‘Based on the available evidence, we are not able to confirm or rule out a causal realtionship with the vaccines.’
The US Food and Drug Administration also warned in July of an ‘increased risk’ of developing the neurological syndrome with Johnson & Johnson’s dose.
The AstraZeneca jab suffered a blow in May after regulators found a very rare blood clot in the brain could be sparked by the vaccine.
Britain’s vaccine advisory committee — the Joint Committee on Vaccinations and Immunisations (JCVI) — has recommended that under-40s are offered an alternative to the jab.
But a study published last month has found the risk of suffering a blood clot is ‘much higher’ after catching Covid compared to people who got the AstraZeneca jab.
The latest Oxford University study suggests the risk from clots is higher from the virus itself than the British-made vaccine.
In the biggest study of its kind, researchers looked at the medical records of 29million people in England who had either tested positive or had a vaccine by April.
Among those who caught Covid, 12,614 per 10million suffered blood clots in a vein who would not have otherwise developed the condition.
Whereas the risk among those given the AstraZeneca vaccine was significantly lower at 66 per 10million.
For Pfizer’s vaccine — which uses a different technology to AstraZeneca’s jab — the researchers did not spot any links between the jab and a clotting complication.