AstraZeneca vaccine: EMA adds new adverse side effect to vaccine – symptoms to spot

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The rolling out of the AstraZeneca vaccin has been a success story, but one that has come at a cost. The vaccine has been marred by production bottlenecks and intense scrutiny by drug regulators following rare cases of severe side effects such as blood clots with low platelets.

Now the vaccine has come under the spotlight once again.

A safety panel of the EMA on Friday, January 14, recommended adding a rare spinal inflammation called transverse myelitis as a side effect of AstraZeneca’s COVID-19 vaccine.

Transverse myelitis is an inflammation of one or both sides of the spinal cord and can cause weakness in the arms or legs, sensory symptoms or problems with bladder or bowel function.

“There is currently no confirmed mechanism that has been verified by which a COVID-19 vaccine could cause the very rare event transverse myelitis,” an AstraZeneca spokesperson said.

The EMA’s committee, after reviewing data, concluded there was a reasonable possibility of a causal relationship between the two vaccines and transverse myelitis.

However, it added the benefit-risk profile of both vaccines remains unchanged.

The EMA’s safety committee also recommended a similar warning be included for Johnson & Johnson’s one-shot vaccine in October, and reiterated the decision on Friday.

The regulatory agency did not provide any information on how many such cases were reported after the vaccination was given but said transverse myelitis has been added as an “adverse reaction” of unknown frequency to the product information.

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Transverse myelitis – what to look for

Transverse myelitis is an inflammation of both sides of one section of the spinal cord. This neurological disorder often damages the insulating material covering nerve cell fibres (myelin).

According to the Mayo Clinic, signs and symptoms of transverse myelitis usually develop over a few hours to a few days and may sometimes progress gradually over several weeks.

“Transverse myelitis usually affects both sides of the body below the affected area of the spinal cord, but sometimes there are symptoms on just one side of the body,” explains the health body.

Typical signs and symptoms include:

• Pain. Transverse myelitis pain may begin suddenly in your lower back. Sharp pain may shoot down your legs or arms or around your chest or abdomen. Pain symptoms vary based on the part of your spinal cord that’s affected
• Abnormal sensations. Some people with transverse myelitis report sensations of numbness, tingling, coldness or burning. Some are especially sensitive to the light touch of clothing or to extreme heat or cold. You may feel as if something is tightly wrapping the skin of your chest, abdomen or legs
• Weakness in your arms or legs. Some people notice heaviness in the legs, or that they’re stumbling or dragging one foot. Others may develop severe weakness or even total paralysis.
• Bladder and bowel problems. This may include needing to urinate more frequently, urinary incontinence, difficulty urinating and constipation.

Benefits vastly outweigh the risks

Serious reactions to the AstraZeneca vaccine remain extremely rare. What’s more, the protection conferred from jab has been central to the fight against the pandemic.

Around 50 million AstraZeneca vaccines have been administered in the UK, saving countless lives, keeping people out of hospital and reducing the pressure on the NHS.

Around 2.5 billion doses have been distributed at-cost to more than 170 countries. Almost two-thirds of these have gone to low and lower-middle-income countries, including more than 30 million doses donated by the UK through COVAX or bilaterally.

The UK will donate a further 20 million AstraZeneca doses to countries in need this year as part of the government’s commitment to donate 100 million doses overall.

Everyone aged 16 and over who had a second dose of the COVID-19 vaccine at least three months ago can now get a booster dose.

A booster dose of the coronavirus (COVID-19) vaccine helps improve the protection you have from your first two doses of the vaccine.

Most people will be offered a booster dose of the Pfizer/BioNTech vaccine or Moderna vaccine.

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