EMA lists rare spinal condition as side effect of AstraZeneca's COVID-19 injection - Market News
Home » EMA lists rare spinal condition as side effect of AstraZeneca’s COVID-19 injection
Covid-19

EMA lists rare spinal condition as side effect of AstraZeneca’s COVID-19 injection

EMA lists rare spinal condition as side effect of AstraZeneca's COVID-19 injection

A health worker holds a vial of the AstraZeneca/Oxford University COVID-19 vaccine at Pentland Medical Practice in Currie, Scotland, UK Jan. 7, 2021. REUTERS/Russell Cheyne/Pool

Register now for FREE unlimited access to Reuters.com

Jan 14 (Reuters) – A European drug regulator safety panel on Friday recommended adding a rare spinal inflammation called transverse myelitis as a side effect of AstraZeneca’s (AZN.L) Covid19 vaccine.

The vaccine has had several setbacks, including delays in production and investigations by regulators after rare cases of serious side effects such as blood clots with low platelet counts, causing several countries to restrict or discontinue its use.

The European Medicines Agency’s Safety Committee also reiterated its recommendation to include a similar warning for Johnson & Johnson’s (JNJ.N) one-time vaccine.

Register now for FREE unlimited access to Reuters.com

Transverse myelitis is characterized by 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.

After examining the data, the Committee concluded that a causal relationship between these two vaccines and transverse myelitis is at least a reasonable possibility.

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

AstraZeneca did not immediately respond to a request from Reuters for comment.

The regulatory agency has not provided information on how many such cases have been reported after the vaccination was given, but said transverse myelitis has been added as an adverse reaction of unknown frequency to the product information of the vaccines.

Reports of the serious neurological disease have also been at the heart of trial halts in the early stages of development for both AstraZeneca and J&J’s shots, which are based on similar technology.

The regulator also recommended updating the product information for AstraZeneca’s vaccine regarding rare blood clotting with low platelet counts after the first injection, saying that fewer such side effects were seen after the second dose.

Of the 1,809 cases of the condition called thrombosis with thrombocytopenia syndrome reported worldwide, 1,643 were reported after the first dose and 166 after the second.

Register now for FREE unlimited access to Reuters.com

Reporting by Mrinalika Roy in Bengaluru; Editing by Shinjini Ganguli and Krishna Chandra Eluri

Our standards: The Thomson Reuters Trust Principles.