EFE Agency

Lima, January 14, 2022Updated on 01/14/2022 09:00 pm

The European Medicines Agency (EMA) today added transverse myelitis, a neurological condition, as a very rare possible adverse reaction to HIV vaccines. COVID-19 developed by AstraZeneca and Janssen, and stressed that this side effect occurs with an “unknown frequency.”

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The Safety Committee (PRAC) has recommended a change to the product information for Vaxzevria (trade name for AstraZeneca’s vaccine) and Janssen to include a warning to healthcare professionals and patients receiving one of these vaccines, so that they be watch out for possible symptoms of transverse myelitis (MT) after vaccination.

In addition, this neurological disorder has been added to the package insert as “side effect of unknown frequency “, which also allows health workers to be alert to the signs and symptoms of this condition for early diagnosis and treatment.

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The EMA explains that transverse myelitis is caused by inflammation of one or both sides of the spinal cord and may cause weakness in the arms or legs, sensory symptoms (such as tingling, numbness, pain, or loss of pain sensation), or problems with bladder or bowel function.

The PRAC has reviewed information on suspected cases of this disorder reported globally after vaccination (which does not necessarily mean that it is a direct side effect of the vaccine in one or all cases), including European data, along with scientific literature on both vaccines.

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After that review, the EMA experts have concluded that there is a “reasonable possibility” that there is a “causal relationship” between these two vaccines and transverse myelitis, but the balance between benefit and risk of both vaccines continues to be positive in avoiding severe COVID-19 and hospitalization for the disease caused by SARS-CoV-2.

On the other hand, the PRAC also recommended updating the AstraZeneca package insert to add more information on very rare cases of thrombosis with thrombocytopenia (TTS), as there were fewer reports of this adverse reaction after vaccination with the second dose.

Of the 1,809 cases of thrombocytopenia reported worldwide, 1,643 were after the first dose and 166 after the second.

The EMA currently advises against a second dose of AstraZeneca in people who have experienced thrombocytopenia after the first vaccination.

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