HeathcareEMA adds transverse myelitis as possible adverse effect of...

EMA adds transverse myelitis as possible adverse effect of AstraZeneca and Janssen vaccines


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Lima, January 14, 2022Updated on 01/14/2022 12:26 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.”

The safety committee (PRAC) has recommended a change to the product information for Vaxzevria (brand name of the AstraZeneca vaccine) and Janssen to include a warning for healthcare professionals and patients receiving one of these vaccines, so that are (MT) after vaccination.

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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.

The EMA explains that transverse myelitis is caused by and can 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. .

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

After this review, EMA experts have concluded that there is a “reasonable possibility” that there is a “causal relationship” between these two vaccines and transverse myelitis, but that of both vaccines remains positive when it comes to preventing COVID -19 severe 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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