Moderna COVID-19 vaccine info needs update to reflect new warning - EU regulator
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The European Medicines Agency (EMA) recommended on Friday to add a warning on capillary leak syndrome (CLS) for the product information of the Moderna (NASDAQ:MRNA) COVID-19 vaccine.
CLS is an extremely rare, but serious condition, characterized by events such as rapid swelling of the arms and legs, sudden weight gain, and low blood pressure.
EMAâs Pharmacovigilance Risk Assessment Committee (PRAC) has taken the decision following the assessment of new cases of CLS related to mRNA COVID-19 vaccines developed by Moderna (MRNA) and Pfizer (NYSE:PFE)/BioNTech (NASDAQ:BNTX) branded as Spikevax and Comirnaty, respectively.
While data were insufficient to establish a causal link between the onset of CLS cases and the two vaccines, the panel has recommended the warning after seeing a link between the Moderna (MRNA) vaccine and some CLS cases.
âThe Committee recommended this warning as some cases of flare-ups of CLS pointed towards an association with Spikevax, while the cases reported after vaccination with Comirnaty did not support such association,â EMA said in a statement.
Out of 55 CLS cases, 11 and 44 cases were found to be related to Spikevax and Comirnaty, respectively. At the time, the use of vaccines was estimated at nearly 559 million doses of Moderna (MRNA) vaccine and 2 billion doses of Pfizer (PFE)/BioNTech (BNTX) vaccine.
Read: Moderna (MRNA) shares tumbled in August after the EMAâs PRAC cited several safety concerns related to the companyâs vaccine.