Elasomeran/tozinameran

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An event is serious (based on the ICH definition) when the patient outcome is:

• * death

• * life-threatening

• * hospitalisation

• * disability

• * congenital anomaly

• * other medically important event

A case report described one man and one woman, aged 48−51 years, who developed multisystem inflammatory syndrome in adults (MIS-A) following administration of elasomeran or tozinameran for immunisation against COVID-19 [routes and dosages not stated].

Case 1: The 48-year-old woman, who had type 2 diabetes, obesity and hypertension, was diagnosed with COVID-19 in January 2021. Thirty days later, she received the first dose of the elasomeran [mRNA-1273; manufactured by Moderna] for immunisation against COVID-19. The following day, she awoke with fever, malaise and a localised pruritic rash. Over the following 5 days, she suffered wors­ening rash, fever, loose stools, headache and disabling joint pain. Physical examination showed fe­ver, swollen hands, tachycardia, relative hypotension, and rash consisting of urticarial pink papules and confluent red plaques involving her abdomen and extremities. Laboratory tests revealed leucocytosis, acute liver injury and increased C-reactive protein, ferritin and D-dimer. She tested positive for nucleo­protein (NP) antibody, which confirmed previous SARS-CoV-2 infection. Imaging and serologic testing were unrevealing. Echocardiography revealed a small pericardial effu­sion. She was diagnosed with MIS-A, which was attributed to elasomeran. She was treated with prednisone and unspecified topical steroids leading to rapid clinical improvement and resolution of the liver injury. Eleven days later, her palms of the hands and soles of the feet desquamated. After her second dose of elasomeran, she developed fever for 3 days. After booster dose with tozinameran [BNT162b2; manufactured by Pfizer-BioNTech], she did not develop any symptoms.

Case 2: The 51-year-old man, who suffered COVID-19 in mid-April 2021, received the first dose of tozinameran [BNT162b2; manufactured by Pfizer-BioNTech] on 11 May 2021 for immunisation against COVID-19. Two weeks later, he developed watery diarrhoea, fever and increasing abdominal discomfort. He presented to hospital on 31 May 2021 due to fever and diarrhoea. He had tachycardia, hy­potension, leucocytosis, anaemia, thrombocytopenia and increased C-reactive protein, pro-brain natriuretic peptide, troponin. He tested positive for nucleo­protein (NP) antibody, which confirmed previous SARS-CoV-2 infection. He tested negative for SARS-CoV-2 and enteric pathogens on PCR testing. Chest and abdomen imaging was initially normal. Despite treatment with fluids, he required unspecified vasopressors and developed overt pulmonary oedema. Echocardiography showed biventric­ular dilatation with ejection fraction of 20%. He was diagnosed with MIS-A, which was attributed to tozinameran. After treatment with prednisone and 1 dose of immune globulin, his symptoms, haemodynamics and inflammatory markers improved. On 14 June 2021 and 28 June 2021, the ejection fraction was normal (60%) while receiving pred­nisone. On steroids, he experienced super­ficial desquamation of the palms of his hands and soles of his feet. As of February 2022, he was fully recovered but had not received further vaccination.