Elasomeran

Intramuscular
Active immunisation against coronavirus disease 2019 (COVID-19)

History of severe allergic reaction (e.g. anaphylaxis) to elasomeran or any component of the formulation (e.g. polyethylene glycol [PEG]).

Patient with history of myocarditis or pericarditis; thrombocytopenia or any coagulation disorder (e.g. haemophilia), history of multisystem inflammatory syndrome, history of capillary leak syndrome (CLS). Immunocompromised individuals (e.g. persons with advanced or untreated HIV infection or those receiving immunosuppressive therapy) may have a reduced immune response to COVID-19 vaccines; local safety guidelines must still be followed in this population. Patients who had received dermal fillers or are receiving anticoagulant therapy. Delay vaccination in patients with acute severe febrile illness or acute infection. Defer any vaccination (including booster doses) in patients with known current SARS-CoV-2 infection until recovery from acute illness (if symptomatic) and no longer requires isolation; may consider delaying vaccination (primary series dose or booster doses) by 3 months from symptom onset or positive test (if asymptomatic) in patients who recently had SARS-CoV-2 infection. Not recommended for postexposure prophylaxis. Children. Pregnancy and lactation.

It should be noted that:

- Elasomeran may be available as a product under conditional approval in some countries. Registration status and/or availability may vary between countries.
- The safety and efficacy of elasomeran for immunisation against COVID-19 continue to be evaluated. Preliminary data suggests a high vaccine efficacy in preventing COVID-19 following a complete course of vaccination.
- The duration of protection against COVID-19 after a complete vaccination course has not been fully evaluated. Clinical trials and epidemiologic surveillance are ongoing to evaluate breakthrough infection in fully vaccinated individuals.
- It is currently recommended to use the same brand of vaccine to complete the primary series, including the 3rd dose for immunocompromised patients. Heterologous vaccination, including booster doses, must be applied with careful consideration of the current vaccine supply or supply projections and other access considerations. Recommendations on interchangeability of vaccines may vary among countries (refer to specific country guidelines).
- An interval of 8 weeks between the 1st and 2nd dose of mRNA COVID-19 vaccine may be optimal for some individuals as this may potentially lower the small risk of myocarditis and pericarditis associated with mRNA COVID-19 vaccines.
- In individuals who developed myocarditis or pericarditis following a dose of mRNA COVID-19 vaccine, subsequent doses of any COVID-19 vaccine are generally not recommended. If a subsequent dose is desired and clinically appropriate, wait until the episode of myocarditis or pericarditis has completely resolved as determined by cardiac testing and the clinical team.
- For traceability of biological medicinal products, the name and batch or lot number of the administered vaccine for each patient must be properly recorded (refer to specific country guidelines).
- Administration of antipyretics, antihistamines, aspirin or anticoagulants prior to the administration of COVID-19 vaccines to prevent post-vaccination symptoms is not recommended. However, antipyretic or analgesic medications may be taken after vaccination to treat post-vaccination symptoms such as local pain or fever.
- Refer to your local health authority for the most up-to-date fact sheet when prescribing or administering elasomeran.
- Minimise any unnecessary co-medication whenever possible, given the lack of information about drug-drug interaction risk.
- To alleviate the risks of this drug, local regulatory agencies require healthcare facilities and healthcare providers to comply with certain regulations for the administration of elasomeran. Please refer to local regulatory agencies for further information.

Significant: Anxiety-related reactions (e.g. syncope, hyperventilation, or stress-related reactions); bleeding or bruising (in patients with coagulation disorder), lymphadenopathy (e.g. axillary lymphadenopathy on the same side as the inj site), CLS flare-ups. Rarely, myocarditis or pericarditis (predominantly in males <40 years of age), severe allergic reactions (including anaphylaxis), facial swelling (in patients with history of inj of facial dermal fillers), Bell's palsy.
Gastrointestinal disorders: Nausea, vomiting, diarrhoea.
General disorders and administration site conditions: Fatigue, fever, chills; pain, erythema, swelling, rash, urticaria at the inj site; delayed-onset local reactions (e.g. induration, pain or tenderness, pruritus) around the inj site.
Metabolism and nutrition disorders: Decreased appetite (particularly in young children).
Musculoskeletal and connective tissue disorders: Arthralgia, myalgia.
Nervous system disorders: Headache; sleepiness (particularly in young children).
Psychiatric disorders: Irritability/crying (particularly in young children).
Skin and subcutaneous tissue disorders: Rash.

Fully vaccinated individuals should continue to observe safety protocols (e.g. wearing a mask, social distancing). Please refer to your local health authorities. Vaccinated individuals should seek immediate medical attention if few days following vaccination they develop breathlessness, irregular heartbeat, or serious and persistent chest pain.

Monitor for hypersensitivity reactions and syncope for 15 minutes after administration. Observe for 30 minutes following vaccination in patients with history of anaphylaxis due to any cause, history of non-severe, immediate (within 4 hours) allergic reaction to a previous dose of COVID-19 vaccine, history of an allergic reaction of any severity within 4 hours of receiving a non-COVID-19 vaccine or injectable therapy, or those with allergy-related contraindication to a different type of COVID-19 vaccine. Monitor for signs and symptoms of myocarditis and pericarditis (e.g. chest pain, shortness of breath, or palpitations).

Risk of haematoma or bleeding following IM inj in patients receiving anticoagulant therapy.

May cause false-positive rapid plasma reagin (RPR; nontreponemal [syphilis screening]) results for certain RPR tests for ≥5 months following vaccination.

Description:
Mechanism of Action: Elasomeran is a monovalent COVID-19 vaccine that contains the mRNA which encodes the viral spike (S) glycoprotein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The nucleoside-modified mRNA is encapsulated in lipid nanoparticles (LNPs) that enable the delivery of the mRNA into host cells to allow expression of the SARS-CoV-2 S antigen. The expressed membrane-bound S protein is then recognised by the immune cells as a foreign antigen, thereby inducing both T-cell and B-cell responses to generate neutralising antibodies, which may contribute to the protection against COVID-19.
Synonym: COVID-19 mRNA (mRNA-1273) vaccine.
Onset: Virus-neutralising antibody activity: 15 days after the 2nd dose.

Intact vial/pre-filled syringe: Store frozen between -50°C to -15°C. Protect from light. Thawed vial/pre-filled syringe: May be stored between 2-8°C for up to 30 days or for a total of 24 hours between 8-25°C before use. Thawed vials may be stored for up to 12 hours between 2-25°C after the 1st use. Do not refreeze thawed vials or pre-filled syringes. Do not shake. Transportation of thawed vial/pre-filled syringe: If it is not feasible to transport vials or pre-filled syringes at the recommended storage conditions (between -50°C to -15°C), thawed vials or pre-filled syringes may be transported in liquid state between 2-8°C; vials may be transported in this state for up to 12 hours. Once thawed and transported between 2-8°C, vials or pre-filled syringes should not be refrozen; store between 2-8°C until use.

Vaccines, Antisera & Immunologicals

J07BN01 - covid-19, RNA-based vaccine ; Belongs to the class of covid-19 vaccines.

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Spikevax 50 mcg Dispersion for Injection in Pre-filled Syringe (Moderna Biotech Spain, S.L.). MHRA. https://products.mhra.gov.uk. Accessed 12/05/2023.

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