Elasomeran


Generic Medicine Info
Indications and Dosage
Intramuscular
Active immunisation against coronavirus disease 2019 (COVID-19)
Adult: As 100 mcg/0.5 mL preparation (vial with red cap): Primary series: 0.5 mL (100 mcg) for 2 doses, given 1 month (28 days) apart. In immunocompromised individuals (e.g. solid organ transplant recipients): A 3rd primary dose of 0.5 mL (100 mcg) may be given ≥1 month (28 days) after the 2nd dose. Booster dose: 0.25 mL (50 mcg) administered ≥5 months after completion of the primary series with elasomeran (as homologous booster) or after completion of primary vaccination with another authorised or approved COVID-19 vaccine (as heterologous booster). Dosing interval for the heterologous booster dose is the same as that authorised for a booster dose of the vaccine used for the primary series. A 2nd booster dose (50 mcg) may be given ≥4 months after the 1st booster dose to individuals ≥50 years of age or individuals ≥18 years of age with certain kinds of immunocompromise. Recommendations and approval of booster doses may vary among countries (refer to specific country guidelines).
Child: ≥6 years Conditional approval for the administration of primary series in this age group has been granted in some countries. Refer to specific product or country guidelines.
Elderly: Same as adult dose.
Contraindications
History of severe allergic reaction (e.g. anaphylaxis) to elasomeran or any component of the formulation (e.g. polyethylene glycol [PEG]).
Special Precautions
Patient with history of myocarditis or pericarditis; thrombocytopenia or any coagulation disorder (e.g. haemophilia), history of multisystem inflammatory syndrome (if clinical recovery has been achieved and it has been ≥90 days following diagnosis), 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 moderate or severe acute illness (with or without fever). 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. Pregnancy and lactation.

It should be noted that:

- Elasomeran may be available as a product under emergency use authorisation (EUA) or 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 only be implemented with careful considerations (e.g. current vaccine supply or vaccine supply projections) alongside the potential benefits and risks of the products being used. Recommendations on interchangeability of vaccines may vary among countries (refer to specific country guidelines).
- To potentially reduce the small risk of myocarditis while possibly increasing the peak antibody responses and vaccine efficacy, a longer interval (8 weeks) between the 1st and 2nd dose of the primary series may be optimal for certain individuals who may be at higher relative risk of myocarditis. However, this consideration must be balanced against the need to attain quick protection, particularly for high-risk groups, in the settings of high intensity of transmission and circulating variants of concern.
- 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.
- It is recommended to give the 1st booster dose to individuals who are immunocompromised ≥3 months after the last primary series dose.
- The Moderna COVID-19 vaccine has 2 authorised presentations, a multiple-dose vial with a red cap (which contains 100 mcg/0.5 mL) and a multiple-dose vial with a dark blue cap (which contains 50 mcg/0.5 mL). The vial with a dark blue cap is authorised for booster doses only and not to provide a primary series dose.
- 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 during pandemic use, 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.
Adverse Reactions
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), capillary leak syndrome (CLS) flare-ups. Rarely, myocarditis or pericarditis (predominantly in young males), 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.
Musculoskeletal and connective tissue disorders: Arthralgia, myalgia.
Nervous system disorders: Headache.
Skin and subcutaneous tissue disorders: Rash.
Patient Counseling Information
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.
Monitoring Parameters
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 a 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).
Drug Interactions
Risk of haematoma or bleeding following IM inj in patients receiving anticoagulant therapy.
Lab Interference
May cause false-positive rapid plasma reagin (RPR; nontreponemal [syphilis screening]) results for certain RPR tests for ≥5 months following vaccination.
Action
Description: Elasomeran is a COVID-19 vaccine that contains messenger RNA (mRNA) encoding 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 of SARS-CoV-2 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: ≥14 days after the 2nd dose.
Storage
Intact vials: Store frozen between -50°C to -15°C. Protect from light. Do not store on dry ice. Thawed vials: 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; may store for up to 12 hours between 2-25°C after the 1st use. Do not refreeze thawed vials. Do not shake. Transportation of thawed vials: If it is not feasible to transport vials at the recommended storage conditions (between -50°C to -15°C), thawed vials may be transported between 2-8°C for up to 12 hours. Once thawed and transported between 2-8°C, vials should not be refrozen; store between 2-8°C until use.
MIMS Class
Vaccines, Antisera & Immunologicals
References
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Emergency Use Instructions for Healthcare Providers: Moderna COVID-19 Vaccine for Primary, Additional, and/or Booster Doses. Centers for Disease Control and Prevention. https://www.cdc.gov. Accessed 03/06/2022.

Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) Emergency Use Authorization (EUA) of the Moderna COVID-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19). U.S. FDA. https://www.fda.gov. Accessed 14/03/2022.

Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States. Centers for Disease Control and Prevention. https://www.cdc.gov. Accessed 25/03/2022.

Interim Recommendations for Use of the Moderna mRNA-1273 Vaccine Against COVID-19. World Health Organization. https://www.who.int. Accessed 25/03/2022.

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Moderna COVID-19 Vaccine Injection, Suspension, Multiple-dose Vial with Red Cap (Moderna US, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 17/06/2022.

Moderna COVID-19 Vaccine Overview and Safety. Centers for Disease Control and Prevention. https://www.cdc.gov. Accessed 19/07/2021.

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Spikevax and Moderna COVID-19 Vaccine. U.S. FDA. https://www.fda.gov. Accessed 03/06/2022.

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Spikevax mRNA Injection, Suspension (Moderna US, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 14/03/2022.

Spikevax Suspension for Injection (Moderna US, Inc). U.S. FDA. https://www.fda.gov. Accessed 15/03/2022.

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Vaccine Information Fact Sheet for Recipients and Caregivers About Spikevax (COVID-19 Vaccine, mRNA) and the Moderna COVID-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19) in Individuals 18 Years of Age and Older. U.S. FDA. https://www.fda.gov. Accessed 03/06/2022.

Disclaimer: This information is independently developed by MIMS based on Elasomeran from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2022 MIMS. All rights reserved. Powered by MIMS.com
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