Elasomeran


Generic Medicine Info
Indications and Dosage
Intramuscular
Active immunisation against coronavirus disease 2019 (COVID-19)
Adult: 0.5 mL (100 mcg) for 2 doses, given 1 month (28 days) apart. The 2nd dose may be administered ≤4 days from the recommended date. If administered earlier than the 4-day grace period, vaccination does not need to be repeated. If unable to adhere to the recommended interval, the 2nd dose may be administered up to 6 weeks (42 days) after the 1st dose.
Child: ≥12 years Conditional approval for use in this age group have been granted in some countries. Refer to specific product or local treatment guidelines.
Elderly: Same as adult dose.
Contraindications
History of a severe or immediate (regardless of severity, occurring within 4 hours) allergic reaction (e.g. anaphylaxis) after the 1st dose or to any component of the formulation (e.g. polyethylene glycol [PEG]).
Special Precautions
Patient with history of myocarditis or pericarditis; bleeding disorders (e.g. thrombocytopenia); history of multisystem inflammatory syndrome (consider delaying vaccination until resolution of illness and for 90 days following diagnosis). Immunocompromised patients (e.g. individuals with HIV infection or those receiving immunosuppressive therapy) may have a reduced immune response to COVID-19 vaccines; local safety guidelines must still be followed as the safety and effectiveness of COVID-19 vaccines in this population are still unknown. Patients who had received dermal fillers or are receiving anticoagulant therapy. Delay vaccination in patients with acute severe febrile illness or acute infection; known COVID-19 exposure or current SARS-CoV-2 infection until recovery from acute illness (if symptomatic) and/or no longer requires isolation (including those who develop infection or are exposed before receiving any vaccine doses or after the 1st dose but prior to 2nd dose). Defer vaccination for at least 90 days in patients who have received COVID-19 convalescent plasma or anti-COVD-19 monoclonal antibody therapy. Not recommended for outbreak management or postexposure prophylaxis. Pregnancy and lactation.

It should be noted that:

- Elasomeran may be available for use 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 for both doses to complete the series. There are ongoing heterologous (mix-and-match) studies with regards to interchangeability of COVID-19 vaccines. Recommendations on interchangeability of vaccines may be updated as further information becomes available.
- 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 unapproved 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: Syncope, lymphadenopathy, lymphadenitis, lymph node pain, axillary swelling or tenderness, axillary mass, inj site lymphadenopathy; Bell's palsy. Rarely, severe allergic reactions (anaphylaxis), acute myocarditis or pericarditis (more common in young males), thrombocytopenia (including immune thrombocytopenia).
Gastrointestinal disorders: Nausea, vomiting.
General disorders and administration site conditions: Fatigue, fever, chills; pain, erythema, swelling, rash or urticaria at 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 an allergic reaction of any severity within 4 hours of receiving a vaccine or injectable therapy, or those with contraindication to 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
Increased risk of bleeding with aspirin or other anticoagulants. Prophylactic administration of antihistamines may mask the cutaneous symptoms of anaphylaxis, which may lead to delayed diagnosis and management.
Lab Interference
May give positive result in SARS-CoV-2 antibody test that detects antibody (IgG and/or IgM) to the SARS-CoV-2 spike protein.
Action
Description: Elasomeran is an investigational 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 immune cells as a foreign antigen, thereby inducing both T-cell and B-cell responses to generate neutralising antibodies which may contribute to 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. Transportation of thawed vials: If it is not feasible to transport vials at recommended storage conditions, 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. 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 1st use. Do not refreeze thawed vials. Do not shake. Pre-drawn syringes: Store between 2-8°C or between 15-25°C. Protect from light. Pre-drawn vaccines in syringes should be administered within 6 hours after the vial is initially pierced.
References
Anon. COVID-19 Vaccine (Moderna). AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 19/07/2021.

Anon. COVID-19 Vaccine (mRNA). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 19/07/2021.

Buckingham R (ed). COVID-19 Vaccines. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 19/07/2021.

COVID-19 Vaccine Moderna Dispersion for Injection; COVID-19 mRNA Vaccine (Nucleoside Modified) (Moderna Biotech Spain, S.L.). MHRA. https://products.mhra.gov.uk. Accessed 19/07/2021.

COVID-19 Vaccine Safety Update - Spikevax. European Medicines Agency [online]. Accessed 13/08/2021.

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 19/07/2021.

Interim Recommendations for Use of the Moderna mRNA-1273 Vaccine Against COVID-19. World Health Organization. https://www.who.int. Accessed 12/08/2021.

Joint Formulary Committee. COVID-19 Vaccine. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 19/07/2021.

Moderna COVID-19 Vaccine Injection, Suspension (Moderna US, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 19/07/2021.

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

Spikevax Dispersion for Injection (Moderna Biotech Spain). European Medicines Agency [online]. Accessed 13/08/2021.

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 © 2021 MIMS. All rights reserved. Powered by MIMS.com
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Sign up for free
Already a member? Sign in