Tozinameran


Generic Medicine Info
Indications and Dosage
Intramuscular
Coronavirus disease 2019 (COVID-19), prophylaxis
Adult: 0.3 mL (30 mcg) for 2 doses given 3 weeks (21 days) apart. Administer the 2nd dose as close to the recommended interval as possible. 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 follow the recommended interval, 2nd dose may be given for up to 6 weeks (42 days) after the first dose, vaccination does not need to be repeated.
Child: ≥16 years Same as adult dose. Dosage recommendation may vary among countries. Refer to specific product or country guidelines.
Elderly: Same as adult dose.
Reconstitution
Thaw vials prior to dilution in the refrigerator between 2-8°C; for immediate use, thaw for 30 minutes at room temperature between 25-30°C; dilute within 2 hours. Before dilution gently invert vial 10 times, do not shake. Add 1.8 mL of preservative-free 0.9% NaCl into the vial. Equalise vial pressure by withdrawing 1.8 of mL air into the empty diluent syringe before removing the needle from the vial. Gently invert 10 times to mix, do not shake. It is recommended to use a low dead-volume syringe and needle with a dead volume of not more than 35 microliters during administration of the vaccine.
Incompatibility
Incompatible with bacteriostatic 0.9% NaCl.
Contraindications
History of hypersensitivity following first dose or immediate allergic reaction (of any severity, occurring within 4 hours of administration) to any component of the formulation (e.g. polyethylene glycol [PEG]).
Special Precautions
Patient with known or risk factors for bleeding disorders, history of any immediate allergic reaction to any other vaccine or injectable therapy; altered immunocompetence; autoimmune conditions. Patient who have received dermal fillers. Defer vaccination in patients with moderate to severe acute febrile illness (with or without fever); known current SARS-CoV-2 infection or exposure, patient who develop SARS-CoV-2 infection before receiving any vaccine dose, or after the first dose but before the 2nd dose, until recovery from acute illness (if symptomatic) and/or no longer requires isolation; those who have received COVID-19 convalescent plasma or anti-COVID-19 monoclonal antibody therapy (for at least 90 days). Not recommended for outbreak management or postexposure prophylaxis. Pregnancy and lactation; use only if potential benefits justify potential risks as there is limited data regarding the use of COVID-19 vaccines in pregnant and lactating women.

It should be noted that:

- Tozinameran may be available for use under emergency use listing or authorisation in some countries. Registration status and or availability may vary between countries.
- The safety and efficacy of tozinameran 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 break-through infection in fully vaccinated individuals.
- COVID-19 vaccines are not interchangeable. It is recommended to use the same brand of vaccine for both doses to complete the series. There are no data available on the interchangeability of COVID-19 vaccines, guidelines may vary among countries.
- For traceability of biological medicinal products, the name of the vaccine, batch, or lot number of the administered product must be properly recorded (refer to specific country guidelines).
- Administration of antipyretic or antihistamines prior to the administration of Covid-19 vaccines for the purpose of preventing post-vaccination symptoms is not recommended. However, antipyretic/analgesic medications may be taken after vaccination to treat post-vaccination symptoms such as local pain or fever.
- Fully vaccinated recipients should continue to observe effective prevention measures (e.g. wearing a mask, social distancing). Refer to specific country guidelines.
- Refer to your local health authority for the most up-to-date fact sheet when prescribing or administering Tozinameran.
- No specific drug-drug interaction data are available. Minimise any unnecessary co-medication whenever possible, given the lack of information about interaction risk.
- To alleviate the risks of this unapproved drug during pandemic use, local regulatory agencies may require healthcare facilities and healthcare providers to comply with certain regulations for administration of tozinameran. Please refer to respective local regulatory agencies for further information.
Adverse Reactions
Significant: Syncope, hypersensitivity (e.g. anaphylaxis); injection site injury/reactions (e.g. shoulder bursitis, tendinopathy, bleeding or haematoma); Bell’s palsy. Temporary swelling at or near the site of filler injection.
Blood and lymphatic system disorders: Lymphadenopathy.
Gastrointestinal disorders: Nausea.
General disorders and administration site conditions: Inj site pain, swelling, redness; malaise, fatigue, chills, fever.
Musculoskeletal and connective tissue disorders: Muscle pain, joint pain.
Nervous system disorders: Headache.
Skin and subcutaneous tissue disorders: Rash, pruritus, urticaria.
Patient Counseling Information
Fully vaccinated individuals should continue to observe effective prevention measures (e.g. hand hygiene, wearing a mask, social distancing), please refer to your local health authorities.
Monitoring Parameters
Monitor for hypersensitivity reactions and syncope for 15 minutes after administration. Observe patients for 30 minutes for those with history of anaphylaxis due to any cause or an allergic reaction of any severity, within 4 hours after administration of a vaccine or injectable therapy.
Drug Interactions
Do not administer concomitantly with other vaccines; allow a minimum interval of 14 days between other vaccines. Diminished therapeutic effect with COVID-19 directed monoclonal antibodies, derma fillers, and immunosuppressants. Antihistamines may mask the symptoms of anaphylaxis caused by COVID-19 vaccine (mRNA) which could lead to delay in diagnosis and management.
Action
Description: Tozinameran is an investigational COVID-19 vaccine that contains messenger RNA (mRNA) encoding the viral spike glycoprotein (S) of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The nucleoside-modified mRNA is encapsulated in lipid nanoparticles, that enable delivery of the RNA into host cells, to direct transient expression of the SARS-CoV-2 spike (S) antigen. It contributes to the protection against COVID-19 by allowing both neutralising antibody and cellular immune responses to the S antigen.
Synonym: vaccine, COVID-19 mRNA (BNT162b2).
Storage
Recommended storage for intact vials: Store between -90 to -60°C. May be stored between -25 to -15°C for up to 2 weeks. Protect from light. Transportation of frozen vials: If cannot be transported at recommended storage condition, may be transported, and stored at -25 to -15°C for up to 2 weeks. Thawed vials before dilution: Thaw and store between 2-8°C for up to 120 hours (5 days) or thaw at 25°C for not more than 2 hours. Protect from direct sunlight and UV light. Thawed vials may be transported between 2-8°C for up to 12 hours. Diluted vials: Store between 2-30°C for up to 6 hours. Minimise exposure to room light and avoid exposure to direct sunlight and UV light. Do not refreeze.
References
Anon. COVID-19 Vaccine (mRNA). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 15/03/2021.

Anon. COVID-19 Vaccine (Pfizer-BioNTech). AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 15/03/2021.

Background Document on the mRNA Vaccine BNT162b2 (Pfizer-BioNTech) Against COVID-19. World Health Organization. http://www.who.int. Accessed 17/03/2021.

Comirnaty Concentrate for Dispersion for Injection COVID-19 mRNA Vaccine (nucleoside modified) (Pfizer Manufacturing Belgium NV). European Medicines Agency [online]. Accessed 15/03/2021.

Comirnaty Concentrate for Dispersion for Injection COVID-19 mRNA Vaccine (nucleoside modified) (Pfizer Manufacturing Belgium NV). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 15/03/2021.

Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Authorized in the United States. Centers for Disease Control and Prevention. https://www.cdc.gov. Accessed 17/03/2021.

Interim Recommendations for Use of the Pfizer-BioNTech COVID-19 Vaccine, BNT162b2, Under Emergency Use Listing. World Health Organization. http://www.who.int. Accessed 17/03/2021.

Pfizer New Zealand Limited. Comirnaty COVID-19 Vaccine 0.5 mg/mL Concentrated Suspension for Injection data sheet 1 03 Feb 2021. Medsafe. http://www.medsafe.govt.nz. Accessed 15/03/2021.

Pfizer-BioNTech COVID-19 Vaccine (Pfizer Inc). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 15/03/2021.

SARS-CoV-2 Virus (COVID-19) mRNA Vaccine. Gold Standard Drug Database in ClinicalKey [online]. Elsevier Inc. https://www.clinicalkey.com. Accessed 15/03/2021.

Disclaimer: This information is independently developed by MIMS based on Tozinameran 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
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