COVID-19 S protein (NVX-CoV2373) vaccine, recombinant

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

Hypersensitivity to NVX-CoV2373 vaccine, recombinant or any component of the formulation (e.g. polysorbate 80).

Patient with history of bleeding disorder (e.g. thrombocytopenia) or any coagulation disorder (e.g. haemophilia); autoimmune conditions; history of myocarditis or pericarditis unrelated to COVID-19 vaccination; history of non-severe, immediate (occurs within 4 hours) allergic reaction to a previous dose of NVX-CoV2373 vaccine, recombinant; history of immediate allergic reaction (e.g. anaphylaxis) to any other vaccine or injectable therapies (excluding SC immunotherapy for allergies); allergy-related contraindication to another type of COVID-19 vaccine (e.g. mRNA or adenovector COVID-19 vaccine). Patients receiving anticoagulant therapy. Immunocompromised patients (e.g. individuals with HIV or those receiving immunosuppressant therapy). Delay administration in patients with acute severe febrile illness or acute infection; vaccination may be given in patients with minor infection and/or low-grade fever. Defer vaccine administration in patients with known current COVID-19 infection until recovery from acute illness (if symptomatic) and no longer need of isolation. Consider delaying the dose by 3 months from symptom onset or positive test (if asymptomatic) in patients who recently had SARS-CoV-2 infection. In individuals with history of multisystem inflammatory syndrome (MIS), may consider delaying the vaccination until clinical recovery. Data on the safety of COVID-19 vaccination following MIS in children or adults are limited; risks and benefits must be considered based on patient-specific factors (e.g. recovery from illness, risk of COVID-19). Subsequent doses of any COVID-19 vaccine are generally not recommended in patients who experience myocarditis or pericarditis after a COVID-19 vaccine dose; if a subsequent dose is desired and clinically appropriate and for those with a history of myocarditis or pericarditis unrelated to COVID-19 vaccination, doses may be given until the signs or symptoms has been completely resolved as determined by cardiac testing and the clinical team. In individuals who are to receive tixagevimab/cilgavimab as pre-exposure prophylaxis, delay administration for at least 2 weeks following a dose of COVID-19 vaccine. Not recommended for postexposure prophylaxis. Pregnancy and lactation; use only if potential benefits justify the potential risk as there is limited data regarding the use of COVID-19 vaccines in pregnant and lactating women.

It should be noted that:

- NVX-CoV2373 vaccine, recombinant is available in some countries under an emergency use authorisation (EUA) or conditional approval scheme. Registration status and/or availability may vary between countries. Refer to your local regulatory agencies for more information.
- The safety and efficacy of NVX-CoV2373 vaccine, recombinant 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.
- Recommendations and approval for booster doses may vary among countries. Refer to specific country guidelines.
- There is currently no data available on the interchangeability of NVX-CoV2373 vaccine, recombinant with other COVID-19 vaccines to complete the primary series. It is recommended to use the same brand of vaccine to complete the vaccination course.
- To potentially decrease the small risk for myocarditis while possibly increasing the peak antibody responses and vaccine efficacy, a longer interval between the 1st and 2nd dose (8 weeks) may be optimal for certain populations ≥12 years, particularly males <12-39 years.
- Administration of antipyretics, analgesics, or antihistamines prior to the administration of COVID-19 vaccines as prophylaxis for 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.
- Minimise any unnecessary co-medication whenever possible, given the lack of information about interaction risk.
- For the traceability of biological medicinal products the vaccine name, batch or lot number, expiration date and other administration details must be properly recorded (refer to country-specific guidelines).
- Refer to your local health authority for the most up-to-date therapeutic drug monitoring protocol when prescribing NVX-CoV2373 vaccine, recombinant.
- 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 the transport, storage, and administration of NVX-CoV2373 vaccine, recombinant. Refer to country-specific recommendations for further information.

Significant: Severe hypersensitivity reactions (e.g. anaphylaxis, angioedema); anxiety-related reactions (e.g. syncope, hyperventilation, or stress-related reactions); shoulder injury (e.g. shoulder bursitis or tendinopathy) due to vaccine administration; bleeding/haematoma (in patients with bleeding disorders). Rarely, Guillain-Barre syndrome, myocarditis, pericarditis.
Blood and lymphatic system disorders: Lymphadenopathy, lymph node pain.
Gastrointestinal disorders: Nausea, vomiting.
General disorders and administration site conditions: Inj site reactions (e.g. pain, tenderness, swelling, erythema, pruritus); fever, chills, malaise, fatigue, axillary pain.
Musculoskeletal and connective tissue disorders: Arthralgia, myalgia, pain in extremity.
Nervous system disorders: Headache, paraesthesia, hypoaesthesia.
Skin and subcutaneous tissue disorders: Rash, erythema, pruritus, urticaria.
Vascular disorders: Hypertension.

Fully vaccinated recipients should continue to observe effective prevention measures (e.g. wearing a mask, social distancing). Refer to specific country guidelines.

Closely monitor for hypersensitivity reactions and syncope for at least 15 minutes after vaccination. Observe patients for 30 minutes after vaccination for individuals with history of anaphylaxis (due to any cause), history of an allergic reaction (regardless of severity) within 4 hours of receiving a non-COVID-19 vaccine or injectable therapy, history of non-severe, immediate (within 4 hours) allergic reaction after receiving a COVID-19 vaccine, or with contraindication to a different type of COVID-19 vaccine. Assess for signs and symptoms of myocarditis or pericarditis (e.g. acute and persisting chest pain, palpitation, shortness of breath).

May cause bleeding or bruising after IM administration in patients receiving anticoagulant therapy. Therapeutic effect may be diminished with immunosuppressants and tixagevimab/cilgavimab. May result in lower binding antibody response to SARS-CoV-2 when given concurrently with inactivated influenza vaccine.

Description: COVID-19 S protein (NVX-CoV2373) vaccine, recombinant is composed of a purified full-length SARS-CoV-2 recombinant spike (S) protein and the Matrix-M adjuvant, a saponin-based adjuvant that facilitates the activation of innate immune cells that enhances the magnitude of S protein-specific immune response. These 2 vaccine components stimulate B- and T-cell immune responses to the S protein including neutralising antibodies, which may contribute to protection against COVID-19 disease.
Synonyms: COVID-19 vaccine (recombinant, adjuvanted); SARS-CoV-2 rS (NVX-CoV2373).

Intact vials: Store between 2-8°C for up to 9 months. Do not freeze. Protect from light. Alternatively (although not a recommended storage condition), vials may be stored at 25°C for up to 12 hours if needed. Opened vials (after 1st needle puncture): Store between 2-25°C for up to 6 hours.

Vaccines, Antisera & Immunologicals

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Biocelect Pty Ltd. Nuvaxovid COVID-19 Vaccine 5 micrograms Adjuvanted, Suspension for Injection data sheet 28 July 2022. Medsafe. http://www.medsafe.govt.nz. Accessed 07/09/2022.

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EMA Recommends Nuvaxovid for Authorisation in the EU. European Medicines Agency [online]. Accessed 06/05/2022.

Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) Emergency Use Authorization (EUA) of the Novavax COVID-19 Vaccine, Adjuvanted to Prevent Coronavirus Disease 2019 (COVID-19). U.S. FDA. https://www.fda.gov. Accessed 07/09/2022.

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 07/09/2022.

Interim Recommendations for Use of the Novavax NVX-CoV2373 Vaccine Against COVID-19. World Health Organization. https://www.who.int. Accessed 06/05/2022.

Myocarditis and Pericarditis Have Been Reported with Nuvaxovid (Novavax COVID-19 Vaccine). Medsafe. http://www.medsafe.govt.nz. Accessed 15/09/2022.

Novavax COVID-19 Vaccine, Adjuvanted Injection, Suspension (Novavax, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 07/09/2022.

Nuvaxovid Dispersion for Injection (Novavax CZ a.s.). European Medicines Agency [online]. Accessed 07/09/2022.