Novavax COVID-19 Vaccine

Introduction

• CDC vaccination recommendations updated as of Sept 1, 2022 for new bivalent booster vaccines.
• Omicron-containing booster vaccines (all booster doses now bivalent) should retain neutralization for original SARS-CoV-2, induce a strong response against BA.5 and induce broad cross-neutralization against future variants.
• Novavax COVID-19 Vaccine, Adjuvanted, monovalent, is restricted to 12 years of age and older for the 2 primary doses 
• Don't mix mRNA and Novavax doses for primary series
• Exceptionally Novavax (monovalent) may be used in persons  >18 yrs of age for a 1st booster only at 6 mos for persons unwilling or unable to get a bivalent
• Only bivalent vaccines are authorized at this time for booster doses; bivalent Novavax vaccine is in development 
  • Any bivalent mRNA vaccine may be used at 2 months to boost a primary series with Novavax, monovalent
• See COVID-19, Vaccines for general vaccine indications, efficacy, duration of protection, choice an

Vaccine

• Type: recombinant protein subunit vaccine, adjuvanted
• Novavax COVID-19 Vaccine, Adjuvanted, monovalent (Nuvaxovid; Indian version branded as Covovax)
  • Contains same original strain spike protein that is coded for by mRNA vaccines

Dose

Schedule (normal host)

Storage

• Store as follows:
  •  2-8°C (36-46°F): Until expiration date
  • After first puncture 2-25°C (36-77°F): Discard after 6 hrs

Toxicities

Contraindications

• Anaphylaxis or immediate allergic reaction (within 4h) to a previous dose of an mRNA vaccine or separately to a vaccine constituent including polyethylene glycol (PEG) or polysorbate. 
  • Do not vaccinate with any mRNA vaccine
• History of a known diagnosed allergy to a vaccine component

Precautions

• Immediate allergic reaction (within 4h) to any other vaccine or injectable therapy not related to a component of mRNA-COVID-19 vaccines or polysorbate.
• Persons with a reaction to a vaccine or injectable therapy that contains PEG
• History of myocarditis or pericarditis after a dose of an mRNA or Novavax COVID-19 vaccine, avoid future doses of any COVID-19 vaccine
• Allergy-related contraindication to one type of COVID-19 vaccine is a precaution to the other types of COVID-19 vaccines
• Defer vaccination until resolution of a moderate or severe acute illness, with or without fever

Not Contraindications

• Food (including egg and gelatin), pet, insect, venom, environmental, latex, oral medications; any other history of anaphylaxis not related to vaccine or injectables.
• History of GBS in proximity to another vaccine.

Adverse Effects

• Pain at the injection site, sometimes severe, occurs frequently
• Fatigue, headache, and myalgia common but are mild to moderate, occurring within 1–3 days of vaccination, and resolving within 1–3 days of onset.
  • More frequent following dose 2 and among ages 12–64 years compared to >65 years
• Myocarditis: cases identified in clinical trials and post-authorization. risk low but as yet unquantified. 
  • Reactions more frequentand after dose 2 than dose 1.
  • 8-week interval between the first and second primary series doses of Moderna, Novavax, and Pfizer-BioNTech COVID-19 vaccines may be optimal for some people to reduce myocarditis.

Special Populations

Pregnancy

• Vaccinate according to standard recommendations if pregnant, breastfeeding, attempting or contemplating conception
  • Pregnant and recently pregnant persons at increased risk for severe illness and the fetus is at increased risk
• Benefits outweighs risks of vaccination
• Antibodies are transferred to the newborn
• No contraindications to breastfeeding

Immunocompromised / HIV

• Self-attestation to moderately or severely immunocompromised status is acceptable
• New immunocompromise after a 2-dose primary series do not need additional primary doses;  immunocompromised schedule with mRNA vaccine for the booster dose.
• Revaccinate HCT or CAR-T-cell therapy recipients with an mRNA vaccine or Novavax >3 months after HCT or CAR-T-cell therapy 
• Consider revaccination if 1 or more doses of vaccine (primary series and bivalent booster doses) received during short-course treatment with B-cell-depleting therapies (e.g., rituximab, ocrelizumab)  beginning at about 6 months after completion of therapy
• Administration of vaccines should not be delayed in patients on ongoing immunosuppressives
  • Administer vaccine doses approximately 4 weeks before the next scheduled therapy for patients on ongoing B-cell-depleting therapies

Serologic Testing

• Antibody testing is not recommended to assess for immunity following COVID-19 vaccination or to assess the need for vaccination in an unvaccinated person
  • No correlates of protection are available and assays vary widely
  • +ve IgG only minimally reassuring, -ve IgG unhelpful in patients whose ability to mount a B-cell response is uncertain