Novavax COVID-19 Vaccine

by David O. Freedman, M.D. last updated 2022-09-13 10:31:30.047410-04:00 © Antimicrobial Therapy, Inc.
Nuvaxovid, Covovax, NVX-CoV2373

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 and may only be used as dose 1 or 2 in a primary series
  • Don't mix  mRNA and Novavax doses for primary series
  • Only bivalent vaccines are authorized at this time for booster doses; bivalent Novavax vaccine is in development 
    • any bivalent mRNA vaccine may be used 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

COVID-19 vaccine products currently approved or authorized in the United States: Novavax
Age indication Vaccine composition Primary series Booster dose
Dose Injection volume Dose Injection volume
12 years and older Monovalent 5 µg rS and
50 µg of Matrix-M™ adjuvant
0.5 mL NA NA

Schedule (normal host)

Age
group

Number of primary doses

Number of bivalent booster doses

Recommended bivalent booster dose

Interval between 1st and 2nd primary dose

Interval between primary series and booster dose

12–17 yrs

2

1

Pfizer-BioNTech

3–8 wks

>2 months

>18 years and older

2

1

Moderna or Pfizer-BioNTech

3–8 wks

>2 months

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

Age
group

Number of primary doses

Number of bivalent booster doses

Recommended bivalent booster dose

Interval between 1st and 2nd primary dose

Interval between 2nd and 3rd primary dose

Interval between primary series and booster dose

12–17 yrs

2

1

Pfizer-BioNTech

3 weeks

NA

>2 months

>18 years and older

2

1

Moderna or Pfizer-BioNTech

3 weeks

NA

>2 months

  • 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