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
Age indication | Vaccine composition | Primary series | Booster dose | ||
---|---|---|---|---|---|
Dose | Injection volume | Dose | Injection volume | ||
12 years and older (>18 yrs if used for a 1st booster dose) | Monovalent | 5 µg rS and 50 µg of Matrix-M™ adjuvant |
0.5 mL | NA | NA |
Schedule (normal host)
Age |
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 yrs |
2 |
1 |
Moderna or Pfizer-BioNTech |
3–8 wks |
>2 months |
>18 yrs (exceptional circumstances) |
2 |
0 |
Use Novavax monovalent |
3-8 wks |
>6 mos |
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 |
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 yrs |
2 |
1 |
Moderna or Pfizer-BioNTech |
3 weeks |
NA |
>2 months |
>18 yrs (exceptional circumstances) |
2 |
0 |
Use Novavax monovalent 6 mos |
3-8 wks |
NA |
>6 mos |
- 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