Articles: NUVAXOVID COVIOD VACCINE

Drug Information Review

 
Generic Name:

SARS-CoV-2 recombinant spike (rS) protein with Matrix-M adjuvant
Brand Name: NUVAXOVID®
Dosage Form(s):
  • 2 dose series intramuscular injection (booster is not approved in the US)
  • Multidose vial (5 mL, containing 10 doses of 0.5 mL) to be withdrawn into a syringe
Strength(s):
  • One dose (0.5 mL) contains 5 mcg of SARS-CoV-2 recombinant spike protein
Usual Daily Dose:
  • The vaccination course for NUVAXOVID is a series of two doses of 0.5 mL each. The second dose is to be administered 3 weeks after the first dose.
Administration:
  • NUVAXOVID is a suspension for intramuscular injection that should be administered by a trained healthcare worker
  • Each 0.5 mL dose is withdrawn into a sterile needle and sterile syringe to be administered by intramuscular injection, preferably in the deltoid muscle of the upper arm.
  • Gently swirl the multidose vial before and in between each dose withdrawal. Do not shake
Usual Cost (AWP):
  • $16 for Novavax's program per dose
Therapeutic Classification:
  • Recombinant protein, Adjuvanted
Primary FDA Approved Indication(s):
  • Indicated for active immunization to prevent COVID-19 caused by the SARS-CoV-2 in individuals 18 years of age and older
Pharmacology
  • NUVAXOVID is composed of purified full-length SARS-CoV-2 recombinant spike (S) protein nanoparticle that is stabilized in its prefusion conformation. The addition of the saponin-based Matrix-M adjuvant facilitates activation of the cells of the innate immune system, which enhances the magnitude of the S protein-specific immune response. The two vaccine components elicit B- and T-cell immune responses to the S protein, including neutralizing antibodies, which may contribute to protection against COVID-19.
Unlabeled Indications / Uses: N/A
Contraindications:
  • Contraindicated in individuals who are hypersensitive to the active ingredient or to any
ingredients in the formulation, including any non-medicinal ingredient, or component of the container
Renal Dosing N/A
Hepatic Impairment
N/A
Side Effects
  • syncope
  • anaphylaxis
Adverse Effects
  • injection site tenderness (68%)
  • injection site pain (56%)
  • fatigue (45%)
  • myalgia (44%)
  • headache (41%)
  • malaise (35%)
  • arthralgia (20%)
  • nausea or vomiting (11%).
Drug-Drug Interaction N/A
Pregnancy & Lactation
  • The safety and efficacy of NUVAXOVID in pregnant women have not yet been established.
  • It is unknown if NUVAXOVID is excreted in human milk. A risk to the newborns/ infants cannot
  • be excluded.
Geriatric Dosing No dose adjustments necessary
Half-Life / Elimination N/A
 
 
 
 
Comments
  • The safety and efficacy of NUVAXOVID in individuals under 18 years of age have not yet been established;
  • Only indicated for ages 18 and older
  • Efficacy: Studies show that it is 90.4% effective in all participants. However, levels of efficacy differed based on the age range:
  • 18-64 years old: 91.5%
  • 65 and older: 57.5%
  • Nuvaxovid® must be stored between 36-46F and must not be frozen and must be protected from light;
  • Each vial contains 5 mL of suspension in a 10-dose vial; It comes in packs of 10 multidose vials;
  • Unopened Nuvaxoid® vaccine can be stored at room temperature (46-77F) for up to 12 hours.
  • The drawn-up vaccine should be administered as close to the time of preparation as possible and within the labelled expiry date/time i.e., within 6 hours from when the vial was first accessed.
  • This cannot be mixed and matched with other covid vaccines such as Pfizer or Moderna. Both doses must be Nuvaxoid, especially as the booster is not yet approved in the US. Studies show that receiving this vaccine as the second dose following Pfizer did not meet the criteria for binding antibodies, which meant that it did not work against the SARS-CoV-2 spike protein.