COVID-19 vaccine, adjuvanted (Investigational)

COVID-19 vaccine, adjuvanted is indicated for emergency use for active immunization to prevent coronavirus disease 2019 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals aged 12 years and older.

• COVID-19 vaccine, adjuvanted-Novavax is available under the following different brand names: Novavax

Common side effects of the COVID-19 vaccine, adjuvanted include:

• injection site reactions (pain, tenderness, redness, swelling, itching)
• fatigue
• feeling unwell (malaise)
• muscle pain
• headache
• joint pain
• nausea
• vomiting
• fever
• chills
• hypersensitivity reactions
• lymphadenopathy-related reactions
• inflammation of the heart muscle (myocarditis)
• inflammation of tissue around the heart (pericarditis)

Serious side effects of the COVID-19 vaccine, adjuvanted include:

• hives
• difficulty breathing
• swelling of the face, lips, tongue, or throat
• chest pain
• abnormal heartbeat
• shortness of breath
• sharp, stabbing chest pain that may travel to the left shoulder and neck

Rare side effects of COVID-19 vaccine, adjuvanted include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Injectable, IM suspension

• 5 mcg/0.5 mL of SARS-CoV-2 recombinant spike (rS) protein and 50 mcg Matrix-M adjuvant
• Multidose vial contains 5 doses of 0.5 mL each

COVID-19 disease prevention

Adult and pediatric dosage

• Previously vaccinated with any COVID-19 vaccine
• 0.5 mL IM as a single dose
• Administer at least 2 months after the last COVID-19 vaccine dose
• Not previously vaccinated
• 2-dose primary series
• 0.5 mL IM × 2 doses administered 3 weeks apart
• Immunosuppressed individuals
  • For individuals with certain kinds of immunocompromise (ie, solid organ transplantation or conditions that are considered to have an equivalent level of immunocompromise), an additional dose may be administered at least 2 months following the last dose of a COVID-19 vaccine (2023-2024 formula)
  • Additional doses may be administered at the discretion of the healthcare provider, taking into consideration the individual’s clinical circumstances
  • The timing of additional doses is based on the individual’s clinical circumstances
• 2023-2024 vaccine components
  • Monovalent COVID-19 vaccine with an XBB-lineage of the Omicron variant (ie, XBB.1.5)

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• COVID-19 vaccine, adjuvanted has no noted severe interactions with any other drugs
• COVID-19 vaccine, adjuvanted has no noted serious interactions with any other drugs
• COVID-19 vaccine, adjuvanted has no noted moderate interactions with any other drugs
• COVID-19 vaccine, adjuvanted has no noted minor interactions with any other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Known history of severe hypersensitivity (eg, anaphylaxis) to any component in the vaccine

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using COVID-19 vaccine, adjuvanted?”

Long-Term Effects

• See “What Are Side Effects Associated with Using COVID-19 vaccine, adjuvanted?”

Cautions

• Appropriate treatment used to manage immediate allergic reactions must be immediately available if an acute anaphylactic reaction occurs following administration
• Syncope (fainting) may occur; procedures should be in place to avoid injury from fainting
• Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response
• May not protect all vaccine recipients
• Myocarditis and pericarditis
  • Myocarditis and/or pericarditis were reported by 2 participants after the Novavax COVID-19 vaccine, adjuvanted (0.01%) and no participants after the placebo
  • 1 serious event reported by a 67-year-old male 28 days after dose 1, associated with concomitant COVID-19 infection, and 1 non-serious event reported by a 20-year-old male 10 days after dose 1

Pregnancy and Lactation

• A growing body of evidence on the safety and effectiveness of COVID-19 vaccination indicates that the benefits of vaccination outweigh any known or potential risks of COVID-19 vaccination during pregnancy
• Recent studies have also shown that antibodies produced after COVID-19 vaccination during pregnancy are transferred to the newborn, and COVID-19 vaccination in people who are pregnant reduces the risk of COVID-19 hospitalization in infants younger than 6 months
• See the CDC guidelines for the vaccination of pregnant or lactating women
• Pregnancy registry
  • Monitor pregnancy outcomes in women exposed to vaccines during pregnancy
  • Encourage women who are vaccinated during pregnancy to enroll in the registry
• Clinical considerations
  • Pregnant individuals infected with SARS-CoV-2 are at increased risk of severe COVID-19 compared with nonpregnant individuals
• Lactation
  • Data are not available to assess the effects on breastfed infants or on milk production/excretion