Nuvaxovid: Uses, Dosage & Side Effects
A protein subunit COVID-19 vaccine containing recombinant SARS-CoV-2 spike protein with Matrix-M adjuvant, used to prevent COVID-19 in adolescents and adults from 12 years of age.
Nuvaxovid (recombinant, adjuvanted SARS-CoV-2 spike protein) is a protein subunit COVID-19 vaccine developed by Novavax (product code NVX-CoV2373). It contains a laboratory-produced copy of the SARS-CoV-2 spike glycoprotein combined with the saponin-based Matrix-M adjuvant, which strengthens the immune response. Unlike mRNA or viral-vector vaccines, Nuvaxovid uses an established protein-based technology also employed in vaccines against hepatitis B, pertussis, and seasonal influenza. Nuvaxovid is authorized for the active immunization of individuals 12 years of age and older to prevent COVID-19 caused by SARS-CoV-2. It is given as an intramuscular injection and must be prescribed and administered by a healthcare professional.
Quick Facts: Nuvaxovid
Key Takeaways
- Nuvaxovid is a recombinant protein subunit COVID-19 vaccine that uses a laboratory-made copy of the SARS-CoV-2 spike protein together with the Matrix-M saponin adjuvant to stimulate a strong neutralizing antibody and T-cell response.
- It is authorized for active immunization against COVID-19 in people aged 12 years and older, and is used both as a primary series (two doses given 3 weeks apart) and as a booster dose.
- The vaccine does not contain mRNA, DNA, polyethylene glycol (PEG), viral vectors, or live virus, making it a suitable alternative for people who cannot receive or prefer not to receive mRNA vaccines.
- The most common adverse reactions are mild-to-moderate injection-site tenderness, fatigue, headache, and muscle pain, usually resolving within 1–2 days; serious side effects such as anaphylaxis or myocarditis are very rare.
- Strain-adapted formulations (for example XBB.1.5 or JN.1-based Nuvaxovid) are reformulated periodically to match circulating SARS-CoV-2 variants, similar to the annual update of seasonal influenza vaccines.
What Is Nuvaxovid and What Is It Used For?
Nuvaxovid is the international brand name for the Novavax COVID-19 vaccine, also known by the research designation NVX-CoV2373. It is classified as a recombinant protein subunit vaccine, a platform that has been used in human vaccines for several decades, including hepatitis B vaccines, the human papillomavirus (HPV) vaccine, and certain recombinant influenza vaccines. Nuvaxovid represents an alternative approach to the mRNA COVID-19 vaccines (Comirnaty and Spikevax) and the viral-vector COVID-19 vaccines (Vaxzevria and Jcovden), providing flexibility for people who cannot receive or prefer not to receive those platforms.
The active component of Nuvaxovid is a highly purified, full-length, prefusion-stabilized version of the SARS-CoV-2 spike glycoprotein. The protein is manufactured using a baculovirus expression system in Spodoptera frugiperda (Sf9) insect cells and self-assembles into nanoparticles containing multiple copies of the spike. Each 0.5 mL dose contains 5 micrograms of the recombinant spike antigen combined with 50 micrograms of the Matrix-M adjuvant, a saponin extract derived from the Quillaja saponaria Molina tree. The adjuvant enhances the uptake of the antigen by antigen-presenting cells in the lymph nodes and strengthens both the antibody and T-cell arms of the immune response.
After intramuscular injection, Nuvaxovid does not enter the nucleus of human cells, does not contain genetic material, and cannot integrate into the human genome. The spike protein antigen is simply presented to the immune system, which then produces neutralizing antibodies directed against the receptor-binding domain (RBD) and other epitopes of the spike. These antibodies block the interaction between the spike and its human cellular receptor, angiotensin-converting enzyme 2 (ACE2), thereby preventing viral entry into host cells. In addition, cellular immune responses (CD4+ helper T cells and CD8+ cytotoxic T cells) contribute to longer-lasting protection, including against severe disease caused by new variants.
Nuvaxovid is authorized by the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), the UK Medicines and Healthcare products Regulatory Agency (MHRA), the Therapeutic Goods Administration (TGA) in Australia, Health Canada, and many other national regulatory authorities worldwide. The World Health Organization (WHO) has granted it Emergency Use Listing (EUL), facilitating its inclusion in COVAX and many national immunization programs.
Nuvaxovid is indicated for the following uses:
- Primary vaccination against COVID-19: Two doses given approximately 3 weeks apart to individuals 12 years of age and older who have not previously been vaccinated against SARS-CoV-2.
- Booster (repeat) vaccination: A single booster dose may be given at least 3 months after completion of a primary series or after a previous COVID-19 vaccination with any approved COVID-19 vaccine, based on national immunization guidance.
- Seasonal COVID-19 vaccination with strain-adapted formulations: Updated versions of Nuvaxovid (for example Nuvaxovid XBB.1.5 and JN.1 lineage variants) are used in seasonal COVID-19 vaccination campaigns, particularly for people at higher risk of severe disease.
- Alternative platform for individuals who cannot receive mRNA or viral-vector vaccines: For example, people with documented severe allergy to polyethylene glycol (PEG) or polysorbate 80 in mRNA vaccines, a history of anaphylaxis to mRNA COVID-19 vaccines, or those who prefer a protein-based vaccine for personal or medical reasons.
COVID-19 is an infectious disease caused by the SARS-CoV-2 coronavirus, first identified in Wuhan, China, in late 2019. While most people recover with supportive care, COVID-19 can cause severe pneumonia, acute respiratory distress syndrome, thromboembolic complications, cardiac injury, and death, particularly in older adults, immunocompromised individuals, pregnant women, and those with underlying cardiovascular, pulmonary, metabolic, or renal disease. COVID-19 can also lead to long-term sequelae known as post-COVID-19 condition or “Long COVID.” Vaccination remains one of the most effective strategies to prevent symptomatic COVID-19 and, critically, to reduce the risk of hospitalization and death.
Protein subunit vaccines have a long and well-characterized safety record, with cumulative experience across billions of doses in vaccines for hepatitis B, pertussis, HPV, and shingles. They are stable at standard refrigeration temperatures (2–8°C), do not require ultra-cold storage, and are easier to transport and administer in routine primary care settings. Nuvaxovid provides a platform-diverse option for global COVID-19 vaccination programs.
What Should You Know Before Receiving Nuvaxovid?
Before receiving Nuvaxovid, a short medical history and eligibility assessment is standard practice at the vaccination visit. This helps identify any contraindications, precautions, or conditions requiring extra care, and allows appropriate counseling about common reactions. The sections below summarize who should not receive Nuvaxovid, who should receive it with caution, and special considerations in pregnancy, breastfeeding, and particular populations.
Contraindications
Nuvaxovid must not be given to anyone with:
- Known hypersensitivity (severe allergic reaction, including anaphylaxis) to the active substance (SARS-CoV-2 recombinant spike protein) or to any of the excipients, which include disodium hydrogen phosphate heptahydrate, sodium dihydrogen phosphate monohydrate, sodium chloride, polysorbate 80, sodium hydroxide, hydrochloric acid, and water for injections. The Matrix-M adjuvant contains fractions extracted from Quillaja saponaria Molina.
- A confirmed severe allergic reaction to a previous dose of Nuvaxovid. If you experienced an immediate severe reaction after dose 1, do not receive dose 2.
Warnings and Precautions
Before receiving Nuvaxovid, inform your healthcare provider if any of the following apply:
- Previous allergic reactions: Any history of serious allergic reactions to a vaccine, medicine, insect stings, latex, or food should be disclosed. Appropriate medical treatment and supervision for anaphylaxis must always be readily available after vaccination. An observation period of at least 15 minutes after injection is recommended; people with a history of severe allergic reactions may require a longer observation period.
- Bleeding disorders or anticoagulant therapy: Because Nuvaxovid is given intramuscularly, individuals with thrombocytopenia, hemophilia, or those on anticoagulants (such as warfarin, direct oral anticoagulants, or heparin) may bruise or bleed at the injection site. Vaccination can still proceed, typically with a narrow-gauge needle and firm pressure for at least 2 minutes afterward.
- Immunocompromised state: People who are severely immunocompromised (for example, due to HIV infection with a low CD4 count, hematological malignancy, solid organ transplant, or use of high-dose immunosuppressive or B-cell-depleting therapy) may have a reduced immune response to Nuvaxovid. Additional doses may be recommended to achieve adequate protection.
- Acute illness or fever: Vaccination is usually postponed in individuals with an acute febrile illness or active infection until they have recovered. Mild infections, such as a cold without fever, are not a reason to postpone vaccination.
- Myocarditis and pericarditis risk awareness: Very rare cases of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining around the heart) have been reported after mRNA COVID-19 vaccines and, more rarely, after Nuvaxovid. Seek medical attention promptly if you develop chest pain, shortness of breath, palpitations, or fainting in the days after vaccination.
- Previous COVID-19 infection: Nuvaxovid can be given after recovery from COVID-19. Some guidelines suggest delaying vaccination for 3 months after infection to maximize the immune response, though this is not mandatory.
- Fainting (vasovagal syncope) risk: Fainting can occur in association with any injection. Remaining seated or lying down for about 15 minutes after vaccination is recommended.
As with all vaccines, vaccination with Nuvaxovid may not protect all recipients. The level and duration of protection against infection can vary depending on individual immune status, age, circulating SARS-CoV-2 variants, and time since the last dose. Vaccination does reduce the risk of symptomatic disease and substantially reduces the risk of severe disease, hospitalization, and death.
Pregnancy and Breastfeeding
Data on the use of Nuvaxovid during pregnancy are limited but increasing. Pregnancy registries and observational studies have not identified specific safety concerns attributable to Nuvaxovid. Because COVID-19 during pregnancy is associated with an increased risk of severe disease, preterm birth, and adverse maternal and neonatal outcomes, WHO and many national authorities recommend that pregnant women at risk of COVID-19 (for example, healthcare workers or those with underlying conditions) may receive Nuvaxovid after balancing the benefits and risks with their healthcare provider. Vaccination can occur at any stage of pregnancy.
Breastfeeding: Nuvaxovid is not expected to pose a risk to breastfed infants. Because the vaccine does not contain a live virus, there is no plausible mechanism for transmission to the infant through breast milk. Women who are breastfeeding can be vaccinated with Nuvaxovid when indicated, consistent with general recommendations for non-live vaccines.
Children and Adolescents
Nuvaxovid is authorized from 12 years of age. Immunogenicity and safety in adolescents aged 12–17 years are similar to those observed in adults, as demonstrated in the PREVENT-19 pediatric expansion trial. The vaccine is not currently authorized for children under 12 in most jurisdictions.
Older Adults
Nuvaxovid can be used in older adults. Clinical trials included participants aged 65 years and older, with efficacy and safety comparable to those in younger adults, although mild reactogenicity (for example, local pain and fatigue) may be slightly less frequent in older adults.
Driving and Using Machines
Nuvaxovid has no or negligible influence on the ability to drive or use machines. However, some of the reported side effects, such as temporary fatigue, headache, or dizziness, may transiently affect these abilities. If you feel unwell, do not drive or operate heavy machinery until you feel better.
How Does Nuvaxovid Interact with Other Medicines and Vaccines?
Nuvaxovid is not metabolized by hepatic enzymes in the way that conventional small-molecule drugs are, so pharmacokinetic drug interactions are not expected. Nevertheless, several clinically relevant considerations apply when Nuvaxovid is used together with other medicines or vaccines. Tell your healthcare provider about all prescription medicines, over-the-counter drugs, herbal products, and supplements you are taking before vaccination.
Major Interactions and Co-Administration
| Agent / Situation | Nature of Interaction | Recommendation |
|---|---|---|
| Seasonal inactivated influenza vaccine | Co-administration studied; slightly higher rates of mild local/systemic reactions but preserved antibody response | May be given on the same day in opposite arms; no need to space out |
| Other non-live vaccines (e.g., pneumococcal, Tdap, shingles) | No specific interaction studies, but same-day administration of non-live vaccines is generally considered safe | Follow national guidance; consider spacing by 7 days if reactogenicity is a concern |
| Other COVID-19 vaccines | Heterologous boosting is acceptable and in some settings preferred | Booster may be given at least 3 months after a previous COVID-19 vaccine |
| Immunosuppressive therapy (chemotherapy, anti-CD20, high-dose corticosteroids, calcineurin inhibitors, etc.) | Reduced immune response; protection may be lower | Vaccinate when possible; additional doses may be recommended; consider timing relative to therapy cycles |
| Anticoagulants (warfarin, DOACs, heparin) | Increased bruising/bleeding risk at IM injection site | Use narrow-gauge needle; firm pressure for ≥2 minutes; vaccinate when INR is therapeutic but stable |
| Antiplatelet medicines (aspirin, clopidogrel, ticagrelor) | Mildly increased injection-site bruising | Routine precautions; no need to stop antiplatelet therapy |
| Paracetamol/ibuprofen before vaccination | Prophylactic analgesics may blunt immune response in some vaccines; unclear for Nuvaxovid | Not recommended prophylactically; can be used after vaccination to treat symptoms |
Minor Considerations
Most common prescription and over-the-counter medicines do not interact meaningfully with Nuvaxovid. Routine medicines for blood pressure, cholesterol, diabetes, asthma, reflux, and similar conditions can be continued around the time of vaccination without adjustment. Iron supplements, vitamins, and most herbal products also have no relevant interaction with Nuvaxovid.
Certain biologic therapies, including B-cell depleting agents (for example, rituximab or ocrelizumab), may significantly blunt antibody responses to Nuvaxovid when given within the weeks preceding or following vaccination. When clinically feasible, your specialist may coordinate the timing of vaccination and biologic therapy to optimize the immune response. This decision is highly individual and should be made in consultation with your treating rheumatologist, neurologist, or hematologist.
There are no known interactions with alcohol, although moderation around the time of vaccination is advisable to avoid amplifying mild reactogenicity symptoms such as headache, fatigue, or nausea. Smoking does not directly interact with the vaccine but is associated with reduced immune responses to many vaccines in general.
What Is the Correct Dosage of Nuvaxovid?
Nuvaxovid is supplied as a multidose vial containing 10 doses of 0.5 mL each. It is administered as an intramuscular (IM) injection, preferably into the deltoid muscle of the upper arm. The injection must never be given intravenously, intradermally, or subcutaneously. The vial is shaken gently before each withdrawal and does not require dilution. After the first puncture, the vial should be used within 6 hours when stored at 2–25°C.
The dose schedule and timing depend on age group, prior vaccination status, and current regulatory guidance, which is updated periodically based on emerging evidence and changes in circulating SARS-CoV-2 variants.
Adults (18 Years and Older)
Primary Vaccination
Two doses of 0.5 mL (5 micrograms of spike protein) administered intramuscularly with an interval of 3 weeks (21 days) between doses. If the second dose is delayed, it should be given as soon as possible; there is no need to restart the series.
Booster Dose
A single booster dose of 0.5 mL administered at least 3 months after completion of a primary COVID-19 vaccination series (with any authorized vaccine). Repeat (seasonal) booster doses using strain-adapted formulations may be recommended annually, particularly for people at higher risk of severe COVID-19.
Adolescents (12–17 Years)
Primary Vaccination
The same dosing as for adults: two doses of 0.5 mL (5 micrograms) intramuscularly, given 3 weeks apart. Immunogenicity and safety in this age group are similar to those in adults.
Booster Dose
A booster dose may be given if recommended by national guidelines, typically at least 3 months after the primary series. Recommendations vary by country and are adjusted based on local epidemiology and risk factors.
Children Under 12 Years
Nuvaxovid is not currently authorized for children younger than 12 years in most jurisdictions. Alternative age-appropriate COVID-19 vaccines should be considered for this age group. Ongoing clinical trials continue to evaluate safety and immunogenicity in younger children.
Older Adults (65 Years and Older)
The standard adult dose and schedule apply. No dose adjustment is required based on age alone. Older adults and people with multiple comorbidities are often prioritized for booster doses, given their higher risk of severe COVID-19.
Immunocompromised Individuals
People who are moderately or severely immunocompromised may require additional doses to mount an adequate immune response. Many national authorities recommend a third primary dose at least 1–3 months after the second dose, followed by additional boosters at regular intervals. Consult your specialist and national immunization authority for the most up-to-date recommendations.
Renal or Hepatic Impairment
No dose adjustment is required for patients with kidney or liver disease. Nuvaxovid is not eliminated by renal or hepatic pathways in a manner that would require adjustment.
Missed Dose
If you miss your scheduled second dose, contact your healthcare provider to reschedule as soon as possible. There is no need to restart the vaccination series. The second dose can still be given effectively even if the 3-week interval has been exceeded.
Overdose
Overdose with Nuvaxovid is unlikely because it is administered by trained healthcare professionals in pre-measured doses. In the event of accidental administration of a higher dose, the person should be monitored and managed symptomatically. Contact a poison control center or emergency department for specific advice.
Nuvaxovid must be administered by a qualified healthcare professional in a setting where medical treatment for rare anaphylactic reactions is available. Patients do not prepare or inject the vaccine themselves.
What Are the Side Effects of Nuvaxovid?
Like all medicines and vaccines, Nuvaxovid can cause side effects, although not everyone experiences them. Most reactions occur within the first 1–3 days after injection and typically last no more than 1–2 days. They reflect the normal activation of the immune system in response to the antigen and adjuvant. Frequencies below are derived from the pooled phase 2 and phase 3 randomized controlled trials (PREVENT-19 and 2019nCoV-301), post-authorization safety surveillance, and pharmacovigilance reporting to the EMA EudraVigilance, FDA VAERS, and WHO VigiBase databases.
Very Common
May affect more than 1 in 10 people
- Tenderness at the injection site
- Pain at the injection site
- Headache
- Muscle pain (myalgia)
- Feeling tired (fatigue)
- General discomfort or feeling unwell (malaise)
- Joint pain (arthralgia)
- Nausea or vomiting
Common
May affect up to 1 in 10 people
- Redness at the injection site
- Swelling at the injection site
- Fever (≥38°C)
- Chills
- Pain in the arm or limb in which the injection was given
- Enlarged lymph nodes (lymphadenopathy)
- Elevated blood pressure (usually transient)
Uncommon
May affect up to 1 in 100 people
- Skin rash (including at sites other than the injection)
- Redness of the skin (erythema)
- Itching (pruritus)
- Hives (urticaria)
- Dizziness
- Itching at the injection site
- Warmth at the injection site
Rare
May affect up to 1 in 1,000 people
- Severe allergic reactions (anaphylaxis, angioedema)
- Paresthesia (tingling or numbness)
- Hypoesthesia (reduced sensation)
Not Known
Frequency cannot be estimated from available data
- Myocarditis (inflammation of the heart muscle)
- Pericarditis (inflammation of the lining around the heart)
- Delayed extensive swelling at the injected limb
Reactogenicity After the Second Dose and Booster
Reactogenicity (the tendency to cause local and systemic reactions) is typically slightly higher after the second dose of the primary series and after a booster dose than after the first dose. This reflects the fact that the immune system is already primed to recognize the antigen. Most symptoms remain mild to moderate and resolve within 1–2 days. Compared with mRNA COVID-19 vaccines, Nuvaxovid tends to produce less frequent and less intense fever, chills, and systemic reactions in head-to-head comparisons, which has been one of the reasons some people prefer it.
Myocarditis and Pericarditis
Cases of myocarditis and pericarditis have been reported very rarely in temporal association with Nuvaxovid, predominantly in younger males and typically within 14 days after vaccination. The reported rates appear similar to or lower than those observed with mRNA COVID-19 vaccines, and far lower than the myocarditis rates associated with COVID-19 infection itself. Seek medical attention promptly if you develop chest pain, shortness of breath, palpitations, or fainting in the days or weeks after vaccination. Most reported cases are mild and respond well to standard supportive care.
Anaphylaxis
Severe allergic reactions (anaphylaxis) are very rare but possible after any vaccine. They typically occur within minutes of administration. Vaccination providers are trained to recognize and treat anaphylaxis and routinely keep the necessary equipment and medicines (such as adrenaline/epinephrine) on hand. The recommended observation period of at least 15 minutes after injection is designed to detect and manage such reactions promptly.
Contact a healthcare professional urgently if you experience severe or worsening chest pain, persistent shortness of breath, swelling of the face, mouth, tongue, or throat, widespread hives, wheezing, fainting, or signs of a severe neurologic reaction (for example, sudden weakness, vision changes, or seizure). Routine reactions like sore arm, mild fever, or fatigue typically resolve within 1–2 days and do not require medical evaluation.
If you experience any side effects, including those not listed here, tell your doctor or nurse. You can also report suspected side effects to your national pharmacovigilance authority (for example, the EMA via national agencies, the FDA Vaccine Adverse Event Reporting System (VAERS) in the United States, or the MHRA Yellow Card Scheme in the United Kingdom). Reporting adverse reactions helps authorities monitor the ongoing benefit-risk profile of the vaccine.
How Should Nuvaxovid Be Stored?
Nuvaxovid is supplied as a ready-to-use liquid dispersion in multidose glass vials. Unlike mRNA COVID-19 vaccines, which require ultra-cold or frozen storage, Nuvaxovid is stable at standard refrigeration temperatures, which greatly simplifies cold-chain logistics and distribution in routine primary care and community vaccination settings worldwide.
Key storage conditions include the following:
- Unopened vial: Store in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze. Keep the vial in the outer carton to protect from light.
- Punctured (opened) vial: After the first dose has been withdrawn, the vial may be stored at 2–25°C and must be used within 6 hours. Any remaining vaccine after this period must be discarded.
- Transport: Nuvaxovid may be transported at 2°C to 8°C. Do not shake vigorously. Protect from light during transport.
- Shelf life: The expiry date is printed on the vial label and outer carton. Do not use the vaccine after this date. The expiry date refers to the last day of that month.
- Visual inspection: Before use, the vaccine should be a colorless to slightly yellowish, clear to mildly opalescent dispersion. Do not use if you observe particles other than expected (some fine, translucent particles may be present as a product characteristic), strong discoloration, or damage to the vial.
Because Nuvaxovid is handled and prepared by trained staff at the vaccination site, you will typically not be responsible for storing the vaccine yourself. Do not dispose of any medicines via wastewater or household waste. Healthcare providers follow local regulations for the safe disposal of vials, syringes, and any unused vaccine to protect the environment and prevent needlestick injuries.
The refrigerator-stable profile of Nuvaxovid (2–8°C) has been a key advantage for vaccine deployment in low- and middle-income countries, where ultra-cold storage infrastructure may be limited. This has supported its role in COVAX and in national programs where robust, flexible, and familiar cold-chain logistics are essential.
What Does Nuvaxovid Contain?
Active Substance
The active substance is a recombinant SARS-CoV-2 spike (S) glycoprotein produced in insect (Sf9) cells using a baculovirus expression system and formulated as a nanoparticle. The spike protein is engineered to be in the prefusion conformation, which is the form that generates the most effective neutralizing antibodies. Each 0.5 mL dose contains 5 micrograms of the recombinant spike protein. Strain-adapted versions (for example Nuvaxovid XBB.1.5 and Nuvaxovid JN.1) use the same quantity of an updated spike antigen matched to currently circulating variants.
Adjuvant
Each dose contains 50 micrograms of Matrix-M adjuvant, a saponin-based adjuvant composed of two fractions extracted from the Quillaja saponaria Molina tree (Fraction-A 42.5 micrograms and Fraction-C 7.5 micrograms), combined with cholesterol and phospholipids to form nanoparticles approximately 40 nm in diameter. Matrix-M enhances the immune response by stimulating antigen uptake and presentation by dendritic cells in the draining lymph nodes and by supporting a balanced Th1/Th2 T-cell response.
Inactive Ingredients (Excipients)
- Disodium hydrogen phosphate heptahydrate
- Sodium dihydrogen phosphate monohydrate
- Sodium chloride
- Polysorbate 80
- Sodium hydroxide (for pH adjustment)
- Hydrochloric acid (for pH adjustment)
- Water for injections
What Nuvaxovid Does Not Contain
Nuvaxovid does not contain any of the following:
- Messenger RNA (mRNA) or DNA
- Live, attenuated, or inactivated virus
- Viral vectors (for example, adenoviruses)
- Polyethylene glycol (PEG) or lipid nanoparticles (LNPs)
- Egg, gelatin, gluten, or pork-derived ingredients
- Preservatives such as thiomersal (thimerosal)
- Aluminum salts
- Antibiotics
Appearance
Nuvaxovid is a colorless to slightly yellowish dispersion, supplied in a clear, multidose glass vial sealed with a rubber stopper and aluminum cap. Each vial contains 2.5 mL (10 doses of 0.5 mL). Some very small translucent to white particles may be present as a product characteristic and do not indicate a problem.
Manufacturer
The marketing authorization holder in the European Union is Novavax CZ a.s., Jevany, Czech Republic. Manufacture involves Novavax, Inc. (Gaithersburg, Maryland, United States) and several licensed partner sites depending on the jurisdiction. Nuvaxovid is marketed under the global brand name Nuvaxovid by Novavax and in some territories (for example the United States) as Novavax COVID-19 Vaccine, Adjuvanted.
Packaging
Nuvaxovid is supplied in packs of 10 multidose vials (2.5 mL per vial). Each vial contains 10 doses of 0.5 mL after the product has equilibrated to room temperature and the vial is gently mixed.
Frequently Asked Questions About Nuvaxovid
Nuvaxovid is a protein subunit COVID-19 vaccine made by Novavax. It contains a laboratory-made copy of the SARS-CoV-2 spike protein combined with the saponin-based Matrix-M adjuvant. Unlike mRNA vaccines, Nuvaxovid uses the same protein-based technology that has been used for decades in vaccines against hepatitis B, HPV, and recombinant influenza. After intramuscular injection, it trains the immune system to recognize the spike protein and produce neutralizing antibodies and T-cell responses that help prevent COVID-19.
Nuvaxovid is authorized for people 12 years of age and older, both as a primary vaccination (two doses 3 weeks apart) and as a booster dose. It is particularly useful for people who prefer or require a non-mRNA, non-viral-vector vaccine, including those with contraindications or severe allergies to mRNA vaccines. Pregnant and breastfeeding women and immunocompromised individuals can generally be vaccinated after discussing individual risks and benefits with their healthcare provider.
The primary vaccination schedule is two doses of 0.5 mL given intramuscularly 3 weeks apart. A booster dose may be given at least 3 months after the primary series or after a previous COVID-19 vaccination with any approved vaccine. Annual booster doses with strain-adapted formulations may be recommended, particularly for people at higher risk of severe COVID-19, based on national immunization guidance.
No. Nuvaxovid does not contain any mRNA, DNA, viral vectors, or live or inactivated virus. It contains only a purified, laboratory-made copy of the SARS-CoV-2 spike protein together with the Matrix-M adjuvant. Nuvaxovid cannot cause a COVID-19 infection and cannot alter your DNA. It also does not contain polyethylene glycol (PEG), eggs, gelatin, or preservatives.
The most common side effects are mild-to-moderate injection-site tenderness and pain, fatigue, headache, muscle pain, joint pain, malaise, and nausea. These typically resolve within 1–2 days. Fever, chills, and local swelling are common but less frequent than with mRNA COVID-19 vaccines. Serious reactions such as anaphylaxis or myocarditis are very rare.
Yes. Co-administration studies have shown that Nuvaxovid can be given on the same day as a seasonal inactivated influenza vaccine using different injection sites (for example, opposite arms). The immune response to both vaccines is preserved, and no new safety signals have been identified, although slightly higher rates of mild reactogenicity may occur. Always follow your national vaccination guidance for the latest recommendations about co-administration with other vaccines.
Current data from pregnancy registries and observational studies have not identified specific safety concerns with Nuvaxovid in pregnancy. Because COVID-19 during pregnancy is associated with a higher risk of severe disease and adverse outcomes, many authorities recommend that pregnant women at risk of COVID-19 may receive Nuvaxovid after discussing the benefits and risks with their healthcare provider. Nuvaxovid does not contain a live virus and is not expected to pose a risk to breastfed infants; breastfeeding women can be vaccinated when indicated.
In the pivotal phase 3 PREVENT-19 trial in North America and the 2019nCoV-301 trial in the United Kingdom, Nuvaxovid showed approximately 90% efficacy against symptomatic laboratory-confirmed COVID-19 and 100% efficacy against severe disease in the pre-Delta era. Real-world effectiveness has been maintained against moderate-to-severe disease in the Omicron era through the use of updated, strain-matched formulations. Like all COVID-19 vaccines, protection against mild infection wanes over months, which is why periodic booster doses are recommended for at-risk groups.
References
- European Medicines Agency (EMA). Nuvaxovid (COVID-19 vaccine, recombinant, adjuvanted) – Summary of Product Characteristics. Last updated 2025. Available from: EMA EPAR.
- U.S. Food and Drug Administration (FDA). Novavax COVID-19 Vaccine, Adjuvanted (2024–2025 Formula) – Prescribing Information and Fact Sheet for Healthcare Providers. Revised 2025. Available from: FDA Novavax Information.
- Dunkle LM, Kotloff KL, Gay CL, et al. Efficacy and Safety of NVX-CoV2373 in Adults in the United States and Mexico (PREVENT-19). N Engl J Med. 2022;386(6):531–543. doi:10.1056/NEJMoa2116185.
- Heath PT, Galiza EP, Baxter DN, et al. Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine (2019nCoV-301). N Engl J Med. 2021;385(13):1172–1183. doi:10.1056/NEJMoa2107659.
- Keech C, Albert G, Cho I, et al. Phase 1–2 Trial of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine. N Engl J Med. 2020;383(24):2320–2332. doi:10.1056/NEJMoa2026920.
- Formica N, Mallory R, Albert G, et al. Different dose regimens of a SARS-CoV-2 recombinant spike protein vaccine (NVX-CoV2373) in younger and older adults: A phase 2 randomized placebo-controlled trial. PLoS Med. 2021;18(10):e1003769.
- Mallory RM, Formica N, Pfeiffer S, et al. Safety and immunogenicity following a homologous booster dose of a SARS-CoV-2 recombinant spike protein vaccine (NVX-CoV2373). Lancet Infect Dis. 2022;22(11):1565–1576.
- Áñez G, Dunkle LM, Gay CL, et al. Safety, Immunogenicity, and Efficacy of the NVX-CoV2373 COVID-19 Vaccine in Adolescents. JAMA Netw Open. 2023;6(4):e239135.
- World Health Organization (WHO). Interim recommendations for use of the Novavax NVX-CoV2373 vaccine against COVID-19. Geneva: WHO; 2024.
- World Health Organization (WHO). WHO lists Novavax NVX-CoV2373 for emergency use. WHO news release, 2021.
- U.S. Centers for Disease Control and Prevention (CDC). ACIP Recommendations: COVID-19 Vaccination. Updated 2025.
- UK Medicines and Healthcare products Regulatory Agency (MHRA). Public Assessment Report: Nuvaxovid COVID-19 vaccine. London: MHRA; 2022 (updated 2025).
- Marchese AM, Beyhaghi H, Orenstein WA, et al. The saponin-based Matrix-M adjuvant: A modern adjuvant for modern vaccines. Expert Rev Vaccines. 2022;21(2):173–185.
- Bennet BM, Wolf J, Laureano R, Sellers RS. Review of Current Vaccine Development Strategies to Prevent Coronavirus Disease 2019 (COVID-19). Toxicol Pathol. 2020;48(7):800–809.
Editorial Team
This article was written and reviewed by the iMedic Medical Editorial Team, comprising licensed specialist physicians with expertise in vaccinology, infectious diseases, and clinical pharmacology.
Medical Content
iMedic Vaccinology Editorial Team – specialist physicians in infectious diseases and immunology with clinical experience in COVID-19 vaccination
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iMedic Medical Review Board – independent panel verifying accuracy against EMA SmPC, FDA label, WHO, and CDC ACIP guidelines
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