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Novavax COVID-19 Vaccine

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March 18, 2024
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Novavax COVID-19 Vaccine (Nuvaxovid™ XBB.1.5) Clinical Trials, Dosage, News, Side Effects, Usage

Novavax Inc.'s COVID-19 Vaccine (Nuvaxovid™XBB.1.5 dispersion for injection) (CovoVax™) (NVX-CoV2373) (NVX-CoV2601) was the first protein-based vaccine engineered from the genetic sequence of the SARS-CoV-2 beta coronavirus. As of March 2024, Novavax's vaccine is the only non-mRNA COVID-19 vaccine available in the United States (U.S.) The COVID-19 vaccine was created using Novavax's proprietary nanoparticle technology, Matrix-M™, an adjuvant to enhance immune responses and stimulate high levels of neutralizing antibodies. Matrix-M has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response and helping an immunized person make antibodies against the coronavirus. 

Novavax's vaccines are genetically engineered using three-dimensional nanostructures of recombinant proteins critical to disease pathogenesis. The baculovirus infects a culture of Sf9 moth cells, which generate and display the spike protein on their cell membranes. Next, the spike proteins are harvested and assembled onto a synthetic lipid nanoparticle about 50 nanometers, each displaying up to 14 spike proteins. 

On Dec. 17, 2021, the World Health Organization (WHO) granted Emergency Use Listing (EUL) for Novavax's NVX‑CoV2373 (CovoVax) vaccine manufactured and marketed by Serum Institute of India Pvt. Ltd. (SII). On Nov. 29, 2022, the WHO issued an updated EUL for the Nuvaxovid™ vaccine as a primary series of two doses in adolescents aged 12 through 17 and as a booster in adults. On Nov. 28, 2023, the WHO authorized Nuvaxovid, enabling its 194 member states to expedite regulatory approvals to import and administer the vaccine. On Dec. 13, 2023, the WHO Technical Advisory Group on COVID-19 Vaccine Composition (TAG-CO-VAC) advised retaining the current COVID-19 vaccine antigen composition (monovalent XBB.1.5) as the COVID-19 vaccine antigen. As of March 2024, Novavax's COVID-19 vaccine was one of 13 vaccines granted EUL by the WHO. 

On Mar. 6, 2024, The Lancet Infectious Disease published results from an interim analysis of phase 3, a randomized, observer-blinded study focused on the immunogenicity and safety of a saponin-adjuvanted, protein-based, omicron-BA.5-containing bivalent vaccine (NVX-CoV2540 plus NVX-CoV2373) versus the prototype vaccine alone (NVX-CoV2373) when used as the fourth (or greater) booster dose (Novavax). These findings show that the bivalent vaccine booster induces more robust immune responses than the prototype booster against clinically relevant variants of interest. Boosting with the monovalent BA.5-containing vaccine alone resulted in the highest neutralizing titers against omicron BA.5. part 2 of the ongoing 2019nCoV-311 study met all three coprimary endpoints. It did not raise any new safety signals, supporting the use of omicron-based booster vaccines.

On Mar. 16, 2024, the journal Vaccine published a positive benefit–risk assessment for the Novavax COVID-19 vaccine (NVX-CoV2373).

Novavax COVID-19 vaccine brands include NuvaxovidCovoVax, NVX-CoV2373, and TAK-019 - (non-USA) Trademark filing #90813423. A global listing of NVX‑CoV2373 studies is available at this link. NNVX-CoV2373's Drugbank Accession Number: DB15810; UNII: UK9AK2IN1P. In addition, the global information about the Novavax COVID-19 Vaccine varies by country and is searchable on this weblink. And at NovavaxMedInfo.com. See the Summary of Product Characteristics with Package Leaflet, Prescribing Information, Important Safety Information, and adverse event reporting instructions, or request additional information; please visit  www.NovavaxCovidVaccine.com.

Nuvaxovid has manufacturing sites in the Czech Republic, Australia, Canada, Japan, and South Korea's S.K. bioscience. On Jul. 19, 2022, Novavax signed agreements with SK Bioscience to manufacture and supply a version of the Novavax COVID-19 vaccine. In 2021, Novavax licensed and transferred its manufacturing technologies and provided the Matrix-M™ adjuvant to enable Takeda to manufacture the vaccine at its Hikari facility in Japan. 

On Feb. 28, 2024, the Company announced total revenue for 2023 was $984 million, compared to $2 billion in the same period in 2022. Furthermore, Advance Purchase Agreement deliveries for 2024 through 2026 of over $1 billion, consisting primarily of deliveries to Australia, New Zealand, Canada, Israel, and Europe. As of Nov. 9, 2023, the Company expects U.S. 2023-2024 season COVID-19 vaccine demand of between 30 and 50 million doses. SK bioscience announced on Aug. 9, 2023, it made an equity investment in Novavax, securing 6.5 million shares of common stock through a private placement.

Maryland-based Novavax, Inc. (Nasdaq: NVAX) is a biotechnology company located at 21 Firstfield Road, Gaithersburg, MD 20878, that promotes improved health globally by discovering, developing, and commercializing innovative vaccines to prevent serious infectious diseases.

NVX-CoV2373 Vaccine U.S. FDA Authorizations

The U.S. FDA announced the Vaccines and Related Biological Products Advisory Committee (VRBPAC) will hold a public discussion to recommend the selection of strain(s) to be included in the 2024-2025 formula for COVID-19 vaccines on May 16, 2024. On Oct. 3, 2023, the U.S. Food and Drug Administration (FDA) amended the Emergency Use Authorization (EUA) of the Novavax COVID-19 Vaccine, Adjuvanted for use in individuals 12 and older, to include the 2023-2024 formula. Individuals 12 years of age and older previously vaccinated with a COVID-19 vaccine (and who have not already been vaccinated with a recently updated mRNA COVID-19 vaccine) are eligible to receive one dose, and unvaccinated individuals receive two doses. On Sept. 12, 2023, Dr. Filip Dubovsky, President of Research & Development, presented Data in Support of Novavax XBB.1.5 Vaccine.

On Jun. 15, 2023, Novavax, Inc. participated in the VRBPAC meeting and presented updated data, which resulted in a unanimous vote recommending updating the current COVID-19 vaccine composition to a monovalent XBB-lineage. On Jun. 6, 2023, the FDA confirmed that the Novavax COVID-19 Vaccine, Adjuvantthat, is available under EUA in the U.S. to prevent COVID-19 in individuals 12 years of age and older and booster doses for certain people.

On Feb. 13, 2023, Novavax announced a modification to its agreement with the U.S. Department of Health and Human Services (HHS) to deliver up to 1.5 million doses of the Novavax COVID-19 Vaccine. The U.S. FDA publishes Fact Sheets for Healthcare ProvidersRECIPIENTS, and CAREGIVERS.  Novavax, Inc. Filip Dubovsky, MD, MPH Executive Vice President & Chief Medical Officer, presented to the VRBPAC on Jan. 26, 2023 - Novavax Vaccine Regimens Addressing COVID-19. Where authorized under state law in the U.S., standing orders enable eligible nurses and other healthcare professionals (e.g., pharmacists) to assess and vaccinate persons who meet the criteria in the "Procedure" section without the need for clinician examination or direct order from the attending provider at the time of the interaction.

On Oct. 19, 2022, Novavax announced that the Novavax COVID-19 Vaccine had received an EUA from the U.S. FDA. The FDA confirmed on Aug. 19, 2022, that the Novavax COVID-19 Vaccine was available under EUA to prevent COVID-19 in individuals 12 years of age and older. The CDC approved this EUA on Aug. 22, 2022. Previously, Novavax, Inc. announced on Aug. 15, 2022, that it submitted an application to the U.S. FDA for EUA of its protein-based COVID-19 Vaccine as a homologous and heterologous booster in adults aged 18 and older. As of Aug. 8, 2022, Novavax received U.S. FDA EUA and CDC recommendations for NVX-CoV2373, marking the first protein-based, non-mRNA COVID-19 vaccine authorized in the U.S. for adults. On Jun. 7, 2022, the VRBPAC's twenty-two members voted 21 yes, with one abstaining, to endorse the protein-based Novavax COVID-19 vaccine authorization. The VRBPAC digital meeting reviewed various authorization presentations.

Nuvaxovid™ XBB.1.5 Dispersion for Injection NVX-CoV2601 COVID-19 Vaccine Authorizations

On Mar. 11, 2024, Canada’s National Advisory Committee on Immunization announced it published updated guidance on the use of Nuvaxovid™ XBB.1.5, a recombinant protein subunit COVID-19 vaccine. The recommendations state that Nuvaxovid XBB.1.5 can be used in unvaccinated or previously vaccinated individuals aged 12 years and older.

On Feb. 7, 2024, the U.K.'s Joint Committee on Vaccination and Immunisation advised that Nuvaxovid may be used as a booster dose for persons aged 12 years and above when alternative vaccines are not considered clinically suitable. In Jan. 2024, Novavax's updated protein-based non-mRNA COVID-19 vaccine became available in the United Kingdom and Taiwan. As of Dec. 19, 2023, Novavax's updated vaccine is available in FranceItalyPolandSweden, and Singapore and is the only COVID-19 vaccine option available in PolandHealth Canada granted expanded authorization on Dec. 5, 2023. On Oct. 31, 2023, the European Commission (EC) approved  Nuvaxovid™ XBB.1.5 dispersion for injection of COVID-19 Vaccine (recombinant, adjuvanted) (NVX-CoV2601) for active immunization to prevent COVID-19 caused by the SARS-CoV-2 coronavirus in individuals aged 12 and older. The EC decision follows a positive opinion for approval from the CHMP of the European Medicines Agency (EMA).

On Jul. 6, 2023, Nuvaxovid received Full Marketing Authorization in the EU for preventing COVID-19 as a primary series in individuals aged 12 and older and booster in adults. On Jun. 16, 2022, the EMA published clinical data EMEA/H/C/005808/0000. The EMA's human medicines committee (CHMP)  recommended granting an extension of indication for the COVID-19 vaccine Nuvaxovid developed by Novavax CZ, a.s., to include adolescents aged 12 to 17 years. Nuvaxovid was authorized by the European Medicines Agency and European Commission for adults on Dec. 20, 2021 - E.U. study number: EudraCT number, 2020-004123-16.

CovoVax™ Authorizations

Novavax, Inc. and Serum Institute of India Pvt. Ltd. (SII) confirmed the CovoVax™ vaccine was authorized in Indonesia on Dec. 1, 2021. India's Drugs Controller General of India (DCGI) issued its authorization on Dec. 28, 2021. And the DCGI authorized the Novavax co-brand vaccine for adolescents aged ≥12 to <18 years in India. On May 2, 2022, the Standing Technical Sub-Committee of the NTAGI authorized Covovax for those aged 12+ years. On Jun. 28, 2022, ANI reported that the Drugs Controller General of India approved Covovax for restricted use for children aged 7-11. On Sept. 13, 2022, the companies confirmed that CovoVax was authorized in South Africa

Novavax COVID-19 Vaccines Availability 2024

In the U.S., the Novavax COVID‑19 Vaccine, Adjuvanted (2023-2024 Formula), is available at certain pharmacies, including Costco, CVS Pharmacy, Giant, Publix, Rite Aid, and Stop & Shop.

Novavax vaccines have been delivered in about 40 global markets. Global information about the Novavax COVID-19 Vaccine is found on this weblink. The Company has announced regulatory filings for its vaccine in the U.K., Austria,   Australia,   CanadaCyprus, EstoniaEuropean Commission,   IndonesiaThe Philippines, Croatia, New ZealandSingaporeSouth Korea, UAEJapan, Finland, South AfricaFrance, Germany, IsraelIndia, IrelandGermanySwitzerland, the NetherlandsTaiwan, ThailandSwitzerland, Portugal, and Singapore.

Novavax COVID-19 Vaccine SARS-CoV-2 Variants

On February 2, 2024, a Research Article disclosed immunity induced by Prototype or BA.5 S protein nanoparticle vaccine boosting can protect against the Omicron BA.5 variant in the Syrian hamster model. Previous data demonstrated that Novavax's vaccine-induced neutralizing antibody responses to subvariants BA.2.86, EG.5.1, FL.1.5.1, and XBB.1.16.6 as well as CD4+ polyfunctional cellular (T-cell) responses against EG.5.1 and XBB.1.16.6. These data indicate Novavax's vaccine can stimulate both arms of the immune system and may induce a broad response against currently circulating variants. On Aug. 22, 2023, Novavax announced its 2023-2024 season CCOVID-19 vaccine candidate-induced neutralizing responses to emerging subvariants EG.5.1 and XBB.1.16.6 in addition to XBB.1.5, XBB.1.16 and XBB.2.3. The JAMA Network reported on Apr. 26, 2023, high levels of humoral responses at day 35 were observed in adolescents (as determined by both anti–S-binding IgG antibodies and functional microneutralization and hACE2 receptor–binding inhibition assays) against prototype virus as well as against more recent Alpha, Beta, Delta, Gamma, Mu, and Omicron variants, including Omicron subvariants BA.1, BA.2, and BA.5, which were 2 to 4 times higher than those observed in PREVENT-19 adult participants. The journal Vaccine published study results on Jun. 2, 2023, that found correlates of protection implies a fourth (5 µg SARS-CoV-2 recombinant spike protein + 50 µg Matrix-M™ adjuvant) post-boost efficacy of ≥ 82% for Omicron variants, did not increase local/systemic reactogenicity, in those aged 18–84 years. No new safety concerns were identified. On Nov. 22, 2023, the Journal of Infectious Disease published a study that concluded, 'Evidence suggests that NVX-CoV,2373 when utilized as a heterologous booster, demonstrates less reactogenicity compared with mRNA vaccines.' On Feb. 19, 2024, a study concluded NVX-CoV2373 has high initial efficacy against pre-Delta and Delta strains of the SARS-CoV-2 coronavirus with little evidence of waning for pre-Delta strains through 90 days and moderate waning against Delta strains over 180 days.

NVX-CoV2373 Side Effects

The CDC published a Morbidity and Mortality Weekly Report on Aug. 4, 2023 - During Jul. 13, 2022–Mar. 13, 2023, a total of 69,227 Novavax doses were administered to persons aged ≥12 years in the U.S., and 230 reports of adverse events after the Vaccine Adverse Event Reporting System received 230 reports of adverse events after vaccinationVID-19 Vaccine, Adjuvanted to individuals with a known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Novavax COVID-19 Vaccine, Adjuvanted. Adverse reactions reported in clinical trials following administration of the Novavax COVID-19 Vaccine Adjuvanted include injection site pain/tenderness, fatigue/malaise, muscle pain, headache, joint pain, nausea/vomiting, injection site redness, injection site swelling, fever, chills, injection site pruritus, hypersensitivity reactions, lymphadenopathy-related reactions. Myocarditis, pericarditis, anaphylaxis, paresthesia, and hypoesthesia have been reported following the Novavax COVID-19 Vaccine, Adjuvanted outside clinical trials. Do not administer the Novavax COVID-19 Vaccine Adjuvanted to individuals with a known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Novavax COVID-19 Vaccine Adjuvanted.

Filip Dubovsky, M.D., MPH, with Novavax, Inc., presented heart health (Post-Authorization Myocarditis / Pericarditis) information - 1,072,074 doses administered worldwide as of Jun. 30, 2022; a Broad search safety database yielded 68 potential reports; Reports often had limited information; Brighton Collaborative Case definition used to evaluate reports: 1 met the definitive case definition of myocarditis, 6 met the probable case definition of myocarditis, 10 met the likely case definition of pericarditis.

The EMA updated the label for Novavax's COVID-19 vaccine (NVX-CoV2373) to include the risk of severe allergic reactions on Jul. 14, 2022. The EMA reported that Nuvaxovid had a total of 964 cases of suspected side effects spontaneously reported from EU/EEA countries; none of these reported a fatal as of May 15, 2022. The WHO says Nuvaxovid is contraindicated in persons with hypersensitivity to the active substance or excipients. Appropriate medical treatment and supervision should be available in an anaphylactic reaction.

To the extent feasible, report adverse events to Novavax, Inc. using the following contact information or by providing a copy of the VAERS form to Novavax, Inc. Website: www.NovavaxMedInfo.com, Fax Number: 1-888-988-8809, Telephone Number: 1-844-NOVAVAX (1-844-668-2829). Also, read more about the side effects on the FDA's Fact Sheet for Recipients and Caregivers.

Novavax COVID-19 Vaccine Pregnancy and Breastfeeding

Available data on the Novavax COVID-19 Vaccine, Adjuvanted administered to pregnant women, are insufficient to inform vaccine-associated risks in pregnancy. The Company says if you are pregnant or breastfeeding, discuss the options with your healthcare provider. A pregnancy exposure registry monitors pregnancy outcomes in women exposed to the Novavax COVID-19 Vaccine, Adjuvanted during pregnancy. Women vaccinated with the Novavax COVID-19 Vaccine, Adjuvanted during pregnancy are encouraged to enroll in the registry by visiting https://c-viper.pregistry.com. 

Novavax COVID-19 Vaccine Immunocompromise

For immunocompromised individuals, an additional dose of Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula), may be administered at least two months following the last dose of a COVID-19 vaccine (2023-2024 Formula). Additional doses of Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) may be administered at the healthcare provider's discretion, considering the individual's clinical circumstances. The timing of the additional doses may be based on the individual's clinical circumstances.

Novavax COVID-19 Vaccine Vs. BNT162b2 Comparison

The Journal of Infection published results from the phase II, single-blind, multi-center, randomized-controlled trial Com-COV3 study on Jun. 16, 2023, that highlighted heterologous and fractional dose COVID-19 vaccine schedules in adolescents are safe, well-tolerated, and immunogenic; NVXCoV2373 following 30µg BNT162b2 as a first dose elicited the highest humoral and peak cellular immune responses; Neutralising antibodies against Omicron BA.1 and BA.2 were higher after NVXCoV2373 than a two-dose 30µg BNT162b2 schedule; The lowest rate of SARS-CoV-2 coronavirus breakthrough infections occurred in participants who received NVXCoV2373 as their second dose; Enhanced protection may be provided by heterologous vaccine schedules using NVXCoV2373 than the homologous BNT162b2 schedule.

Novavax COVID-19 Vaccine Coadministration

The U.S. CDC publishes Interim Clinical Considerations for Use of COVID-19 Vaccines. In Nov. 2023, 2023–24 Formula Vaccine Presentation. In 2022, Coadministration of influenza and COVID-19 vaccines: A systematic review of clinical studies was published. Novavax's COVID-Influenza Combination Vaccine (CIC), the COVID-NanoFlu™, is a combination vaccine candidate that integrates NanoFlu™ and NVX-CoV2373. 

Novavax COVID-19 Vaccine Price

As of 2024, the Novavax COVID-19 vaccine is offered to the Vaccine for Children uninsured through immunization programs at $58 per dose, while the cost to those with private insurance is $130 per dose.

NVX-CoV2373 Vaccine Cell Lines

"No human fetal-derived cell lines or tissue, including HEK293 cells, are used to develop, manufacture, or produce NVX-CoV2373," a Novavax spokesperson told Religion News Service on Feb. 8, 2022.

Novavax and Pharmacists

Silvia Taylor, Executive Vice President, Chief Corporate Affairs, and Advocacy Officer of Novavax, Inc., stated on January 12, 2024, that Novavax is proud to celebrate the invaluable contributions of pharmacists. Perhaps pharmacists have never been more essential to our health and well-being than they have been over the past three years, working tirelessly to ensure access to vaccines in communities everywhere. We recognize the vital role pharmacists and their teams play in communities worldwide in promoting public health and wellness, and we want to Thank You for your commitment. 

Novavax Vaccine News

February 28, 2024 - John C. Jacobs, President, and Chief Executive Officer, Novavax, commented, "Moving into the next chapter of our business journey as a more lean and agile organization, we are laser-focused on improving our commercial performance in 2024 and 2025 and diversifying our revenue opportunity with our potential combination vaccine launch which we expect in the fall of 2026."

January 31, 2024 - John C. Jacobs, President and Chief Executive Officer, Novavax, commented in a press release, "We are redefining how we do business and are purposefully focusing only on the critical activities needed to achieve our objectives and strengthen the financial performance of the Company."

January 3, 2024 - Florida State Surgeon General Dr. Joseph A. Ladapo published an open letter that stated... Providers concerned about patient health risks associated with COVID-19 should prioritize patient access to non-mRNA COVID-19 vaccines.

December 19, 2023 - The French Ministry of Health had the new (Novavax) vaccine available primarily in retail pharmacies by 2023.

November 28, 2023 - "The WHO Emergency Use Listing of our updated protein-based non-mRNA COVID-19 vaccine enables expedited regulatory approvals for its 194 member states and UN procurement agencies, such as UNICEF, thereby supporting equitable access to our vaccine around the world," said John C. Jacobs, President and Chief Executive Officer, Novavax.

November 9, 2023 - The Company announced that its total revenue for the third quarter of 2023 was $187 million, compared to $735 million in the same period in 2022.

October 3, 2023 - Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research, commented in a press release, "Today's (Novavax) authorization provides an additional COVID-19 vaccine option that meets the FDA's standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization.

June 15, 2023: Novavax confirmed it is Prepared to Deliver a Protein-based Monovalent XBB COVID Vaccine Consistent with the FDA VRBPAC Recommendation for Fall 2023.

May 25, 2023 - "The positive CHMP Opinion for full Marketing Authorization for our COVID vaccine brings us one step closer to full authorization and will provide an approval pathway for an updated vaccine in time for the fall," said John C. Jacobs, President and Chief Executive Officer of Novavax.

April 8, 2020 - Novavax, Inc announced it had identified a coronavirus vaccine candidate, NVX-CoV2373. The clinical development plan combines Phase 1/Phatwoe two approaches to allow rapid advancement.

Novavax Clinical Trials

The NVX-CoV2373 vaccine continues to be evaluated in multiple clinical trials.

On October 3, 2022, a peer-reviewed journal of Clinical Investigation published a study that found the protein-based vaccine NVX-CoV2373 induces robust T-cell immunity capable of recognizing SARS-CoV-2 antigens and supporting humoral immune responses. On Oct. 25, 2022, a non-peer-reviewed study reported that after the third dose of NVX-CoV2373, titers against Omicron BA.1 (GMT: 1,197) and BA.4/BA.5 (GMT: 582), with responses similar in magnitude to those triggered by three doses of an mRNA vaccine. On Nov. 8, 2022, the Company reported the Novavax BA.1 vaccine candidate (NVX-CoV2515) met its primary strain-change endpoint, allowing for the development of variant vaccines, if necessary; Novavax's prototype vaccine induced a broad immune response against the original Wuhan, BA.1, and BA.5 strains; and the phase 3 trial showed no benefit for a bivalent vaccine utilizing Novavax' recombinant protein/adjuvant technology.