Novavax COVID-19 Vaccine Adjuvanted (Nuvaxovid™XBB.1.5)
Novavax COVID-19 Vaccine (Nuvaxovid™XBB.1.5) (CovoVax™) (NVX-CoV2373) (NVX-CoV2601) was the first protein-based vaccine engineered from the genetic sequence of the SARS-CoV-2 beta coronavirus. The COVID-19 (SARS-CoV-2 rS [Recombinant, adjuvanted)) the 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 adjuvant 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 Inc.'s vaccines are genetically engineered using three-dimensional nanostructures of recombinant proteins critical to disease pathogenesis. For example, the COVID-19 vaccine creates an engineered baculovirus containing a modified coronavirus spike protein gene. The baculovirus then 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 of about 50 nanometers, each displaying up to 14 spike proteins.
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.
On Dec. 17, 2021, the World Health Organization (WHO) granted Emergency Use Listing 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. In addition, the global information about the Novavax COVID-19 Vaccine varies by country and is searchable on this weblink. And at NovavaxMedInfo.com. On Aug. 4, 2023, the CDC published Notes from the Field: Safety Monitoring of Novavax COVID-19 Vaccine Among Persons Aged ≥12 Years — United States, July 13, 2022–March 13, 2023, although post-authorization safety data after receipt of a primary Novavax dose are limited, available data are consistent with those from preauthorization clinical trials. No new safety concerns were identified.
Novavax's protein-based vaccine is the only non-mRNA COVID-19 vaccine available in the U.S. Novavax COVID-19 vaccine brands include Nuvaxovid, CovoVax, 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. 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. On Nov. 9, 2023, Novavax announced that its total revenue for the third quarter of 2023 was $187 million, compared to $735 million in the same period in 2022.
NVX-CoV2373 Vaccine U.S. FDA Authorizations
On Sept 11, 2023, doses of the updated protein-based Novavax COVID-19 Vaccine, Adjuvanted (Formula 2023-2024), arrived in the U.S., pending FDA and CDC action. On October 3, 2023, the FDA amended the 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. 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.
On Aug. 8, 2023, Novavax announced it had initiated FDA submission for approval of our updated XBB COVID-19 vaccine for the 2023 fall vaccination season. 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 U.S. FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting and presented updated data, which resulted in a unanimous vote recommending updating the current COVID vaccine composition to a monovalent XBB-lineage.
On Jun. 6, 2023, the U.S. Food and Drug Administration (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. See the Summary of Product Characteristics with Package Leaflet, Prescribing Information, and Important Safety Information, adverse event reporting instructions, or request additional information; please visit www.NovavaxCovidVaccine.com.
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 Providers, RECIPIENTS, 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 COVID-19 vaccine authorized in the U.S. for adults.
Novavax, Inc. participated in a VRBPAC meeting, which resulted in a 19-2 vote to recommend the inclusion of a SARS-CoV-2 Omicron component for COVID-19 booster vaccines in the U.S. beginning in the Fall of 2022. 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 COVID-19 Vaccine (NVX-CoV2601) Authorizations
Health Canada granted expanded authorization for Nuvaxovid™ XBB.1.5 Vaccine (Recombinant protein, Adjuvanted) (NVX-CoV2601) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals aged 12 and older on Dec. 5, 2023. On Nov. 28, 2023, the WHO granted Emergency Use Listing (EUL) for Nuvaxovid™ XBB.1.5 COVID-19 Vaccine (NVX-CoV2601) for active immunization to prevent COVID-19 in individuals aged 12 and older. The EUL enables the WHO's 194 member states to expedite regulatory approvals to import and administer the Novavax vaccine. On Oct. 31, 2023, the 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. This decision follows a positive opinion for approval from the CHMP of the EMA. As of Nov. 9, 2023, the Company expects U.S. 2023-2024 season COVID-19 vaccine demand of between 30 and 50 million doses. Poland's Ministry of Health told PAP that the vaccine would become available on Dec. 6, 2023.
On Oct. 18, 2023, the Medicines and Healthcare products Regulatory Agency in the United Kingdom granted full marketing authorization for its prototype COVID-19 vaccine, Nuvaxovid, as did Singapore. 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. Nuvaxovid was the first protein-based COVID-19 vaccine granted authorization from the U.K.'s Medicines and Healthcare Products Regulatory Agency (MHRA) and is offered per the Joint Committee on Vaccination and Immunisation advice. The MHRA granted Conditional Marketing Authorization (CMA) for Nuvaxovid's use as a two-dose primary series vaccine for active immunization to prevent COVID-19. On Nov. 9, 2022, Novavax announced the MHRA expanded the CMA for Nuvaxovid as a homologous and heterologous booster dose after the primary series of Nuvaxovid (six months) or of an mRNA or adenoviral vector vaccine for active immunization to prevent COVID-19 in adults aged 18 and older. In addition, on Nov. 29, 2022, the WHO issued an updated EUL for Nuvaxovid™ as a primary series of two doses for people aged 12 through 17 and as a booster in adults. As a result, the Nuvaxovid label expanded to an adult booster and primary adolescent series.
Novavax announced in Jan. 2023 that Nuvaxovid was recommended for expanded authorization in Canada and other countries as a heterologous and homologous booster dose in adults aged 18 and older.
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. On Jul. 5, 2022, the EC approved the expanded conditional marketing authorization. Novavax announced on May 26, 2023, that Nuvaxovid had been recommended for complete Marketing Authorization (MA) for use as a primary series in individuals aged 12 and older and as a booster in individuals aged 18 and older for the prevention of COVID-19 in the European Union (EU) following a positive opinion issued by the Committee for Medicinal Products for Human Use of the EMA.
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 supplied the Matrix-M™ adjuvant to enable Takeda to manufacture the vaccine at its Hikari facility in Japan.
Nuvaxovid was authorized by the European Medicines Agency (EMA) and European Commission (EC) for adults on Dec. 20, 2021 - E.U. study number: EudraCT number, 2020-004123-16.
CovoVax™ Authorizations 2023
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 2023
As of December 2023, Novacax vaccines have been delivered globally in about 40 markets. The Company has announced regulatory filings for its vaccine in the U.K., Austria, Australia, Canada, Cyprus, Estonia, European Commission, Indonesia, The Philippines, Croatia, New Zealand, Singapore, South Korea, UAE, Japan, Finland, South Africa, France, Germany, Israel, India, Ireland, Germany, Switzerland, the Netherlands, Taiwan, Thailand, Switzerland, Portugal, and Singapore. Global information about the Novavax COVID-19 Vaccine is found on this weblink.
Novavax COVID-19 Vaccine SARS-CoV-2 Variants
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.
NVX-CoV2373 Side Effects
The CDC published a Morbidity and Mortality Weekly Report on Aug. 4, 2023 - During July 13, 2022–March 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.
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
The Company says if you or your child 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 Vs. BNT162b2 Comparison
The Journal of Infection published results from the phase II, single-blind, multi-center, randomized-controlled trial Com-COV3 study on June 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 Influenza Vaccines
Novavax's COVID-Influenza Combination Vaccine (CIC), formerly known as the COVID-NanoFlu™ combination vaccine candidate, combines NanoFlu™ and NVX-CoV2373.
Novavax COVID-19 Vaccine Coadministration
The U.S. CDC publishes Interim Clinical Considerations for Use of COVID-19 Vaccines. And in November 2023, 2023–24 Formula Vaccine Presentation. IN 2022, Coadministration of influenza and COVID-19 vaccines: A systematic review of clinical studies was published.
Novavax COVID-19 Vaccine Price
As of 2023, 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 Vaccine News 2023
December 5, 2023 - John C. Jacobs, President and Chief Executive Officer, Novavax, stated, "We look forward to helping to protect Canadians in time for the upcoming holiday season and, pending vaccine batch release, have doses in the market for access across the country."
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. John C. Jacobs, President and Chief Executive Officer of Novavax, commented in a press release, "With the delayed start of respiratory vaccinations, we believe we have yet to reach the midpoint of the vaccination season and, with early and encouraging signs of demand for our vaccine, we believe there remains an opportunity to deliver doses and grow our share. This reinforces our belief that the long-term COVID-19 market represents a sustainable opportunity for Novavax in the coming years."
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 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.
July 7, 2023 - Novavax Inc. announced that it had reached an agreement with Canada, under which the country would pay $349.6 million to settle forfeiting specific doses of the Company's COVID-19 vaccine.
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, Novavax.
May 9, 2023 - The Company announced that due to an emerging seasonal demand pattern for COVID-19 vaccines, the total revenue for the first quarter of 2023 was $81 million compared to $704 million in the same period in 2022.
April 8, 2020 - Novavax, Inc announced it had identified a coronavirus vaccine candidate, NVX-CoV2373. The clinical development plan combines Phase 1/Phase 2 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.
