Novavax COVID-19 Vaccine Clinical Trials, Dosage, Indication, Side Effects
Novavax Inc. COVID-19 vaccine (Nuvaxovid™XBB.1.5 dispersion for injection) (NVX-CoV2373) (NVX-CoV2601) (NVX-CoV2705) is a protein-based vaccine engineered from the genetic sequence of the SARS-CoV-2 beta coronavirus. 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.
As of June 28, 2024, Novavax's vaccine is the only non-mRNA COVID-19 vaccine available in the U.S. On June 27, 2024, the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted unanimously in favor of a universal recommendation for the use of 2024-2025 COVID-19 vaccines authorized under Emergency Use Authorization (EUA) or approved by Biologics License Application in individuals aged six months and older. Novavax intends to provide doses of our 2024-2025 JN.1 COVID-19 vaccine at the start of the 2024-2025 vaccination season and upon EUA by the U.S. Food and Drug Administration (FDA). On June 24, 2024, Novavax confirmed the JN.1 COVID-19 vaccine is active against current circulating strains, including KP.2 and KP.3.
The U.S. FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) June 5, 2024 meeting Presentation was led by Robert Walker MD, Novavax Data in Support of 2024-2025 Vaccine. The data support the JN.1-lineage vaccine, aligned with World Health Organization (WHO) and European Medicines Agency recommendations.
On Nov. 28, 2023, the WHO authorized Nuvaxovid, enabling its 194 member states to expedite regulatory approvals to import and administer the vaccine. As of June 2024, Novavax's COVID-19 vaccine was one of 13 vaccines granted EUL by the WHO.
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. 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.
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 May 10, 2024, Novavax announced total revenue for the first quarter of 2024 was $94 million, compared to $81 million in the same period in 2023. Furthermore, Advance Purchase Agreement deliveries for 2024 through 2026 total over $1 billion, primarily deliveries to Australia, New Zealand, Canada, Israel, and Europe. SK bioscience announced on Aug. 9, 2023, it made an equity investment in Novavax, as did Sanofi in May 2024. Novavax announced it will participate in the 2024 Jefferies Global Healthcare Conference on June 6, 2024.
Novavax COVID-19 Vaccine History
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.
Novavax JN.1 Vaccine
Novavax's updated JN.1 COVID-19 vaccine targets the "parent strain" of KP.2 and KP.3. NVX-CoV2705 is an updated version of Novavax's prototype COVID-19 vaccine (NVX-CoV2373) formulated to target the JN.1 variant. The JN.1 vaccine has demonstrated broad cross-neutralizing antibodies against multiple variant strains, including KP.2 and KP.3, indicating the potential to protect against forward drift variants. As discussed at the June 2024 FDA Vaccines and Related Biological Products Advisory Committee meeting, targeting JN.1, the parent strain of the most common currently circulating variants, has a public health benefit. Nonclinical data have demonstrated that Novavax's JN.1 vaccine induces broad neutralization responses to JN.1 lineage viruses, including those containing the F456L and R346T mutations, and to "FLiRT" and "FLuQE" variants. Novavax's vaccine also produces conserved polyfunctional, Th1-biased CD4+ T cell responses to a range of JN.1 lineage variants.
Novavax and Sanofi Agreement
Novavax and Sanofi announced on May 10, 2024, that they have entered into a co-exclusive licensing agreement that includes a co-exclusive license to co-commercialize Novavax's current stand-alone adjuvanted COVID-19 vaccine worldwide (except in countries with existing Advance Purchase Agreements and in India, Japan and South Korea where Novavax has existing partnership agreements); a sole license to Novavax's adjuvanted COVID-19 vaccine for use in combination with Sanofi's flu vaccines, while Novavax retains the right to and is developing its own COVID-19-Influenza Combination vaccine candidate; a non-exclusive license to use Novavax's adjuvanted COVID-19 vaccine for use in combination with non-flu vaccines; and a non-exclusive license to use the Matrix-M adjuvant in vaccine products.
In addition, Sanofi will take a minority (<5%) $70 million equity investment in Novavax, issue a $500 million upfront payment, Up to $700 million in COVID-19, and combination product near-term milestones, plus ongoing tiered royalties on product sales; Up to $200 million in milestones plus royalties for each new vaccine developed utilizing Novavax's Matrix-MTM adjuvant.
NVX-CoV2373 Vaccine U.S. FDA Authorizations
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 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, 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 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 France, Italy, Poland, Sweden, and Singapore and is the only COVID-19 vaccine option available in Poland. Health 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 European Medicines Agency (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 EMA and European Commission for adults on Dec. 20, 2021 - E.U. study number: EudraCT number, 2020-004123-16.
As of April 2024, the Novavax XBB.1.5 vaccine is under evaluation in Australia (TGA). The Novavax XBB.1.5 vaccine will be introduced into the program as soon as possible following approval by the TGA.
Novavax COVID-19 Vaccine Production
Nuvaxovid has manufacturing sites in the Czech Republic, Australia, Canada, Japan, and South Korea's S.K. bioscience. 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.
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 India DCGI 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 Vaccine 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. Pharmacies in the UK are offering Novavax to patients in 2024. 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, 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.
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.
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 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
June 24, 2024—John C. Jacobs, President and CEO of Novavax, stated, "Our updated COVID-19 vaccine is active against current circulating strains, including KP.2 and KP.3."
June 14, 2024 - "Novavax is committed to having a protein-based COVID-19 option available at the start of the vaccination season, which is critical because research suggests that providing vaccine choice, along with healthcare provider recommendations, may help improve vaccination rates," said John C. Jacobs, President and Chief Executive Officer, Novavax.
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 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 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). On Apr. 6, 2024, MDPI's journal Vaccines published results from a Real-World Retrospective Study in Germany funded by Novavax Europe. These researchers stated the Tolerability and COVID-19 protection support using NVX-CoV2373 as a primary/booster vaccination for all authorized populations, including high-risk. On April 24, 2024, the JAMA Network published an Original Investigation that did not find a statistical signal for seizure when 2019 or 2022 background rates were analyzed.
On Oct. 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.
