Delving into the Latest Updates on SARS-CoV-2 Spike Protein Vaccine (Recombinant) (Novavax) with Synapse

Overview

Basic Info

Drug Type

Prophylactic vaccine, Genetically engineered subunit vaccine

Synonyms

Coronavirus vaccine - Novavax, COVID-19 Vaccine (recombinant, adjuvanted), COVID-19 vaccine - Novavax

+ [14]

Target

SARS-CoV-2 S protein

Action

modulators, stimulants

Mechanism

SARS-CoV-2 S protein modulators(SARS-CoV-2 S protein modulators), Immunostimulants

Therapeutic Areas

Infectious DiseasesRespiratory Diseases

Active Indication

COVID-19

Inactive Indication-

Originator Organization

Novavax, Inc.

Active Organization

Takeda Pharmaceutical Co., Ltd.

Novavax, Inc.

Sanofi Winthrop Industrie SA

+ [4]

Inactive Organization-

License Organization

Novavax, Inc.

Siegfried Holding AG

Takeda Pharmaceutical Co., Ltd.

+ [3]

Drug Highest PhaseApproved

First Approval Date

European Union (20 Dec 2021),

COVID-19

RegulationFast Track (United States), Emergency Use Authorization (United States), Emergency Use Authorization (India), Emergency Use Authorization (Thailand), Conditional marketing approval (European Union), Emergency Use Authorization (Taiwan Province)

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Structure/Sequence

Sequence Code 708729224

This is a medical study where participants will be randomly assigned to receive either a new combination vaccine that protects against both COVID-19 and the flu, or a standard flu vaccine. The researchers conducting the study won't know which vaccine each participant receives, ensuring their observations are unbiased. This study compares the new combination vaccine to an already available flu vaccine to see how well it works. It's a large-scale, final-stage study designed to thoroughly check how well the vaccines trigger an immune response (immunogenicity) and how safe they are.

Start Date09 Dec 2024

Sponsor / Collaborator

Novavax, Inc.

100 Clinical Results associated with SARS-CoV-2 Spike Protein Vaccine (Recombinant) (Novavax)

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100 Translational Medicine associated with SARS-CoV-2 Spike Protein Vaccine (Recombinant) (Novavax)

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100 Patents (Medical) associated with SARS-CoV-2 Spike Protein Vaccine (Recombinant) (Novavax)

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189

Literatures (Medical) associated with SARS-CoV-2 Spike Protein Vaccine (Recombinant) (Novavax)

01 Aug 2026·VACCINE

Comparison of immunogenicity of mRNA and protein subunit SARS-CoV-2 vaccines in dialysis patients: a multicenter study

Article

Author: Takeda, Kazuaki ; Yoshida, Masakata ; Funakoshi, Satoshi ; Morio, Ryosuke ; Iwanaga, Naoki ; Hirano, Katsuji ; Yanagihara, Katsunori ; Takazono, Takahiro ; Hirayama, Tatsuro ; Hosogaya, Naoki ; Ashizawa, Nobuyuki ; Morimoto, Shimpei ; Mukae, Hiroshi ; Ide, Shotaro

Patients on maintenance hemodialysis (HD) have impaired immune function and are at high risk of severe COVID-19; however, comparative data on immunogenicity and vaccine choice behavior between mRNA and protein subunit SARS-CoV-2 vaccines remain limited. In this observational study, 227 participants (202 patients on HD and 25 non-dialysis individuals) received either an mRNA vaccine (BNT162b2) or a protein subunit vaccine (NVX-CoV2373) in 2024 vaccination season. Anti-SARS-CoV-2 spike antibody levels were assessed at weeks 0, 4, and 24, with week 4 defined as the primary outcome and week 24 as a secondary time point for longer-term persistence; the association between previous adverse events and vaccine choice was evaluated. At week 4, BNT162b2 induced significantly higher antibody levels than NVX-CoV2373 in patients on HD. BNT162b2 also induced significantly higher antibody levels than NVX-CoV2373 in non-dialysis individuals. Antibody levels declined by week 24 in both vaccine groups, although differences in antibody levels were observed up to week 24. Previous adverse events did not deter selection of BNT162b2 (OR 8.08, 95% CI 0.98-66.5), although this association may reflect participant perceptions or other unmeasured factors. Non-dialysis subgroup with limited number of patients also showed higher antibody levels in the BNT162b2 group. These findings suggest that BNT162b2 is associated with higher anti-spike antibody levels at predefined post-vaccination time points in patients on HD. However, these findings should be interpreted cautiously because clinical outcomes and formal antibody decay modeling were not evaluated.

01 May 2026·VACCINE

Effect of time-of-day vaccination on the antibody response to mRNA and protein COVID-19 vaccine in adults

Article

Author: Do, Lien Anh Ha ; Higgins, Rachel Ann ; Neal, Eleanor ; Mazarakis, Nadia ; Bright, Kathryn ; Sun, Cong ; Mulholland, Kim ; Toh, Zheng Quan ; Orsini, Francesca ; Luu, Skyy ; Nguyen, Cattram ; Quah, Leanne ; Hart, John ; Licciardi, Paul Vincent ; von Mollendorf, Claire ; Ng, Yan Yung

Time-of-day vaccination has been suggested as a feasible method to boost COVID-19 vaccine immunogenicity particularly in high-risk groups. However, several studies report inconsistent findings. We explored if time-of-day vaccination influences antibody responses to a fourth dose of mRNA (Moderna bivalent vaccine; mRNA-1273.214/mRNA-1273.222) or protein (Novavax; NVX-CoV-2373) COVID-19 vaccine as part of a randomised controlled trial (RCT) in Melbourne, Australia. Furthermore, we assessed if time-of-day vaccination effects differed by vaccine type or sex. At day 28 post-vaccination, antibody responses to all SARS-CoV-2 variants tested were higher for morning compared to afternoon vaccination in the Moderna group. Males in the Moderna group responded with higher antibodies to all SARS-CoV-2 variants tested after morning vaccination while responses in females were unaffected by time-of-day vaccination. Time-of-day vaccination had no effect on the response to Novavax, regardless of sex. Larger randomised trials are needed to confirm these findings to optimise vaccine timing strategies.

01 Apr 2026·VACCINE

Immune response and IgG subclass dynamics following repeated SARS-CoV-2 mRNA vaccination in Japanese healthcare workers

Article

Author: Kato, Hideaki ; Miyakawa, Kei ; Sano, Kaori ; Ryo, Akihide ; Hasegawa, Hideki

In Japan, many healthcare workers received up to seven doses of SARS-CoV-2 mRNA vaccines by April 2024. While repeated vaccination aims to strengthen immunity, concerns about immune imprinting and IgG subclass switching, particularly to IgG4, have arisen. This study examined 19 healthcare workers who completed seven doses. Serum and PBMCs collected at five or three time points respectively to measure were analyzed for IgG subclasses, neutralizing antibodies and cellular responses. IgG1-3 levels declined after the second dose but recovered after the third, whereas IgG4 increased post-second dose and remained stable. Neutralizing antibodies against Omicron XBB.1.5 were undetectable after two doses but appeared after the third, despite all being Wuhan strain vaccines, and rose further after the sixth and seventh doses with updated formulations. Cellular immunity remained stable throughout. These findings indicate repeated mRNA vaccination enhances humoral immunity without progressive IgG4 elevation or additional cellular response boosts.

631

News (Medical) associated with SARS-CoV-2 Spike Protein Vaccine (Recombinant) (Novavax)

09 Sep 2026

·www.fiercepharma.com

Sanofi hits the pickleball court in education push for COVID vax Nuvaxovid

Sanofi is fending off COVID and promoting its vaccine Nuvaxovid with the help of another fast-growing viral trend sweeping the nation: pickleball. A new partnership with USA Pickleball lays the groundwork for a joint “Serve Up Protection” campaign, targeting older adults through an education push that will take place on and off the court, the French Big Pharma said in a Sept. 10 release. Pickleball has drawn in a large following as the sport has swelled in popularity in recent years, with many older adults joining the activity to stay active. However, nearly 70% of adults aged 65 and up remain unvaccinated against COVID-19, putting them at higher risk of serious illness. According to Sanofi, many within this age group remain unvaccinated due to concerns about side effects and uncertainty about evolving health guidance. “Concerns about potential vaccine side effects can be a barrier to vaccination for older adults, who don’t want disruption in their daily lives and hobbies,” Sanofi’s head of marketing and commercial strategy, U.S. vaccines Sriram Jambunathan explained. “By teaming up with USA Pickleball on ‘Serve Up Protection,’ we’re educating older adults that Nuvaxovid can help provide powerful protection against COVID-19 with manageable side effects.” “Serve Up Protection” looks to specifically reach the older adult demographic during this year’s incoming COVID season through multimedia education, fan experiences, “trusted pickleball voices,” and a presence at major events, such as USA Pickleball’s National Championships this November in San Diego, according to Sanofi. USA Pickleball is the U.S.’s official governing body for the sport. USA Pickleball, for its part, is “proud” to work with Sanofi to offer education and resources that can help people make informed decisions about their health, as the organization is “committed to creating meaningful partnerships that help our community enjoy the sport for years to come,” the group’s VP of partnerships Christian Portaro added. “By helping players better understand risk and prevention options, we're supporting their ability to stay active, connected and on the court,” Portaro said. Sanofi figures that having multiple vaccine options could help to address vaccine hesitancy, it noted. Protein-based Nuvaxovid is a more recent addition to the COVID vaccine landscape and presents an alternative to the mRNA-based shots made by Moderna and Pfizer. Originally developed by Novavax and handed over to Sanofi through a co-collaboration licensing agreement that went through last year, the vaccine earned full FDA approval last May in adults aged 65 years and older and people between the ages of 12 and 64 who have at least one underlying health condition. COVID vaccines have been subject to shifting vaccine guidance and heavy regulatory scrutiny under Robert F. Kennedy Jr.’s Department of Health and Human Services (HHS). Most recently, the HHS proposed a table that would list injuries “presumed to be caused by covered COVID-19 countermeasures.” In trials, Nuvaxovid proved high efficacy against COVID and the majority of side effects seen were “mild to moderate and would not prevent daily activities,” Sanofi pointed out in its release. The company is currently focused on expanding the vaccine’s availability to additional markets, including the U.K., Germany and Canada after launching in the U.S., Taiwan and Morocco last year.

VaccineLicense out/inDrug ApprovalmRNA

02 Sep 2026

·www.prnewswire.com

Novavax to Participate in September Investor Conferences

GAITHERSBURG, Md., Sept. 2, 2026 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX) today announced that company management will participate in the following upcoming investor conferences: 2026 Cantor Global Healthcare Conference, New York Fireside chat on Wednesday, September 9, 2026, at 9:45 a.m. EDT Citi's 2026 BioPharma Back to School Conference, New York Fireside chat on Thursday, September 10, 2026, at 10:00 a.m. EDT A live webcast of the fireside chats will be available on the "Events & Presentations" page of the Company's website at ir.novavax.com. A replay of each webcast will be available for 30 days following the presentation. About Novavax Novavax, Inc. (Nasdaq: NVAX) tackles some of the world's most pressing health challenges with its scientific expertise in vaccines and its proven technology platform, including its Matrix-M® adjuvant and protein-based nanoparticles. The Company's corporate growth strategy is designed to deliver value via three key strategic pillars: partnering its technology, capital-efficient research and development (R&D) innovation and a lean and efficient operating model. This includes maximizing impact through partnerships for its marketed products (Nuvaxovid™, R21/Matrix-M™), Matrix technology and R&D assets. Please visit novavax.com and LinkedIn for more information. Contacts: Investors Naina Zaman 844-668-2829 [email protected] Media Yvonne Sprow 844-264-8571 [email protected] SOURCE Novavax, Inc. 21% more press release views with Request a Demo

30 Aug 2026

·www.prnewswire.com

Novavax's Partnership Strategy Continues to Deliver with XFG-adapted Nuvaxovid™ Approvals in the U.S., EU and Japan for 2026-2027 Vaccination Season

COVID-19 remains a public health challenge, particularly among older adults and high-risk populations1 Novavax's partners are ready to bring its protein-based, non-mRNA vaccine with a favorable tolerability profile to global markets, providing an important option for healthcare providers and patients Aug. 28, 2026 -- Novavax, Inc.'s (Nasdaq: NVAX) partners have received approvals for the Nuvaxovid™ formulation to target the SARS-CoV-2 XFG variant for the 2026-2027 vaccination season in major markets including the U.S., European Union (EU) and Japan. These approvals position Novavax to continue earning royalties on net sales in these markets this season. "We believe our partners Sanofi and Takeda are well-positioned for this commercial season. Sanofi has an expanded U.S. marketing campaign and launches in additional international markets, and under Takeda's leadership, Nuvaxovid® has become the second-leading COVID-19 vaccine in one of the world's largest healthcare markets," said John C. Jacobs, President and Chief Executive Officer, Novavax. "With these approvals, Novavax is eligible for continued royalties on partner sales without carrying commercial infrastructure of our own, a testament to the value creation of our business model." COVID-19 continues to present a meaningful public health challenge, particularly among older adults and other high-risk populations. Novavax is committed to working with its partners to ensure a protein-based, non-mRNA vaccine option is available for the fall season. Results from Sanofi's Phase 4 COMPARE study – a large head-to-head evaluation of Nuvaxovid and a next-generation mRNA COVID-19 vaccine – demonstrated Nuvaxovid's favorable tolerability profile, an important consideration for healthcare providers and patients when making informed vaccine choices. Sanofi, Novavax's largest partner, leads Nuvaxovid commercial activities across most major markets and looks to be positioned for a robust 2026-2027 season, expanding the vaccine's commercial reach through broader activities in the U.S. and launches in Germany, Canada and other international markets from 2026 onward. Novavax is eligible to receive ongoing royalties from sales of the vaccine per their 2024 collaboration and license agreement (CLA). Takeda commercializes Nuvaxovid in Japan. In the 2025-2026 season, Nuvaxovid was the second-most used COVID-19 vaccine in Japan, with delivery volumes and the number of sites receiving the vaccine increasing significantly year over year. Under the CLA terms announced in May 2025, Novavax earns annual milestones tied to regulatory approvals and royalties on net sales each season. Nuvaxovid is formulated to target the XFG variant. It is a protein-based vaccine made by creating copies of the surface spike protein of the SARS-CoV-2 that causes COVID-19. With Novavax's unique recombinant nanoparticle technology, the non-infectious spike protein serves as the antigen that primes the immune system to recognize the virus, while Novavax's Matrix-M adjuvant enhances and broadens the immune response. The vaccine is packaged in pre-filled syringes and is stored at 2° to 8°C, enabling the use of existing vaccine supply and cold chain channels. Matrix-M is Novavax's proprietary adjuvant that can be added to a vaccine to stimulate a stronger immune response and is currently used in globally approved vaccines. It is clinically proven to induce potent, durable and broad immune responses with an acceptable safety and tolerability profile.2 The Company's recombinant, protein-based nanoparticles are combined with its Matrix-M adjuvant, constituting the basis of Novavax's expanding pipeline. Novavax, Inc. (Nasdaq: NVAX) tackles some of the world's most pressing health challenges with its scientific expertise in vaccines and its proven technology platform, including its Matrix-M adjuvant and protein-based nanoparticles. The Company's corporate growth strategy is designed to deliver value via three key strategic pillars: partnering its technology, targeted and capital-efficient R&D innovation and a lean and efficient operating model. This includes maximizing impact through partnerships for its marketed products (Nuvaxovid, R21/Matrix-M), Matrix technology and R&D assets. References CDC. (2025). People with Certain Medical Conditions and COVID-19 Risk Factors, Updated June 11, 2025. Available from: https://www.cdc.gov/covid/risk-factors/index.html. Accessed August 24, 2026. Stertman L. et al.; The Matrix-M™ adjuvant: A critical component of vaccines for the 21st century. Hum Vaccin Immunother. 2023 Dec 31;19(1):2189885. doi: 10.1080/21645515.2023.2189885. The content above comes from the network. if any infringement, please contact us to modify.

VaccineLicense out/inDrug ApprovalmRNA

100 Deals associated with SARS-CoV-2 Spike Protein Vaccine (Recombinant) (Novavax)

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB15810

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
COVID-19	European Union	Sanofi Winthrop Industrie SA	20 Dec 2021
COVID-19	Iceland	Sanofi Winthrop Industrie SA	20 Dec 2021
COVID-19	Liechtenstein	Sanofi Winthrop Industrie SA	20 Dec 2021
COVID-19	Norway	Sanofi Winthrop Industrie SA	20 Dec 2021

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05463068 (2019nCoV-307, CTgov)	Phase 3	COVID-19	911	NVX-Cov2373 (Lot 1)	vctbqtgdgf(onavcgexck) = dlvcogtmjf uxxjrdmtzk (ezlvnyrywq, apqkbkputs - ugjgdrzomq) View more	-	17 Apr 2026
				NVX-Cov2373 (Lot 2)	vctbqtgdgf(onavcgexck) = cbmpataxqz uxxjrdmtzk (ezlvnyrywq, szuamueymj - gvbrwqxdhr) View more
NCT05973006 (COVID-19, CTgov)	Phase 3	COVID-19	400	NVX-CoV2601 co-formulated Omicron XBB.1.5 SARS-CoV-2 rS vaccine (Group-A NVX-CoV2601)	ajgytayebk = roeoleptov utxiksmjgf (mebqzxujyj, lfqmnvdbty - fnaeadcrzw) View more	-	15 Jul 2025
				XBB.1.5 Bivalent Vaccine (Group-B Bivalent NVX CoV2373 + NVX CoV2601)	ajgytayebk = mrfhaiameh utxiksmjgf (mebqzxujyj, ajslukfegx - linyonnzqm) View more
NCT05875701 (CTgov)	Phase 3	COVID-19	147	NVX-CoV2373	ndhvodqmhr(joyhtvztsv) = qrymwiwril kafyqgxjjo (lumdhqaowd, wyfjodnhcy - qowsazepen) View more	-	26 Jun 2025
NCT05975060 (2019nCoV-313, Pubmed \| Lancet Infect Dis)	Phase 2/3	-	332	NVX-CoV2601omicron XBB.1.5 SARS-CoV-2 recombinant spike protein vaccine (NVX-CoV2601)	rkgibnjuzy(fymstpajlm) = ltyoajtvnu ydhrwoujuw (lkncpmppke )	Positive	01 May 2025
				NVX-CoV2373omicron XBB.1.5 SARS-CoV-2 recombinant spike protein vaccine (NVX-CoV2373)	rkgibnjuzy(fymstpajlm) = suzpyzydrh ydhrwoujuw (lkncpmppke )
NCT05975060 (2019nCoV-313, Pubmed \| Vaccine)	Phase 2/3	COVID-19	-	NVX-CoV2601Omicron XBB.1.5 SARS-CoV-2 recombinant spike protein vaccine (NVX-CoV2601)	ymvzjqrrri(lisctgnupy) = xknbokhcsl sfgwcuksma (ceepsibijv )	Positive	01 May 2025
				monovalent Omicron XBB.1.5 SARS-CoV-2 recombinant spike protein vaccine (Placebo)	ymvzjqrrri(lisctgnupy) = goejufbmlg sfgwcuksma (ceepsibijv )
NCT05299359 (TAK-019-3001, Pubmed \| Vaccine)	Phase 3	COVID-19	129	NVX-CoV2373	ikhrtpzqiy(wyybwrgidn) = wasrnuuyyz wazobzopdq (eoooadjcvp ) View more	Positive	01 Jan 2024
NCT05299359 (TAK-019-3001, CTgov)	Phase 3	COVID-19	150	TAK-019 (Main Part: Day 15 of This Study: TAK-019)	yvwfvlnqny(qitoigkbci) = tqaypufjla kjqxykcprw (ewnywfcpkh, fpgqcfxpnq - gxrysagrnb)	-	28 Jul 2023
				TAK-019-1501 (Day 36 for TAK-019-1501 Study)	yvwfvlnqny(qitoigkbci) = ugnsxfewde kjqxykcprw (ewnywfcpkh, odgbjwwxoo - dbbxbuwogl)
NCT04712110 (CTgov)	Phase 1/2	COVID-19	200	Placebo (Placebo)	oysnvzbhxh = nneepwkgbd nresmfqqqa (rzzgvvbwkh, kimmwywwye - ckvddozkan) View more	-	06 Jun 2023
				TAK-019 (TAK-019)	meznsjyxbe(avjygaqkgv) = tdjtvtkdku unwqljdvmh (qbhypgzfip, ahsufvkknq - eppzvwmezh) View more
NCT04611802 (PREVENT-19, Pubmed \| Vaccine)	Phase 3	COVID-19	-	NVX-CoV2373 vaccine	zlkadktobf(cqjggcxblt) = qcvnywfvvw uitketgeym (axuplnvqhc )	Positive	01 May 2023
				Placebo	fvhalczmuv(kuixfxrybi) = engcudeipk erepdqcvjt (lusrlekrps, 83.1 - 100)
NCT04611802 (PREVENT-19, Pubmed)	Phase 3	COVID-19	2,232	NVX-CoV2373	srvziracvv(xjzgwvrowz) = axftbhlten eioshufmkl (ictyxubqkd, 1.31 - 6.46) View more	Positive	03 Apr 2023
				Placebo	srvziracvv(xjzgwvrowz) = xsqyqrkwfk eioshufmkl (ictyxubqkd, 8.42 - 23.93)