Novavax Profile
Novavax, Inc. (Novavax), together with its wholly owned subsidiaries, operates as a biotechnology company.
The company promotes improved global health through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. The company's proprietary recombinant technology platform harnesses the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticle vaccines designed to address urgent global health needs.
The company's vaccine candidates are nanostructures of conformationally correct recombinant proteins that mimic those found on pathogens. This technology enables the immune system to recognize target proteins and develop protective immune responses. The company's vaccine technology may lead to the induction of a differentiated immune response that may be more efficacious than naturally occurring immunity or other vaccine approaches. The company's vaccine candidates also incorporate the company's proprietary saponin-based Matrix-M adjuvant to enhance the immune response, stimulate higher levels of functional antibodies, and induce a cellular immune response.
The company has developed an updated COVID-19 vaccine for the 2023-2024 vaccination season. In October 2023, the U.S. FDA granted EUA for the company's updated vaccine for active immunization to prevent COVID-19. The updated vaccine is authorized as (1) a single dose in individuals 12 years and older who have been vaccinated with any COVID-19 vaccine at least 2 months after receipt of the last previous dose of COVID-19 vaccine, and (2) a series of 2 doses administered 3 weeks apart to individuals 12 years and older who were not previously vaccinated with any COVID-19 vaccine. The company's updated vaccine is available within the U.S. at many major pharmacy retailers. Outside the U.S. for the company's updated vaccine, in January 2024, the company was granted marketing authorization by the United Kingdom's ('UK') Medicines and Healthcare Products Regulatory Agency ('MHRA'), in December 2023, the company was granted expanded authorization by Health Canada, and in October 2023, the company was granted approval by the European Commission ('EC'). The company is committed to supplying of the company's key target markets through advance purchase agreements ('APAs') covering such markets. The company continues to work closely with regulatory authorities in many jurisdictions for authorization of the company's updated vaccine. The company previously developed a prototype COVID-19 vaccine, which has received full marketing authorization ('MA'), marketing approval, interim authorization, provisional approval, CMA, from multiple regulatory authorities in over 40 countries globally. The company continues to progress its regulatory authorizations for the company's prototype vaccine in select territories, as these may facilitate authorization of the company's vaccine candidates for updated strains in the future.
Additionally, the company is developing a COVID-19 Influenza Combination ('CIC') vaccine candidate. The company's other areas of focus include providing Matrix-M adjuvant for collaborations, including in R21/Matrix-M adjuvant malaria vaccine, which in December 2023 received prequalification from the World Health Organization ('WHO') and previously received authorization in several countries, as well as other preclinical vaccine research with the company's Matrix-M adjuvant, including through a partnership with the Bill & Melinda Gates Medical Research Institute.
COVID-19 Vaccine Regulatory and Licensure
The company has received full authorizations in select territories for the company's prototype vaccine developed for the 2022-2023 COVID-19 vaccination season and continue to receive authorizations for the company's updated vaccine developed for the 2023-2024 COVID-19 vaccination season in accordance with the updated strain protocol guidance. The company continues to progress its regulatory authorizations for the company's prototype vaccine in select territories, as these may facilitate authorization of the company's vaccine candidates for updated strains in the future. Additionally, the company progresses its regulatory authorizations for the company's updated vaccine and plan to continue to do so for subsequent future variant strains for each annual respiratory season.
Within the U.S. market, the company's updated vaccine received EUA in October 2023 from the U.S. FDA to prevent COVID-19 in individuals aged 12 and older. The company's updated vaccine is marketed in the U.S. under the name Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula). The formulation for the company's updated vaccine aligns with global harmonized guidance from the U.S. FDA, the European Medicines Agency ('EMA'), and WHO recommendations for the 2023-2024 vaccination season. In September 2023, the U.S. Centers for Disease Control and Prevention ('CDC') Advisory Committee on Immunization Practices ('ACIP') voted in favor of a recommendation for the use of 2023-2024 monovalent XBB containing COVID-19 vaccines authorized under EUA or approved by Biologics License Application ('BLA') in individuals 6 months and older, which was adopted by the CDC Director. The U.S. FDA's grant of EUA and CDC's September 2023 recommendation makes the company's updated vaccine the only protein-based non-mRNA COVID-19 vaccine available in the U.S.
Outside of the U.S. market, the company continues to progress regulatory authorizations for the company's updated vaccine globally.
In January 2024, the company was granted marketing authorization by the UK MHRA for the company's updated vaccine, marketed under the name Nuvaxovid XBB.1.5 Vaccine, in individuals aged 12 and older.
In December 2023, the company was granted expanded authorization by Health Canada and EUA by the Taiwan Food and Drug Administration for the company's updated vaccine, marketed under the name Nuvaxovid XBB.1.5 Vaccine, in individuals aged 12 and older.
In November 2023, the company's updated vaccine received EUA in South Korea where SK bioscience has exclusive commercial rights to the company's updated vaccine. Additionally, in November 2023, the company was granted emergency use license ('EUL') by the WHO for the company's updated vaccine, marketed under the name Nuvaxovid XBB.1.5 Vaccine, in individuals aged 12 and older. The EUL assists WHO member states in assessing vaccines with the aim of expediting availability and enables the WHO's 194 member states to expedite regulatory approvals to import and administer the vaccine.
In October 2023, the company was granted approval by the EC for the company's updated vaccine in individuals aged 12 and older, which followed the positive opinion for approval from the Committee for Medicinal Products for Human Use of the EMA. The company expects to deliver doses to European countries pursuant to existing APAs.
The company has previously received authorizations for the company's prototype COVID-19 vaccine in over 40 countries globally including from major regulatory agencies such as the U.S. FDA, WHO, EMA, and MHRA. As of December 31, 2023, the company had received full MA, approval, interim authorization, provisional approval, CMA, and EUA for the adult population, aged 18 and older, the adolescent population, aged 12 to 17 years, and the pediatric population, aged 7 to 11 years in select territories. The regulatory authorizations for the company's prototype vaccine include primary series and both homologous and heterologous booster indications within specific countries. For the territories in which the company's vaccine has received regulatory authorizations, the company's prototype vaccine is marketed under the names (i) Nuvaxovid (SARS-CoV-2 rS Recombinant, adjuvanted), (ii) Covovax (manufacturing and commercialization by SIIPL), or (iii) Novavax COVID-19 Vaccine, Adjuvanted.
In October 2023, the company's prototype vaccine received full marketing authorization in the UK from the MHRA in individuals aged 12 and older, full approval in Singapore from Singapore's Health Sciences Authority in individuals aged 12 and older, full registration in Australia from Australia's Therapeutic Goods Administration as a booster in individuals aged 12 and older, and authorization in the EU from EMA for use as a booster in adolescents aged 12 through 17 years. These authorizations for the company's prototype vaccine may facilitate authorizations of the company's vaccine candidates for the company's COVID-19 vaccine strain updates in the future.
The company is working to continue to expand the company's label for heterologous boosting in adults and adolescents, to expand the company's label for primary and re-vaccination in younger children, and to achieve supportive policy recommendations enabling broad market access. The company continues to work closely with governments, regulatory authorities, and non-governmental organizations in the company's commitment to facilitate global access to the company's COVID-19 vaccine.
APAs
The company has entered into APAs (also referred to as 'supply agreements') with the EC and various countries globally. The APAs typically contain terms that include upfront payments intended to assist the company in funding investments related to building out and operating the company's manufacturing and distribution network, among other expenses, in the support of the company's global supply commitment.
The company had an APA with the EC, acting on behalf of various European Union member states to supply a minimum of 20 million and up to 100 million initial doses of prototype vaccine, with the option for the EC to purchase an additional 100 million doses up to a maximum aggregate of 200 million doses in one or more tranches through 2023. In 2022, the company was notified by the EC that it was cancelling approximately 7 million doses of its prior commitment originally scheduled for delivery in the first and second quarters of 2022, in accordance with the APA, and reducing the order to approximately 63 million doses. In January 2023, the company finalized a revised delivery schedule for the remaining 20 million committed doses under the APA that were originally scheduled for delivery during the first and second quarters of 2022. The APA expired in August 2023 and required that any open and outstanding orders from European Union member states be satisfied by February 2024. Since August 2023, any additional doses have been managed by amending outstanding orders with deliveries made by February 2024.
The company has an APA with the Commonwealth of Australia for the purchase of doses of COVID-19 Vaccine (the 'Australia APA'). In April 2023, the company amended the Australia APA to reduce the number of doses to be delivered with a commensurate increase in the per-dose price, such that the total contract value of the Australia APA is maintained with doses to be delivered through 2024. In May 2023, the company extended a credit for certain doses delivered in 2022 to Australia that qualified for replacement under the Australia APA. This credit is the result of a single lot sold to the Australian government that upon pre-planned 6-month stability testing was found to have fallen below the defined specifications and the lot therefore was removed from the market. The credit will be applied against the future sale of doses to Australia. In July 2023, the company amended the Australia APA to provide for replacement doses and to extend the delivery schedule through 2025. As of February 2024, the company had not yet received Therapeutic Goods Administration ('TGA') authorization or delivered doses as contemplated in the July 2023 amendment and are in active discussions with the Australian government on both the TGA authorization and delivery of the doses previously scheduled for the fourth quarter of 2023. In February 2024, the company received notice from the Australian government purporting to cancel its order for such prototype vaccine doses. The cancellation was not proper under the amended Australia APA.
The company has an APA with His Majesty the King in Right of Canada as represented by the Minister of Public Works and Government Services, as successor in interest to Her Majesty the Queen in Right of Canada, as represented by the Minister of Public Works and Government Services (the 'Canadian government'), for the purchase of doses of COVID-19 Vaccine (the 'Canada APA'). In April 2023, the company amended the Canada APA, pursuant to which the Canadian government forfeited certain doses originally scheduled for delivery in 2022, which the company received in the second quarter of 2023. In June 2023, the company entered into an additional amendment (the 'June 2023 Amendment') to the Canada APA.
In July 2022, the company entered into an Amended and Restated SARS-CoV-2 Vaccine Supply Agreement (as amended on September 26, 2022, the 'Amended and Restated UK Supply Agreement') with The Secretary of State for Business, Energy and Industrial Strategy (as assigned to the UK Health Security Agency), acting on behalf of the government of the United Kingdom of Great Britain and Northern Ireland (the 'Authority'), which amended and restated in its entirety the SARS-CoV-2 Vaccine Supply Agreement, dated October 22, 2020, between the parties (the 'Original UK Supply Agreement').
In May 2021, the company entered into an APA with Gavi, the Vaccine Alliance ('Gavi' and 'the Gavi APA'). Under the terms of the Gavi APA and a separate purchase agreement between Gavi and SIIPL, 1.1 billion doses of the prototype vaccine were to be made available to countries participating in the COVAX Facility, which was established to allocate and distribute vaccines equitably to participating countries and economies. The company expected to manufacture and distribute 350 million doses of the prototype vaccine to countries participating in the COVAX Facility.
On November 18, 2022, the company delivered written notice to Gavi to terminate the Gavi APA on the basis of Gavi's failure to procure the purchase of 350 million doses of the company's prototype vaccine from the company as required by the Gavi APA. As of November 18, 2022, the company had only received orders under the Gavi APA for approximately 2 million doses.
Product Pipeline
The company's clinical pipeline encompasses vaccine candidates for infectious diseases, with the company's COVID-19 prototype vaccine (NVX-CoV2373) and the company's COVID-19 updated vaccine (NVX-CoV2601), as the company's lead products. The company's prototype and updated vaccine has received authorizations for both adult and adolescent populations globally. The company's updated vaccine has received authorization from the U.S. FDA, the EC, the WHO, and several other countries globally. The company advanced its updated vaccine to a post-authorization Phase 3 safety and immunogenicity trial. Beyond the company's COVID-19 vaccine, the company's clinical pipeline includes a CIC vaccine candidate, in addition to the company's Matrix-M adjuvant being used for collaboration in R21/Matrix-M adjuvant malaria vaccine.
The company is developing a CIC vaccine candidate, which combines the company's COVID-19 vaccine and the company's updated seasonal nanoparticle influenza vaccine candidate in a single formulation. The company continues to progress a Phase 2 trial of its CIC vaccine candidate. The company has selected the CIC dose formulation for advanced development, and contingent upon U.S. FDA concurrence, the company is prepared to move directly into a Phase 3 trial in the second half of 2024 to support accelerated approval, with a potential launch in the U.S. in the fall of 2026.
In addition to the company's CIC vaccine candidate, the company's partner-led R21/Matrix adjuvant malaria vaccine presents significant potential. Based on preliminary results from an ongoing Phase 3 trial in infants and toddlers in Africa, showing 72-79% efficacy, the R21/Matrix adjuvant malaria vaccine has been authorized in Ghana, Nigeria, and Burkina Faso, and in December 2023, was granted prequalification by the WHO.
Coronavirus Vaccine Clinical Development
The company remains focused on expanding its COVID-19 vaccine label within the booster, adolescent, and pediatric indications. The company continues to evaluate vaccine safety, immunogenicity, and effectiveness through ongoing clinical trials and collaborative evidence-generating real-world studies. The company expects to leverage these clinical insights to advance additional regulatory approvals of the company's COVID-19 vaccine globally, amidst the evolving COVID-19 landscape.
Phase 3 Strain-Change and Re-vaccination Studies
Study 311 Part 2: In August 2023, the company announced topline results demonstrating immunologic superiority of the company's bivalent prototype and Omicron BA.5 vaccine compared to the company's prototype vaccine (NVX-CoV2373) for Omicron BA.5 specific responses. This study is ongoing with the last patient visit expected to occur in the first quarter of 2024. This study design was developed in consultation with regulatory agencies to support the company's U.S. BLA and regulatory filings in other territories for the company's strain-change request for the company's updated vaccine (NVX-CoV2601), and to demonstrate that the company's protein-based vaccine can be successfully adapted to new variant strains.
Study 313: In September 2023, the company fully enrolled 332 adults aged 18 and older in Part 1 of the study to evaluate the immunogenicity and safety of the company's updated vaccine (NVX-CoV2601) in previously mRNA vaccinated individuals. Preliminary topline results indicate that the study achieved its co-primary endpoints and successfully demonstrated immunological superiority of NVX-CoV2601 compared to the company's prototype vaccine for Omicron XBB.1.5 specific immune responses. In November 2023, the company fully enrolled 338 adults aged 18 and older in Part 2 of the study which will evaluate the immunogenicity of the company's updated vaccine (NVX-CoV2601) in previously unvaccinated individuals. Part 2 topline results are expected in the second quarter of 2024. Data from Study 313 are intended to support BLA supplements and similar regulatory submissions in other territories for future variant strain formulations.
Study 314: In September 2023, the company fully enrolled 401 adolescents aged 12 to 17 years who were previously vaccinated with mRNA vaccines to evaluate the immunogenicity of boosting with the company's updated vaccine (NVX-CoV2601) and with a bivalent format vaccine containing the company's updated vaccine (NVX-CoV2373 + NVX-CoV2601). These data are intended to support adolescent heterologous booster label expansion in some territories with topline results expected in the second quarter of 2024.
Phase 2b/3 Pediatric Hummingbird Study
In August 2023, the company announced topline results from its Phase 2b/3 Hummingbird trial that met its primary endpoints in children aged 6 through 11 years demonstrating both tolerability and immunologic responses. The company remains on track to submit data for this cohort to the U.S. FDA in the first half of 2024. This ongoing trial is evaluating the safety, effectiveness (immunogenicity), and efficacy of two doses of the company's prototype vaccine (NVX-CoV2373), followed by a booster 6 months after the primary vaccination series. The trial includes three age de-escalation cohorts of 1,200 children each. The next cohort aged 2 through 5 years is fully enrolled, with topline results expected in the first quarter of 2024. The last cohort aged 6 to 23 months is fully enrolled and topline results are expected in the second quarter of 2024.
COVID-19 Vaccine Funding
The company obtained critical funding from the U.S. government to support the development of COVID-19 Vaccine for the U.S. population. In July 2020, the company entered into a Project Agreement (the 'Project Agreement') with Advanced Technology International, Inc. ('ATI'), the Consortium Management Firm acting on behalf of the Medical CBRN Defense Consortium in connection with the partnership. The partnership was among components of the U.S. Department of Health and Human Services and the U.S. Department of Defense working to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics. The Project Agreement relates to the Base Agreement the company entered into with ATI in June 2020 (the 'Base Agreement,' together with the Project Agreement, the 'USG Agreement'). The original USG Agreement required the company to conduct certain clinical, regulatory, and other activities, including a pivotal Phase 3 clinical trial to determine the safety and efficacy of prototype vaccine, and to manufacture and deliver to the U.S. government 100 million doses of the vaccine candidate.
COVID-19-Influenza Combination Vaccine
Phase 2 Clinical Trial of COVID-19-Influenza Combination Vaccine
In November 2023, the company shared that it previously evaluated 11 discrete CIC formulations in the company's Phase 2 dose-confirming trial, in which the company then selected the CIC dose formulation and remain on track to initiate the Phase 3 trial. The company also observed a favorable reactogenicity profile with the company's combination vaccine that was clinically indistinguishable from the licensed influenza vaccine comparators. This preliminary data suggests that the company's technology can increase the antigen load while maintaining acceptable tolerability. Pending regulatory concurrence from the U.S. FDA, the company expects to initiate a pivotal Phase 3 trial for the company's CIC vaccine candidate in the second half of 2024, with potential accelerated approval and launch in the fall of 2026.
In May 2023, the company announced preliminary topline data from the company's Phase 2 trial for CIC, stand-alone influenza, and high-dose COVID-19 vaccine candidates. All three vaccine candidates contain the company's Matrix-M adjuvant, showed preliminary robust immune responses, reassuring safety profiles, and reactogenicity that was comparable to the licensed influenza vaccine comparator arms. The Phase 2 dose-confirming randomized, observer-blinded trial evaluated the safety and effectiveness (immunogenicity) of different formulations of the CIC and influenza vaccine candidates, and higher doses of Novavax's COVID-19 vaccine in 1,575 adults aged 50 through 80 years. The CIC vaccine candidate achieved both anti-SARS-CoV-2 immunoglobulin G (IgG) and neutralizing levels comparable to the company's prototype vaccine. In addition, several of the combination formulations achieved responses to both SARS-CoV-2 and to the four homologous influenza strains that were comparable to the reference comparators, supporting their prioritization for advanced development.
High-dose COVID-19 Vaccine Study
Study 205: In October 2023, the company completed enrollment in a Phase 2 trial to evaluate the company's high-dose COVID-19 vaccine for annual vaccination in 994 adults ages 50 years and older. The trial will compare immunogenicity levels of 5 micrograms of the company's prototype vaccine (NVX-CoV2373) against 5 micrograms, 35 micrograms, and 50 micrograms of the company's updated vaccine (NVX-CoV2601) that are matched with different levels of adjuvant. Data from this trial is intended to potentially support further development of a higher-dose formulation for older adults, similar to that of influenza vaccines. Topline results are expected in the first quarter of 2024.
Malaria
Malaria has the potential to be preventable through the company's partner-led R21/Matrix-M adjuvant malaria vaccine, which in 2023 received authorization in several countries and prequalification by the WHO.
R21/Matrix-M Adjuvant Malaria Vaccine
R21/Matrix-M adjuvant malaria vaccine, formulated with the company's Matrix-M adjuvant is developed by the company's partner, the Jenner Institute, University of Oxford, and manufactured by SIIPL. The company has an agreement with SIIPL related to its manufacture of R21/Matrix-M adjuvant malaria vaccine under which SIIPL purchases the company's Matrix-M adjuvant for use in development activities at cost and for commercial purposes at a tiered commercial supply price, and pays a royalty in the single-to low-double digit range based on vaccine sales for a period of 15 years after the first commercial sale of the vaccine in each country.
Phase 3 Clinical Trial of R21/Matrix-M Adjuvant Malaria Vaccine
R21/Matrix-M adjuvant malaria vaccine is being evaluated in an ongoing Phase 3 trial conducted by the company's partner, the Jenner Institute, University of Oxford. In February 2024, peer-reviewed results from the Phase 3 efficacy trial were published in The Lancet reporting R21/Matrix-M adjuvant malaria vaccine has a well-tolerated safety profile and offers high-level efficacy against clinical malaria in African children at sites of both seasonal and perennial transmission. This Phase 3 trial enrolled 4,800 children aged 5 to 36 months across five sites in four African countries with differing malaria transmission intensities and seasonality. The trial demonstrated efficacy of 75% when administered prior to the high transmission season during the 12 months following a three-dose series and efficacy of 68% when administered in an age-based schedule in regions where malaria is present perennially during the 12 months following the first three doses. This R21/Matrix-M adjuvant malaria vaccine is a low-cost vaccine and has the potential to make a substantial contribution to reducing the burden of malaria disease and deaths in sub-Saharan Africa.
R21/Matrix-M Adjuvant Malaria Vaccine Regulatory and Licensure
In December 2023, the WHO announced it prequalified the R21/Matrix-M adjuvant malaria vaccine to prevent malaria disease in children caused by the P. falciparum parasite in endemic areas. Prequalification status enables United Nations agencies to procure the vaccine for eligible countries and will enable rollout of the vaccine in mid-2024. The WHO recommended that the R21/Matrix-M adjuvant malaria vaccine be administered in a four-dose schedule beginning at five months of age.
In July 2023, R21/Matrix-M adjuvant malaria vaccine received authorization in Burkina Faso and in April 2023, received authorizations in Ghana and Nigeria.
License and Collaboration
The company's commitment to partnering globally in efforts to further develop the company's COVID-19 Vaccine is demonstrated through the company's partnership with SIIPL to supply COVID-19 vaccines to India and low- and middle-income countries.
A summary of the company's license and collaboration agreements follows:
SIIPL
The company previously granted SIIPL exclusive and non-exclusive licenses for the development, co-formulation, filling and finishing, registration, and commercialization of the company's prototype vaccine, its proprietary COVID-19 variant antigen candidate(s), and the company's CIC vaccine candidate. SIIPL agreed to purchase the company's Matrix-M adjuvant, and the company granted SIIPL a non-exclusive license to manufacture the antigen drug substance component of the company's COVID-19 Vaccine in SIIPL's licensed territory solely for use in the manufacture of COVID-19 Vaccine. The company also has a supply agreement with SIIPL and SLS under which SIIPL and SLS supply the company with prototype vaccine, the company's proprietary COVID-19 variant antigen candidate(s), and the company's CIC vaccine candidate for commercialization and sale in certain territories, as well as a contract development manufacture agreement with SLS, under which SLS manufactures and supplies finished vaccine product to the company using antigen drug substance and Matrix-M adjuvant supplied by the company. In March 2020, the company entered into an agreement with SIIPL that granted SIIPL a non-exclusive license for the use of Matrix-M adjuvant supplied by the company to develop, manufacture, and commercialize R21/Matrix-M adjuvant, a malaria vaccine created by the Jenner Institute, University of Oxford ('R21/Matrix-M'). R21/Matrix-M adjuvant vaccine has been licensed to SIIPL for commercialization and in December 2023 received prequalification by the WHO.
Takeda
The company has a collaboration and license agreement with Takeda Pharmaceutical Company Limited ('Takeda') under which the company granted Takeda an exclusive license to develop, manufacture, and commercialize the company's COVID-19 Vaccine in Japan. Under the agreement, Takeda purchases Matrix-M adjuvant from the company to manufacture doses of COVID-19 Vaccine.
SK bioscience, Co., Ltd. (SK bioscience)
The company has a collaboration and license agreement with SK bioscience to manufacture and commercialize the company's prototype vaccine for sale to the governments of South Korea, Thailand, and Vietnam. SK bioscience pays a royalty in the low to middle double-digit range.
Manufacturing and Supply
A summary of the company's key manufacturing and supply arrangements follows:
Matrix-MTM Adjuvant
The company manufactures its proprietary saponin-based Matrix-M adjuvant at the company's Novavax AB facility in Uppsala, Sweden. The company also has contract manufacturing arrangements with AGC Biologics and the Polypeptide Group to provide contract development and manufacturing services, supplying the company with large-scale production of Matrix-M adjuvant.
Antigen Component of COVID-19 Vaccine
The company has a supply agreement with SIIPL (Serum Institute of India Pvt. Ltd.) and SLS (Serum Life Sciences Limited), an affiliate of SIIPL, for the manufacture of the antigen component of COVID-19 Vaccine and the co-formulation, fill, and finishing of the finished vaccine product. In May and August 2022, the company expanded its license and supply arrangements with SIIPL to include the company's proprietary COVID-19 variant antigen candidate(s), and the company's CIC vaccine candidate, so that SIIPL can manufacture and commercialize a vaccine targeting COVID-19 variants, including the Omicron subvariants, and CIC vaccine, and supply such vaccines to the company.
Finished COVID-19 Vaccine
In addition to the supply agreement with SIIPL and SLS for the co-formulation, fill, and finishing of the finished vaccine product, the company has a contract development manufacture agreement with SLS, pursuant to which SLS will manufacture and supply finished vaccine product to the company using antigen drug substance and Matrix-M adjuvant supplied by the company. The company depends primarily on this supply agreement for co-formulation, filling and finishing (other than in Europe) and the company's service agreement with PCI Pharma Services ('PCI') for finishing in Europe.
Patents and Proprietary Rights
Patent Rights; Licenses
The company has or has rights to over 630 U.S. and foreign patents and patent applications relating to vaccines and vaccine-related technologies.
Patents related to the company's Virus-Like Particle ('VLP') program include U.S. Patent No. 7,763,450, which covers, in part, the use of influenza gene sequences for high-yield production of consistent influenza VLP vaccines to protect against seasonal and pandemic strains of influenza viruses. Corresponding European patent, European Patent No. 1644037 also covers this technology. U.S. Patent Nos. 8,080,255, 8,551,756, 8,506,967 and 8,592,197 are directed to methods of producing VLPs and inducing substantial immunity to an influenza virus infection by administering VLPs comprising HA and NA proteins, and the company's M1 protein derived from the avian influenza strain, A/Indonesia/5/05. Certain claims also encompass similar methods and compositions where the M1 protein is from a different strain of influenza virus than the influenza HA protein and the influenza NA protein. Related patent protection in Europe is provided by European Patent No. 2343084, which covers, in part, vaccine compositions containing VLPs that contain M1, HA, and NA proteins. The company's VLP patent portfolio contains many other patents, including U.S. Patent Nos. 8,951,537, 8,992,939, 9,144,607, 9,050,290, 9,180,180, 9,381,239, 9,464,276, 9,474,799, and other patents in multiple ex-U.S. jurisdictions.
In addition to the company's focus on vaccine programs, the company pursues patent protection for its Matrix Adjuvant program. Issued U.S. Patent Nos. 7,838,019, 9,205,147, 9,901,634, 8,821,881, and 10,729,764 provide examples of patents related to the company's Matrix Adjuvant program.
The company pursues patents related to its COVID-19 vaccine program, including to NVX-CoV2373, the company's COVID-19 vaccine candidate. Issued U.S. Patent Nos. 10,953,089, 11,253,586, 11,541,112 provide examples of patents related to the company's COVID-19 program.
The company also has four pending PCT applications directed to the company's COVID program (PCT/US2022/020974, PCT/US2022/080700, PCT/US2022/082331 and PCT/US2022/027465) and two pending PCT applications directed to the company's malaria program (PCT/US2022/078665 and PCT/US2022/080334).
Trademarks
Novavax, Nuvaxovid, Matrix-M, Matrix, Prepare, Resolve, and ResVax are trademarks of the company.
Government Regulations
The company must then conduct Phase 1 clinical trials and larger-scale Phase 2 and 3 clinical trials that demonstrate the safety, immunogenicity, and efficacy of the company's vaccine candidate to the satisfaction of the U.S. FDA.
The U.S. FDA granted Fast Track Designation for the company's prototype vaccine in November 2020 and for the company's recombinant quadrivalent seasonal influenza vaccine candidate, in January 2020.
The company is also subject to regulation under the Occupational Safety and Health Act, the Environmental Protection Act, the Toxic Substances Control Act, the Resource Conservation and Recovery Act, and other federal, state, or local regulations, including national and local regulations that govern the company's facilities in Sweden, the Czech Republic and Switzerland. These and other laws govern the company's use, handling, and disposal of various biological and chemical substances used in, and waste generated by, the company's operations. Additionally, for formulations containing controlled substances, the company is subject to Drug Enforcement Act regulations.
The company is also subject to the U.S. Foreign Corrupt Practices Act ('FCPA'), which prohibits any U.S. individual or business from paying, offering, authorizing payment of, or offering anything of value, directly or indirectly, to any foreign official, political party, or candidate for the purpose of influencing any act or decision of the foreign entity in order to assist the individual or business in obtaining or retaining business. The FCPA also obligates companies whose securities are listed in the U.S. to comply with certain accounting provisions requiring the company to maintain books and records that accurately and fairly reflect all transactions of the corporation, including international subsidiaries, and to devise and maintain an adequate system of internal accounting controls for international operations.
The company is also subject to state and foreign laws governing the privacy and security of health or personal information such as the European Union General Data Protection Regulation ('GDPR') and the California Consumer Privacy Act of 2018 ('CCPA').
Research and Development
The company's research and development expenses were $737.5 million for 2023.
History
Novavax, Inc. was founded in 1987. The company was incorporated in 1987 under the laws of the state of Delaware.
