SARS-CoV-2 Spike Protein Vaccine(Recombinant)(Novavax, Inc.)

Pictured: BioNTech's signage outside its headquarters in Germany/iStock, U.J. Alexander The National Institutes of Health has slapped BioNTech with a notice of default over alleged royalty payments the biotech owes the agency related to sales of its Pfizer-partnered COVID-19 vaccine Comirnaty, according to the company’s SEC filing. A notice of default informs a contract partner that they have failed to fulfill an obligation and that legal action will be taken if they continue to default. In this case, the National Institutes of Health (NIH) maintains that BioNTech breached its license agreement, under which the agency claims it is entitled to certain royalty payments on Comirnaty revenues since its commercialization. BioNTech in Friday’s SEC filing said that it “disagrees with the positions being taken by the NIH and intends to vigorously defend against all allegations of breach.” In developing Comirnaty, an mRNA vaccine that uses lipid particles to deliver a short stretch of modified messenger RNA, BioNTech and Pfizer obtained a non-exclusive license from NIH which allowed the partners to use specific technology related to the SARS-CoV-2’s spike protein and certain mutations that lock the protein “in an antigenically preferred perfusion conformation,” according to BioNTech’s annual report filed last week. In its annual report, the biotech pointed to its ongoing royalty disagreement with NIH, though the agency was still only threatening to send a notice of default at that point. “We cannot guarantee that our interpretation of these license agreements will prevail, or that we will not ultimately need to pay some or all of the royalty and other related amounts in dispute,” BioNTech noted in its annual report. In addition to its payment spat with NIH, BioNTech is also involved in a long-running patent dispute with Moderna. The contention covers betacoronavirus vaccine technology using at least one RNA polynucleotide with an open reading frame that encodes at least one betacoronavirus antigenic peptide. In November 2023, the European Patent Office ruled against Moderna and found that this claim was invalid. There have also been other COVID-19 vaccine payment disputes beyond the BioNTech-NIH feud. In February 2024, Novavax settled its ongoing disagreement with public-private partnership Gavi over the company’s COVID-19 vaccine NVX-CoV2373. To end all litigation surrounding the dispute, Novavax made an upfront $75 million payment and promised deferred payments of $80 million annually through 2028. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

DUBLIN--( BUSINESS WIRE )--The "COVID-19 Monthly Snapshot" newsletter has been added to ResearchAndMarkets.com's offering. Newsletter includes: Impact of the COVID-19 pandemic on the healthcare industry, along with major highlights Comparative analysis (November 2023 vs. October 2023) pertaining to COVID19-related diagnostics, therapeutics, and vaccine developments Pipeline analysis of therapies and assessment of the most promising drug candidates Business strategies adopted by market players in the field of COVID-19 diagnostics in November 2023 Implications of faster clinical trials and approvals of Food and Drug Administration (FDA) Key findings and impact analysis of COVID-19 on pharmaceutical business Growth Opportunities in an Era of Change Advancements since October 2023 November 2023 There was one non-commercial partnership reported, while no commercial collaboration was reported in November 2023 among the COVID-19 diagnostics, therapeutics, and vaccines market. In November 2023, the total number of treatment options was 226. Key players evaluating Phase 3 vaccine and drug candidates included Biological E. Limited, SK Bioscience Co., Ltd., AstraZeneca/the University of Oxford, Novavax, Sinopharm, Moderna Inc., Pfizer Inc./BioNTech SE, AstraZeneca, CureVacAG, CanSino Biological Inc., Johnson & Johnson, Zydus Cadila, and Bharat Biotech, among others. In November 2023, 64 investigational drugs were active in Phase 3 of clinical development. Globally, the overall confirmed cases of COVID-19 reached more than 772 million as of November 22, 2023. Fifty-eight COVID-19 vaccines were evaluated in Phase 3, 40 in Phase 2, 84 in Phase 1, and 199 in pre-clinical stages. October 2023 There was a collaboration reported in October 2023 among COVID-19 diagnostics, therapeutics, and vaccines market. In October 2023, the total number of treatment options was 226. Key players evaluating Phase 3 vaccine and drug candidates included Biological E. Limited, SK Bioscience Co., Ltd., Abivax, AstraZeneca/the University of Oxford, Novavax, Sinopharm, Fulcrum, Therapeutics Moderna Inc., Pfizer Inc./BioNTech SE, AstraZeneca, CureVacAG, Insmed Inc., CanSino Biological Inc., Beijing Minhai Biotechnology, Johnson & Johnson, Zydus Cadila, and Bharat Biotech, among others. In October 2023, 64 investigational drugs were active in Phase 3 of clinical development. Globally, the overall confirmed cases of COVID-19 reached more than 771.5 million as of October 21, 2023. Fifty-eight COVID-19 vaccines were evaluated in Phase 3, 40 in Phase 2, 84 in Phase 1, and 199 in pre-clinical stages. COVID-19 Major Highlights of November 2023 U.S. FDA Grants Marketing Clearance to ACON Laboratories, Inc. for its COVID-19 Rapid Antigen Test November 09, 2023: The U.S. Food & Drug Administration (FDA) granted 510(k) marketing clearance to ACON Laboratories, Inc. for its COVID-19 Antigen Home Test Flowflex. This is the first FDA 510(k) for an over-the-counter (OTC) rapid antigen test for COVID-19. The Flowflex COVID-19 Antigen Home Test is indicated only for symptomatic individuals within the first six days after symptom onset. The company intends to start distribution of the test in 2024. The emergency use authorization (EUA) for the Flowflex COVID-19 Antigen Home Test has not been revoked, and ACON Laboratories, Inc. will continue to supply EUA test kits to meet the public demand for safe and easy home testing through the upcoming cough and cold season. World Health Organization (WHO) Grants Emergency Use Listing (EUL) Status to COVID-19 Vaccine, Nuvaxovid XBB.1.5 November 28, 2023: The World Health Organization (WHO) granted Emergency Use Listing (EUL) status to Novavax, Inc. for its COVID-19 vaccine (Nuvaxovid XBB.1.5) for active immunization to prevent COVID-19 in individuals aged 12 years and above. The EUL of Nuvaxovid XBB.1.5 enables expedited regulatory approvals in 194 WHO member states and UN procurement agencies, such as UNICEF, supporting broader access to a larger population. Nuvaxovid XBB.1.5 is the updated shot targeting the XBB lineage of the COVID-19 virus. The Korean Ministry of Food and Drug Safety Grants Emergency Use Authorization to Updated Vaccine from Novavax November 29, 2023: The updated COVID-19 vaccine (NVX-CoV2601) produced by Novavax was given emergency use authorization (EUA) by the Ministry of Food and Drug Safety, Korea, marking the first approval of its kind in Asia. SK Bioscience intends to ship the improved version of the COVID-19 vaccine to South Korea by the end of 2023 Japan's Ministry of Health, Labour and Welfare (MHLW) Approves COVID-19 Vaccine Developed by CSL and Arcturus Therapeutics November 29, 2023: The self-amplifying mRNA (sa-mRNA) COVID-19 vaccine, ARCT-154, developed by CSL and Arcturus Therapeutics, received approval from Japan's Ministry of Health, Labour and Welfare (MHLW). This vaccine is designated for initial vaccination and as a booster for individuals aged 18 years and older. The approval is based on positive Phase III clinical trial results conducted on 16,000 participants in Vietnam and a Phase III COVID-19 booster trial. In Japan, Seqirus, a subsidiary of CSL Limited entered into a distribution agreement with Meiji Seika Pharma for the supply of ARCT-154 in April 2023. 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