COVID-19 Vaccine, Adjuvanted (Novavax)

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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Researchers from Imperial College London (ICL) have revealed that T cells could provide more protection in COVID-19 vaccines against Omicron, a SARS-CoV-2 virus strain, than antibodies do. The new review, published in Cell Host and Microbe , offers new insights into the development of COVID-19 vaccines and how T cells could play a crucial role in protecting people from these emerging variants. Since being first identified in 2019, the SARS-CoV-2 virus has evolved with several variants and subvariants, such as Omicron, Pirola and Juno, leading to new waves of infection. Although neutralising antibodies were considered to be the primary defence mechanism against COVID-19 during the pandemic, the virus has since evolved to become better at evading them. The new research reveals that memory T cells, which play a key role in the body’s adaptive immune response to recurring viral infections, are more effective at recognising and combating the virus’ in comparison to antibodies. This is especially true for people living with hybrid immunity obtained through vaccination and natural infection. While further research is needed to understand the role of T cells in immunity to the virus’ different strains, researchers suggest that boosting T cell responses could provide stronger and longer-lasting protection against different strains of the virus. Danny Altmann, co-author of the review and professor of immunology, ICL, said: "This recent work reminds us that… we’re still very much locked in a fast-moving arms-race against the virus. “We need to be alert to keep reappraising strategies, making it important to understand these different immune mechanisms, including T cells.” Last month, Novavax announced that its updated COVID-19 vaccine, Nuvaxovid XBB.1.5, had been approved by the Medicines and Healthcare products Regulatory Agency for the active immunisation of individuals aged 12 years and older. The protein-based vaccine, which has been updated to include the spike proteins from the SARS-CoV-2 omicron variant lineage XBB.1.5, induced functional immune responses against the COVID-19 variants XBB.1.5, XBB.1.16 and XBB.2.3. The vaccine also induced neutralising antibody responses to the newly emerging subvariants of the virus, JN.1, BA.2.86, EG.5.1, FL.1.5.1 and XBB.1.16.6, as well as strong CD4+ polyfunctional cellular (T-cell) responses against EG.5.1 and XBB.1.16.6.