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All rights reserved. Like the mRNA vaccine makers, Novavax says it is also studying a version of its shots redesigned to target the BA.4 and BA.5 subvariants of Omicron now dominant across the country. Primary and secondary objectives of the study are to assess the safety, tolerability, and immune responses to various formulations of the CIC and influenza vaccine candidates. We take your privacy seriously. Novavax has submitted an application to the Food and Drug Administration for Emergency Use Authorization of its COVID-19 vaccine as a booster in adults that can be used on top of its primary vaccine series or to mix and match with a different primary series, the company announced. Global Business and Financial News, Stock Quotes, and Market Data and Analysis. The data revealed on 3 June by FDA described five cases of myocarditis that occurred in people in the vaccine arms of the Novavax clinical trials in the United States and the United Kingdom. If we've learned anything from the COVID-19 pandemic, it's that we cannot wait for a crisis to respond. Use of the Novavax COVID-19 Vaccine, Adjuvanted in the U.S. Novavax, a global company based in Gaithersburg, Md., U.S., offers a differentiated vaccine platform that combines a recombinant protein approach, innovative nanoparticle technology and Novavax's patented Matrix-M adjuvant to enhance the immune response. The .gov means its official.Federal government websites often end in .gov or .mil. Dr. Peter Marks, a senior FDA official, said Novavax's vaccine would potentially appeal to unvaccinated people who would prefer a shot that is not based on the messenger RNA technology used by Pfizer and Moderna. Treatment for: COVID-19. Most reactions were mild or moderate, but reactogenicity was greater following the second dose. FDA Authorizes Novavaxs Covid-19 Vaccine For Adults (Forbes), How a Struggling Company Won $1.6 Billion to Make a Coronavirus Vaccine (New York Times), This is a BETA experience. Waning interest in Covid-19 vaccines has left a long-standing drug developer, Novavax Inc., struggling to stay afloat and handed short sellers a windfall. However, 27 million adults still have not gotten a single shot yet, according to CDC data from June. Novavax Reports Fourth Quarter and Full Year 2022 Financial Results and Operational Highlights. The thumbs up from the FDA advisers likely means the agency will allow the company to enter the U.S. market, as FDA usually follows its advisers lead. Download a prevaccination checklist in multiple languages. You may opt-out by. Tracking Covid-19. The Food and Drug Administration advisory committee recommends the agency authorize another COVID-19 vaccine in the hopes it might entice more people to FDA Approved: No (Emergency Use Authorization) The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. If authorized in the United States, the product will initially be manufactured, as all Novavax vaccine currently is, by the Serum Institute of India, one of the worlds largest vaccine manufacturers. The trial will assess a CIC vaccine comprised of Novavax's recombinant protein-based COVID-19 vaccine, quadrivalent influenza vaccine candidate, and patented saponin-based Matrix-M adjuvant. Im very skeptical that vaccine-hesitant people will elect to get this vaccine, said committee member Jay Portnoy, an allergist and immunologist at Childrens Mercy Hospital. Download a prevaccination checklist in multiple languages. Novavax COVID-19 Vaccine, Adjuvanted contains the SARS-CoV-2 spike protein and Matrix-M adjuvant. But in response to a query from Doran Fink, acting deputy director of FDAs vaccine approval branch, Nelson said the agency should include a warning about heart risks in the package insert. I cover breaking and trending news, focused on national politics. Share Your Design Ideas, New JerseysMurphy Defends $10 Billion Rainy Day Fund as States Economy Slows, What Led to Europe's Deadliest Train Crash in a Decade, This Week in Crypto: Ukraine War, Marathon Digital, FTX. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. Get this delivered to your inbox, and more info about our products and services. 2023 American Association for the Advancement of Science. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner. Novavax's shots have received FDA authorization at a time when nearly 77% of adults ages 18 and over are already fully vaccinated. Insight and analysis of top stories from our award winning magazine "Bloomberg Businessweek". However, the small Maryland biotech company struggled to quickly get manufacturing in place and its clinical trial data read out much later than Pfizer or Moderna. Its statement about its future financial framework was even more troubling, saying, Substantial doubt exists regarding our ability to continue over the next year. Complete and submit reports to VAERS online. It worked. Stock is most profitable biotech short since pandemic high: S3, Company valuation topped $20 billion amid 2021s biotech mania. Amazon Pauses Construction on Second Headquarters in Virginia as It Cuts Jobs, iPhone Maker Plans $700 Million India Plant in Shift From China, S&P 500 Notches Best Week Since Late January: Markets Wrap, Amazon Is Closing Its Cashierless Stores in NYC, San Francisco and Seattle, Zoom Abruptly FiresPresident Greg Tomb Without Cause. Novavax will host its quarterly conference call today at 4:30 p.m. Johnson & Johnson's Janssen vaccine uses a cell line that was originally developed from an abortion. The company plans to ask the FDA to authorize a third dose of its vaccine. Novavax is committed to accelerating the development of new and promising vaccines by building on years of study and experience. (Bloomberg) -- Waning interest in Covid-19 vaccines has left a long-standing drug developer, Novavax Inc., struggling to stay afloat and handed short sellers a windfall. The UK Phase 3 pivotal clinical trial commenced September 2020 to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373 with Matrix-M in up to 10,000 subjects aged 18 to 84 years. Booster dose:A booster dose for individuals 18 years of age and older, given at least 6 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine:-for individuals that a FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and-for individuals who elect to receive the Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine. The committee recommended authorization for the two-shot series in adults 18 years and older. Novavax has otherwise touted its use of older vaccine technology for its COVID shot as a good alternative to the country's stable of effective vaccines because it has been administered with fewer side effects during trials than the Pfizer or Moderna shots. Novavax's COVID-19 vaccine is a protein-based vaccine made by creating copies of the surface spike protein of SARS-CoV-2 that causes COVID-19. Some committee members raised eyebrows at the suggestion that the Novavax vaccine would win over a substantial number of the 27 million unvaccinated Americans with its familiar technology. In July 2022, the FDA authorized the Novavax COVID-19 vaccine for adults. Novavax is not responsible for the privacy policy of any third-party websites. The Novavax vaccine also appears to carry a risk of heart inflammation for younger men, known as myocarditis and pericarditis, similar to Pfizer and Moderna's shots. Copyright 2023 CBS Interactive Inc. All rights reserved. Certainly the benefits outweigh the risks, said adviser Michael Nelson, an allergist and immunologist at the University of Virginia School of Medicine. A replay of the conference call will be available starting at 7:30 p.m. Cookies used to make website functionality more relevant to you. You have selected a link that will take you to a site maintained by a third party who is solely responsible for its contents. We caution investors not to place considerable reliance on forward-looking statements contained in this press release. The relevance of a particular drug interaction to a specific individual is difficult to determine. Shares of Novavax fell more than 25% in after-hours trading Tuesday, following a dismal fourth quarter earnings report and a warning from the Covid Bets against the company have earned shorts about $2.7 billion from the stocks 2021 zenith through Wednesday, S3 Partners compiled data show. You will be subject to the destination website's privacy policy when you follow the link. Myocarditis is an inflammation of the heart muscle and pericarditis is inflammation of the outer lining of the heart. Reporting is encouraged for other clinically significant adverse events, even if it is not clear that a vaccine caused the adverse event. In 2023, Novavax intends to focus the organization to align our investments and activities with our top priority of delivering an updated Covid-19 vaccine consistent with public health recommendations for strain composition for the 2023 fall vaccination season. Just days before todays meeting, the companys stock price tumbled when FDA published data indicating the vaccine may rarely cause myocarditis and pericarditis, a problem that has also dogged mRNA vaccines from Moderna and the Pfizer-BioNTech collaboration. The immune system responds to these copies of the spike, which prepares the human body to attack the actual virus. Continued manufacturing problems led to a delay in winning regulatory approval, and by the time Novavaxs shot became available in July 2022, Americans initial rush to get vaccinated was long over. The effectiveness of Covid vaccines against mild illness has slipped substantially as the virus as evolved, though they still generally protect against severe disease. The U.S. Centers for Disease Control and Preventions Advisory Committee on Immunization Practices would also need to make a recommendation for who should receive the vaccine, and that committee has not yet scheduled a meeting. Omicron is so distinct from the original strain of Covid that the antibodies produced by the vaccines have trouble recognizing and attacking the variant. "Much has been achieved over the past three years, and based on the foundation that has been laid to date, I believe that Novavax has significant potential for a bright future. The company stated it believes it has enough capital to run for another year, but the forecast is of low confidence, in part because the Biden Administration is expected to stop buying Covid vaccines and distributing them to Americans for free at some point this year. You can review and change the way we collect information below. Coronavirus Disease 2019 (COVID-19), Recalls, Market Withdrawals and Safety Alerts, COVID-19-Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders, Fact Sheet for Healthcare Providers Administering Vaccine, HOJA INFORMATIVA PARA RECEPTORES Y PROVEEDORES DE CUIDADO, FACT SHEET PARA SA MGA TATANGGAP AT MGA TAGAPAG-ALAGA, T THNG TIN CHO NGI NHN V NHNG NGI CHM SC. The mRNA vaccines that are already available work by providing cells with a blueprint to create spike proteins to trigger an immune response from the body. Thank you for taking the time to confirm your preferences. It found a new life as it collected $2 billion to develop a vaccine, first from an international organization that supports vaccinemaking and then from the U.S. government. In the case of the mRNA shots, the CDC has found that the risk of myocarditis is higher from Covid infection than vaccination. Novavax hopes holdouts skeptical of mRNA vaccines and, ultimately, others seeking booster shots will opt for its tried-and-true technology. This special highlights the best of the fifth annual event which was held in Singapore from November 14-17. Yet Gellin was the lone abstaining vote, saying the committee wasnt given data on how the vaccine performs against the Omicron variants now circulating, or for how many months its protection lasts. The company has said it plans to pursue an authorization for its current vaccine to be used as a booster shot as well. Help News from Science publish trustworthy, high-impact stories about research and the people who shape it. Novavax's vaccine, like all the other shots, is based on the original version of the virus that first emerged in Wuhan, China. WebNovavax COVID-19 Vaccine, Adjuvanted is available under emergency use authorization (EUA) to prevent COVID-19 in individuals 12 years of age and older. Novavax COVID-19 Vaccine, Adjuvanted indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Waning interest in Covid-19 vaccines has left a long-standing drug developer, Novavax Inc., struggling to stay afloat and handed short sellers Reorganized executive leadership team to better align internal resources and operate more efficiently; key changes include: Strengthened Board of Directors with appointment of. These data will inform the phase 3 trials for both influenza stand-alone and COVID-19-influenza combination vaccine candidates. On August 19, 2022, the Food and Drug Administration (FDA) authorized the Novavax COVID-19 Vaccine, Adjuvanted for emergency use in individuals ages 12 and older. WebThese classifications are only a guideline. Novavax's vaccine might also overcome some religious objections that have been lodged over how the Moderna and Pfizer-BioNTech shots were initially studied. 2 men found drugged after leaving NYC gay bars were killed, medical examiner says, Flu and COVID combo shots won't be ready this year, FDA official says, White House pushing Congress to pass funding to combat pandemic-related fraud, FBI chief says agency feels pandemic likely started with Chinese lab leak. WebThese classifications are only a guideline. This Novavax website is for US medical professionals only. The maker of the only traditional COVID-19 vaccine still widely available in the United States is raising doubts about its ability to stay Always consult your healthcare provider before starting or stopping any medication. It contains Novavaxs patented saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. Tracking Covid-19. A man receives a Novavax injection in Seattle in February 2021 as part of the companys North American clinical trial. Previous Name: NVX-CoV2373 If the Food and Drug Administration (FDA) accepts the group's recommendation and Centers for Disease Novavax did not present any on data on the shot's effectiveness against the variant at the FDA committee meeting in June. *Included in current and noncurrent liabilities as of December 31, 2022 and non-current liabilities as of December 31, 2021. The finished spike copies are injected into the human body, inducing an immune response against Covid. Topline. We want to hear from you. The law governing emergency use authorizations (EUAs) by FDA requires that there is no adequate, approved and available alternative to a product. Fugitive in $18 million COVID fraud scheme extradited to U.S. Energy Department report on COVID's origins rekindles ongoing debate. People who develop heart inflammation as a side effect of Covid vaccines are usually hospitalized for several days as a precaution but then recover. The Matrix-M adjuvant stimulates the entry of antigen-presenting cells at the injection site and enhances antigen presentation in local lymph nodes. An official website of the United States government, : The US Food and Drug Administration on Wednesday authorized Novavaxs Covid-19 vaccine for emergency use in adults. Company: Novavax, Inc. One advisory committee member asked Peter Marks, FDAs top vaccine official, why the Novavax vaccine meets that requirement given that three other vaccines are already available to people in the United States. Credit: Unsplash/CC0 Public Domain. It would be a travesty if we didnt mention this in the documentation for the public to show the concern that we have.. Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. The COVID-19-Influenza Combination (CIC) Vaccine Candidate Phase 2 Trial is a dose-confirming, randomized, observer-blinded trial evaluating the safety and effectiveness (immunogenicity) of different formulations of the CIC and influenza vaccine candidates in adults aged 50 through 80. The Novavax COVID-19 Vaccine, Adjuvanted has not been approved or licensed by the US Food and Drug Administration (FDA), but has been authorized for Given these uncertainties, substantial doubt exists regarding our ability to continue as a going concern through one year from the date that these financial statements are issued. With Novavax, each vaccine is spaced three weeks apart. The Department of Health and Human Services said Monday that it is still conducting quality testing of the Novavax vaccine. The FDA has authorized Novavaxs COVID-19 vaccine in the United States. Approved vaccines for shingles, hepatitis B, and influenza use similar protein-based technology. The FDA also said last month it was at loggerheads with Novavax over whether to attach a warning of myocarditis potentially linked to the shots. Alastair Grant, Associated Press. Generic name: SARS-CoV-2 vaccine The first data on those shots are expected "in the late summer or fall," the company says. articles a month for anyone to read, even non-subscribers! Science and AAAS are working tirelessly to provide credible, evidence-based information on the latest scientific research and policy, with extensive free coverage of the pandemic. Novavax, in use in the U.S. since mid-2022, warned it may not survive in its latest earnings report, released after the market closed on Tuesday, CNN reported. The Food and Drug Administration has authorized Novavax's two-dose vaccine for adults ages 18 and over, the fourth Covid shot to get emergency approval in the U.S. since the pandemic began. Novavax makes copies of the virus spike outside human cells. The Food and Drug Administration o n Wednesday authorized a Covid-19 vaccine developed by Novavax, a biotechnology company in Maryland that 2022 CBS Interactive Inc. All Rights Reserved. In clinical trials conducted before the Omicron variant, Novavax was found to have 90.4% efficacy in preventing any symptomatic COVID-19 infections and as much as 100% efficacy against moderate-to-severe disease. CBS News reporter covering public health and the pandemic. FDA authorization of Novavaxs vaccines comes as the U.S. is preparing to updated Covid shots to target the omicron BA.4 and BA.5 variants to increase protection ET on March 7, 2023. June 3 (Reuters) - The U.S. Food and Drug Administration hasraised concerns about a possible risk of heart inflammation from Novavax Inc's (NVAX.O) WebOn February 1, 2022, FDA received a request from Novavax (the Sponsor) for emergency use authorization (EUA) of the Novavax COVID-19 Vaccine. At their June 7 meeting, FDA officials had said the agency was still in the midst of vetting the company's process for manufacturing and checking the quality of shots an issue that the company's executives acknowledged was one of the biggest obstacles to completing its submission to the regulator. The trial assessed two doses (5 and 25 g), each with 50 g of MatrixM. Presented data to the U.S. FDA Vaccine and Related Biological Products Advisory Committee demonstrating that when used as a booster, Novavax's COVID-19 vaccine induces broad functional immune responses, including for contemporary variants Novavax's COVID-19 vaccine is a protein-based vaccine made by creating copies of the Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. Novavax has otherwise touted its use of older vaccine However, the trial was conducted from December 2020 through September 2021, months before the omicron variant became dominant. Novavax COVID-19 Vaccine, Adjuvanted is available under emergency use authorization (EUA) to prevent COVID-19 in individuals 12 years of age and older. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Evaluation of the Safety and Immunogenicity of a SARS-CoV-2 rS (COVID-19) Nanoparticle Vaccine With/Without Matrix-M Adjuvant, Novavax Phase 3 COVID-19 Omicron Trial Supports the Continued and Future Use of Novavax Prototype Vaccine as a Booster, U.S. Centers for Disease Control and Prevention Recommends Novavax COVID-19 Vaccine, Adjuvanted as a Booster in Adults, U.S. Centers for Disease Control and Prevention Expands Recommendation for Novavax COVID-19 Vaccine, Adjuvanted to Adolescents Aged 12 Through 17, U.S. FDA Grants Emergency Use Authorization for Novavax COVID-19 Vaccine, Adjuvanted for Adolescents Aged 12 Through 17, Novavax Submits Application to the U.S. FDA for Emergency Use Authorization for Novavax COVID-19 Vaccine, Adjuvanted as a Booster in Adults Aged 18 and Older, Novavax Announces Initiation of Phase 2b/3 Hummingbird Global Clinical Trial for the Novavax COVID-19 Vaccine in Children Aged Six Months Through 11 Years, U.S. FDA Grants Emergency Use Authorization for Novavax COVID-19 Vaccine, Adjuvanted for Individuals Aged 18 and Over, FDA Advisory Committee Recommends Emergency Use Authorization of Novavax COVID-19 Vaccine for People Aged 18 Years and Older, Novavax Announces Initiation of COVID-19 Vaccine Booster Study in Adolescents in Phase 3 PREVENT-19 Trial, Health Canada Authorizes Novavax COVID-19 Vaccine, Novavax Announces Positive Results of COVID-19 Vaccine in Pediatric Population of PREVENT-19 Phase 3 Clinical Trial, New Zealand's Medsafe Grants Provisional Approval for Novavax' COVID-19 Vaccine, Novavax Submits Request to the U.S. FDA for Emergency Use Authorization of COVID-19 Vaccine, Novavax Submits Final Data Packages to U.S. FDA as Prerequisite to Emergency Use Authorization Application Request for COVID-19 Vaccine, Novavax Announces Initial Omicron Cross-Reactivity Data from COVID-19 Vaccine Booster and Adolescent Studies, Novavax Announces Initiation of PREVENT-19 COVID-19 Vaccine Phase 3 Trial Booster Study, World Health Organization Grants Second Emergency Use Listing for Novavax COVID-19 Vaccine, Novavax and Serum Institute of India Announce World Health Organization Grants Emergency Use Listing for NVX-CoV2373 COVID-19 Vaccine, Novavax Statement on PREVENT-19 Phase 3 Clinical Trial Results Publication in the New England Journal of Medicine, Novavax Statement on Omicron Variant Response, Novavax Confirms European Medicines Agency Review of COVID-19 Vaccine Filing for Conditional Marketing Authorization, Novavax Files COVID-19 Vaccine for Emergency Use Listing with World Health Organization, Novavax Files COVID-19 Vaccine for Provisional Approval in New Zealand, Novavax and Serum Institute of India Receive Emergency Use Authorization for COVID-19 Vaccine in Indonesia, Novavax Files for COVID-19 Vaccine Authorization with Health Canada and Completes Submission for Rolling Review to European Medicines Agency, Novavax Files for Provisional Approval of its COVID-19 Vaccine in Australia, Novavax Files for Authorization of its COVID-19 Vaccine in the United Kingdom. But the Novavax process may not move so speedily: FDA says it needs additional manufacturing and product information before an EUA can be issued. The genetic code for the spike is put into an insect virus that infects moth cells, which produce copies that are then purified and extracted during the manufacturing process. "What really took the longest time, however, wasn't the manufacturing of the product. 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Novavax, Inc. (Nasdaq: NVAX) promotes improved health by discovering, developing and commercializing innovative vaccines to protect against serious infectious diseases. Brand name: Novavax COVID-19 Vaccine The 21-0 vote, with one abstention, marks a hard-won and long-sought milestone for the small Gaithersburg, Marylandbased biotechnology company that was moribund as the pandemic began. A spokesperson for the Department of Health and Human Services did not return a request for comment. A key committee of advisers to the U.S. Food and Drug Administration (FDA) today recommended nearly unanimously that the agency grant an emergency We need to provide options to reduce excuses, Martha Dawson, president of the National Black Nurses Association, told the advisers. With nearly 22% of the nation yet to receive a single COVID-19 vaccine dose, federal vaccine advisers today recommended that the Novavax COVID-19 vaccine be approved under an emergency use authorization (EUA). Subscribe to News from Science for full access to breaking news and analysis on research and science policy. It could be the next thing that saves your life or your loved ones life.. Novavax seeks FDA emergency use authorization of its coronavirus vaccine Novavaxs request for authorization was based on data including the results of two large While our current cash flow forecast for the one-year going concern look forward period estimates that we have sufficient capital available to fund operations, this forecast is subject to significant uncertainty, including as it relates to 2023 revenue, funding from the U.S. government, and pending arbitration. Alastair Grant, Associated Press. The Phase 2 clinical trial commenced August 2020 expanding on the age range of the Phase 1 portion by including older adults 60-84 years of age as approximately 50 percent of the trials population. These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. The fact sheets authorized for Novavax's shots will ultimately include the warning, the FDA said. The spike protein in this vaccine is produced in insect cells; the Matrix M-adjuvant contains saponin extracts from the bark of the Soapbark tree that is native to Chile. The study evaluated two doses (administered 21 days apart) of NVXCoV2373 across two dose levels (5 g and 25 g), with and without the MatrixM adjuvant. A key committee of advisers to the U.S. Food and Drug Administration (FDA) today recommended nearly unanimously that the agency grant an emergency authorization to a COVID-19 vaccine from Novavax, opening the way for the first protein-based COVID-19 vaccine to become available to people in the United States. Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. Dosage form: intramuscular injection The companys stock price rose more than 6.8% to $9.26 before the market closed Tuesday, but plummeted some 25.7% to $6.88 following the after-hours earnings report. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. Major: Highly clinically significant. These risks and uncertainties include, without limitation, challenges satisfying, alone or together with partners, various safety, efficacy, and product characterization requirements, including those related to process qualification and assay validation, necessary to satisfy applicable regulatory authorities; difficulty obtaining scarce raw materials and supplies; resource constraints, including human capital and manufacturing capacity, on the ability of Novavax to pursue planned regulatory pathways; unanticipated challenges or delays in conducting clinical trials; challenges meeting contractual requirements under agreements with multiple commercial, governmental, and other entities; manufacturing delays or challenges, including as a result of the timing of the anticipated regulatory requirements for the fall 2023 vaccination season; the loss of future funding from the U.S. government; the potential for an unfavorable outcome in disputes, including the pending arbitration with Gavi; and those other risk factors identified in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Novavax's Annual Report on Form 10-K for the year ended December 31, 2021 and subsequent Quarterly Reports on Form 10-Q, as filed with the Securities and Exchange Commission (SEC).