"We're in the process of assessing the global footprint of Novavax, rationalizing our supply chain, rationalizing the portfolio and rationalizing the company structure and our infrastructure," Jacobs told Reuters. Covid Vaccine Avoid combinations; the risk of the interaction outweighs the benefit. Novavax COVID-19 Vaccine, Adjuvanted is available under emergency use authorization (EUA) to prevent COVID-19 in individuals 12 years of age and older. 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. WebApart from supportive care, there is only one drug approved, an antiviral (remdesivir), which can be used as a medical treatment for people with COVID-19, and an FDA emergency use-authorized nonvaccine antibody combination (casirivimab and imdevimab) to prevent infection. Linking to a non-federal website does not constitute an endorsement by CDC or any of its employees of the sponsors or the information and products presented on the website. 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. 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. Novavax Reports Fourth Quarter and Full Year 2022 Financial "What really took the longest time, however, wasn't the manufacturing of the product. 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). *Included in current and noncurrent liabilities as of December 31, 2022 and non-current liabilities as of December 31, 2021. Novavax will likely cut some jobs to reduce its hot rate of spending, CEO John Jacobs told Reuters. You will be subject to the destination website's privacy policy when you follow the link. The immune system responds to these copies of the spike, which prepares the human body to attack the actual virus. 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. 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. Novavax' vaccine is the first protein-based COVID-19 vaccine authorized in the U.S. Prepare and administer the vaccine following manufacturers guidance which is outlined in CDCs Preparation and Administration summary below. It would be a travesty if we didnt mention this in the documentation for the public to show the concern that we have.. You can review and change the way we collect information below. The U.S. is getting another COVID-19 vaccine choice as the Food and Drug Administration on Wednesday cleared Novavax shots for adults. Dont yet have access? ET on February 28, 2023 until 11:59 p.m. But the Novavax process may not move so speedily: FDA says it needs additional manufacturing and product information before an EUA can be issued. Novavax has demonstrated its ability to quickly produce viable vaccine candidates for emerging infectious diseases such as COVID-19. Reporting is encouraged for other clinically significant adverse events, even if it is not clear that a vaccine caused the adverse event. Select one or more newsletters to continue. People who experience chest pain, shortness of breath and feelings of a fluttering or pounding heart should immediately seek medical attention, according to the FDA. COVID Novavax creates transformational vaccines that help address some of the worlds most pressing infectious diseases. Two doses of the Novavax vaccine were 90% effective at preventing illness from Covid across the board and 100% effective at preventing severe illness, according to clinical trial data from the U.S. and Mexico. 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. These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. We want to hear from you. Having a protein-based alternative may be more comfortable for some in terms of their acceptance of vaccines, Marks replied, noting that the law allows us some leeway to address unmet needs. FDA Approved: No (Emergency Use Authorization) The finished spike copies are injected into the human body, inducing an immune response against Covid. Its statement about its future financial framework was even more troubling, saying, Substantial doubt exists regarding our ability to continue over the next year. 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. Insight and analysis of top stories from our award winning magazine "Bloomberg Businessweek". Our Research: COVID-19 | Novavax - New Era of Revolutionary Mitsubishi Signs $1.9b Commuter Rail Deal With Manila: Nikkei, AllianceBernstein Wins China Approval to Set Up Mutual Fund Unit, Sorry, Fed, Most US Mortgage Rates Were Locked in During Pandemic Lows, Fed Says MoreRate Hikes Are Needed to Curb Inflation, US Service Sector Expands More Than Forecast Suggesting Hiring Success, Rivian Tells Staff EV Output May Be 24% More Than Forecast, China E-Commerce Giant JD Set for $1.4 Billion Discount Spree, SoftBanks Son to Join Modi at Oyo Founders Wedding Gala, US-Sanctioned Huawei Makes a Show of Force at Mobile Conference, Hong Kong Court Convicts Activists Behind Tiananmen Vigil, Bidens About-Face on DC Crime Bill Shows Democrats on Defensive, Wealthy NYC Family Feuds Over $258 Million Madison Avenue Sale, NYC TikTok Dating Diary Chronicles Love in the Time of Inflation, Tom Sizemore, 'Saving Private Ryan' actor, dies at 61, AP Says, The Exhibit Reality TV Show PittingArtist Against ArtistIs No Masterpiece, Video Roundup: Opinions Must-See Footage of the Week, How Democrats Got Away From Third Way Politics, YellowstoneBackers Wanted to Cash OutThen the Streaming Bubble Burst, How Countries Leading on Early Years of Child Care Get It Right, Female Execs Are Exhausted, Frustrated and Heading for the Exits, Harrods Shrugs Off Recession Fears as Rich Get Richer, FT Says, Biden Gives Medal of Honor to Trailblazing Special Forces Member, Panic Over Metals for EVs Goes All the Way to Automakers C-Suites, What Do You Want to See in a Covid Memorial? Novavax COVID-19 Vaccine FDA Approval Status - Drugs.com 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. 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. Major: Highly clinically significant. Myocarditis is an inflammation of the heart muscle and pericarditis is inflammation of the outer lining of the heart. 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. (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. 1. 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 vaccine maker that uncertainty over future funding for coronavirus shots has prompted substantial doubt about its ability to stay in business. 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. An 8-week interval is recommended between However, the trial was conducted from December 2020 through September 2021, months before the omicron variant became dominant. Generic name: SARS-CoV-2 vaccine Most reactions were mild or moderate, but reactogenicity was greater following the second dose. Novavax: FDA gives emergency use authorization to Covid-19 The .gov means its official.Federal government websites often end in .gov or .mil. Pavlo Gonchar | LightRocket | Getty Images, oted overwhelming in favor of Novavax's shot, changes to the company's manufacturing process, Lilly to cut insulin prices by 70%, cap prices at $35 per month for people with private insurance, FDA advisors recommend Pfizer RSV vaccine for older adults, despite possible Guillain-Barre risks, Novavax raises doubts about its ability to remain in business, Op-ed: DEA and FDA rules exacerbate Adderall shortage, Democratic attorneys general sue FDA to drop all remaining restrictions on abortion pill, FDA says Guillain-Barre syndrome is possible risk of Pfizers RSV vaccine for older adults, Medicare rejects Alzheimers Association request for unrestricted coverage of treatments like Leqembi, Moderna misses on earnings as costs rise from surplus production capacity, lower demand for Covid shots, West Virginia asks judge to dismiss lawsuit seeking to overturn state restrictions on abortion pill, CDC advisors recommend mpox vaccine for at-risk adults in future outbreaks, Flu vaccine was 68% effective at preventing hospitalization in children, but less protective for seniors this season, Pfizer RSV vaccine that protects infants could receive FDA approval this summer, Senators call on Medicare to offer broad coverage of Alzheimers treatments as public pressure grows, Maker of promising Alzheimers drug Leqembi expects full FDA approval this summer, expanded Medicare coverage. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS, (in thousands, except per share information). Novavax hopes holdouts skeptical of mRNA vaccines and, ultimately, others seeking booster shots will opt for its tried-and-true technology. *Included in current and noncurrent liabilities as of December 31, 2022 and non-current liabilities as of, Recombinant protein-based nanoparticle vaccine, Global vaccine authorization / approval map, Diversity matters: Inclusivity in clinical trials, From pandemic to endemic: Why COVID-19 may be here to stay, Standing on the shoulders of giants: How a Novavax vaccine is developed, Recombinant nanoparticle vaccine technology, Global vaccine authorization/approval map, Global authorization site of Novavax COVID-19 Vaccine (recombinant, adjuvanted), Ask medical questions, report adverse events, and product quality complaints, Pay Transparency Nondiscrimination Provision, Delivered over 100 million doses of Nuvaxovid, Novavax's COVID-19 vaccine, globally to date, Modified agreement with the U.S. government for up to 1.5 million additional doses of Novavax's COVID-19 vaccine for delivery in 2023, Agreement maintains the U.S. public's access to Novavax's COVID-19 vaccine and supports the development of smaller dose vials, strain selection in line with U.S. Food and Drug Administration (FDA) recommendations and a smooth transition to the commercial market, Reaffirmed intent to deliver an updated mono- or bivalent strain vaccine for the 2023 fall vaccination season, consistent with public health recommendations, Secured European Medicines Agency (EMA) and FDA approval of Nuvaxovid five-dose vial variation and EMA approval of the Company's, 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, Part 2 to evaluate our prototype vaccine compared to an Omicron BA.5 vaccine, as well as a bivalent containing prototype and Omicron BA.5 vaccine, Expanded Nuvaxovid label in adult booster and adolescent primary series to enable broader uptake in the long-term commercial market, Initiated Phase 2 dose-confirming trial to evaluate safety and immunogenicity of different formulations of CIC and influenza stand-alone vaccine candidates in adults aged 50 to 80 years, with topline results expected by mid-year 2023, CIC Phase 2 trial includes additional study arms exploring alternate influenza stand-alone formulations. WebOn February 1, 2022, FDA received a request from Novavax (the Sponsor) for emergency use authorization (EUA) of the Novavax COVID-19 Vaccine. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. To maximize our opportunities and mitigate the significant risks and uncertainties of the COVID-19 market, our goal is to reduce spend, extend our cash runway and operate efficiently to best position the company to deliver long-term growth. Amazon Pauses Construction At Second Headquarters Outside Washington D.C. Fox Unlikely To Settle With Dominion Over Election Lies As High-Stakes Trial Nears, Experts Say, Alex Murdaugh Was Found Guilty Of Murdering His Wife And SonHeres What Legal Experts Say Led To His Conviction, Murdaugh Gets Consecutive Life Sentences For Murdering Wife And Son, Everything You Need To Know About Mad Cow Disease After Brazil Confirms Infection, Latest Crypto Collapse: Bitcoin And Ethereums Losses Top $24 Billion As Silvergate Unravels, Walgreens Wont Sell Abortion Pills In These StatesEven Though Abortion Is Legal There, iPhone Maker Foxconn Reportedly Expands In India Amid Claims Apple Wants To Bolster Manufacturing There, Sen. Feinstein Hospitalized With ShinglesStraining Democrats Narrow Majority, FDA Authorizes Novavaxs Covid-19 Vaccine For Adults, How a Struggling Company Won $1.6 Billion to Make a Coronavirus Vaccine. Cookies used to enable you to share pages and content that you find interesting on CDC.gov through third party social networking and other websites. Previous Name: NVX-CoV2373 A replay of the webcast will be available on the Novavax website until May 28, 2023. All Rights Reserved. The US Food and Drug Administration on Wednesday authorized Novavaxs Covid-19 vaccine for emergency use in adults. Novavax COVID-19 Vaccine, Adjuvanted received Emergency Use Authorization to protect against COVID-19. The Phase 2 dose-confirmation trial will be conducted in two parts. A two-dose primary series to individuals 12 years of age and older. Sign up for free newsletters and get more CNBC delivered to your inbox. Johnson & Johnson's Janssen vaccine uses a cell line that was originally developed from an abortion. Novavax reported fourth-quarter losses of $182 million after only posting $357 million in saleswell below expectations of $383 million. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Complete and submit reports to VAERS online. WebThese classifications are only a guideline. That could happen as soon as next Tuesday, when the agency's outside vaccine advisers are next scheduled to meet. Saving Lives, Protecting People, National Center for Immunization and Respiratory Diseases, Use of COVID-19 Vaccines in the U.S.: Appendices, FAQs for the Interim Clinical Considerations, Myocarditis and Pericarditis Considerations, Jurisdictions: Vaccinating Older Adults and People with Disabilities, Vaccination Sites: Vaccinating Older Adults and People with Disabilities, Vaccinating Patients upon Discharge from Hospitals, Emergency Departments & Urgent Care Facilities, Vaccines for Children Program vs. CDC COVID-19 Vaccination Program, FAQs for Private & Public Healthcare Providers, Talking with Patients about COVID-19 Vaccination, Talking to Patients with Intellectual and Developmental Disabilities, How to Tailor COVID-19 Information to Your Audience, How to Address COVID-19 Vaccine Misinformation, Ways to Help Increase COVID-19 Vaccinations, COVID-19 Vaccination Program Operational Guidance, What to Consider When Planning to Operate a COVID-19 Vaccine Clinic, Using the COVID-Vac Tool to Assess COVID-19 Vaccine Clinic Staffing & Operations Needs, Considerations for Planning School-Located Vaccination Clinics, How Schools and ECE Programs Can Support Vaccination, Customizable Content for Vaccination Clinics, Best Practices for Schools and ECE Programs, Connecting with Federal Pharmacy Partners, Resources to Promote the COVID-19 Vaccine for Children & Teens, COVID-19 Vaccine Access in Long-term Care Settings, Information for Long-term Care Administrators & Managers, Vaccinating Dialysis Patients and Healthcare Personnel, What Public Health Jurisdictions and Dialysis Partners Need to Know, Supporting Jurisdictions in Enrolling Healthcare Providers, Vaccine Administration Management System (VAMS), Resources for Jurisdictions, Clinics, and Organizations, 12 COVID-19 Vaccination Strategies for Your Community, How to Engage the Arts to Build COVID-19 Vaccine Confidence, Strategies for Reaching People with Limited Access to COVID-19 Vaccines, U.S. Department of Health & Human Services. The You will be subject to the destination website's privacy policy when you follow the link. Prepare and administer the vaccine following manufacturers guidance John Deere boasted record profits in 2021 and finally struck a deal with striking union workers. 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. Omicron is so distinct from the original strain of Covid that the antibodies produced by the vaccines have trouble recognizing and attacking the variant. It was the generation of the assays to illustrate that we could make the product over and over again, the same way, and to deploy those assays against the multiple lots," said Novavax's Filip Dubovsky. Use of the Novavax COVID-19 Vaccine, Adjuvanted in the U.S. FDA advisers greenlight Novavax COVID-19 vaccine. Pfizer and Moderna's vaccines use mRNA, a molecule encoded with genetic instructions, to tell human cells to produce copies of a virus particle called the spike protein. Myocarditis is usually caused by viral infections. To access the replay by telephone, dial (877) 344-7529 (Domestic) or (412) 317-0088 (International) and use passcode 1137418. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. This kind of technique, called protein subunit vaccines, has long been used widely in other shots. Novavax is not responsible for the privacy policy of any third-party websites. So I think that is likely a cause and not a coincidental association.. Only about 80,000 Novavax shots have reportedly been given in the U.S., compared to hundreds of millions of Pfizer and Moderna doses. Download a prevaccination checklist in multiple languages. When added to vaccines, Novavax's patented saponin-based Matrix-M adjuvant enhances the immune system response, making it broader, and more durable. These cookies may also be used for advertising purposes by these third parties. The first data on those shots are expected "in the late summer or fall," the company says. 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. The Novavax vaccine against COVID-19: What you need to know Alex Murdaugh sentenced to life in prison for murders of wife and son, Biden had cancerous skin lesion removed last month, doctor says, White supremacist and Holocaust denier Nick Fuentes kicked out of CPAC, Tom Sizemore, actor known for "Saving Private Ryan" and "Heat," dies at 61, Biden team readies new advisory panel ahead of expected reelection bid, At least 10 dead after winter storm slams South, Midwest, House Democrats unhappy with White House handling of D.C.'s new criminal code. Prepare and administer the appropriate product based on the recipients age. Novavax has otherwise touted its use of older vaccine 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. Vaccines The company says it has more than 1,500 employees. Still, Gellin said, This vaccine has incredible potential. It is easy to store and transport, lasting at refrigerator temperatures for months, unlike the dominant messenger RNA (mRNA) vaccines. The recipients health condition or recommendations for vaccination may change from one visit to the next. of The Phase 1/2 randomized, observer-blinded, placebo-controlled trial of NVXCoV2373 commenced in May 2020 and included 131 healthy volunteers aged 18-59 years at two Australian sites (Melbourne and Brisbane). Saving Lives, Protecting People, National Center for Immunization and Respiratory Diseases, Use of COVID-19 Vaccines in the U.S.: Appendices, FAQs for the Interim Clinical Considerations, Myocarditis and Pericarditis Considerations, Jurisdictions: Vaccinating Older Adults and People with Disabilities, Vaccination Sites: Vaccinating Older Adults and People with Disabilities, Vaccinating Patients upon Discharge from Hospitals, Emergency Departments & Urgent Care Facilities, Vaccines for Children Program vs. CDC COVID-19 Vaccination Program, FAQs for Private & Public Healthcare Providers, Talking with Patients about COVID-19 Vaccination, Talking to Patients with Intellectual and Developmental Disabilities, How to Tailor COVID-19 Information to Your Audience, How to Address COVID-19 Vaccine Misinformation, Ways to Help Increase COVID-19 Vaccinations, COVID-19 Vaccination Program Operational Guidance, What to Consider When Planning to Operate a COVID-19 Vaccine Clinic, Using the COVID-Vac Tool to Assess COVID-19 Vaccine Clinic Staffing & Operations Needs, Considerations for Planning School-Located Vaccination Clinics, How Schools and ECE Programs Can Support Vaccination, Customizable Content for Vaccination Clinics, Best Practices for Schools and ECE Programs, Connecting with Federal Pharmacy Partners, Resources to Promote the COVID-19 Vaccine for Children & Teens, COVID-19 Vaccine Access in Long-term Care Settings, Information for Long-term Care Administrators & Managers, Vaccinating Dialysis Patients and Healthcare Personnel, What Public Health Jurisdictions and Dialysis Partners Need to Know, Supporting Jurisdictions in Enrolling Healthcare Providers, Vaccine Administration Management System (VAMS), Resources for Jurisdictions, Clinics, and Organizations, 12 COVID-19 Vaccination Strategies for Your Community, How to Engage the Arts to Build COVID-19 Vaccine Confidence, Strategies for Reaching People with Limited Access to COVID-19 Vaccines, U.S. Department of Health & Human Services. 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. You are encouraged to read our filings with the SEC, available at www.sec.govand www.novavax.com, for a discussion of these and other risks and uncertainties. "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 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. About the COVID-19-Influenza Combination (CIC) Vaccine Candidate Phase 2 Trial. Novavax COVID-19 Vaccine (SARS-CoV-2 vaccine) Consumer information. Earliest evidence of horseback riding found in eastern cowboys, Funding woes force 500 Women Scientists to scale back operations, Lawmakers offer contrasting views on how to compete with China in science, U.K. scientists hope to regain access to EU grants after Northern Ireland deal, Astronomers stumble in diplomatic push to protect the night sky, Satellites spoiling more and more Hubble images, Pablo Neruda was poisoned to death, a new forensic report suggests, Europes well-preserved bog bodies surrender their secrets, Teens leukemia goes into remission after experimental gene-editing therapy, Novavaxs long-awaited COVID-19 vaccine authorizations offer an alternative to mRNA, Vaccine designers take first shots at COVID-19, Novavax launches pivotal U.S. trial of dark horse COVID-19 vaccine after manufacturing delays. Centers for Disease Control and Prevention. Updated on: July 13, 2022 / 5:00 PM The fact sheets authorized for Novavax's shots will ultimately include the warning, the FDA said. Always consult your healthcare provider before 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. The accompanying condensed consolidated financial statements have been prepared assuming Novavax will continue as a going concern. It could be the next thing that saves your life or your loved ones life.. Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. FDA authorization of Novavax's vaccine was delayed for weeks as the agency reviewed changes to the company's manufacturing process. Their hesitancy is more ideological than technological., But a parade of public speakers at the meeting mostly urged the committee to authorize the vaccine. Myocarditis concerns may also dog the vaccine. Three cases were in men ages 16 to 20. The trade name Nuvaxovid has not yet been approved by the U.S. Food and Drug Administration. InvestorsErika Schultz | 240-268-2022ir@novavax.com, MediaAli Chartan or Giovanna Chandler | 202-709-5563media@novavax.com, Novavax is proud to be recognized by the 2021 Top Workplaces USA, reflecting our dedication to an exceptional work culture. Novavax's vaccine might also overcome some religious objections that have been lodged over how the Moderna and Pfizer-BioNTech shots were initially studied. Statements herein relating to the future of Novavax, its near term priorities including delivering an updated vaccine for the 2023 fall vaccination season, streamlining its investment and organizational structure and building value for Novavax from its technology platform and Matrix-M adjuvant, its operating plans, objectives and prospects, including Novavax's ability to continue as a going concern within one year after the issuance date of the financial statements for the year ended December 31, 2022, its anticipated strategic plan, its future financial or business performance, conditions or strategies, its partnerships, the timing of clinical trial results, the ongoing development of NVX-CoV2373, and a bivalent or monovalent Omicron-based / original strain based vaccine, the CIC investigational vaccine candidate, a quadrivalent influenza investigational vaccine candidate, the scope, timing and outcome of future and pending regulatory filings and actions and additional worldwide authorizations of NVX-CoV2373 for use in adults and adolescents and as a booster, are forward-looking statements.