It is the fourth coronavirus vaccine 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. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. 1. The Novavax COVID-19 vaccine has been authorized for emergency use by the U.S. Food and Drug Administration (FDA), the agency announced Wednesday. of A spokesperson for the Department of Health and Human Services did not return a request for comment. 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. articles a month for anyone to read, even non-subscribers! 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. Primary series:Two-dose primary series given three weeks apart, for individuals 16 years and older. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. But Paul Offit, a committee member and infectious disease physician at the Childrens Hospital of Philadelphia, told todays meeting that the handful of cases of myocarditis [that] occurred within 3 or 4 days of receiving the second dose of vaccine in young men is consistent with what was seen with the mRNA-induced myocarditis. 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. 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. CDC twenty four seven. However, the trial was conducted from December 2020 through September 2021, months before the omicron variant became dominant. 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Criminal Justice ReformsHeres Why. ET on March 7, 2023. Four occurred within 20 days of vaccination, a time frame during which there were no cases in the placebo arm. All Rights Reserved. Generic name: SARS-CoV-2 vaccine 10+ years. 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. Novavax was one of the original participants in the U.S. government's race to develop a Covid vaccine in 2020, receiving $1.8 billion in taxpayer funding from Operation Warp Speed. "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. These data will inform the phase 3 trials for both influenza stand-alone and COVID-19-influenza combination vaccine candidates. The Food and Drug Administration o n Wednesday authorized a Covid-19 vaccine developed by Novavax, a biotechnology company in Maryland that Myocarditis is usually caused by viral infections. If we've learned anything from the COVID-19 pandemic, it's that we cannot wait for a crisis to respond. Like the other available COVID-19 vaccines, Novavax's shots will need to be formally recommended by the Centers for Disease Control and Prevention before they can be made available. 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. We believe that the totality of the clinical evidence here is not enough to establish an overall causal relationship with the vaccine, Denny Kim, Novavaxs chief safety officer, told the FDA advisers. First published on July 13, 2022 / 4:18 PM. July 13, 2022. Novavax's vaccine, like all the other shots, is based on the original version of the virus that first emerged in Wuhan, China. A replay of the conference call will be available starting at 7:30 p.m. Get more great content like this delivered right to you! 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. Anything we can do to get people to be able to accept these potentially lifesaving medical products is something that we feel we are compelled to do.. Individuals 18 years of age and older 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 trade name Nuvaxovid has not yet been approved by the U.S. Food and Drug Administration. Novavax makes copies of the virus spike outside human cells. Tracking Covid-19. The FDA has authorized Novavaxs COVID-19 vaccine in the United States. We are a biotechnology company committed to help address serious infectious disease globally through the discovery, development, and delivery of innovative vaccines to patients around the world. Novavax's vaccine might also overcome some religious objections that have been lodged over how the Moderna and Pfizer-BioNTech shots were initially studied. Previous Name: NVX-CoV2373 Find information and resources for each of the available Novavax COVID-19 Vaccines. Reporting is encouraged for other clinically significant adverse events, even if it is not clear that a vaccine caused the adverse event. The company has said it plans to pursue an authorization for its current vaccine to be used as a booster shot as well. Unlike the other three, which deliver genetic material that directs host cells to make the coronavirus spike protein, Novavaxs product delivers spike protein directly to recipients. Thank you for taking the time to confirm your preferences. We caution investors not to place considerable reliance on forward-looking statements contained in this press release. The recipients health condition or recommendations for vaccination may change from one visit to the next. Alastair Grant, Associated Press. 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. With Novavax, each vaccine is spaced three weeks apart. Some 3.2 million doses of Novavax's vaccine have been secured by the Biden administration. Focused on the world's most urgent health challenges, Novavax is currently evaluating vaccines for COVID-19, influenza, and COVID-19 and influenza combined. 2023 American Association for the Advancement of Science. The maker of the only traditional COVID-19 vaccine still widely available in the United States is raising doubts about its ability to stay in business. 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. SAGE recommends the use of the Novavax (NVX-CoV2373) vaccine as 2 doses (0.5 ml) given intramuscularly. Novavax creates transformational vaccines that help address some of the worlds most pressing infectious diseases. Latest update. Novavax COVID-19 Vaccine, Adjuvanted is available under emergency use authorization (EUA) to prevent COVID-19 in individuals 12 years of age and older. Novavaxs vaccine was the fourth to reach the U.S. market, entering U.S. arms more than a year after Pfizer, Moderna and Johnson & Johnson. Dosage form: intramuscular injection 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. 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. Stock is most profitable biotech short since pandemic high: S3, Company valuation topped $20 billion amid 2021s biotech mania. The relevance of a particular drug interaction to a specific individual is difficult to determine. Please enter valid email address to continue. The Novavax COVID-19 Vaccine (NVX-CoV2373) is an investigational SARS-CoV-2 vaccine for the prevention of COVID-19. The Novavax COVID-19 Vaccine (NVXCoV2373) is engineered from the genetic sequence of SARSCoV2, and uses recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein. The first part seeks to enroll a total of approximately 1,500 participants in Australia and New Zealand. 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. 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). Amazon Pauses Construction At Second Headquarters Outside Washington D.C. 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FDA authorization of Novavax's 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 against the virus. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS, (in thousands, except per share information). Select one or more newsletters to continue. The Perhaps in response to the volatility, NASDAQ froze trading of the stock today before the meeting opened. Thank you for taking the time to confirm your preferences. These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. It could be the next thing that saves your life or your loved ones life.. 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. CDC twenty four seven. The Matrix-M adjuvant stimulates the entry of antigen-presenting cells at the injection site and enhances antigen presentation in local lymph nodes. FDA requires vaccination providers to report vaccine administration errors, serious adverse events, cases of multisystem inflammatory syndrome, and cases of COVID-19 that result in hospitalization or death after administration of COVID-19 vaccine under an EUA. Follow the COVID-19 vaccination schedule (below) based on age and medical condition. Credit: Unsplash/CC0 Public Domain. You have selected a link that will take you to a site maintained by a third party who is solely responsible for its contents. These cookies perform functions like remembering presentation options or choices and, in some cases, delivery of web content that based on self-identified area of interests. This type of heart inflammation side effect has also been noted by the CDC as a "rare risk" associated with the mRNA vaccines from Pfizer-BioNTech and Moderna, according to multiple studies. 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. Initial results are expected mid-year 2023. 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. 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. This special highlights the best of the fifth annual event which was held in Singapore from November 14-17. The U.S. is getting another COVID-19 vaccine choice as the Food and Drug Administration on Wednesday cleared Novavax shots for adults. 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 uses a protein-based technology, a more traditional approach than the novel technologies used by other vaccine manufacturers. 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. Young men have had the highest rates of myocarditis or pericarditis after receiving mRNA vaccines. We take your privacy seriously. WebNovavax COVID-19 vaccine (recombinant, adjuvanted) is now conditionally authorized in several regions. 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. The company is among the original roster of Operation Warp Speed contracted vaccines from 2020. Brand name: Novavax COVID-19 Vaccine Company: Novavax, Inc. Clinical trial data shows the shot to be highly effective with fewer side effects than other vaccines available in the U.S. The finished spike copies are injected into the human body, inducing an immune response against Covid. Certainly the benefits outweigh the risks, said adviser Michael Nelson, an allergist and immunologist at the University of Virginia School of Medicine. 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. All rights reserved. The Novavax shot is based on more conventional protein technology used for decades in hepatitis B and HPV vaccines, while Pfizer and Moderna are the first FDA approved vaccines to use mRNA. 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). 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. The Centers for Disease Control and Prevention still needs to sign off on Novavax's vaccine before pharmacies and other health-care providers can start administering shots. You may opt-out by. Novavax COVID-19 Vaccine, Adjuvanted contains the SARS-CoV-2 spike protein and Matrix-M adjuvant. The vaccine is authorized for emergency use to provide: Novavax COVID-19 Vaccine, Adjuvanted contains the SARS-CoV-2 spike protein and Matrix-M adjuvant. A first booster dose to the following individuals at least 6 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine: Individuals 18 years of age and older for whom an FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate. FDA authorization of Novavax's vaccine was delayed for weeks as the agency reviewed changes to the company's manufacturing process. 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In addition, the company struggled mightily to show it could make the vaccine consistently. Alastair Grant, Associated Press. 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. Please make a tax-deductible gift today. Novavax has otherwise touted its use of older vaccine Novavax presented data at an FDA committee meeting in late June demonstrating that a third dose of its vaccine produced a strong immune response against omicron and its subvariants. 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). Novavax reported fourth-quarter losses of $182 million after only posting $357 million in saleswell below expectations of $383 million. Investors, potential investors, and others should give careful consideration to these risks and uncertainties. They help us to know which pages are the most and least popular and see how visitors move around the site. The trial assessed two doses (5 and 25 g), each with 50 g of MatrixM. Last updated by Melisa Puckey, BPharm on Oct 19, 2022. Their hesitancy is more ideological than technological., But a parade of public speakers at the meeting mostly urged the committee to authorize the vaccine. It worked. These events raise the concern for a causal association with this vaccine, similar to the association documented with mRNA COVID-19 vaccines, FDA wrote. Novavax hopes holdouts skeptical of mRNA vaccines and, ultimately, others seeking booster shots will opt for its tried-and-true technology. It would be a travesty if we didnt mention this in the documentation for the public to show the concern that we have.. Approved vaccines for shingles, hepatitis B, and influenza use similar protein-based technology. 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. The fact sheets authorized for Novavax's shots will ultimately include the warning, the FDA said. 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. WebNovavax COVID-19 Vaccine, Adjuvanted is available under emergency use authorization (EUA) to prevent COVID-19 in individuals 12 years of age and older. That could happen as soon as next Tuesday, when the agency's outside vaccine advisers are next scheduled to meet. The shots consist of 5 micrograms of the spike copy and 50 micrograms of the adjuvant. We take your privacy seriously. Novavax Statement on Proof of COVID-19 Vaccine Requirements for PREVENT-19 Clinical Trial Participants in the U.S. Novavax to Participate in University of Oxford Com-COV3 Study Comparing Mixed COVID-19 Vaccine Schedule in Adolescents, Novavax Statement on CDC Guidance Update for COVID-19 Clinical Trial Participants, Novavax to Participate in OCTAVE-DUO Study to Evaluate Third Dose of Vaccine in Participants with Impaired Immune Systems, Novavax Announces COVID-19 Vaccine Booster Data Demonstrating Four-Fold Increase in Neutralizing Antibody Levels Versus Peak Responses After Primary Vaccination, Novavax Publishes Results of United Kingdom Phase 3 Clinical Trial in New England Journal of Medicine, Demonstrating High Levels of Efficacy of COVID-19 Vaccine, Novavax Announces Positive Results from First Study of Influenza Vaccine and COVID-19 Vaccine Candidate Administered Simultaneously, Novavax COVID-19 Vaccine Demonstrates 90% Overall Efficacy and 100% Protection Against Moderate and Severe Disease in PREVENT-19 Phase 3 Trial, U.S. Clinical Trial Results Show Novavax Vaccine is Safe and Prevents COVID-19, Novavax Announces Positive Data from Three Complementary Studies of COVID-19 Beta (B.1.351) Variant Strain Vaccine, New England Journal of Medicine Publishes Phase 2b Clinical Trial Results Demonstrating Efficacy of Novavax COVID-19 Vaccine Against the B.1.351 Variant, Novavax Initiates Pediatric Expansion for Phase 3 Clinical Trial of COVID-19 Vaccine, Novavax to Participate in University of Oxford Com-COV2 Study Comparing Mixed COVID-19 Vaccine Combinations, Novavax Initiates COVID-19 Vaccine Clinical Trial Crossover, Novavax Confirms High Levels of Efficacy Against Original and Variant COVID-19 Strains in United Kingdom and South Africa Trials, Novavax and Takeda Finalize License Agreement for Novavax COVID-19 Vaccine Candidate in Japan; Takeda Initiates Phase 1/2 Trial in Japan, Novavax Completes Enrollment of PREVENT-19, COVID-19 Vaccine Pivotal Phase 3 Trial in the United States and Mexico, Novavax Announces Memorandum of Understanding with Gavi for Cumulative Supply to COVAX Facility of 1.1 Billion Doses of COVID-19 Vaccine, Novavax Announces Expanded Collaboration and License Agreement with SK Bioscience for 40 Million Doses of COVID-19 Vaccine for South Korea, Novavax Announces Start of Rolling Review by Multiple Regulatory Authorities for COVID-19 Vaccine Authorization, Novavax and Government of Switzerland Announce Agreement in Principle to Supply COVID-19 Vaccine, Novavax COVID-19 Vaccine Demonstrates 89.3% Efficacy in UK Phase 3 Trial, Novavax and Government of Canada Finalize Advance Purchase Agreement for COVID-19 Vaccine, Novavax Finalizes Agreement with Commonwealth of Australia for 51 Million Doses of COVID-19 Vaccine, Novavax Announces Initiation of PREVENT-19 Pivotal Phase 3 Efficacy Trial of COVID-19 Vaccine in the United States and Mexico, Novavax Announces Agreement with Government of New Zealand for 10.7 Million Doses of COVID-19 Vaccine, Novavax Announces COVID-19 Vaccine Clinical Development Progress, Novavax COVID-19 Vaccine Granted Fast Track Designation by U.S. FDA, Novavax and Commonwealth of Australia Announce Agreement in Principle for Acquisition of Novavax COVID-19 Vaccine, Novavax Announces Facility Expansion to Support Global Vaccine Development, Novavax Provides Phase 3 COVID-19 Vaccine Clinical Development Update, Novavax Initiates Phase 3 Efficacy Trial of COVID-19 Vaccine in the United Kingdom, Novavax Announces COVID-19 Vaccine Manufacturing Agreement with Serum Institute of India, Increasing Novavax Global Production Capacity to Over 2 Billion Doses Annually, Novavax Announces Publication of Phase 1 Data for COVID-19 Vaccine Candidate in The New England Journal of Medicine, Novavax Initiates Phase 2 Portion of Phase 1/2 Clinical Trial of COVID-19 Vaccine, Novavax Initiates Efficacy Trial of COVID-19 Vaccine in South Africa, Novavax and Takeda Announce Collaboration for Novavax COVID-19 Vaccine Candidate in Japan, Novavax and Serum Institute of India Announce Development and Commercial Collaboration, Novavax Announces Positive Phase 1 Data for its COVID-19 Vaccine Candidate, Novavax and FUJIFILM Diosynth Biotechnologies Initiate Large Scale Manufacturing of COVID-19 Vaccine Candidate, Novavax Announces $1.6 Billion Funding from Operation Warp Speed, Novavax Awarded Department of Defense Contract for COVID-19 Vaccine, Novavax Initiates Phase 1/2 Clinical Trial of COVID-19 Vaccine.