novavax covid vaccine fda novavax covid vaccine fda

It could be the next thing that saves your life or your loved ones life.. 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 AAAS is a partner of HINARI, AGORA, OARE, CHORUS, CLOCKSS, CrossRef and COUNTER. "Our vaccine has been demonstrated to be efficacious against variants, induces broad immune responses against Omicron variants, and this may be the best choice for people who prefer a vaccine with an extensive safety and efficacy database," Novavax's Gregory Glenn told the FDA's advisers at a meeting in late June. 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. All information these cookies collect is aggregated and therefore anonymous. If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance. Prepare and administer the appropriate product based on the recipients age. The U.S. is getting another COVID-19 vaccine choice as the Food and Drug Administration on Wednesday cleared Novavax shots for adults. Its statement about its future financial framework was even more troubling, saying, Substantial doubt exists regarding our ability to continue over the next year. 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. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS, (in thousands, except per share information). Last updated by Melisa Puckey, BPharm on Oct 19, 2022. Novavax, on the other hand, includes the proteins in its vaccine. However, 27 million adults still have not gotten a single shot yet, according to CDC data from June. Novavax raised doubts about its future Tuesday as concerns grow about whether the Covid vaccine [+] maker will ever get a significant foothold in the United States. 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. 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. Novavax uses a protein-based technology, a more traditional approach than the novel technologies used by other vaccine manufacturers. This is a case study of perseverance, Bruce Gellin, chief of global public health strategy at the Rockefeller Foundation, said after the vote. A man receives a Novavax injection in Seattle in February 2021 as part of the companys North American clinical trial. (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. When FDAs advisers gave a green light to the Moderna and Pfizer vaccines in late 2020, the agency acted quickly to issue EUAs for those vaccines. Generic name: SARS-CoV-2 vaccine FDA authorization of Novavax's vaccine was delayed for weeks as the agency reviewed changes to the company's manufacturing process. ET. The Phase 2 dose-confirmation trial will be conducted in two parts. 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. 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. July 13, 2022. Alastair Grant, Associated Press. Waning interest in Covid-19 vaccines has left a long-standing drug developer, Novavax Inc., struggling to stay afloat and handed short sellers 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. Similar to the Pfizer-BioNTech and Moderna COVID-19 vaccines, the Novavax vaccine is administered in two doses, per the FDA. 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 Stock is most profitable biotech short since pandemic high: S3, Company valuation topped $20 billion amid 2021s biotech mania. Novavax will likely cut some jobs to reduce its hot rate of spending, CEO John Jacobs told Reuters. For further assistance with reporting to VAERS, call 1-800-822-7967. Novavax countered that collectively across all of its clinical trials, the risk of myocarditis and pericarditis was not significantly different in the vaccine group (0.007%) and in the placebo groups (0.005%). It contains Novavaxs patented saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. Myocarditis concerns may also dog the 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. Early in their development, studies of those two vaccines included testing on a controversial cell line linked to an abortion in the 1970s that is widely used in medical research though neither shot ultimately uses any fetal tissue in manufacturing their vaccines. 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. Subscribe to News from Science for full access to breaking news and analysis on research and science policy. Novavax has demonstrated its ability to quickly produce viable vaccine candidates for emerging infectious diseases such as COVID-19. The FDA has authorized Novavaxs COVID-19 vaccine in the United States. That could happen as soon as next Tuesday, when the agency's outside vaccine advisers are next scheduled to meet. 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. Previous Name: NVX-CoV2373 The Food and Drug Administration o n Wednesday authorized a Covid-19 vaccine developed by Novavax, a biotechnology company in Maryland that 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. The relevance of a particular drug interaction to a specific individual is difficult to determine. Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. In this photo illustration the Food and Drug Administration (FDA) and Novavax logos are seen behind a medical syringe and vials. FDA officials flagged four cases of myocarditis and pericarditis from Novavax's clinical trial in young men ages 16 to 28. A replay of the conference call will be available starting at 7:30 p.m. We take your privacy seriously. The shots consist of 5 micrograms of the spike copy and 50 micrograms of the adjuvant. But now it has a bigger problem: farmers are revolting against restrictions on how they repair complex equipment. Alastair Grant, Associated Press. Most reactions were mild or moderate, but reactogenicity was greater following the second dose. Novavax's vaccine might also overcome some religious objections that have been lodged over how the Moderna and Pfizer-BioNTech shots were initially studied. 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. But it's unclear when or how many of those doses will be initially available for states and pharmacies to order. "Today's authorization offers adults in the United States who have not yet received a COVID-19 vaccine another option that meets the FDA's rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization," said FDA Commissioner Dr. Robert Califf in a release on Wednesday. Three cases were in men ages 16 to 20. 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. (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 If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. 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. When added to vaccines, Novavax's patented saponin-based Matrix-M adjuvant enhances the immune system response, making it broader, and more durable. It worked. We comply with the HONcode standard for trustworthy health information. A Division of NBCUniversal. 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. Novavax hopes holdouts skeptical of mRNA vaccines and, ultimately, others seeking booster shots will opt for its tried-and-true technology. 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. The maker of the only traditional COVID-19 vaccine still widely available in the United States is raising doubts about its ability to stay "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. 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.. Adverse events that occur in a recipient after COVID-19 vaccination are required to be reported to the Vaccine Adverse Event Reporting System (VAERS). 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. The company is among the original roster of Operation Warp Speed contracted vaccines from 2020. Please enter valid email address to continue. The relevance of a particular drug interaction to a specific individual is difficult to determine. You will be subject to the destination website's privacy policy when you follow the link. All information these cookies collect is aggregated and therefore anonymous. Tracking Covid-19. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. 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. We want to hear from you. Get browser notifications for breaking news, live events, and exclusive reporting. WebThese classifications are only a guideline. 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'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. 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 emergency use by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19). WebThe recipients health condition or recommendations for vaccination may change from one visit to the next. 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 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. 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. 2 billion. 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. 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. 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. We need to provide options to reduce excuses, Martha Dawson, president of the National Black Nurses Association, told the advisers. ET on March 7, 2023. They help us to know which pages are the most and least popular and see how visitors move around the site. 10+ years. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. 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. WebAmpoules containing the COVID-19 vaccine Nuvaxovid from the manufacturer Novavax sit on a table at a vaccination center on April 1, 2022, in Quedlinburg, Germany. In July 2022, the FDA authorized the Novavax COVID-19 vaccine for adults. These cookies may also be used for advertising purposes by these third parties. 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. CBS News reporter covering public health and the pandemic. Meredith Wadman's beat includes biology research, policy, and sexual harassment . 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. 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. They help us to know which pages are the most and least popular and see how visitors move around the site. 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. Prepare and administer the vaccine following manufacturers guidance which is outlined in CDCs Preparation and Administration summary below. ", "Over the past few weeks, the management team and I have identified three near-term priorities that we believe are essential to our success this year and beyond: 1) to deliver a competitive product for the upcoming 2023 fall vaccination season; 2) to reduce our rate of spend, manage our cash flow, and evolve our scale and structure; and 3) to leverage our technology platform, our capabilities and our portfolio of assets to drive additional value beyond Nuvaxovid alone. Johnson & Johnson's Janssen vaccine uses a cell line that was originally developed from an abortion. Perhaps in response to the volatility, NASDAQ froze trading of the stock today before the meeting opened. Novavax creates transformational vaccines that help address some of the worlds most pressing infectious diseases. 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. Primary series:Two-dose primary series given three weeks apart, for individuals 16 years and older. Thank you for taking the time to confirm your preferences. The Department of Health and Human Services said Monday that it is still conducting quality testing of the Novavax vaccine. However, the vaccine will likely have lower effectiveness against omicron as is the case with Pfizer and Moderna's shots. WebNovavax COVID-19 vaccine (recombinant, adjuvanted) is now conditionally authorized in several regions. 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. We take your privacy seriously. Novavax published data in December showing that a third shot boosted the immune response to levels comparable to the first two doses which had 90% effectiveness against illness. All Rights Reserved. Credit: Unsplash/CC0 Public Domain. ET on February 28, 2023 until 11:59 p.m. 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. The Novavax COVID-19 vaccine has been authorized for emergency use by the U.S. Food and Drug Administration (FDA), the agency announced Wednesday. 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. Get this delivered to your inbox, and more info about our products and services. We believe that if we succeed in executing against these priorities, we will position the company well for long-term success. Help News from Science publish trustworthy, high-impact stories about research and the people who shape it. maker will ever get a significant foothold in the United States. The Matrix-M adjuvant stimulates the entry of antigen-presenting cells at the injection site and enhances antigen presentation in local lymph nodes. 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. 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. An 8-week interval is recommended between With Novavax, each vaccine is spaced three weeks apart. Bets against the company have earned shorts about $2.7 billion from the stocks 2021 zenith through Wednesday, S3 Partners compiled data show. 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. 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. The fact sheets authorized for Novavax's shots will ultimately include the warning, the FDA said. 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. Initial results are expected mid-year 2023. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. Cookies used to make website functionality more relevant to you. Novavax' vaccine is the first protein-based COVID-19 vaccine authorized in the U.S. The site is secure. 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.