novavax covid vaccine fda

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 vaccine, like all the other shots, is based on the original version of the virus that first emerged in Wuhan, China. 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. 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) Previous Name: NVX-CoV2373 Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. The relevance of a particular drug interaction to a specific individual is difficult to determine. Novavax on Wednesday received Food and Drug Administration authorization for a booster dose of its COVID-19 vaccine. FDA advisers greenlight Novavax COVID-19 vaccine - Science Novavaxs Covid-19 vaccine was the first product the 36-year-old company brought to the market. 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. It was reportedly nearing collapse in 2020 before the Trump Administration awarded it a $1.6 billion contract to develop a vaccine as part of Operation Warp Speed. 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. FDA Our Research: COVID-19 | Novavax - New Era of Revolutionary Cookies used to make website functionality more relevant to you. However, the trial was conducted from December 2020 through September 2021, months before the omicron variant became dominant. Novavax COVID-19 Vaccine, Adjuvanted received Emergency Use Authorization to protect against COVID-19. The CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. Sign up for free newsletters and get more CNBC delivered to your inbox. 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. 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. 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. Novavax has demonstrated its ability to quickly produce viable vaccine candidates for emerging infectious diseases such as COVID-19. 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. When added to vaccines, Novavax's patented saponin-based Matrix-M adjuvant enhances the immune system response, making it broader, and more durable. If we've learned anything from the COVID-19 pandemic, it's that we cannot wait for a crisis to respond. Prepare and administer the vaccine following manufacturers guidance which is outlined in CDCs Preparation and Administration summary below. Focused on the world's most urgent health challenges, Novavax is currently evaluating vaccines for COVID-19, influenza, and COVID-19 and influenza combined. WebNovavax COVID-19 Vaccine, Adjuvanted is available under emergency use authorization (EUA) to prevent COVID-19 in individuals 12 years of age and older. The trial assessed two doses (5 and 25 g), each with 50 g of MatrixM. Brand name: Novavax COVID-19 Vaccine Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. Alastair Grant, Associated Press. 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. 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. (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 An official website of the United States government, : 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. 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. ET. 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. WebThe recipients health condition or recommendations for vaccination may change from one visit to the next. 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. The Food and Drug Administration advisory committee recommends the agency authorize another COVID-19 vaccine in the hopes it might entice more people to *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. 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). Updated on: July 13, 2022 / 5:00 PM Data is a real-time snapshot *Data is delayed at least 15 minutes. An additional Phase 3 pivotal clinical trial conducted in the United States and Mexico commenced December 2020 and included 30,000 participants with proportional representation among diverse populations most vulnerable to COVID-19 distributed across race/ethnicity, age, and those living with co-morbidities. 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. Clinical trial data shows the shot to be highly effective with fewer side effects than other vaccines available in the U.S. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS, (in thousands, except per share information). John Deere boasted record profits in 2021 and finally struck a deal with striking union workers. Novavax seeks FDA emergency use authorization of its coronavirus vaccine Novavaxs request for authorization was based on data including the results of two large Thank you for taking the time to confirm your preferences. 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. 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. How To Get Novavax, the Recently Authorized COVID-19 Novavax COVID-19 Vaccine, Adjuvanted is available under emergency use authorization (EUA) to prevent COVID-19 in individuals 12 years of age and older. 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. An 8-week interval is recommended between Waning interest in Covid-19 vaccines has left a long-standing drug developer, Novavax Inc., struggling to stay afloat and handed short sellers Help News from Science publish trustworthy, high-impact stories about research and the people who shape it. Covid Vaccine Maker Novavaxs Flameout Mints Shorts $2.7 Billion I cover breaking and trending news, focused on national politics. The maker of the only traditional COVID-19 vaccine still widely available in the United States is raising doubts about its ability to stay The Department of Health and Human Services said Monday that it is still conducting quality testing of the Novavax vaccine. 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. 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. 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. Tracking Covid-19. FDA Grants Emergency Use Authorization for Novavax's COVID FDA requires vaccination providers to report vaccine administration errors, serious adverse events, cases of multisystem inflammatory syndrome, and cases of CDC twenty four seven. "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. SAGE recommends the use of the Novavax (NVX-CoV2373) vaccine as 2 doses (0.5 ml) given intramuscularly. Vaccines FDA authorizes Novavax as new alternative to mRNA COVID-19 FDA Dosage form: intramuscular injection 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 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. 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. To access the replay by telephone, dial (877) 344-7529 (Domestic) or (412) 317-0088 (International) and use passcode 1137418. Committee members were impressed by the company's data on omicron. The committee recommended authorization for the two-shot series in adults 18 years and older. It worked. ", "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. 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. 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. Meredith Wadman's beat includes biology research, policy, and sexual harassment . maker will ever get a significant foothold in the United States. FDA authorization of Novavax's vaccine was delayed for weeks as the agency reviewed changes to the company's manufacturing process. It is the fourth coronavirus vaccine "No human fetal-derived cell lines or tissue, including HEK293 cells, are used in the development, manufacture or production of the Novavax COVID-19 vaccine candidate, NVX-CoV2373," Alison Chartan, a spokesperson for Novavax, told CBS News last month. 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. Topline. The Novavax COVID-19 Vaccine (NVX-CoV2373) is an investigational SARS-CoV-2 vaccine for the prevention of COVID-19. / CBS News. The recipients health condition or recommendations for vaccination may change from one visit to the next. Myocarditis is usually caused by viral infections. 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. At the time, most U.S. adults had received at least one COVID-19 vaccine dose. 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. Its statement about its future financial framework was even more troubling, saying, Substantial doubt exists regarding our ability to continue over the next year. A replay of the webcast will be available on the Novavax website until May 28, 2023. This U.S. COVID-19 vaccine maker faces uncertain future But it's unclear when or how many of those doses will be initially available for states and pharmacies to order. However, 27 million adults still have not gotten a single shot yet, according to CDC data from June. 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. Download a prevaccination checklist in multiple languages. 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 company plans to ask the FDA to authorize a third dose of its vaccine. FDA 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. 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. 2023 American Association for the Advancement of Science. Novavax, Inc. (Nasdaq: NVAX) promotes improved health by discovering, developing and commercializing innovative vaccines to protect against serious infectious diseases. 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. Myocarditis concerns may also dog the vaccine. Please enter valid email address to continue. July 13, 2022. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Download a prevaccination checklist in multiple languages. 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. Novavax Reports Fourth Quarter and Full Year 2022 Financial A webcast of the conference call can also be accessed on the Novavax website at novavax.com/events. 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. Young men have had the highest rates of myocarditis or pericarditis after receiving mRNA vaccines. Covid Vaccine FDA officials flagged four cases of myocarditis and pericarditis from Novavax's clinical trial in young men ages 16 to 28. Novavax uses a protein-based technology, a more traditional approach than the novel technologies used by other vaccine manufacturers. 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. It could be the next thing that saves your life or your loved ones life.. Use of the Novavax COVID-19 Vaccine, Adjuvanted in the U.S. This is a case study of perseverance, Bruce Gellin, chief of global public health strategy at the Rockefeller Foundation, said after the vote. They help us to know which pages are the most and least popular and see how visitors move around the site. For further assistance with reporting to VAERS, call 1-800-822-7967. Novavax hopes holdouts skeptical of mRNA vaccines and, ultimately, others seeking booster shots will opt for its tried-and-true technology. A man receives a Novavax injection in Seattle in February 2021 as part of the companys North American clinical trial. Primary series:Two-dose primary series given three weeks apart, for individuals 16 years and older. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. Initial results are expected mid-year 2023. 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. Adverse events that occur in a recipient after COVID-19 vaccination are required to be reported to the Vaccine Adverse Event Reporting System (VAERS). Novavax makes copies of the virus spike outside human cells. Covid Vaccine Treatment for: COVID-19. A replay of the conference call will be available starting at 7:30 p.m. Drug Interactions between Advair Diskus and Novavax COVID-19 Covid-19 vaccine maker Novavax raised doubts Tuesday about its ability to continue its business, announcing plans to cut You have selected a link that will take you to a site maintained by a third party who is solely responsible for its contents. A new investigational treatment for COVID-19: The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Dont yet have access? In the case of the mRNA shots, the CDC has found that the risk of myocarditis is higher from Covid infection than vaccination. Get more great content like this delivered right to you! If the Food and Drug Administration (FDA) accepts the group's recommendation and Centers for Disease 1. Your tax-deductible contribution plays a critical role in sustaining this effort. 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.

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