Novavax itself says it is continuing to work with Fujifilm and plans to update its submission to the UK medicines regulator so that doses produced in Teesside can be used by the NHS. ", "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. Sponsor and vaccine. 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. Every fortnight, a team from Imperial College London has logged the reasons for vaccine hesitancy. Clinical trials suggest that two doses of the Novavax jab have an efficacy of about 90% against symptomatic Covid similar to the other approved UK vaccines. July 13 (Reuters) - The U.S. Food and Drug Administration authorized the use of Novavax Inc's (NVAX.O) COVID-19 vaccine on Wednesday, clearing the way for a shot whose more traditional. The TGA has received applications and is assessing data for the following COVID-19 vaccines. It will take only 2 minutes to fill in. [50], In March 2020, Novavax announced a collaboration with Emergent BioSolutions for preclinical and early-stage human research on the vaccine candidate. Chevy Chase, MD 20815. Participants will be prompted to request to join the Novavax, Inc. call. Focused on the world's most urgent health challenges, Novavax is currently evaluating vaccines for COVID-19, influenza, and COVID-19 and influenza combined. (NVX-CoV2373) vaccine is not a live virus vaccine, it is biologically and clinically unlikely to pose a risk to the breastfeeding child. 2023 BBC. ET. WHO lists 10th COVID-19 vaccine for emergency use : Nuvaxovid, The Janssen Ad26.COV2.S COVID-19 vaccine: What you need to know, The Moderna COVID-19 (mRNA-1273) vaccine: what you need to know, The Pfizer BioNTech (BNT162b2) COVID-19 vaccine: What you need to know, The Sinovac-CoronaVac COVID-19 vaccine: What you need to know, The Sinopharm COVID-19 vaccine: What you need to know, The Oxford/AstraZeneca (ChAdOx1-S [recombinant] vaccine) COVID-19 vaccine: what you need to know, Independent Oversight and Advisory Committee, Strategic Advisory Group of Experts on Immunization, Interim recommendations for use of the Novavax NVX-CoV2373 vaccine against COVID-19, The Novavax vaccine against COVID-19: What you need to know. Nuvaxovid is distinct from other COVID-19 vaccines currently in use in the UK as it uses recombinant protein-based technology which has been used for many years in the development of vaccines to prevent other illnesses, for example Hepatitis B. SAGE has thoroughly assessed the data on the safety and efficacy of the vaccine and has recommended its use for people aged 12 and above. Up until now, the FDA has only given the OK to three . Archived post. Dont worry we wont send you spam or share your email address with anyone. Government advice on public health and social measures should continue to be followed by both vaccinated and unvaccinated individuals. In line with the WHO Prioritization Roadmap and the WHO Values Framework, older adults, health workers and immunocompromised persons should be prioritised. He stresses that he is not anti-vaccination. [4], A vaccine is generally considered effective if the estimate is 50% with a >30% lower limit of the 95% confidence interval. Dont include personal or financial information like your National Insurance number or credit card details. We also carry out independent batch testing on all the approved COVID-19 vaccines to ensure that every batch meets the expected quality standards. About 300 people at FujiFilm are said to have been working on the vaccine, though delays had prompted concerns that jobs would be hit. from 8 AM - 9 PM ET. Type: protein-based vaccine Status: Approved by Health Canada Approved for: Primary series in individuals age 12 years and older, or as a booster dose in individuals age 18 years and older How it's given: Injection in muscle (usually the upper arm) [44] In 2020 it was reported, that the vaccine would be manufactured in Spain[45] and in November 2021 it was reported to be produced in Poland by the Mabion company. They give you the best protection against COVID-19. "When you think about people in intensive care and the pressure on the NHS, it is the unvaccinated who are making up a disproportionate number of those in hospital with Covid. Privacy Policy. Novavax has received the largest US government award for developing a coronavirus vaccine to-date. So what difference would this additional weapon make to the UKs vaccination armoury? [4], Additional possible side effects include anaphylaxis (severe allergic reaction), paresthesia (unusual feeling in the skin, such as tingling or a crawling sensation) and hypoesthesia (decreased feeling or sensitivity, especially in the skin), and pericarditis (inflammation of lining around the heart). Novavax began developing its COVID vaccine in 2020 with government funding, but its vaccine did not receive final emergency-use approval until July 2022, well after mRNA vaccines from Pfizer and Moderna had dominated the market for COVID vaccines. Well send you a link to a feedback form. This extension has been. [48], In January 2020, Novavax announced development of a vaccine candidate, codenamed NVX-CoV2373, to establish immunity to SARS-CoV-2. 26 August 2022 Nuvaxovid, the COVID-19 vaccine developed by Novavax, has today been granted an extension to its existing UK approval, for 12- to 17-year-olds. The Novavax COVID vaccine also looks like it performs well. . 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 local Labour MP, Alex Cunningham, who represents Stockton North, met with a representative of Novavax and said he felt reassured. The Novavax COVID-19 vaccine, sold under the brand names Nuvaxovid and Covovax,[1] among others, is a subunit COVID-19 vaccine developed by Novavax and the Coalition for Epidemic Preparedness Innovations (CEPI). But they are based on a newer type of technology which delivers genetic code, known as messenger RNA (mRNA), into the bodies' cells - instructing them to produce copies of the distinctive spike protein found on the surface of the SARS-CoV-2 virus. Covid vaccines: How fast is worldwide progress? This webpage was updated on 28 September 2022 to reflected updated interim recommendations. A webcast of the conference call can also be accessed on the Novavax website at novavax.com/events. Novavax shares jump ahead of expected approval from the EU's drug regulator for its Covid-19 vaccine, which uses a more conventional technology than mRNA. A replay of the conference call will be available starting at 7:30 p.m. The fact that it uses a more established vaccine technology could also make it more appealing. [32], On 27 January 2023, Australia's Therapeutic Goods Administration indicated it will add tinnitus to its label. The vaccine is stored at 2- 8 Celsius, enabling the use of existing vaccine supply and . Get breaking news and daily headlines delivered to your email inbox by signing up here. In countries such as Germany, France and the Netherlands, it was quickly recommended for use - as an alternative to the mRNA vaccines, for people who may have had an allergic reaction to them in the past, or those who are still unvaccinated. Whereas existing UK Covid-19 jabs instruct our cells to manufacture the coronavirus spike protein, protein-based vaccines deliver pre-made fragments of it alongside an immune-stimulating adjuvant. had previously been approved in Canada for another use. Novavax told the Guardian that it was now routinely producing high-quality product at commercial scale at multiple sites across the world. The first part seeks to enroll a total of approximately 1,500 participants in Australia and New Zealand. *Included in current and noncurrent liabilities as of December 31, 2022 and non-current liabilities as of December 31, 2021. [29] On 19 July 2022, the US Centers for Disease Control and Prevention (CDC) recommended the Novavax COVID19 vaccine as a two-dose primary series for adults age 18 and older, thus endorsing the recommendation from the Advisory Committee on Immunization Practices (ACIP) regarding this vaccine. [33], The vaccine requires two doses[34] and is stable at 2 to 8C (36 to 46F) refrigerated temperatures. Achieved revenues in fourth quarter 2022 of $357 million and full year 2022 of $2.0 billion; Appointed John C. Jacobs as President and Chief Executive Officer; Updated U.S. government agreement to include up to 1.5 million additional doses of Novavax's COVID-19 vaccine for delivery in 2023; Expanded Nuvaxovid label in adult booster and adolescent primary series Coalition for Epidemic Preparedness Innovations, Full list of Novavax vaccine authorizations, List of COVID-19 vaccine authorizations Novavax, Centers for Disease Control and Prevention, Advisory Committee on Immunization Practices, "WHO issues emergency use listing to Novavax-Serum Institute's COVID-19 vaccine", "Regulatory approval of COVID-19 vaccine Nuvaxovid", Medicines and Healthcare products Regulatory Agency, "EMA starts rolling review of Novavax's COVID-19 vaccine (NVX-CoV2373)", "Novavax and Takeda Finalize License Agreement for Novavax' COVID-19 Vaccine Candidate in Japan; Takeda Initiates Phase 1/2 Trial in Japan", "SARS-CoV-2 rS (NVX-CoV-2373) vaccine for prevention of COVID-19", "Updates to the Prescribing Medicines in Pregnancy database", "TGA eBS - Product and Consumer Medicine Information Licence", "AusPAR: SARS-CoV-2 rS with Matrix-M adjuvant", "AusPAR: SARS-CoV-2 rS vaccine with Matrix-M1 adjuvant", "Product Monograph, NUVAXOVID , COVID-19 Vaccine (Recombinant protein, Adjuvanted)", "Summary Basis of Decision (SBD) for Nuvaxovid", "Novavax COVID-19 Vaccine: Standing Orders for Administering Vaccine to Persons 12 Years of Age and Older", "Coronavirus (COVID-19) Update: FDA Authorizes Emergency Use of Novavax COVID-19 Vaccine, Adjuvanted", "Hope to launch Covovax by September, says Serum Institute CEO", "COVID-19 vaccine trials should seek worthwhile efficacy", "Neutralizing antibody levels are highly predictive of immune protection from symptomatic SARS-CoV-2 infection", "Efficacy and Safety of NVX-CoV2373 in Adults in the United States and Mexico", "A fourth Covid vaccine is cleared for use in the United States", "Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine", "Efficacy of NVX-CoV2373 Covid-19 Vaccine against the B.1.351 Variant", "COVID-19 vaccine safety report - 27-01-2023", "Novavax vaccine delivers 89% efficacy against COVID-19 in UK but is less potent in South Africa", "New Covid vaccine shows 89% efficacy in UK trials", "Novavax launches pivotal U.S. trial of dark horse COVID-19 vaccine after manufacturing delays", "COVID-19 Vaccine Frontrunners and Their Nanotechnology Design", "Selective Naked-Eye Detection of SARS-CoV-2 Mediated by N Gene Targeted Antisense Oligonucleotide Capped Plasmonic Nanoparticles", "Urgent global health needs addressed by Novavax", "Researchers Are Hatching a Low-Cost Coronavirus Vaccine", "Takeda Provides Updates on Phase 1/2 Clinical Trials of Novavax' and Moderna's COVID-19 Vaccine Candidates in Japan", "Novavax signs COVID-19 vaccine supply deal with India's Serum Institute", "Spain, again chosen to produce the vaccine to combat COVID-19", "Novavax Deal With Mabion Boosts Poland's Nascent Biotech Scene", "EU approves Novavax shot as fifth COVID vaccine", "SII begins manufacturing, stockpiling 2nd Covid vaccine Covovax after Modi govt nod", "Novavax is working to advance a potential coronavirus vaccine. [23] On 22 August 2022, the CDC recommended the Novavax COVID19 vaccine for adolescents aged 12-17 years. The vaccine is authorized for. Novavax reported that a part II of its phase III study on the COVID-19 Omicron BA.1 vaccine candidate will evaluate the candidate vaccine compared with an Omicron BA.5 vaccine, as well as a . Reddit and its partners use cookies and similar technologies to provide you with a better experience. When typing in this field, a list of search results will appear and be automatically updated as you type. [Originally published: July 20, 2022. However, a caveat with any new vaccine is that rarer side-effects may not become apparent until a vaccine is used widely, said Azeem Majeed, professor of primary care and public health at Imperial College London. Investors, potential investors, and others should give careful consideration to these risks and uncertainties. By rejecting non-essential cookies, Reddit may still use certain cookies to ensure the proper functionality of our platform. Meanwhile, Novavax got its first approval anywhere in the world on Monday, when the company and partner Serum received emergency-use authorization for their COVID-19 vaccine in Indonesia. The most common reason for remaining unvaccinated is concern about side effects, followed by worries the jabs have not been tested sufficiently. [88][89] As of December 2021 it was validated by the World Health Organization. [54][55] The first human safety studies of the candidate, codenamed NVX-CoV2373, started in May 2020 in Australia. Pfizer and BioNTech applied for U.S. EUA of their COVID-19 vaccine on Nov. 20, 2020. Most side effects - like a sore arm or headache - are mild, with the risk of a severe reaction extremely low. News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports, The Medicines and Healthcare products Regulatory Agency has concluded that Nuvaxovid is safe and effective in this age group. Check benefits and financial support you can get, Find out about the Energy Bills Support Scheme, Medicines and Healthcare products Regulatory Agency, The Conditional Marketing Authorisation (CMA) granted by the MHRA, The Medicines and Healthcare products Regulatory Agency, Pfizer/BioNTech COVID-19 vaccine shelf-life extended from 5 to 31 days, says MHRA, Commission on Human Medicines advice on ibuprofen and coronavirus (COVID-19). Nuvaxovid. Its a testament to the countrys first-rate research and development capabilities for vaccines with tens of thousands of people taking part in clinical trials here in the UK, contributing to the invaluable research that shows our vaccines are safe and effective. The MHRA is an executive agency of the Department of Health and Social Care. A first booster dose (0.5 mL) of Novavax COVID-19 Vaccine, Adjuvanted may be administered intramuscularly at least 6 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine in individuals 18 years of age and older for whom an FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate and in individuals 18 years of . ", Fourth Quarter 2022 and Recent Highlights, COVID-19 Vaccine Orders and Plans for the 2023 Fall Vaccination Season, COVID-19 Vaccine Clinical Development Program and Expanded Authorizations, COVID-19-Influenza Combination (CIC) Vaccine Candidate Clinical Development, Fourth Quarter and Full Year 2022 Financial Results. The $1.6 billion award is to fund the production of 100 million doses by early 2021. comment s A more detailed discussion of Novavax's liquidity position and risk related thereto will be set forth in Novavax's Annual Report on Form 10-K that will be filed with the SEC. We use some essential cookies to make this website work. WHO has identified pregnant persons as a high priority-use group for COVID-19 vaccination, given their increased risk of severe outcomes. Dont include personal or financial information like your National Insurance number or credit card details. [43], Novavax signed an agreement with Serum Institute of India for mass scale production for developing and low-income countries. The Novavax vaccine was one of the first on the market to work in a more traditional way - the spike protein is grown outside the body in a laboratory and then injected, alongside a separate ingredient which boosts the immune response called an adjuvant. We are pleased to say that we have advised that the benefit risk balance of Nuvaxovid is positive. Trials were conducted before the emergence of the SARS-CoV-2 Omicron variant, which has sharply reduced the effectiveness of authorized vaccines in preventing infections. Monday, June 14, 2021 U.S. clinical trial results show Novavax vaccine is safe and prevents COVID-19 Results from a Phase 3 clinical trial enrolling 29,960 adult volunteers in the United States and Mexico show that the investigational vaccine known as NVX-CoV2373 demonstrated 90.4% efficacy in preventing symptomatic COVID-19 disease. Late last month the US company, with a factory on Teesside primed to manufacture doses, submitted final data to UK regulators and a positive decision is anticipated within days or weeks. The WHO EUL process also evaluates the quality of manufacturing along with safety and efficacy. Final data from its phase 3 trial is expected any day now, paving the way for the companies to seek regulatory approval. On 13 July 2022, the FDA authorized NVX-CoV2373 for emergency use as a primary immunization (not booster) in adults. The Novavax COVID-19 Vaccine, Adjuvanted is administered as a two-dose primary series, three weeks apart. Under the interim order, a company could submit an application for a drug or vaccine for use in COVID-19 that: had never been approved in Canada. By accepting all cookies, you agree to our use of cookies to deliver and maintain our services and site, improve the quality of Reddit, personalize Reddit content and advertising, and measure the effectiveness of advertising. Dr. Nita Patel, Director of Antibody discovery and Vaccine development, lifts a vial with a potential coronavirus, COVID-19, vaccine at Novavax labs in Gaithersburg, Maryland on March 20, 2020 . ", "By now, someone in Germany who got their first Novavax vaccine at the end of February could have had their full primary series and be getting on with their life - whereas I'm still waiting around in a sort-of personal lockdown, so that is really frustrating.". Can Nigeria's election result be overturned? Even lifting it [vaccination rates] by a few per cent would be worth it.". 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. Trial data appear to show the potential for lower reactogenicity compared with existing jabs, meaning side-effects such as injection-site swelling, fatigue, headaches and muscle pain occur less frequently. On Jan. 31, Novavax formally submitted its request to the Food and Drug Administration (FDA) to have its COVID-19 vaccine approved for EUA. This combination of easier transport and storage is even more important in developing countries, where low temperature-controlled supply chains are less well established. [73], About 216,000 doses of the Novavax COVID-19 vaccine were administered in the EU/EEA from authorization to 26 June 2022. Novavax's COVID-19 vaccine is for people age 12 and older who haven't received any COVID-19 vaccine yet. [56][57], In July 2020, the company announced it might receive US$1.6 billion from Operation Warp Speed to expedite development of its coronavirus vaccine candidate by 2021 if clinical trials show the vaccine to be effective. You can change your cookie settings at any time. Novavax, Inc. (Nasdaq: NVAX) promotes improved health by discovering, developing and commercializing innovative vaccines to protect against serious infectious diseases. News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. Very rare serious adverse events of myocarditis and pericarditis have been observed though cases typically occurred within a few days after vaccination, and were generally mild. [67][35], On 12 March 2021, Novavax announced their vaccine candidate was 96.4% effective in preventing the original strain of COVID-19 and 86% effective against the Alpha variant. When autocomplete results are available use up and down arrows to review and enter to select. It is impossible to compare vaccine head-to-head due to the different approaches taken in designing the respective studies, but overall, all of the vaccines that have achieved WHO Emergency Use Listing are highly effective in preventing severe disease In reaching this decision, we have taken advice from the governments independent scientific advisory body, the Commission on Human Medicines. More than 92% of over-12s in the UK have already received at least one of those Covid jabs - but that still leaves around five million people unvaccinated. The MHRA is an executive agency of the Department of Health and Social Care. 3 February 2022 Nuvaxovid, the COVID-19 vaccine developed by Novavax, has today been given regulatory approval by the Medicines and Healthcare products Regulatory Agency (MHRA). Novavax has further delayed the submission of data for its Covid-19 vaccine to the US regulator as the biotechnology company continues to struggle with collating consistent manufacturing . An 8-week interval is recommended between primary series doses of NVX-CoV2373. 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. 10 South ColonnadeLondonE14 4PU, During office hours: 020 3080 7651 (08:30 - 17:00), Out of office hours: 07770 446 189 (17:00 - 08:30), Office hours are Monday to Friday, 8:30am to 5pm. The Novavax vaccine can be offered to people who have had COVID-19 in the past. [93][20] making it the fourth COVID19 vaccine authorized in the US. Silvia Taylor, the senior vice-president of global corporate communications and investor relations at Novavax, said: Now that the submission [to the UK Medicine and Healthcare products Regulatory Authority] is complete, the timeline is in the hands of the regulatory agencies., Original reporting and incisive analysis, direct from the Guardian every morning. Log in to your WTOP account for notifications and alerts customized for you. We also use cookies set by other sites to help us deliver content from their services. Fujifilm Diosynth would manufacture them at its plant in Billingham, while GSK would fill and finish them package them up in vials at its operation in Barnard Castle. [61], On 24 September 2020, Novavax started for a phase III trial with 15,000 in the UK. After months of promises, and a series of delays, the Novavax jab was finally approved for use in adults by the European Medicines Agency (EMA) in late December 2021, followed by the British equivalent, the MHRA, on 3 February 2022. [96], "Covovax" redirects here. The vaccine is already available for use in at least 170 countries, but if . 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. Another "more traditional" vaccine - produced by the French company Valneva - has just been approved by the UK medicines regulator, although the UK government currently has no doses of that jab on order. Our approval of Nuvaxovid today follows a rigorous review of the safety, quality and effectiveness of this vaccine, and expert advice from the governments independent scientific advisory body, the Commission on Human Medicines. Novavax's Covid-19 Vaccine Moves Closer to FDA Authorization Decision Company says it has resolved manufacturing problems that led to earlier delays; FDA is reviewing shot's authorization. You can change your cookie settings at any time. [40], The vaccine is produced by creating an engineered baculovirus containing a gene for a modified SARS-CoV-2 spike protein. At the time, Novavax said production should be up and running by April 2021. Novavax also was dealt a setback late last year when an international vaccine initiative known as COVAX backed off earlier plans to order up to 350 million doses of the Novavax vaccine because of an oversupply of other vaccines. 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. 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. 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. Bakhmut attacks still being repelled, says Ukraine, Saving Private Ryan actor Tom Sizemore dies at 61, US lawyer jailed for murdering wife and son, The children left behind in Cuba's mass exodus, Xi Jinping is unveiling a new deputy - why it matters, Snow, Fire and Lights: Photos of the Week. There are insufficient data still for Omicron. The vaccination regimen calls for two 0.5 ml doses (5 microgram antigen and 50 microgram Matrix-M adjuvant) given intramuscularly 21 days apart. A replay of the webcast will be available on the Novavax website until May 28, 2023. "I had to blag it a bit," she says. 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