View source for Company:Novavax

{{short description|American biotechnology company}}
{{coord|39.1371|-77.2267|display=title}}
{{Infobox company
| name = Novavax, Inc.
| logo = Novavax-logo.svg
| image = 
| image_caption = Novavax research and development laboratories in Gaithersburg
| type = [[Finance:Public company|Public company]]
| traded_as = {{ubl 
 | class=nowrap
 | {{NASDAQ|NVAX}}
 | Russell 2000 component 
 | {{fwb|NVV1|isin=US6700024010}}
}}
| ISIN = {{ISIN|sl=n|pl=y|US6700024010}}
| area_served = Worldwide
| industry = [[Engineering:Biotechnology|Biotechnology]]
| products = Vaccines
| num_employees = 1,541<ref>{{cite web|title=Novavax Inc - Company Profile and News - Bloomberg Markets|url=https://www.bloomberg.com/profile/company/NVAX:US|website=Bloomberg.com}}</ref>
| num_employees_year = 2022
| key_people = {{ubl
 | John Jacobs ([[Social:Chief executive officer|CEO]])
 | Filip Dubovsky ([[Research and development|R&D]])
}}
| founded = {{Start date and age|1987}}<ref>{{cite web|title=Company Overview of Novavax, Inc|url=https://www.bloomberg.com/research/stocks/private/snapshot.asp?privcapId=350381|website=Bloomberg.com|access-date=2 June 2019|archive-date=24 February 2017|archive-url=https://web.archive.org/web/20170224054237/http://www.bloomberg.com/research/stocks/private/snapshot.asp?privcapId=350381|url-status=live}}</ref>
| hq_location = 
| hq_location_city = Gaithersburg, Maryland
| hq_location_country = U.S.
| revenue = {{nowrap|{{Increase}} {{US$|1.982 billion|link=yes}} (2022)<ref>{{Cite web|url=https://ir.novavax.com/2023-02-28-Novavax-Reports-Fourth-Quarter-and-Full-Year-2022-Financial-Results-and-Operational-Highlights#:~:text=Total%20revenue%20for%20the%20fourth,the%20same%20period%20in%202021.|title = Novavax Reports Fourth Quarter and Full Year 2022 Financial Results and Operational Highlights|date = 28 February 2023}}</ref>}}
| website = {{Official URL}}
}}

'''Novavax, Inc.''' is an American [[Engineering:Biotechnology|biotechnology]] company based in Gaithersburg, Maryland, that develops vaccines to counter serious infectious diseases. Prior to 2020, company scientists developed experimental vaccines for [[Medicine:Influenza|influenza]] and [[Biology:Respiratory syncytial virus|respiratory syncytial virus]] (RSV), as well as [[Medicine:Ebola|Ebola]] and other emerging infectious diseases. During 2020, the company redirected its efforts to focus on development and approval of its NVX-CoV2373 vaccine for [[Medicine:COVID-19|COVID-19]].<ref>Novavax Inc. [https://www.novavax.com/sites/default/files/2021-05/NVAX_2020_Annual_Report_FINAL.pdf 2020 Annual Report] {{Webarchive|url=https://web.archive.org/web/20210814001719/https://www.novavax.com/sites/default/files/2021-05/NVAX_2020_Annual_Report_FINAL.pdf |date=14 August 2021 }}. Accessed 10 May 2021.</ref>

The COVID-19 vaccine [[Medicine:Novavax COVID-19 vaccine|Nuvaxovid]] was approved in the European Union at the end of 2021,<ref name=":3">{{cite press release | title=EMA recommends Nuvaxovid for authorisation in the EU | website=European Medicines Agency | date=20 December 2021 | url=https://www.ema.europa.eu/en/news/ema-recommends-nuvaxovid-authorisation-eu | access-date=6 January 2022}}</ref> and in Canada in February 2022,<ref name="canada">{{cite web |title=Health Canada authorizes Novavax's Nuvaxovid COVID-19 vaccine |url=https://www.canada.ca/en/health-canada/news/2022/02/health-canada-authorizes-novavaxs-nuvaxovid-covid-19-vaccine.html |publisher=Health Canada, Government of Canada |access-date=21 February 2022 |date=17 February 2022}}</ref> as the fifth vaccine against COVID-19, following [[Medicine:Pfizer–BioNTech COVID-19 vaccine|Pfizer/BioNTech]], [[Company:Moderna|Moderna]], [[Medicine:Janssen COVID-19 vaccine|Janssen]] and [[Medicine:Oxford–AstraZeneca COVID-19 vaccine|AstraZeneca]].

== History ==
In June 2013, Novavax acquired the Matrix-M adjuvant platform with the purchase of Swedish company Isconova AB and renamed its new subsidiary Novavax AB.<ref>{{cite news|last1=Taylor|first1=Nick Paul|title=Novavax makes $30M bid for adjuvant business|url=http://www.fiercepharma.com/vaccines/novavax-makes-30m-bid-for-adjuvant-business|access-date=9 September 2016|work=FiercePharma|date=3 June 2013|archive-date=14 September 2016|archive-url=https://web.archive.org/web/20160914235336/http://www.fiercepharma.com/vaccines/novavax-makes-30m-bid-for-adjuvant-business|url-status=live}}</ref>

=== ResVax ===

In March 2015, the company completed a Phase I trial for its [[Medicine:Ebola vaccine|Ebola vaccine]] candidate,<ref>{{Cite news|url=https://www.reuters.com/article/us-health-ebola-novavax-idUSKCN0PV1V720150721|title=Novavax's Ebola vaccine shows promise in early-stage trial|date=21 July 2017|work=Reuters|access-date=28 March 2017|archive-date=2 October 2016|archive-url=https://web.archive.org/web/20161002130324/http://www.reuters.com/article/us-health-ebola-novavax-idUSKCN0PV1V720150721|url-status=live}}</ref> as well as a phase II study in adults for its RSV vaccine, which would become ResVax.<ref name=":2">{{Cite web|url=http://www.fiercebiotech.com/biotech/novavax-craters-after-phase-iii-rsv-f-vaccine-failure-seeks-path-forward|title=Novavax craters after Phase III RSV F vaccine failure; seeks path forward|last=Adams|first=Ben|date=16 September 2016|website=FierceBiotech|publisher=Questex|url-status=live|archive-url=https://web.archive.org/web/20200818074115/https://www.fiercebiotech.com/biotech/novavax-craters-after-phase-iii-rsv-f-vaccine-failure-seeks-path-forward|archive-date=18 August 2020|access-date=25 January 2020}}</ref> The ResVax trial was encouraging as it showed significant efficacy against RSV infection,<ref name=":2" /> using a nanoparticle-based treatment using a recombinant F lipoprotein or [[Chemistry:Saponin|saponin]], "extracted from the [[Biology:Quillaja saponaria|Quillaja saponaria]] [or?] [[Biology:Dysopsis glechomoides|Molina]] bark together with [[Chemistry:Cholesterol|cholesterol]] and [[Chemistry:Phospholipid|phospholipid]]."<ref name="nvaxa">{{cite web |title=Novavax addresses urgent global public health needs with innovative technology |url=https://novavax.com/our-unique-technology |website=novavax.com |access-date=30 August 2020 |archive-date=10 September 2020 |archive-url=https://web.archive.org/web/20200910142543/https://novavax.com/our-unique-technology |url-status=live }}</ref> It is aimed at stimulating resistance to respiratory syncytial virus infection, targeting both adult and infant populations.<ref name=":2" />

[[File: Novavax - 50380276616.jpg|thumb|Novavax CEO and President Stanley Erck, in conference during Governor Larry Hogan's visit to Novavax Laboratories in Gaithersburg, Maryland, in September 2020<ref name= stan>{{Cite web|url=https://twitter.com/govlarryhogan/status/1309155951954530305| language=en-US|work=Twitter|title= Since the very beginning, I have said that our state would lead the way to develop treatments and perhaps even a vaccine for #COVID19. This morning in Gaithersburg, I joined representatives of @Novavax and @IAmBioTech to provide an update on these efforts.}}</ref>]]

2016 saw the company's first phase III trial, the 12,000 adult Resolve trial,<ref name=":2" /> for its [[Biology:Respiratory syncytial virus|respiratory syncytial virus]] vaccine, which would come to be known as ResVax, fail in September.<ref name="Dive">{{Cite news|url=http://www.biopharmadive.com/news/Novavax-q3-restructure-RSV/430370/|title=Novavax aims to rebound with restructuring, more trials|last=Bell|first=Jacob|date=14 November 2016|work=BioPharma Dive|access-date=28 March 2017|url-status=live|publisher=Industry Dive|location=Washington, D.C.|archive-date=29 March 2017|archive-url=https://web.archive.org/web/20170329140758/http://www.biopharmadive.com/news/Novavax-q3-restructure-RSV/430370/}}</ref> This triggered an eighty-five percent dive in the company's stock price.<ref name="Dive" /> Phase II adult trial results also released in 2016 showed a stimulation of antigenicity, but failure in efficacy.<ref name=":2" /> Evaluation of these results suggested that an alternative dosing strategy might lead to success, leading to plans to run new phase II trials.<ref name="Dive" /> The company's difficulties in 2016 led to a three-part strategy for 2017: cost reduction through restructuring and the termination of 30% of their workforce; pouring more effort into getting ResVax to market; and beginning clinical trials on a [[Medicine:Zika virus|Zika virus]] vaccine.<ref name="Dive" />

[[File: Novavax research and development.jpg|thumb|Novavax research and development laboratories in Gaithersburg.]]
Alongside the adult studies of ResVax, the vaccine was also in 2016 being tested against infant RSV infection through the route of maternal immunization.<ref name=":2" />

In 2019, late-stage clinical testing of ResVax failed for a second time, which resulted in a major downturn in investor confidence and a seventy percent reduction in capital value for the firm.<ref>{{Cite web|url=https://www.nasdaq.com/articles/3-biotech-stocks-that-offer-the-highest-upside-on-wall-street-2019-12-12|title=3 Biotech Stocks That Offer the Highest Upside on Wall Street|last=Shtrubel|first=Marty|date=12 December 2019|website=Biotech|publisher=Nasdaq|url-status=live|archive-url=https://web.archive.org/web/20200126014804/https://www.nasdaq.com/articles/3-biotech-stocks-that-offer-the-highest-upside-on-wall-street-2019-12-12|archive-date=26 January 2020|access-date=25 January 2020}}</ref><ref name=":1">{{Cite web|url=https://www.nasdaq.com/articles/3-top-biotech-picks-for-2020-2020-01-20|title=3 Top Biotech Picks for 2020|last=Budwell|first=George|date=20 January 2020|website=Markets|publisher=Nasdaq|at=Novavax: A catalyst awaits|url-status=live|archive-url=https://web.archive.org/web/20200125233600/https://www.nasdaq.com/articles/3-top-biotech-picks-for-2020-2020-01-20|archive-date=25 January 2020|access-date=25 January 2020}}</ref> As a secondary result, the company was forced to conduct a [[Finance:Reverse stock split|reverse stock split]] in order to maintain [[Finance:Nasdaq|Nasdaq]] minimum qualification, meaning it was in risk of being delisted.<ref name=":1" />

=== NanoFlu ===

NanoFlu is a quadrivalent [[Medicine:Influenza vaccine|influenza vaccine]], which completed Phase II clinical trials successfully in 2019. In January 2020, it was granted fast track designation by the U.S. [[Organization:Food and Drug Administration|Food and Drug Administration]] (FDA) to move into Phase III trials, which completed in March 2020.<ref>{{Cite web|last=Gilgore|first=Sara|date=2020-03-24|title=Novavax's seasonal flu vaccine just got great news. And it's a big deal.|url=https://www.bizjournals.com/washington/news/2020/03/24/novavax-s-seasonal-flu-vaccine-just-got-great-news.html|access-date=2021-06-18|website=www.bizjournals.com}}</ref><ref>{{Cite web|title=A Universal Influenza Vaccine: How Close Are We?|url=https://asm.org/Articles/2019/August/A-Universal-Influenza-Vaccine-How-Close-Are-We|access-date=2021-06-18|website=ASM.org}}</ref><ref>{{Cite web|date=2020-11-10|title=Novavax Secured a Critical Second-Place Finish|url=https://investorplace.com/2020/11/novavax-nvax-stock-steals-pfizers-thunder-with-fast-track-designation/|access-date=2021-06-18|website=InvestorPlace}}</ref>

==Finance and external sponsorships==

Novavax is financed by both public and private [[Finance:Investor|investor]]s, of which approximately 50% of the [[Finance:Public float|free float shares]] are held by institutional investors.<ref name=":0"/>

[[File: Novavax.jpg |thumb|Stanley Erck (right) and Gregory Glenn (left) at the biotech labs in Gaithersburg during the visit of the Governor of Maryland in September 2020<ref name= stan/>]]
Novavax is funded by a mix of private and public investment.<ref name=":0">{{Cite news|last1=Thomas|first1=Katie|last2=Twohey|first2=Megan|date=16 July 2020|title=How a Struggling Company Won $1.6 Billion to Make a Coronavirus Vaccine|work=The New York Times|url=https://www.nytimes.com/2020/07/16/health/coronavirus-vaccine-novavax.html|access-date=29 January 2021|issn=0362-4331}}</ref> In 2015, Novavax received a US$89 million research grant from the Bill and Melinda Gates Foundation to support the development of a vaccine against [[Medicine:Human respiratory syncytial virus|human respiratory syncytial virus]] for infants via [[Biology:Passive immunity|maternal immunization]].<ref>{{Cite web|title=Gaithersburg Biotech Receives Grant Worth up to $89&nbsp;million|url=http://www.bizjournals.com/washington/blog/2015/09/gaithersburg-biotech-receives-grant-worth-up-to-89.html|url-status=live|archive-url=https://web.archive.org/web/20170401134305/http://www.bizjournals.com/washington/blog/2015/09/gaithersburg-biotech-receives-grant-worth-up-to-89.html|archive-date=1 April 2017|access-date=28 March 2017|website=Bizjournals.com}}</ref><ref>{{Cite web|title=With promising RSV data in hand, Novavax wins $89M Gates grant for PhIII {{!}} FierceBiotech|url=http://www.fiercebiotech.com/r-d/promising-rsv-data-hand-novavax-wins-89m-gates-grant-for-phiii|url-status=live|archive-url=https://web.archive.org/web/20170414010252/http://www.fiercebiotech.com/r-d/promising-rsv-data-hand-novavax-wins-89m-gates-grant-for-phiii|archive-date=14 April 2017|access-date=28 March 2017|website=Fiercebiotech.com}}</ref><ref>{{Cite news|date=29 September 2016|title=Novavax RSV vaccine found safe for pregnant women, fetus|work=Reuters|url=https://www.reuters.com/article/us-novavax-study-idUSKCN0RT19V20150929|url-status=live|access-date=28 March 2017|archive-url=https://web.archive.org/web/20161007194803/http://www.reuters.com/article/us-novavax-study-idUSKCN0RT19V20150929|archive-date=7 October 2016}}</ref><ref>{{Cite news|last=Herper|first=Matthew|title=Gates Foundation Backs New Shot To Prevent Babies From Dying Of Pneumonia|work=Forbes|url=https://www.forbes.com/sites/matthewherper/2015/09/29/gates-foundation-backs-new-shot-to-prevent-babies-from-dying-of-pneumonia/#1a3b1aea78d4|url-status=live|access-date=28 March 2017|archive-url=https://web.archive.org/web/20160921122505/http://www.forbes.com/sites/matthewherper/2015/09/29/gates-foundation-backs-new-shot-to-prevent-babies-from-dying-of-pneumonia/#1a3b1aea78d4|archive-date=21 September 2016}}</ref>

In May 2020, Novavax received {{USD|384 million}} from the [[Organization:Coalition for Epidemic Preparedness Innovations|Coalition for Epidemic Preparedness Innovations]] to fund early-stage evaluation in healthy adults of the company's COVID-19 vaccine candidate NVX-CoV2373 and to develop resources in preparation for large-scale manufacturing, if the vaccine proves successful.<ref name="fp">{{Cite news|title=Novavax scores $384M deal, CEPI's largest ever, to fund coronavirus vaccine work|author=Eric Sagonowsky|url=https://www.fiercepharma.com/vaccines/novavax-scores-cepi-s-largest-award-up-to-384m-to-support-covid-19-vaccine-work|work=FiercePharma|date=11 May 2020|access-date=12 May 2020|archive-date=16 May 2020|archive-url=https://web.archive.org/web/20200516215744/https://www.fiercepharma.com/vaccines/novavax-scores-cepi-s-largest-award-up-to-384m-to-support-covid-19-vaccine-work|url-status=live}}</ref> CEPI had already invested $4&nbsp;million in March.<ref name=fp/>

On July 7, 2020, during the Donald Trump administration, the company was awarded a {{USD|1.6 billion}} loan from the United States government from Operation Warp Speed program to cover the testing, commercialization and production of a potential coronavirus vaccine in the United States, with a goal of delivering 100 million doses by January 2021.<ref>{{cite web|url= https://www.cnbc.com/2020/07/07/us-government-awards-novavax-1point6-billion-for-coronavirus-vaccine.html |title= Novavax soars after U.S. government awards firm $1.6 billion for coronavirus vaccine development |website= cnbc.com|date= 7 July 2020  }}</ref>

== COVID-19 vaccine ==


=== Vaccine research and development ===
In January 2020, Novavax announced development of a vaccine candidate, named NVX-CoV2373, to establish immunity to [[Biology:SARS-CoV-2|SARS-CoV-2]].<ref name="gilgore">{{cite news |author1=Sara Gilgore |title=Novavax is working to advance a potential coronavirus vaccine. So are competitors. |url=https://www.bizjournals.com/washington/news/2020/02/26/novavax-is-moving-forward-with-a.html |work=Washington Business Journal |access-date=6 March 2020 |date=26 February 2020 |archive-date=16 March 2020 |archive-url=https://web.archive.org/web/20200316041227/https://www.bizjournals.com/washington/news/2020/02/26/novavax-is-moving-forward-with-a.html |url-status=live }}</ref> NVX-CoV2373 is a protein [[Medicine:Subunit vaccine|subunit vaccine]] that contains the spike protein of the SARS-CoV-2 virus.<ref name="Novavax">{{cite news |author1=Nidhi Parekh |title=Novavax: A SARS-CoV-2 Protein Factory to Beat COVID-19. |url=https://fancycomma.com/2020/07/24/novavax-protein-subunit-covid-19-vaccine/ |access-date=24 July 2020 |date=24 July 2020 |archive-date=22 November 2020 |archive-url=https://web.archive.org/web/20201122040118/https://fancycomma.com/2020/07/24/novavax-protein-subunit-covid-19-vaccine/ |url-status=live }}</ref> Novavax's work is in competition for vaccine development among dozens of other companies.

[[File:Larry Hogan at Novavax campus (51239176189).jpg|thumb|Governor Larry Hogan at Novavax's future Vaccines Innovation Campus and global headquarters in Maryland.<ref>{{cite web| url=https://finance.yahoo.com/news/novavax-host-maryland-governor-larry-130300046.html| title=Novavax to Host Maryland Governor Larry Hogan at Site of Future Novavax Vaccines Innovation Campus and Global Headquarters| date=9 June 2021| website=yahoo.com}}</ref>]]

In January 2021, the company released phase III trials showing that it has 89% efficacy against Covid-19, and also provides strong immunity against new variants.<ref>{{cite news |title=Covid-19: Novavax vaccine shows 89% efficacy in UK trials |work=BBC News |date=29 January 2021 |url=https://www.bbc.co.uk/news/uk-55850352 |access-date=1 February 2021}}</ref> It has applied for emergency use in the US and UK but will be distributed in the UK first.{{citation needed|date=May 2021}} {{As of|May 2021}}, the company does not anticipate that it will file for approval in the UK "until July at the earliest".<ref>{{cite news |title=Novavax volunteers in UK threaten to quit over approval delays. Participants cannot prove they are fully vaccinated on NHS app leaving them unable to travel to Europe | first=Sarah |last =Marsh |work={{wipe|The Guardian}} | date= 21 May 2021 |url=https://www.theguardian.com/society/2021/may/21/novavax-volunteers-in-uk-threaten-to-quit-over-approval-delays }}</ref>{{Update inline|date=December 2023}} On 14 June 2021, Novavax announced overall 90.4% efficacy in the [[Medicine:Phases of clinical research|Phase 3]] US and Mexico trial. Of the total 77 cases of COVID-19 among the trial's volunteers, 14 occurred in the vaccine group, while 63 occurred in the placebo group.<ref>{{cite news |last1=Howard |first1=Jacqueline |title=Novavax says Covid-19 vaccine shows 90.4% overall efficacy in US/Mexico Phase 3 trial |url=https://edition.cnn.com/2021/06/14/health/novavax-covid-19-vaccine-us-phase-3-trial-study/index.html |access-date=14 June 2021 |agency=CNN |date=14 June 2021}}</ref>

On May 22, 2021, Novavax and [[Company:Moderna|Moderna]] announced a deal with the South Korean government to manufacture their COVID-19 vaccines.<ref>{{Cite web|date=2021-05-22|title=Moderna, Novavax to produce more COVID-19 vaccines in S.Korea|url=https://www.reuters.com/business/healthcare-pharmaceuticals/moderna-south-korea-sign-production-deal-mrna-vaccines-2021-05-22/|access-date=2021-07-17|website=Reuters}}</ref> The vaccine is also being co-developed (with the [[Organization:Coalition for Epidemic Preparedness Innovations|Coalition for Epidemic Preparedness Innovations]]) in India under the brand name [[Medicine:Novavax COVID-19 vaccine|Covovax]].<ref>{{Cite web|last=Leo|first=Leroy|date=2021-03-27|title=Hope to launch Covovax by September, says Serum Institute CEO|url=https://www.livemint.com/companies/news/hope-to-launch-covovax-by-september-says-serum-institute-ceo-11616834205232.html|access-date=2021-07-17|website=mint}}</ref> CEPI granted Novavax up to $399 million to support the development of the candidate vaccine.<ref>{{Cite web |title=Our portfolio |url=https://cepi.net/research_dev/our-portfolio/ |url-status=live |archive-url=https://web.archive.org/web/20221021070613/https://cepi.net/research_dev/our-portfolio/ |archive-date=2022-10-21 |access-date=2023-07-18 |website=[[Organization:Coalition for Epidemic Preparedness Innovations|Coalition for Epidemic Preparedness Innovations]] |language=en-US}}</ref>

On September 6, 2021, Novavax and [[Company:Takeda Pharmaceutical Company|Takeda Pharmaceutical Company]] announced that the Government of Japan's [[Organization:Ministry of Health, Labour and Welfare|Ministry of Health, Labour and Welfare]] will purchase 150 million doses of Novavax's vaccine candidate TAK-019 pending regulatory approval.<ref>{{Cite web|date=2021-09-07|title=Japan to purchase 150 mln doses of Takeda-produced Novavax vaccines - drugmaker|url=https://www.reuters.com/business/healthcare-pharmaceuticals/japan-purchase-150-mln-doses-takeda-produced-novavax-vaccines-drugmaker-2021-09-07/|access-date=2021-09-07|website=Reuters}}</ref> The Government of Japan's Ministry of Health, Labour and Welfare signed an agreement with [[Company:Takeda Pharmaceutical Company|Takeda Pharmaceutical Company]] for Takeda to manufacture and distribute Novavax's TAK-019 upon regulatory approval.<ref>{{Cite web|date=2021-09-07|title=Japan secures 150 million Novavax vaccine doses|url=https://www.japantimes.co.jp/news/2021/09/07/national/japan-secures-150-million-novavax/|access-date=2021-09-07|website=The Japan Times}}</ref>

On December 22, 2021, Novavax confirmed the efficacy of two doses of vaccine against the omicron variant of [[Biology:SARS-CoV-2|SARS-CoV-2]].<ref name = Forbes/><ref name=yahoo/><ref name = nova/> The new data suggest that the vaccine provides an [[Biology:Immune response|immune response]] against the Omicron variant and other variants of the [[Biology:Coronavirus|coronavirus]]. The response of [[Biology:Antibodies|antibodies]] against omicron is four times lower than the original variant. A third dose of the vaccine given to adults, six months after the first two doses, increased the level of neutralizing antibodies against the omicron variant by 73.5 times, making it more effective in preventing omicron from entering human cells.<ref name = Forbes/><ref name=yahoo/><ref name = nova/>

The data shows that the 73.5-fold increase in antibody level following a third dose of Novavax vaccine ([[Biology:Protein subunit|protein subunit]] vaccine) was higher than the booster doses of [[Company:Pfizer|Pfizer]] and [[Company:Moderna|Moderna]] (mRNA vaccines), which increased the antibody levels 25-fold and 37-fold, respectively.<ref name = Forbes>{{cite web| website= forbes.com| language=en|url= https://www.forbes.com/sites/kimberleespeakman/2021/12/22/novavax-covid-vaccine-provides-antibody-response-against-omicron-data-suggests/?sh=29f126eb4c5e |title= Novavax Covid Vaccine Provides Antibody Response Against Omicron, Data Suggests}}</ref><ref>{{cite news |website= reuters.com|url= https://www.reuters.com/business/healthcare-pharmaceuticals/novavax-says-covid-vaccine-boosts-response-omicron-variant-2021-12-22/|title= Novavax says COVID vaccine triggers immune response to Omicron variant|date= 22 December 2021|last1= O'Donnell|first1= Carl}}</ref><ref name=yahoo>{{cite web |website=yahoo finance|url= https://finance.yahoo.com/news/early-data-shows-novavaxs-covid-113455025.html |title= Early Data Shows Novavax's COVID-19 Vaccine Triggers Immune Response To Omicron|date= 23 December 2021 }}</ref><ref name = nova>{{cite press release|url= https://ir.novavax.com/2021-12-22-Novavax-Announces-Initial-Omicron-Cross-Reactivity-Data-from-COVID-19-Vaccine-Booster-and-Adolescent-Studies |website= Novavax Inc. |title= Novavax Announces Initial Omicron Cross-Reactivity Data from COVID-19 Vaccine Booster and Adolescent Studies}}</ref>

=== Authorization and application ===
On November 1, 2021, Novavax and [[Organization:Serum Institute of India|Serum Institute of India]] announced that the National Agency of Drug and Food Control of Indonesia, or Badan Peng was Obat dan Makanan (Badan POM), has granted emergency use authorization (EUA) for Novavax' recombinant nanoparticle protein-based COVID-19 vaccine with [[Chemistry:Matrix-M|Matrix-M]] adjuvant. It will be manufactured by SII in India and marketed by SII in Indonesia under the brand name Covovax.<ref>{{Cite news|last=Zimmer|first=Carl|date=2021-11-01|title=The Novavax vaccine, backed by Operation Warp Speed, has won its first authorization — in Indonesia.|work=The New York Times|url=https://www.nytimes.com/2021/11/01/health/novavax-vaccine-indonesia.html|access-date=2021-12-15|issn=0362-4331}}</ref>

On December 17, 2021, the [[Organization:World Health Organization|World Health Organization (WHO)]] added Novavax's Covovax vaccine, jointly developed with the Serum Institute of India (SII), to the list of approved coronavirus vaccines for emergency use. The vaccine can then be used in the Covax programme for the supply of vaccines to low and middle income countries. Novavax and SII provide Covax program with 1.1 billion doses of vaccine.<ref>{{Cite web|title=World Health Organization Grants Second Emergency Use Listing for Novavax COVID-19 Vaccine|url=https://finance.yahoo.com/news/world-health-organization-grants-second-171900072.html|access-date=2021-12-21|website=finance.yahoo.com}}</ref>

On 20 December 2021, the [[Organization:European Medicines Agency|European Medicines Agency]] recommended Novavax's Nuvaxovid vaccine for conditional marketing authorisation, which was formally approved by the European Commission, making it the fifth approved COVID-19 vaccine in the European Union after Pfizer/BioNTech, Moderna, Janssen and AstraZeneca.<ref name=":3" />

On 20 January 2022, The Therapeutic Goods Administration (TGA) has granted provisional approval to Biocelect Pty Ltd (on behalf of Novavax Inc) for its COVID-19 vaccine, NUVAXOVID. This is the first protein COVID-19 vaccine to receive regulatory approval in Australia.<ref>{{Cite web|url = https://www.tga.gov.au/node/942115|title = TGA provisionally approves Novavax (Biocelect Pty LTD's) COVID-19 vaccine NUVAXOVID|date = 20 January 2022}}{{Dead link|date=October 2023 |bot=InternetArchiveBot |fix-attempted=yes }}</ref>

On 31 January 2022, Novavax applied to the Federal Drug Administration (FDA) for emergency use authorization (EUA) for NVX-CoV2373,<ref>{{Cite web|url=https://ir.novavax.com/2022-01-31-Novavax-Submits-Request-to-the-U-S-FDA-for-Emergency-Use-Authorization-of-COVID-19-Vaccine|title = Novavax Submits Request to the U.S. FDA for Emergency Use Authorization of COVID-19 Vaccine - Jan 31, 2022}}</ref> and on June 7, FDA's panel of outside advisors recommended FDA grant the EUA.<ref>Carolyn Y. Johnson and Laurie McGinley. [https://www.washingtonpost.com/health/2022/06/07/novavax-coronavirus-vaccine-fda/ FDA advisers recommend authorizing Novavax coronavirus vaccine.] Washington Post, June 7, 2022.</ref>

In February 2022, [[Organization:Health Canada|Health Canada]] authorized Nuvaxovid for the prevention of COVID-19 in adults 18 years of age and older.<ref name=canada/>

On 13 July 2022, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the Novavax COVID-19 Vaccine, Adjuvanted for the prevention of COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older.<ref>{{Cite web|url=https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-emergency-use-novavax-covid-19-vaccine-adjuvanted|title = Coronavirus (COVID-19) Update: FDA Authorizes Emergency Use of Novavax COVID-19 Vaccine, Adjuvanted| website=[[Organization:Food and Drug Administration|Food and Drug Administration]] | date=13 July 2022 }}</ref>

In July 2023, Novavax announced that it has received full Marketing Authorization from the European Commission for its [[Medicine:COVID-19|COVID-19]] vaccine, Nuvaxovid (''NVX-CoV2373''), allowing its use as a primary series in individuals aged 12 and older and as a booster dose in adults aged 18 and older. The authorization establishes a foundation for future regulatory approvals and Novavax plans to seek full approval in the United States and other markets while emphasizing the importance of vaccine choice in public health measures.<ref name="pr6july2023">{{Cite press release |url=https://www.prnewswire.com/news-releases/novavaxs-nuvaxovid-receives-full-marketing-authorization-in-the-eu-for-the-prevention-of-covid-301871212.html |title=Novavax's Nuvaxovid Receives Full Marketing Authorization in the EU for the Prevention of COVID |author=Novavax, Inc.}}</ref>

In early October 2023, the FDA amended the EUA to include the reformulated Novavax vaccine "updated to include the spike protein from the SARS-CoV-2 Omicron variant lineage XBB.1.5 (2023-2024 formula)" for age 12 and above.<ref>{{Cite journal |last=Research |first=Center for Biologics Evaluation and |date=2023-10-02 |title=Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) Authorized For Individuals 12 Years of Age and Older |url=https://www.fda.gov/vaccines-blood-biologics/coronavirus-covid-19-cber-regulated-biologics/novavax-covid-19-vaccine-adjuvanted |journal=FDA |language=en}}</ref>

In December 2023, the WHO provided prequalification status to the R21/Matrix-M malaria vaccine developed by the University of Oxford and the Serum Institute of India.<ref>{{cite press release | title=Highly effective, R21/Matrix-M malaria vaccine developed by University of Oxford and the Serum Institute of India awarded WHO 'stamp of approval' | website=University of Oxford | date=21 December 2023 | url=https://www.ox.ac.uk/news/2023-12-21-highly-effective-r21matrix-m-malaria-vaccine-developed-university-oxford-and-serum | access-date=28 December 2023}}</ref>

==Vaccine adjuvants==
Novavax also develops proprietary immune-stimulating [[Chemistry:Saponin|saponin]]-based [[Biology:Immunologic adjuvant|immunologic adjuvant]]s at a wholly-owned Swedish subsidiary, Novavax AB. One of these, Matrix-M,<ref>{{Cite journal|doi=10.1007/s12026-018-8991-x|title=Matrix-M adjuvant enhances immunogenicity of both protein- and modified vaccinia virus Ankara-based influenza vaccines in mice|year=2018|last1=Magnusson|first1=Sofia E.|last2=Altenburg|first2=Arwen F.|last3=Bengtsson|first3=Karin Lövgren|last4=Bosman|first4=Fons|last5=De Vries|first5=Rory D.|last6=Rimmelzwaan|first6=Guus F.|last7=Stertman|first7=Linda|journal=Immunologic Research|volume=66|issue=2|pages=224–233|pmid=29594879|pmc=5899102}}</ref> is used in Novavax's approved vaccine for COVID-19 (NVX-CoV2373).<ref>{{Cite press release|title=Novavax Announces Positive Phase 1 Data for its COVID-19 Vaccine Candidate|url=https://ir.novavax.com/news-releases/news-release-details/novavax-announces-positive-phase-1-data-its-covid-19-vaccine|access-date=2021-06-19|website=Novavax Inc.|archive-date=13 June 2021|archive-url=https://web.archive.org/web/20210613192737/http://ir.novavax.com/news-releases/news-release-details/novavax-announces-positive-phase-1-data-its-covid-19-vaccine|url-status=dead}}</ref><ref name=KHN>Sarah Jane Tribble and Rachana Pradhan. [https://khn.org/news/article/covid-vaccine-novavax-vaccination-effort-from-zero-to-not-quite-warp-speed/ Novavax’s Effort to Vaccinate the World, From Zero to Not Quite Warp Speed] Kaiser Health News, Kaiser Family Foundation, July 19, 2021.</ref>

==References==
{{Reflist}}

==External links==
{{Finance links
| name = Novavax, Inc.
| symbol = NVAX
| reuters = NVAX.O
| bloomberg = NVAX:US
| sec_cik = 1000694
| yahoo = NVAX
| google = NVAX:NASDAQ
}}

[[Category:Vaccine producers]]

{{Sourceattribution|Novavax}}