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Novavax, Inc., is an American biotechnology company based in Gaithersburg, Maryland that develops vaccines to counter serious infectious diseases. Prior to 2020, company scientists developed experimental vaccines for Ebola, influenza, respiratory syncytial virus (RSV), and other emerging infectious diseases. During 2020, the company redirected its efforts to focus on development and approval of its vaccine for COVID-19. Novavax has indicated it recognizes a continued need for innovative vaccines in other therapeutic areas and reports it has taken steps to ensure continued advancement of its influenza vaccine.^[4]

Contents

History[edit]

Novavax was founded in 1987 to focus on experimental vaccine development, but as of early 2021 has not yet completed commercialization of any vaccine product.^[5]

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.^[6]

ResVax[edit]

In March 2015 the company completed a Phase I trial for its Ebola vaccine candidate,^[7] as well as a phase II study in adults for its RSV vaccine, which would become ResVax.^[8] The ResVax trial was encouraging as it showed significant efficacy against RSV infection,^[8] using a nanoparticle-based treatment using a recombinant F lipoprotein or saponin, "extracted from the Quillaja saponaria [or?] Molina bark together with cholesterol and phospholipid."^[9] It is aimed at stimulating resistance to respiratory syncytial virus infection, targeting both adult and infant populations.^[8]

2016 saw the company's first phase III trial, the 12,000 adult Resolve trial,^[8] for its respiratory syncytial virus vaccine, which would come to be known as ResVax, fail in September.^[10] This triggered an eighty-five percent dive in the company's stock price.^[10] Phase II adult trial results also released in 2016 showed a stimulation of antigenicity, but failure in efficacy.^[8] Evaluation of these results suggested that an alternative dosing strategy might lead to success, leading to plans to run new phase II trials.^[10] 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 Zika virus vaccine.^[10]

Alongside the adult studies of ResVax, the vaccine was also in 2016 being tested against infant RSV infection through the route of maternal immunization.^[8]

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.^[11][12] As a secondary result, the company was forced to conduct a reverse stock split in order to maintain Nasdaq minimum qualification, meaning it was in risk of being delisted.^[12]

NanoFlu[edit]

Governor Larry Hogan at Novavax's future Vaccines Innovation Campus and global headquarters in Maryland.^[13]

NanoFlu is a quadrivalent influenza vaccine, which completed Phase 2 clinical trials successfully in 2019. In January 2020, it was granted fast track status by the U.S. Food and Drug Administration (FDA) to move into Phase 3 trials, which completed in March 2020.^[14][15][16]

External sponsorships[edit]

Novavax is funded by a mix of private and public investment.^[5] 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 human respiratory syncytial virus for infants via maternal immunization.^{[17][18][19][20]}

In May 2020, Novavax received US$384 million from the 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.^[21] CEPI had already invested $4 million in March.^[21]

Drugs/Vaccines in development[edit]

COVID-19 vaccine candidate[edit]

See also: NVX-CoV2373 and COVID-19 vaccine

In January 2020, Novavax announced development of a vaccine candidate, named NVX-CoV2373, to establish immunity to SARS-CoV-2.^[22] NVX-CoV2373 is a protein subunit vaccine that contains the spike protein of the SARS-CoV-2 virus.^[23] Novavax's work is in competition for vaccine development among dozens of other companies.

In January 2021, the company released phase 3 trials showing that it has 89% efficacy against Covid-19, and also provides strong immunity against new variants.^[24] It has applied for emergency use in the US and UK but will be distributed in the UK first.^[^{citation needed}^] As of May 2021, the company does not anticipate that it will file for approval in the UK "until July at the earliest".^[25] On 14 June 2021, Novavax announced overall 90.4% efficacy in Phase 3 U.S & Mexico trial. Of the total 77 COVID-19 cases among the volunteer of the trial, 14 occurred in the vaccine group, while 63 occurred in the placebo group.^[26]

On May 22, 2021, Novavax and Moderna announced a deal with the South Korean government to manufacture their COVID-19 vaccines.^[27]The vaccine is also being co-developed (with the Coalition for Epidemic Preparedness Innovations) in India under the name Covovax.^[28]

On September 6, 2021, Novavax and Takeda Pharmaceutical Company announced that the Government of Japan's Ministry of Health, Labour and Welfare will purchase 150 million doses of Novavax's vaccine candidate TAK-019 pending regulatory approval.^[29] The Government of Japan's Ministry of Health, Labour and Welfare signed an agreement with Takeda Pharmaceutical Company for Takeda Pharmaceutical Company to manufacture and distribute Novavax's TAK-019 upon regulatory approval.^[30]

Vaccine adjuvants[edit]

Novavax also develops proprietary immune-stimulating saponin-based immunologic adjuvants at a wholly owned Swedish subsidiary, Novavax AB. One of these, Matrix-M,^[31] is used in one of Novavax's experimental test vaccines for COVID-19.^[32][33]

References[edit]

^ "Company Overview of Novavax, Inc". Bloomberg.com. Archived from the original on 24 February 2017. Retrieved 2 June 2019.
^ "Novavax Reports Fourth Quarter and Full Year 2020 Financial Results and Operational Highlights". March 2021.
^ https://ir.novavax.com/static-files/576c461a-c3af-4c3e-bf9a-ecc9cf251d1c
^ Novavax Inc. 2020 Annual Report. Accessed 10 May 2021.
^
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^a ^b Thomas, Katie; Twohey, Megan (16 July 2020). "How a Struggling Company Won $1.6 Billion to Make a Coronavirus Vaccine". The New York Times. ISSN 0362-4331. Retrieved 29 January 2021.
^ Taylor, Nick Paul (3 June 2013). "Novavax makes $30M bid for adjuvant business". FiercePharma. Archived from the original on 14 September 2016. Retrieved 9 September 2016.
^ "Novavax's Ebola vaccine shows promise in early-stage trial". Reuters. 21 July 2017. Archived from the original on 2 October 2016. Retrieved 28 March 2017.
^
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^a ^b ^c ^d ^e ^f Adams, Ben (16 September 2016). "Novavax craters after Phase III RSV F vaccine failure; seeks path forward". FierceBiotech. Questex. Archived from the original on 18 August 2020. Retrieved 25 January 2020.
^ "Novavax addresses urgent global public health needs with innovative technology". novavax.com. Archived from the original on 10 September 2020. Retrieved 30 August 2020.
^
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^a ^b ^c ^d Bell, Jacob (14 November 2016). "Novavax aims to rebound with restructuring, more trials". BioPharma Dive. Washington, D.C.: Industry Dive. Archived from the original on 29 March 2017. Retrieved 28 March 2017.
^ Shtrubel, Marty (12 December 2019). "3 Biotech Stocks That Offer the Highest Upside on Wall Street". Biotech. Nasdaq. Archived from the original on 26 January 2020. Retrieved 25 January 2020.
^
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^a ^b Budwell, George (20 January 2020). "3 Top Biotech Picks for 2020". Markets. Nasdaq. Novavax: A catalyst awaits. Archived from the original on 25 January 2020. Retrieved 25 January 2020.
^ "Novavax to Host Maryland Governor Larry Hogan at Site of Future Novavax Vaccines Innovation Campus and Global Headquarters". yahoo.com. 9 June 2021.
^ Gilgore, Sara (24 March 2020). "Novavax's seasonal flu vaccine just got great news. And it's a big deal". www.bizjournals.com. Retrieved 18 June 2021.
^ "A Universal Influenza Vaccine: How Close Are We?". ASM.org. Retrieved 18 June 2021.
^ "Novavax Secured a Critical Second-Place Finish". InvestorPlace. 10 November 2020. Retrieved 18 June 2021.
^ "Gaithersburg Biotech Receives Grant Worth up to $89 million". Bizjournals.com. Archived from the original on 1 April 2017. Retrieved 28 March 2017.
^ "With promising RSV data in hand, Novavax wins $89M Gates grant for PhIII | FierceBiotech". Fiercebiotech.com. Archived from the original on 14 April 2017. Retrieved 28 March 2017.
^ "Novavax RSV vaccine found safe for pregnant women, fetus". Reuters. 29 September 2016. Archived from the original on 7 October 2016. Retrieved 28 March 2017.
^ Herper, Matthew. "Gates Foundation Backs New Shot To Prevent Babies From Dying Of Pneumonia". Forbes. Archived from the original on 21 September 2016. Retrieved 28 March 2017.
^
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^a ^b Eric Sagonowsky (11 May 2020). "Novavax scores $384M deal, CEPI's largest ever, to fund coronavirus vaccine work". FiercePharma. Archived from the original on 16 May 2020. Retrieved 12 May 2020.
^ Sara Gilgore (26 February 2020). "Novavax is working to advance a potential coronavirus vaccine. So are competitors". Washington Business Journal. Archived from the original on 16 March 2020. Retrieved 6 March 2020.
^ Nidhi Parekh (24 July 2020). "Novavax: A SARS-CoV-2 Protein Factory to Beat COVID-19". Archived from the original on 22 November 2020. Retrieved 24 July 2020.
^ "Covid-19: Novavax vaccine shows 89% efficacy in UK trials". BBC News. 29 January 2021. Retrieved 1 February 2021.
^ Marsh, Sarah (21 May 2021). "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". The Guardian.
^ Howard, Jacqueline (14 June 2021). "Novavax says Covid-19 vaccine shows 90.4% overall efficacy in US/Mexico Phase 3 trial". CNN. Retrieved 14 June 2021.
^ "Moderna, Novavax to produce more COVID-19 vaccines in S.Korea". Reuters. 22 May 2021. Retrieved 17 July 2021.
^ Leo, Leroy (27 March 2021). "Hope to launch Covovax by September, says Serum Institute CEO". mint. Retrieved 17 July2021.
^ "Japan to purchase 150 mln doses of Takeda-produced Novavax vaccines - drugmaker". Reuters. 7 September 2021. Retrieved 7 September 2021.
^ "Japan secures 150 million Novavax vaccine doses". The Japan Times. 7 September 2021. Retrieved 7 September 2021.
^ Magnusson, Sofia E.; Altenburg, Arwen F.; Bengtsson, Karin Lövgren; Bosman, Fons; De Vries, Rory D.; Rimmelzwaan, Guus F.; Stertman, Linda (2018). "Matrix-M™ adjuvant enhances immunogenicity of both protein- and modified vaccinia virus Ankara-based influenza vaccines in mice". Immunologic Research. 66 (2): 224–233. doi:10.1007/s12026-018-8991-x. PMC 5899102. PMID 29594879.
^ "Novavax Announces Positive Phase 1 Data for its COVID-19 Vaccine Candidate | Novavax Inc. - IR Site". ir.novavax.com. Retrieved 19 June 2021.
^ Sarah Jane Tribble and Rachana Pradhan. Novavax’s Effort to Vaccinate the World, From Zero to Not Quite Warp SpeedKaiser Health News, Kaiser Family Foundation, July 19, 2021.

External links[edit]

Official website
Business data for Novavax, Inc.:
- SEC filings

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