Novavax

Last updated

Novavax, Inc.
Company type Public
ISIN US6700024010
Industry Biotechnology
Founded1987;37 years ago (1987) [1]
Headquarters
Gaithersburg   OOjs UI icon edit-ltr-progressive.svg
,
United States  OOjs UI icon edit-ltr-progressive.svg
Area served
Worldwide
Key people
  • John Jacobs (CEO)
  • Ruxandra Draghia-Akli (R&D) [2]
Products Vaccines
RevenueDecrease2.svg US$983.7 million (2023) [3]
Number of employees
1,541 [4]  (2022)
Website www.novavax.com OOjs UI icon edit-ltr-progressive.svg

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 influenza and respiratory syncytial virus (RSV), as well as 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 COVID-19. [5]

Contents

The COVID-19 vaccine Nuvaxovid was approved in the European Union at the end of 2021, [6] and in Canada in February 2022, [7] as the fifth vaccine against COVID-19, following Pfizer/BioNTech, Moderna, Janssen and 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. [8]

ResVax

In March 2015, the company completed a Phase I trial for its Ebola vaccine candidate, [9] as well as a phase II study in adults for its respiratory syncytial virus vaccine, which would become ResVax. [10] The ResVax trial was encouraging as it showed significant efficacy against respiratory syncytial virus (RSV) infection, [10] 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." [11] It is aimed at stimulating resistance to RSV infection, targeting both adult and infant populations. [10]

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

Novavax research and development laboratories in Gaithersburg Novavax research and development.jpg
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. [10]

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. [13] [14] 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. [14]

NanoFlu

NanoFlu is a quadrivalent influenza vaccine, which completed Phase II clinical trials successfully in 2019. In January 2020, it was granted fast track designation by the U.S. Food and Drug Administration (FDA) to move into Phase III trials, which completed in March 2020. [15] [16] [17]

Finance and external sponsorships

Novavax is financed by both public and private investors, of which approximately 50% of the free float shares are held by institutional investors. [18]

Stanley Erck (right) and Gregory Glenn (left) at the biotech labs in Gaithersburg during the visit of the Governor of Maryland in September 2020 Novavax.jpg
Stanley Erck (right) and Gregory Glenn (left) at the biotech labs in Gaithersburg during the visit of the Governor of Maryland in September 2020

Novavax is funded by a mix of private and public investment. [18] 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 RSV for infants via maternal immunization. [20] [21] [22] [23]

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. [24] CEPI had already invested $4 million in March. [24]

On July 7, 2020, during the Donald Trump administration, the company was awarded a US$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. [25]

COVID-19 vaccine

Vaccine research and development

In January 2020, Novavax announced development of a vaccine candidate, named NVX-CoV2373, to establish immunity to SARS-CoV-2. [26] NVX-CoV2373 is a protein subunit vaccine that contains the spike protein of the SARS-CoV-2 virus. [27] Novavax's work is in competition for vaccine development among dozens of other companies.

Governor Larry Hogan at Novavax's future Vaccines Innovation Campus and global headquarters in Maryland Larry Hogan at Novavax campus (51239176189).jpg
Governor Larry Hogan at Novavax's future Vaccines Innovation Campus and global headquarters in Maryland

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. [29] 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". [30] [ needs update ] On 14 June 2021, Novavax announced overall 90.4% efficacy in the 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. [31]

On May 22, 2021, Novavax and Moderna announced a deal with the South Korean government to manufacture their COVID-19 vaccines. [32] The vaccine is also being co-developed (with the Coalition for Epidemic Preparedness Innovations) in India under the brand name Covovax. [33] CEPI granted Novavax up to $399 million to support the development of the candidate vaccine. [34]

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. [35] The Government of Japan's Ministry of Health, Labour and Welfare signed an agreement with Takeda Pharmaceutical Company for Takeda to manufacture and distribute Novavax's TAK-019 upon regulatory approval. [36]

On December 22, 2021, Novavax confirmed the efficacy of two doses of vaccine against the omicron variant of SARS-CoV-2. [37] [38] [39] The new data suggest that the vaccine provides an immune response against the Omicron variant and other variants of the coronavirus. The response of 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. [37] [38] [39]

The data shows that the 73.5-fold increase in antibody level following a third dose of Novavax vaccine (protein subunit vaccine) was higher than the booster doses of Pfizer and Moderna (mRNA vaccines), which increased the antibody levels 25-fold and 37-fold, respectively. [37] [40] [38] [39]

Authorization and application

On November 1, 2021, Novavax and 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 Matrix-M adjuvant. It will be manufactured by SII in India and marketed by SII in Indonesia under the brand name Covovax. [41]

On December 17, 2021, the 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. [42]

On 20 December 2021, the 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. [6]

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. [43]

On 31 January 2022, Novavax applied to the Federal Drug Administration (FDA) for Emergency Use Authorization (EUA) for NVX-CoV2373, [44] and on June 7, FDA's panel of outside advisors recommended FDA grant the EUA. [45]

In February 2022, Health Canada authorized Nuvaxovid for the prevention of COVID-19 in adults 18 years of age and older. [7]

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. [46]

In July 2023, Novavax announced that it has received full Marketing Authorization from the European Commission for its 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. [47]

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. [48]

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. [49]

Vaccine adjuvants

Novavax also develops proprietary immune-stimulating saponin-based immunologic adjuvants at a wholly-owned Swedish subsidiary, Novavax AB. One of these, Matrix-M, [50] is used in Novavax's approved vaccine for COVID-19 (NVX-CoV2373). [51] [52]

Related Research Articles

Serum Institute of India (SII) is an Indian multinational biotechnology and biopharmaceuticals company, based in Pune. It is the world's largest manufacturer of vaccines by volume. It was founded by Cyrus Poonawalla in 1966 and is a part of Cyrus Poonawalla Group.

<span class="mw-page-title-main">COVID-19 vaccine</span> Vaccine against SARS-CoV-2

A COVID‑19 vaccine is a vaccine intended to provide acquired immunity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes coronavirus disease 2019 (COVID‑19).

<span class="mw-page-title-main">Moderna COVID-19 vaccine</span> RNA COVID-19 vaccine

The Moderna COVID‑19 vaccine, sold under the brand name Spikevax, is a COVID-19 vaccine developed by the American company Moderna, the United States National Institute of Allergy and Infectious Diseases (NIAID), and the Biomedical Advanced Research and Development Authority (BARDA). Depending on the jurisdiction, it is authorized for use in humans aged six months, twelve years, or eighteen years and older. It provides protection against COVID-19, which is caused by infection by the SARS-CoV-2 virus.

<span class="mw-page-title-main">COVID-19 drug development</span> Preventative and therapeutic medications for COVID-19 infection

COVID-19 drug development is the research process to develop preventative therapeutic prescription drugs that would alleviate the severity of coronavirus disease 2019 (COVID-19). From early 2020 through 2021, several hundred drug companies, biotechnology firms, university research groups, and health organizations were developing therapeutic candidates for COVID-19 disease in various stages of preclinical or clinical research, with 419 potential COVID-19 drugs in clinical trials, as of April 2021.

<span class="mw-page-title-main">Operation Warp Speed</span> US program to accelerate COVID-19 vaccine efforts

Operation Warp Speed (OWS) was a public–private partnership initiated by the United States government to facilitate and accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics. The first news report of Operation Warp Speed was on April 29, 2020, and the program was officially announced on May 15, 2020. It was headed by Moncef Slaoui from May 2020 to January 2021 and by David A. Kessler from January to February 2021. At the end of February 2021, Operation Warp Speed was transferred into the responsibilities of the White House COVID-19 Response Team.

<span class="mw-page-title-main">Casirivimab/imdevimab</span> Antiviral combination medication

Casirivimab/imdevimab, sold under the brand name REGEN‑COV among others, is a combination medicine used for the treatment and prevention of COVID‑19. It consists of two human monoclonal antibodies, casirivimab and imdevimab that must be mixed together and administered as an infusion or subcutaneous injection. The combination of two antibodies is intended to prevent mutational escape. It is also available as a co-formulated product. It was developed by the American biotechnology company Regeneron Pharmaceuticals.

<span class="mw-page-title-main">Pfizer–BioNTech COVID-19 vaccine</span> Type of vaccine for humans

The Pfizer–BioNTech COVID-19 vaccine, sold under the brand name Comirnaty, is an mRNA-based COVID-19 vaccine developed by the German biotechnology company BioNTech. For its development, BioNTech collaborated with the American company Pfizer to carry out clinical trials, logistics, and manufacturing. It is authorized for use in humans to provide protection against COVID-19, caused by infection with the SARS-CoV-2 virus. The vaccine is given by intramuscular injection. It is composed of nucleoside-modified mRNA (modRNA) that encodes a mutated form of the full-length spike protein of SARS-CoV-2, which is encapsulated in lipid nanoparticles. Initial guidance recommended a two-dose regimen, given 21 days apart; this interval was subsequently extended to up to 42 days in the United States, and up to four months in Canada.

<span class="mw-page-title-main">Covaxin</span> Vaccine against COVID-19

Covaxin is a whole inactivated virus-based COVID-19 vaccine developed by Bharat Biotech in collaboration with the Indian Council of Medical Research - National Institute of Virology.

<span class="mw-page-title-main">Novavax COVID-19 vaccine</span> Vaccine against COVID-19

The Novavax COVID-19 vaccine, sold under the brand names Nuvaxovid and Covovax, among others, is a subunit COVID-19 vaccine developed by Novavax and the Coalition for Epidemic Preparedness Innovations. It contains a recombinant spike protein from the SARS-CoV-2 Omicron variant lineage JN.1.

The COVID-19 vaccination program in the Philippines was a mass immunization campaign against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes coronavirus disease 2019 (COVID-19), in response to the pandemic in the country. The vaccination program was initiated by the Duterte administration on March 1, 2021, a day after the arrival of the country's first vaccine doses which were donated by the Chinese government.

<span class="mw-page-title-main">Janssen COVID-19 vaccine</span> Vaccine against COVID-19

The Janssen COVID‑19 vaccine, (Ad26.COV2.S) sold under the brand name Jcovden, is a COVID‑19 vaccine that was developed by Janssen Vaccines in Leiden, Netherlands, and its Belgian parent company Janssen Pharmaceuticals, a subsidiary of American company Johnson & Johnson.

<span class="mw-page-title-main">History of COVID-19 vaccine development</span> Scientific work to develop a vaccine for COVID-19

SARS-CoV-2, the virus that causes COVID-19, was isolated in late 2019. Its genetic sequence was published on 11 January 2020, triggering an urgent international response to prepare for an outbreak and hasten the development of a preventive COVID-19 vaccine. Since 2020, vaccine development has been expedited via unprecedented collaboration in the multinational pharmaceutical industry and between governments. By June 2020, tens of billions of dollars were invested by corporations, governments, international health organizations, and university research groups to develop dozens of vaccine candidates and prepare for global vaccination programs to immunize against COVID‑19 infection. According to the Coalition for Epidemic Preparedness Innovations (CEPI), the geographic distribution of COVID‑19 vaccine development shows North American entities to have about 40% of the activity, compared to 30% in Asia and Australia, 26% in Europe, and a few projects in South America and Africa.

<span class="mw-page-title-main">SCB-2019</span> Vaccine candidate against COVID-19

SCB-2019 is a protein subunit COVID-19 vaccine developed by Clover Biopharmaceuticals using an adjuvant from Dynavax technologies. Positive results of Phase I trials for the vaccine were published in The Lancet and the vaccine completed enrollment of 29,000 participants in Phase II/III trials in July 2021. In September 2021, SCB-2019 announced Phase III results showing 67% efficacy against all cases of COVID-19 and 79% efficacy against all cases of the Delta variant. Additionally, the vaccine was 84% effective against moderate cases and 100% effective against hospitalization.

<span class="mw-page-title-main">Sanofi–GSK COVID-19 vaccine</span> Protein subunit vaccine against COVID-19

The Sanofi–GSK COVID-19 vaccine, sold under the brand name VidPrevtyn Beta, is a COVID-19 vaccine developed by Sanofi Pasteur and GSK.

<span class="mw-page-title-main">MVC COVID-19 vaccine</span> Vaccine against COVID-19

The MVC COVID-19 vaccine, designated MVC-COV1901 and also known as the Medigen COVID-19 vaccine, is a protein subunit COVID-19 vaccine developed by Medigen Vaccine Biologics Corporation in Taiwan, American company Dynavax Technologies, and the U.S. National Institutes of Health.

<span class="mw-page-title-main">Corbevax</span> Protein subunit vaccine against COVID-19

Corbevax is a protein subunit COVID-19 vaccine developed by Texas Children's Hospital Center for Vaccine Development and Baylor College of Medicine in Houston, Texas and Dynavax technologies based in Emeryville, California. It is licensed to Indian biopharmaceutical firm Biological E. Limited (BioE) for development and production.

<span class="mw-page-title-main">COVAX-19</span> Vaccine candidate against COVID-19

COVAX-19 is a recombinant protein-based COVID-19 vaccine developed by South Australian-based biotech company Vaxine, in collaboration with CinnaGen, a private company with operations in the Middle East. It is under clinical trial in collaboration with the Iranian company CinnaGen.

<span class="mw-page-title-main">COVID-19 vaccine clinical research</span> Clinical research to establish the characteristics of COVID-19 vaccines

COVID-19 vaccine clinical research uses clinical research to establish the characteristics of COVID-19 vaccines. These characteristics include efficacy, effectiveness, and safety. As of November 2022, 40 vaccines are authorized by at least one national regulatory authority for public use:

Bebtelovimab is a monoclonal antibody developed by AbCellera and Eli Lilly as a treatment for COVID-19.

References

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  19. ↑ "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". Twitter.
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  30. ↑ 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 .
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  33. ↑ Leo, Leroy (27 March 2021). "Hope to launch Covovax by September, says Serum Institute CEO". mint. Retrieved 17 July 2021.
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  49. ↑ "Highly effective, R21/Matrix-M malaria vaccine developed by University of Oxford and the Serum Institute of India awarded WHO 'stamp of approval'". University of Oxford (Press release). 21 December 2023. Retrieved 28 December 2023.
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  52. ↑ Sarah Jane Tribble and Rachana Pradhan. Novavax’s Effort to Vaccinate the World, From Zero to Not Quite Warp Speed Kaiser Health News, Kaiser Family Foundation, July 19, 2021.

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