NVX-CoV2373
NVX-CoV2373
is a recombinant nanoparticle vaccine candidate using Matrix-M™ adjuvant.
Under development by Novavax, Inc., and Novavax AB, Uppsala, with manufacturing of both antigen and adjuvant anticipated to occur in the EU.
CEPI announced
an investment of up to $ 388 mio. into Novavax' NVX-CoV2373 vaccine candidate on May 11, 2020.
Novavax announced
$ 60 mio. funding for manufacturing of NVX-CoV2373 from the Department of Defense on June 4, 2020.
The U.S. Department of Health and Human Services (HHS) and Department of Defense (DoD) jointly announced
$1.6 Billion Funding from Operation Warp Speed into Novavax' NVX-CoV2373 vaccine candidate on July 7, 2020.
Novavax and Serum Institute of India announced
cooperation on a minimum of 1 bn dosis of NVX-CoV2373 for LMIC on August 6, 2020.
Novavax announced
licensure of NVX-CoV2373 to Takeda for local production and commercialization in Japan on August 7, 2020.
Novavax, SK bioscience and Republic of Korea on August 13, 2020 announced
a partnership for manufacture and supply of of NVX-CoV2373 for global markets including South Korea.
On August 14, 2020 the UK Government announced
the purchase of 60 million doses of NVX-CoV2373.
Novavax Inc. announced
on August 17, 2020 the dedication of a $15 million grant from the Bill & Melinda Gates Foundation in support of its Phase 2b clinical trial in South Africa of NVX-CoV2373.
On August 31, 2020 Novavax Inc. announced
it has reached an agreement in principle with the Government of Canada to supply up to 76 million doses of NVX-CoV2373,.
Novavax and Commonwealth of Australia announced
on November 4, 2020, the signature of Heads of Terms for acquisition of 40 million doses of NVX-CoV2373.
On December 16, 2020 Novavax announced
an Agreement with Government of New Zealand for 10.7 Million Doses of COVID-19 Vaccine.
On December 17, 2020 Novavax concluded exploratory talks with the European Commission to purchase an initial 100 Million doses of Covid-19 vaccine.
Novavax announces
the finalization of its Agreement with Commonwealth of Australia for 51 Million Doses of COVID-19 Vaccine.
On January 22, 2021, the Canadian government commits
to purchase 52 million doses with option for additional 24 million of Novavax NVX-CoV2373.
Switzerland announces
on February 3, 2021, its purchase of six million doses of Novavax NVX-CoV2373
NVX-CoV2373
The NVX-CoV2373 vaccine, a stable, prefusion protein made using Novavax’ proprietary nanoparticle technology and Matrix-M™ adjuvant, is being developed to provide protection against SARS-CoV-2, the virus responsible for COVID-19, thus helping to control the spread of this global disease.
Novavax’ proprietary recombinant nanoparticle technology platform combines the power and speed of genetic engineering to efficiently produce a new class of highly immunogenic nanoparticles addressing urgent global health needs. Together the nanoparticle technology and clinically proven Matrix-M™ adjuvant enhance immune response and stimulate high levels of neutralizing antibodies against COVID-19.
Preclinical and Phase I studies provided strong evidence that NVX-CoV2373 would be highly immunogenic in humans. In November 2020, Novavax was granted fast track designation by the U.S. FDA for its COVID candidate. In the end of December 2020, Novavax announced the initiation of its pivotal PREVENT-19 Pivotal Phase 3 Efficacy Trial in the United States and Mexico to evaluate the efficacy, safety and immunogenicity. The company is also currently conducting a large pivotal Phase 3 clinical study in the United Kingdom (U.K.), a Phase 2b safety and efficacy study in South Africa, and an ongoing Phase1/2 trial in the U.S. and Australia.
... at the forefront of delivering a vaccine for Sars-Cov-2
our insight of the week - November 30, 2020
Novavax Phase 3 clinical trial, photo courtesy company
Even as cases of the coronavirus spike throughout Europe, and we head into the midst of the long-feared second wave, hope may yet be on the horizon. From the outset of the COVID-19 pandemic, Novavax has been at the forefront of the race to develop a vaccine for the virus. Its vaccine–titled NVX-CoV2373– is one of most promising of all the candidates. Early trials have indicated that Novavax’s vaccine, which uses its recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein, has triggered highly immunogenic responses from participants, and was generally well tolerated.
Today, Novavax is going full speed ahead. In late September, the company has announced the start of Phase 3 trials for its vaccine in the U.K., in partnership with the U.K. Government’s Vaccines Taskforce. The trial has been expanded from 10,000 to 15,000 participants in order to expedite the assessment of safety and efficacy in a shorter period of time. In the over 5,500 volunteers that have been recruited so far, Novavax has made great efforts to ensure trial participants are representative of at-risk groups, including minorities, those with comorbidities, and at least 25% who are over the age of 65. Novavax also expects these pivotal late stage trials to begin for its vaccine in the U.S. and Mexico by the end of November.
Will it be the one? Novavax’s vaccine is part of an increasingly crowded marketplace of contenders. Given how disruptive and deadly this pandemic has been, it is undoubtedly positive to have so many promising vaccine candidates, which increases the likelihood there will a safe and effective vaccine on the market as quickly as possible.
Even so, there are a number of factors that point to some of the advantages of Novavax’s vaccine that may help it stand out from the pack. For one, it is based on the proven methods of using proteins from the corona-virus that cannot replicate in the body, and an adjuvant to boost the immune response. There is also the fact that Novavax’s vaccine is distributed through standard cold chain, requiring refrigeration of just 2-8 degrees centigrade as opposed to subzero temperatures. It is also worthy to note that Novavax will work on combining the influenza and the COVID-19 vaccine for use after the pandemic, which would be valuable both from a convenience and a safety standpoint.
Novavax Phase 3 clinical trial, photo courtesy company
Even as we wait patiently for a vaccine, it is worthwhile to take a step back and remember how remarkable it is that we are even at this point, where we can speak of vaccine approval and rollout in a matter of months rather than years. The typical development time for a vaccine, from research to clinical trials to manufacturing, is over ten years. Without cutting corners or compromising on safety, quality, and efficacy, Novavax and several other companies have are working to slice that time to just a small fraction of the time this process normally requires.
Of course, in no small part this is also due to government support and programs like the US’s Operation Warp Speed, from which Novavax has received $1.6 billion for research and development and manufacturing. Novavax is aiming to produce two billion annualised doses of its vaccine by next year. It has already announced agreements with the U.S., Canada, and the U.K. to provide its vaccine.
The sums that have been invested in COVID-19 vaccine development may seem large, but they pale in comparison to the trillions of dollars governments have spent to prop up struggling businesses and to support the unemployed, in what has been the largest economic contraction since the Great Depression. In one thought experiment, The Economist magazine calculated in terms of economic output saved, it would make sense to spend as much as $200 billion to move up a vaccine rollout just one week.
Of course, it will not require that much to get a safe and effective vaccine out to the market. But still, with cases of COVID-19 going up throughout Europe and the second wave upon us, hopes of a vaccine may yet be the light we need to get through the long, dark winter ahead. As Albert Camus put it in his allegorical novel The Plague, "Once the faintest stirring of hope became possible, the dominion of the plague was ended."
November 30, 2020 by kENUP
Novavax gears up to deliver COVID-19 vaccine doses by year-end
our insight of the week - August 20, 2020
Stanley ("Stan") C. Erck, President and CEO of Novavax, Inc., photo courtesy company
Novavax has significantly ramped up development work on a vaccine, titled NVX-CoV2373, for Covid-19
On July 7, the late-stage biotechnology company won an impressive 1.6 bn USD grant from the US Department of Health and Human Services through a programme called Operation Warp Speed. This represents an enormous show of confidence in Novavax’ hopes to deliver millions of doses in a normally undreamt-of timescale. Production is already underway.
It’s all in the name: by the end of 2020 a vaccine should be ready to be distributed at “warp speed.” Indeed, in normal circumstances, such progress would take at least several years, but here we’re talking about less than six months. The company's stock price, already rising at unprecedented rates prior to this announcement, won a further big “shot in the arm” and is up 3000% this year.
On US news channel CNBC, Novavax President and CEO Stanley C. Erck claimed that the funding would mean that Novavax would be able to conduct Phase I and Phase II trials while “in parallel we would be able to manufacture large quantities at multiple different locations in five or six countries.” Normally manufacturing would begin only after testing is complete, and regulatory approval won, but because the manufacturing process alone can take over 6 months, delaying the production at such a critical time would mean not having large enough quantities of the vaccine for distribution.
Online Signature Event, Novavax, Inc. and SK bioscience, August 13, 2020, photo courtesy company
This is of course a double-edged sword: if the vaccine is safe and effective it will be immediately available, but if it isn’t these doses have to be discarded. However, as Dr Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases, explains, this is “a financial risk. It is not a risk for safety, nor is it a risk for scientific integrity.”
The U.S. money from Operation Warp Speed, together with the up to 60m USD investment of the Department of Defense (DoD) allows Novavax to take these risks, thanks to which Dr Gregory Glenn, Novavax’ President of Research and Development, claimed that Novavax was “on track” to deliver 100 million vaccines by the end of the year although this was a “very challenging task.” Furthermore, the funding it received from the Coalition for Epidemic Preparedness Innovations (CEPI) in May, up to 338m USD in total, would be used to modernise and upscale the vaccine manufacturing facilities of its recently-acquired Praha Vaccines, now Novavax CZ, in the Czech Republic so as to produce more than 1bn vaccine doses for next year.
Online Signature Event, Novavax, Inc. and SK bioscience, August 13, 2020, photo courtesy company
Recent partnerships fuelled optimism in late July and August that it could meet this punishing schedule by disclosing partnerships with AGC Biologics, Polypeptide Group, Fujifilm Diosynth Biotechnologies (FDB), Takeda, Serum Institute of India, SK bioscience, Republic of Korea and the UK government.
Mr Erck has said that the arrangements would “ensure the large-scale manufacture of our COVID-19 vaccine candidate.” He added: “We are committed to working together with unprecedented speed to deliver a vaccine to protect our nation’s population.”
The results of Phase I of clinical trials which have just been released show that NVX-CoV2373 was generally well-tolerated and had a reassuring safety profile; Phase II trials are due to begin almost immediately and expand to countries beyond Australia, with those key Phase III trials scheduled for mid-October. As the world holds its breath, Dr Glenn has provided some clues indicating that trial results would include details on T-Cell response and antibodies.
August 20, 2020 by ACUMEN
The Novavax story - a trans-atlantic vaccine candidate sparring to protect against COVID-19
our insight of the week - June 12, 2020
Initiation of phase I trial of NVX-CoV2373. photo courtesy Novavax, Inc.
"The clock is ticking," says Stanley Erck, President and CEO of the aptly named biotech company Novavax, that sees itself surging ahead in the race to develop, manufacture and distribute a safe, effective and scalable vaccine against COVID-19. Its stock on the Nasdaq has leapt over 1000% this year alone on investor hopes it has discovered a winning formula.
Already under the spotlight, its vaccine against COVID-19 is progressing towards the end of Phase 1 clinical trials – in Australia – with results expected in July. But Mr Erck has wooed markets by ramping up production capacity globally already. "If we had waited for Phase 1 results, we would have lost 4-6 months and in a pandemic that's huge."
His company has become the fourth candidate to receive financial support from the Coalition for Epidemic Preparedness Innovations (CEPI) designed to accelerate the development and manufacturing capacity of the company. The $388 million, Mr Erck says, will potentially enable Novavax to meet its goal of producing 100 million doses of the new vaccine by the end of this year – heading towards the finishing line of perhaps over 1 billion sometime in 2021. Novavax also just announced a $60 million contract from the US Department of Defense to support its production of the vaccine.
photo courtesy Novavax, Inc.
NVX-CoV2373 is the vaccine candidate in development. The company, based in Gaithersburg, Maryland, uses its proprietary recombinant technology platform, which combines the power and speed of genetic engineering, to efficiently produce highly immunogenic nanoparticles to address urgent global health needs, such as the ones that have emerged in the current pandemic. NVX-CoV2373 includes Novavax’ proprietary Matrix‑M™ adjuvant, to enhance immune responses and stimulate high levels of neutralizing antibodies.
Novavax has already proved that its technology is especially adapted to counteract respiratory viruses thanks to its influenza candidate, NanoFlu™, a protein nanoparticle vaccine. Novavax is also working on vaccines against RSV (respiratory syncytial virus) and Ebola and is clearly unafraid of taking high risks in producing vaccines for infectious emerging diseases. NVX-CoV2373 is its third candidate for a coronavirus. "We have been producing vaccine at risk," Mr Erck says disarmingly. "This is right up our alley."
With such a vaccine track record, the prospect of finding a vaccine against the coronavirus did not come as a complete surprise. On the contrary, they have the knowledge and means to develop it – now it remains a matter of time before they are able to prove that their vaccine candidate makes it to the finish line.
Today Novavax is working to scale up the production of their solution against COVID-19 and has recently acquired Praha Vaccines a.s. that includes a vaccine manufacturing facility in the Czech Republic that could help produce more than the goal of 1 billion doses per year. Such an acquisition is clearly ideal for any company that is looking to step up their game in fighting COVID-19.
It seems that Novavax is checking all the boxes for a successful vaccine: Safety and effectiveness have already been demonstrated in animals and the company is now pursuing the human trials (Phase 1/2) in Australia, with possible inclusion of other countries in the near future.
“We are very happy with the results of our other vaccines in the pipeline and NVX-CoV2373 could make it to the top, especially given the significant efforts being directed to it now” adds Stanley Erck “If everything goes well we might see the Phase 2 proving that the vaccine is efficacious this Fall”. Mr Erck admits he and his team are working to an "aggressive goal" in the race to find a safe, effective vaccine solution.
June 12, 2020 by ACUMEN
NVX-Co2373 administered to first patients in phase I clinical trial. photo courtesy Novavax, Inc.