Category Archives: Transhuman News

Life goes on as gene-edited foods begin to hit the market. Japanese consumers have recently startedbuying tomatoes that fight high blood pressure, and Americans have been consuming soy engineered to produce high amounts of heart-healthy oils for a little over two years. Few people noticed these developments because, as scientists have said for a long time, the safety profile of a crop is not dictated by the breeding method that produced it. For all intents and purposes, it seems that food-safety regulators have done a reasonablejob of safeguarding public health against whatever hypothetical risks gene editing may pose.

But this has not stopped critics of genetic engineering from advocating for more federal oversight of CRISPR and othertechniquesused to make discrete changes to the genomes of plants, animals and other organisms we use for food or medicine. Over at The Conversation, a team of scientists recently made the case for tighter rules in Calling the latest gene technologies natural is a semantic distraction they must still be regulated.

Many scientists have defended gene editing, in part, by arguing that it simply mimics nature. A mutation that boosts the nutrient content of rice, for example, is the same whether it was induced by a plant breeder or some natural phenomenon. Indeed, the DNA of plants and animals we eat contains untold numbers of harmless, naturally occurringmutations. But The Conversation authors will have none of this:

Unfortunately, the risks from technology dont disappear by calling it natural... Proponents of deregulation of gene technology use the naturalness argument to make their case. But we argue this is not a good basis for deciding whether a technology should be regulated.

They have written a very long peer-reviewed article outlining a regulatory framework based on "scale of use."The ideais that the more widely a technology is implemented, the greater risk it may pose to human health and the environment, which necessitates regulatory "control points" to ensure its safe use. It's an interesting proposal, but it's plagued by several serious flaws.

Where's the data?

The most significant issue with a scale-based regulatory approachis that it's a reaction to risks that have never materialized. This isn't to say that a potentially harmful genetically engineered organism will never be commercialized. But if we're going to upend our biotechnology regulatory framework, we need to do so based on real-world evidence. Some experts have actually argued, based on decades of safety data, that the US over-regulates biotech products. As biologist and ACSHadvisorDr. Henry Miller and legal scholar John Cohrssen wrote recently in Nature:

After 35 years of real-world experience with genetically engineered plants and microorganisms, and countless risk-assessment experiments, it is past time to reevaluate the rationale for, and the costs and benefits of, the case-by-case reviews of genetically engineered products now required by the US Environmental Protection Agency (EPA), US Department of Agriculture (USDA) and US Food and Drug Administration (FDA).

The problem with scale

Real-world data aside for the moment, there are some theoretical problems with the scalabilitymodel as well. Theargument assumes thatrisks associated with gene editing proliferate as use of the technology expands, because each gene edit carries a certain level of risk. This is a false assumption, as plant geneticist Kevin Folta pointed out on a recent episode of the podcast we co-host (21 minute mark).

Scientists have a variety of tools with which to monitor and limit the effects of specific gene edits. For example, proteins known as anti-CRISPRs can be utilized to halt the gene-editing machinery so it makes only the changes we want it to. University of Toronto biochemist Karen Maxwell has explained how this could work in practice:

In genome editing applications, anti-CRISPRs may provide a valuable 'off switch for Cas9 activity for therapeutic uses and gene drives. One concern of CRISPR-Cas gene editing technology is the limited ability to control its activity after it has been delivered to the cell . which can lead to off-target mutations. Anti-CRISPRs can potentially be exploited to target Cas9 activity to particular tissues or organs, to particular points of the cell cycle, or to limit the amount of time it is active

Suffice it to say that these and other safeguards significantly alter the risk equation and weaken concerns about a gene-edits-gone-wild scenario. Parenthetically, scientists design these sorts of preventative measures as they develop more genetic engineering applications for widespread use. This is why the wide variety of cars in production today have safety features that would have been unheard of in years past.

Absurdity alert: The A-Bomb analogy

To bolster their argument, The Conversation authors made the following analogy:

Imagine if other technologies with the capacity to harm were governed by resemblance to nature. Should we deregulate nuclear bombs because the natural decay chain of uranium-238 also produces heat, gamma radiation and alpha and beta particles? We inherently recognize the fallacy of this logic. The technology risk equation is more complicated than a supercilious 'its just like nature' argument

If someone has to resort to this kind of rhetoric, the chances are excellent that their argument is weak. Fat Man and Little Boy, the bombs dropped on Japan in 1945, didn't destroy two cities because a nuclear physicist in New Mexico made a technical mistake. These weapons are designed to wreak havoc. Tomatoes bred to produce more of an amino acid, in contrast, are not.

The point of arguing that gene-editing techniques mimic natural processes isn't to assert that natural stuff is good; therefore, gene editing is also good. Instead, the point is to illustrate that inducing mutations in the genomes of plants and animals is not novel or uniquely risky. Even the overpriced products marketed as all-natural have been improved by mutations resulting from many years of plant breeding.

Nonetheless, some scientists have argued that reframing the gene-editing conversation in terms of risk vs benefit would be a smarter approach than making comparisons to nature. I agree with them, so let's start now. The benefits of employing gene editing to improve our food supply and treat disease far outweigh the potential risks, which we can mitigate. Very little about modern life is naturaland it's time we all got over it.

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CRISPR Revolution: Do We Need Tighter Gene-Editing Regulations? No - American Council on Science and Health

Humble microalgae may seem minor at first glance, but when optimally farmed and converted into biofuels, the potential of this renewable resource to combat climate change is anything but insignificant.

Through the extraction of lipids, they can be converted into biofuels. And, like plants, photosynthesizing algae absorb carbon dioxide, or CO2, and release oxygen into the atmosphere. But algae can do that at much faster rates and higher efficiencies than plants, and they dont need arable land or even fresh water to grow, which has sustainability scientists and engineers intrigued. Taylor Weiss (left), co-PI and assistant professor of environmental and resource management at the Polytechnic School, and Duane Barbano (right), a biological design PhD candidate in the School for Engineering of Matter, Transport and Energy, are farming algae in a pond at the Arizona Center for Algae Technology and Innovation on ASU's Polytechnic campus. Photo by Deanna Dent/ASU Download Full Image

On a small scale, converting algae into biofuels can be fairly straightforward. However, for an algal system to be sustainable, scalable and economical, it must be able to deliver and utilize CO2 efficiently.

A new U.S. Department of Energy grant awarded to the Arizona Center for Algae Technology and Innovation, or AzCATI, will investigate novel methods of CO2 sourcing, delivery and absorption with the goal of promoting algae resiliency and pathways to large-scale biomass production and eventual conversion into low-carbon biofuels an alternative to petroleum.

This initiative is especially important in reducing the carbon footprint of the transportation sector specifically airplanes and ships which accounts for approximately 30% of total U.S. energy consumption and generates the largest share of the countrys greenhouse gas emissions.

AzCATI, located on 4 acres of Arizona State Universitys Polytechnic campus, is home to one of the countrys largest and most comprehensive algae test-bed facilities. In partnership with researchers from all over the world, AzCATI has been investigating algal technology since its establishment in 2010 and has since attracted more than $45 million in federal, state and private funding.

AzCATI will receive $3.2 million for this DOE-supported effort out of a total $34 million in funding for 11 industry- and university-led projects to support the high-impact research and development of biofuels, biopower and bioproducts.

John McGowen, a portfolio manager for research in the Knowledge Enterprise at ASU, will lead the project. He says that about 80% of algae funding at ASU is from the DOE.

We are essentially a national test bed, the longest-running, continually funded outdoor cultivation test bed in the country that isnt commercial. With our experienced faculty, staff, upwards of 30 students and unique testing abilities, we are set up to test new technologies, break them and move on, or improve them and make breakthroughs.

McGowen was one of AzCATIs first researchers and has witnessed the evolution of algae research over the past 11 years.

He explains that the high levels of oils and carbohydrates and proteins created by algae are refined and used as various forms of biofuels and valuable bioproducts.

McGowen says its important to know that the high-density algae needed to create biofuel cant be grown naturally in the environment because of current CO2 levels in the atmosphere, and that they need an additional source delivered directly to them to be viable for this purpose.

A trifecta of research objectives will define AzCATIs three-year DOE project, titled, Direct Air Capture Integration With Algae Carbon Biocatalysis. Researchers at AzCATI will model a novel technology called passive-direct air capture, or PDAC, developed by Klaus Lackner, a professor at the School of Sustainable Engineering and the Built Environment, one of the seven Ira A. Fulton Schools of Engineering at ASU.

Coinciding research entails precisely delivering the CO2 product derived from PDAC to the algae for optimal absorption and low product loss, followed by improving the algaes ability to assimilate CO2 for more resilient and robust ponds.

The goal of PDAC is to offer a sustainable and efficient supply of self-sourced CO2 from the atmosphere versus conventionally purchasing costly CO2 from the merchant market. It also may help in shifting the paradigm on the cost of CO2, McGowen says. This method of CO2 sourcing would remove the necessity for algae to be co-located near a point source emitter, such as a power plant or a CO2 pipeline, meaning they could potentially grow anywhere at scale an essential step in large-scale biofuel production.

The collaboration of key partners will make this concept a reality. Carbon Collect Limited, which has licensed technology developed by Lackner and the Center for Negative Carbon Emissions at ASU, has commercialized PDAC through the development of MechanicalTrees, which according to their website are a thousand times more efficient than natural trees at removing CO2 from the air.

AzCATI will leverage Carbon Collects installation in Tempe, Arizona, and use the CO2 generated from their MechanicalTrees. It will be transported in truckloads to AzCATI and will serve as the main CO2 source for their research, meaning there will be two wholly completed unique test-bed facilities at ASU directly interacting with each other, says Taylor Weiss, co-PI and assistant professor of environmental and resource management at The Polytechnic School.

In this case, the MechanicalTrees arent in close proximity to the algae ponds at AzCATI, requiring the need for CO2 transportation. However, in theory, strategically placing a cluster of MechanicalTrees on an algae crop would offer a continuous and unlimited source of CO2, achieving a self-sustaining crop wherever it makes sense to grow it, McGowen says.

The most promising locations possessing both the water resources and ideal climate for high-productivity algae cultivation are not near pipeline infrastructure, nor do they have the available land, he says. This is where the need for PDAC technology becomes apparent.

Weiss says that even with a sustainably sourced supply of CO2 through PDAC, there remain additional challenges in achieving high productivity, including how efficiently you can deliver that CO2 into the culture and how efficiently the algae can actually convert that CO2 into the most ideal form, in particular for biofuels.

Additional research partners the National Renewable Energy Laboratory, or NREL, and Burge Environmentalwill assist in taking on these challenges. They will offer expertise in innovative CO2 delivery and biocatalysis or supporting the CO2 uptake within algae cells, as well as providing support in genetically engineering algae to give them the ability to assimilate CO2 to improve the microbial ecology within a pond to enable robust outdoor cultivation.

Weiss believes that NRELs expertise will not only improve the efficiency of CO2 dissolution into the culture once it has been captured by PDAC, but will also leverage years of experience building a genetic engineering toolkit to enhance the rate of CO2 uptake by the algae cells.

McGowen and Weiss say that using algae for atmospheric CO2 mitigation to combat climate change is a promising pathway. They also think that algae are only part of the toolbox when it comes to decarbonizing the atmosphere, and they hope to see other technologies and innovations work in tandem with algae to make significant breakthroughs.

This investigation is about redirecting the CO2 within the cell into different forms of more valuable carbon products, while eliminating environmental threats to the algae that contribute to lower output, Weiss says. We look forward to putting this technology into action and empowering algae to reach their full potential.

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Empowering algae to shape the future of bioenergy - ASU Now

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Global CRISPR Cas9 Market to 2027 Industry Perspective, Comprehensive Analysis, and Forecast Chip Design Magazine - Chip Design Magazine

Facebook on Thursday announced it is changing its name to Meta, joining a long list of well-known companies that have undergone major rebrands.

The new name is meant to reflect the technology company's shifting focus on its virtual "metaverse" world, which chief executive Mark Zuckerberg showcased during Facebook's annual conference on virtual and augmented reality.

Here are five other companies that taken on new names:

After changing its name to Alphabet in 2015, a new "slimmed-down" Google allowed investors to focus on the core search business. AP

Search behemoth Google worth more than $400 billion at the time shockingly announced in 2015 that it was changing its name to Alphabet, a technology conglomerate.

We liked the name 'Alphabet' because it means a collection of letters that represent language, one of humanity's most important innovations, and is the core of how we index with Google search, former chief executive Larry Page said in a blog post.

The slimmed-down Google allowed investors to focus on the strengths of the core search business.

Alphabet would take on some of the riskier ventures including genetic engineering and self-driving cars.

Dunkin' Donuts launched the tagline America runs on Dunkin' in 2006 and, after months of testing over a decade later, dropped Donuts from its name and logo.

Growing pressure from coffee chains and changes in Americans' eating habits led the company to shift its focus to drinks, which Dunkin' Brands chief executive David Hoffmann said has a higher margin for profit than its food.

The 2018 rebrand, complete with a new, modern logo, was meant to reflect a more streamlined concept.

By simplifying and modernising our name, while still paying homage to our heritage, we have an opportunity to create an incredible new energy for Dunkin," Mr Hoffman said.

But doughnuts are still on the menu and the chain sells billions of the pastries every year.

In 2002, the world's biggest wrestling company was forced to change its name after a legal battle.

The World Wrestling Federation, as it was then known, found itself in trouble with the World Wildlife Fund. The wilderness preservation charity had branded itself under the same abbreviation, WWF, 18 years before the Federation.

The World Wildlife Fund in 1994 insisted the Federation sign a legal document ensuring the wrestling company would limit its use of WWF outside of North America. In return, the Fund would not press further charges.

But the wrestling company largely ignored the agreement and continued to brand itself as WWF worldwide, going so far as to register a web domain nearly identical with that of the Fund. Following the wrestling boom of the late 1990s, Federation chief Vince McMachon's company landed in hot water again.

The charity successfully sued the Federation in 2000, forcing Mr McMahon to rebrand his wrestling empire.

Mr McMahon changed the wrestling company's name in 2002 to World Wrestling Entertainment, where it eventually came to be known simply as WWE.

The logo of Exxon Mobil Corporation is shown on a monitor above the floor of the New York Stock Exchange. Reuters

Famed entrepreneur John D Rockefeller's Standard Oil company once controlled more than 90 per cent of oil production in the US. As a result, an antitrust suit was filed in 1906, with the company accused of raising prices where it had a monopoly and slashing prices where it faced competition.

The oil company was broken up into 34 different companies in 1911, primarily based on geographical region. Two of these successor companies are now the largest oil companies in the US: Chevron and ExxonMobil.

In 2000, Chevron acquired Texaco in a deal valued at $45 billion, becoming ChevronTexaco only to drop Texaco from its name a few years later.

A year earlier, two of Standard Oil's largest offshoots reunited in a blockbuster merger.

Exxon, part of the Standard Oil New Jersey branch, signed a $75.3bn merger agreement with the New York successor, Mobil. Following this merger, the company rebranded itself as ExxonMobil and is now Standard Oil's largest direct descendant.

Disgraced US cyclist Lance Armstrong stepped down from his role as chairman at his foundation after being stripped of his seven Tour de France titles. AP

Following the biggest doping scandal in cycling history, the Lance Armstrong Foundation changed its name to Livestrong in 2012 to distance itself from the disgraced American cyclist.

Armstrong founded the charity in 1997 after he was diagnosed with testicular cancer and before his first Tour de France title.

In October 2012, Armstrong announced he was stepping down as chairman of the foundation after the International Cycling Union stripped him of his seven Tour de France wins.

That followed an earlier report from the US Anti-Doping Agency accusing him of running the most sophisticated, professionalised and successful doping programme that sport has ever seen".

The foundation soon changed its name to Livestrong the word inscribed on its signature yellow wristbands.

All of us especially Lance wanted Livestrong to have a presence that was bigger than its founder, board member Mark McKinnon said.

Updated: October 28th 2021, 8:57 PM

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Five companies that underwent major rebrands - The National

The International Centre for Genetic Engineering and Biotechnology (ICGEB) and the University of KwaZulu-Natal (UKZN) this week signed a ground-breaking agreement that will see the university partnering with local companies to develop advanced biotherapeutics to be used in the treatment of various conditions including diabetes, arthritis, cancer and others.

The ICGEB was created by the United Nations in 1983 to facilitate biotechnology developments in the developing world. The organisations council of scientific advisors comprises the worlds leading scientists, among them Nobel prize-winners for medicine.

The ICGEB has three global centres: one is in Cape Town, and the others are in Trieste in Italy and New Delhi in India.

ICGEB Director-General Dr Lawrence Banks said during the signing ceremony that the partnership with UKZN is perfect, as the two organisations have lots of shared values and aims.

Dr Banks said the cornerstone of the collaboration is to ensure that state-of-the-art technology and science can bring benefits for all people in the world. He said this should begin with education, which forms the core mandate of the UKZN.

He said they must ensure that nobody is left behind in the partnership, and that this will be done in practical ways. He said they will ensure that they have fellowship programmes that will bring people not only from South Africa, but also from across the continent to work on state-of-the-art programmes within the life sciences.

What we do is not only for South Africa, but for the entire continent, said Dr Banks. He emphasised that the partnership must ensure that the fruits of modern biotechnology reach the people who need it.

At the end of the day, you can have wonderful therapeutics, but if its not affordable to the people its a complete waste of time, he said, adding that the partnership with UKZN is fundamental in bringing this about.

Dr Phil Mjwara, Director-General of the Department of Science and Innovation, said the partnership was in line with the White Paper on Science, Technology and Innovation adopted by the government in 2019.

The White Paper introduced a number of policy shifts, which relate to, among others, increasing the focus on inclusivity, transformation and linkages in the NSI; enhancing the innovation culture in society and government and improving policy coherence and budget co-ordination across government.

UKZNs Deputy Vice-Chancellor of Research and Innovation, Professor Mosa Moshabela, and the Dean of the School of Clinical Medicine, Professor Ncoza Dlova, will be responsible for conducting clinical trials within the next year.

The partnership is set to allow poor people to access expensive life saving medicines for the first time. The collaboration will be facilitated by AfricaBio through its President Dr Nhlanhla Msomi.

AfricaBio is an independent non-profit stakeholders association which represents the interests of all stakeholders involved in the biotechnology sector throughout Africa. It focuses on agriculture, health, industrial, environmental and marine biotech.

Dr Thami Chiliza, Microbiologist at the School of Life Sciences, UKZN, and a stakeholder of AfricaBio, said the partnership with the ICGEB will ensure that expertise rubs off onto students in an easier way, exposes them to what is out in there in the world of science, and contributes to job creation.

I really believe this will allow students to gain more exposure and experience in terms of the biotechnology sector, said Dr Chiliza.

It is expected that the collaboration will soon include other partnerships with the universities of Limpopo, Venda and Walter Sisulu.

Researcher Dr Thandeka Khoza said the partnership fits in with the UKZNs mission statement and goals, which include achievement of excellence in teaching and learning, excellence and high impact in research, innovation and entrepreneurship.

She said the university has various innovative research projects lined up that can offer various solutions to various diseases, and they have identified products from natural products from plants for use in cancer and TB research.

If we have ICGEB on board, these projects can move faster towards the project development stage so we can have a wide door of opportunities for all members of the university, said Dr Khoza.

What it does is, it bridges the gap between academic research and product-driven or industry-based research, which is what we are at this point in time, gearing ourselves towards and also attracting skills that position us for such research. So, we are confident that in no time our research will be applied research, and it will also be cost effective. We are going to have graduates that are fit for purpose, she said.

UKZN Deputy Vice-Chancellor Professor Mosa Moshabela said the partnership underlined the reality that institutions must work together: Ivory towers have to come to an end; we need to flatten the hierarchy, we have to get into equal partnerships with different stakeholders, we have to create a culture of sharing, and we must have the humility to learn from others. There is no way we can advance by working in isolation.

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UKZN and UN agency partnership paves the way for access to medicine - Mail and Guardian

GAITHERSBURG, Md., Oct. 27, 2021 /PRNewswire/ --Novavax,Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced the completion of its rolling regulatory submission to the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) for authorization of its COVID-19 vaccine candidate. The company's application for Conditional Marketing Authorization (CMA) marks the first submission for authorization of a protein-based COVID-19 vaccine in the United Kingdom.

"This submission brings Novavax significantly closer to delivering millions of doses of the first protein-based COVID-19 vaccine, built on a proven, well-understood vaccine platform that demonstrated high efficacy against multiple strains of the coronavirus," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "We look forward to MHRA's review and will be prepared to deliver vaccine doses following what we anticipate will be a positive decision. We thank the clinical trial participants and trial sites in the United Kingdom, as well as the U.K. Vaccines Taskforce, for their support and vital contributions to this program."

Novavax has now completed the submission of all modules required by MHRA for the regulatory review of NVX-CoV2373, the company's recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M adjuvant. This includes preclinical, clinical, and chemistry, manufacturing and controls (CMC) data. Clinical data from a pivotal Phase 3 trial of 15,000 volunteers in the U.K. was submitted to MHRA earlier this yearin which NVX-CoV2373 demonstrated efficacy of 96.4% against the original virus strain, 86.3% against the Alpha (B.1.1.7) variant and 89.7% efficacy overall, as well as a favorable safety and tolerability profile. The submission also includes data from PREVENT-19, a 30,000-person trial in the U.S. and Mexico, which demonstrated 100% protection against moderate and severe disease and 90.4% efficacy overall. NVX-CoV2373 was generally well-tolerated and elicited a robust antibody response.

Novavax expects to complete additional regulatory filings in key markets, including Europe, Canada, Australia, New Zealand, the World Health Organization and other markets around the world shortly following the U.K. submission. In the U.S., Novavax expects to submit the complete package to the FDA by the end of the year. The company continues to work closely with governments, regulatory authorities and non-governmental organizations (NGOs) in its commitment to ensuring equitable global access to its COVID-19 vaccine.

"The submission to MHRA leverages our manufacturing partnership with the Serum Institute of India, the world's largest supplier of COVID-19 vaccines," said Rick Crowley, Executive Vice President, Chief Operations Officer, Novavax. "In the near future, we expect to supplement this filing with supply from our global supply chain."

Clickhereto view multimedia content, including B-roll and other resources that accompany this press release.

About NVX-CoV2373NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax' patented saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate nor can it cause COVID-19.

Novavax' COVID-19 vaccine is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination regimen calls for two 0.5 ml doses (5 microgram antigen and 50 microgram Matrix-Madjuvant) given intramuscularly 21 days apart. The vaccine is stored at 2- 8Celsius, enabling the use of existing vaccine supply and cold chain channels.

About Matrix-M AdjuvantNovavax' patented saponin-based Matrix-M adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

About NovavaxNovavax, Inc.(Nasdaq: NVAX) is a biotechnology company that promotes improved health globally through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. The company's proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs.Novavaxis conducting late-stage clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporateNovavax' proprietary saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

For more information, visitwww.novavax.comand connect with us on TwitterandLinkedIn.

Forward-Looking StatementsStatements herein relating to the future of Novavax, its operating plans and prospects, its partnerships, the ongoing development of NVX-CoV2373 and other Novavax vaccine product candidates, the scope, timing and outcome of future regulatory filings and actions and the preparedness of Novavax to deliver vaccine doses are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include challenges satisfying, alone or together with partners, various safety, efficacy, and product characterization requirements, including those related to process qualification and assay validation, necessary to satisfy applicable regulatory authorities; difficulty obtaining scarce raw materials and supplies; resource constraints, including human capital and manufacturing capacity, on the ability of Novavax to pursue planned regulatory pathways; challenges meeting contractual requirements under agreements with multiple commercial, governmental, and other entities; and those other risk factors identified in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Novavax' Annual Report on Form 10-K for the year ended December 31, 2020 and subsequent Quarterly Reports on Form 10-Q, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at http://www.sec.gov and http://www.novavax.com, for a discussion of these and other risks and uncertainties. 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. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

Contacts:

InvestorsNovavax, Inc.Erika Schultz| 240-268-2022[emailprotected]

Solebury TroutAlexandra Roy| 617-221-9197[emailprotected]

MediaAlison Chartan| 240-720-7804Laura KeenanLindsey | 202-709-7521[emailprotected]

SOURCE Novavax, Inc.

http://www.novavax.com

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Novavax Files for Authorization of its COVID-19 Vaccine in the United Kingdom - PRNewswire