Category Archives: Genetic Engineering

A biologist releases genetically modified mosquitoes in February 2016 in Piracicaba, Brazil. Technicians from the Oxitec laboratory released genetically modified mosquitoes Aedes Egypti to combat Zika virus. (Photo by Victor Moriyama/Getty Images)

Editors note: This story was originally published by UNDARK.It appears here as part of theClimate Deskcollaboration.

This spring, the biotechnology companyOxitecplans to release genetically modified (GM) mosquitoes in the Florida Keys. Oxitec says its technology will combat dengue fever, a potentially life-threatening disease, and other mosquito-borne viruses such as Zika mainly transmitted by theAedes aegyptimosquito.

While there have been more than7,300 dengue casesreported in the United States between 2010 and 2020, a majority are contracted in Asia and the Caribbean,accordingto the U.S. Centers for Disease Control and Prevention. In Florida, however, there were 41 travel-relatedcases in 2020, compared with 71 cases that were transmitted locally.

Native mosquitoes in Florida are increasingly resistant to the most common form of control insecticide and scientists say they need new and better techniques to control the insects and the diseases they carry. There arent any other tools that we have. Mosquito nets dont work. Vaccines are under development but need to be fully efficacious, saysMichael Bonsall, a mathematical biologist at the University of Oxford, who is not affiliated with Oxitec but has collaborated with the company in the past, and who worked with the World Health Organization to produce a GM mosquito-testing framework.

Bonsall and other scientists think a combination of approaches is essential to reducing the burden of diseases and that, maybe, newer ideas like GM mosquitoes should be added to the mix. Oxitecs mosquitoes, for instance, are genetically altered to pass what the company calls self-limiting genes to their offspring; when released GM males breed with wild female mosquitoes, the resulting generation does not survive into adulthood, reducing the overall population.

But Oxitec has been proposing to experimentally release GM mosquitos in the Keys since 2011, and the plan has long been met with suspicion among locals and debate among scientists. Some locals say they fear beingguinea pigs. Critics say they are concerned about the possible effects GM mosquitoes could have on human health and the environment. In 2012, the Key West City Commissionobjected to Oxitecs plan; in a non-binding referendum four years later, residents of Key Haven where the mosquitoes would have been released rejected it, while residents in the surrounding county voted in support of the release. With the decision left up to the Florida Keys Mosquito Control District, officialsapproved the trialto be conducted elsewhere in the Keys.

According to Oxitec, the releasewas delayeddue to a transfer of jurisdiction over the project from the U.S. Food and Drug Administration to the Environmental Protection Agency.

The company reapplied for approval to release a new version of the mosquitoes, called OX5034,in the Keys. In May, the EPAgranteda two-year experimental use permit, which the agency can cancel at any time.Stateandlocal sign-off soon followed finally giving the project the greenlight.

Oxitecs OX5034 mosquitoes are the first GM mosquitoesapprovedfor release in the U.S. The company has alreadyconducted a trialwith the OX5034 mosquitoes in Brazil and released more than a billion of a previous version, called OX513A, there and in other locations over the years including the Cayman Islands. The company says it is confident in the effectiveness and safety of the technology.

But some scientists want to hit pause on Oxitecs Florida trial, to find what they say is a fairer process in deciding to release the mosquitoes. Others want to see clearer proof that this technology is even necessary, claiming that the company has only released its most positive data with the public and has kept other key data, including whether the mosquitoes curb disease transmission, private. And if the release actually launches as planned, some Keys residents say they aim to interfere.

Critics also say that Oxitec failed to engage with local communities in Florida and get their consent to release the mosquitoes. Whats the most upsetting is that the very people that are going to be most impacted, both by the benefits or the risks of such a decision, have like the smallest voice in how these choices are made. I think thats a really big issue, says Natalie Kofler, a molecular biologist and bioethicist who founded Editing Nature, a platformthat advocatesfor inclusive decision-making processes to steer the use of genetic technology. If Oxitec doesnt do this right, she adds, we could have huge impact on delaying the use of other beneficial technologies like that in the future.

OXITECS OX5034 MOSQUITOESare programmed to combat the transmission of mosquito-borne illnesses by suppressing localAedes aegyptipopulations. Oxitec which is U.S.-owned and based in the United Kingdom describes their mosquitoes asfriendly because they will only release males, which, unlike females, do not bite humans or transmit disease.

At Oxitecs laboratory in the U.K., the company genetically engineers the mosquitoes, giving the insects the self-limitinggenethat makes the females dependent on the antibiotic tetracycline. Without the drug, they will die. Eggs from these genetically-altered mosquitoes which will hatch both male and female insects will be shipped to the Keys. Mosquitoes require water to mature from an egg to an adult; when Oxitecs team adds water to the boxes the mosquitoes will be deployed in, both GM males and GM females will hatch. With no tetracycline present in the box, the GM females are expected to die in early larval stages.

The male mosquitoes will survive and carry the gene. When they leave the boxes, the insects will, hypothetically, fly away to mate with wild females to pass the gene to the next wild generation, according to Nathan Rose, head of regulatory affairs at Oxitec. Kevin Gorman, the companys chief development officer, says the local female mosquito population will be increasingly reduced which will also reduce the number of wild male mosquitoes in the treatment areas.

Gorman emphasized to Undark that the EPA and other regulators found no risk in using tetracycline in breeding their genetically-altered mosquitoes. But some scientists think the presence of this antibiotic in the environment does pose a risk. According to Jennifer Kuzma, co-founder and co-director of the Genetic Engineering and Society Center at North Carolina State University, tetracyline is commonly used in Florida to prevent bacterial diseases in agriculture particularly incitrus groves and to treat bacteria insewage plants. The use of the antibiotic for these purposes may mean that it will remain in the environment, especially in water where the mosquitoes breed, which could allow Oxitecs female mosquitoes to survive. While the company does not plan to release the mosquitos near areas where the antibiotic is used, Kuzma says the EPAsrisk assessment did not include testing of any standing water for tetracycline something, she adds, would have been easy enough to do for good due diligence.

Skeptics of Oxitecs GM mosquitoes include local residents,physicians, scientists, and environmental activists. Many of these opponents say they arent anti-GMO, but disagree with how the approval process has been handled. One group has even kept arunning listof what it sees as Oxitecs wrongdoings since it first began experimental releases. The list includes Oxitecs lack of disease monitoring in the countries where it has released mosquitoes; the unknown price of its technology; andcomplaintsthat the company hasoverstatedthe success of some of it its trials.

I cannot trust this company. I cannot trust this technology, says Mara Daly, a resident of Key Largo who says shes been following Oxitecs plans for nine years.

This is not a traditional pesticide, she adds. This is not a chemical that you can trace. This is something completely different, new emerging technology and we need better regulation.

Phil Goodman, chairman of the Florida Keys Mosquito Control District (FKMCD), an independently-elected commission carrying out mosquito control within Monroe County, says that many of those who discredit Oxitecs evidence do not understand the technology. Theyre fearmongering, he says.

They have very little credibility here in the Florida Keys as far as Im concerned, he adds.

But people like Daly and Barry Wray, executive director of theFlorida Keys Environmental Coalition, disagree. We want to know its safe, says Wray, who notes that his group more generally supports GM technology. We dont have another Florida Keys ecosystem. We dont have another Florida Keys community. We have this one.

Daly, Wray, and others point to what they perceive as the FKMCDs disrespect for public opinion. They argue that the community wasnt given a chance to consent before the EPA approval. There was a 30-daypublic forumin September 2019 about Oxitecs technology application, with 31,174 comments opposing release and 56 in support. A statement emailed to Undark by Melissa Sullivan, an EPA spokesperson, noted that the agencyconsideredthese comments during the review, but critics think it happened too quickly to be of real use.

Oxitec has already released more than a billion of a previous version of GM mosquitoes, OX513A, in Brazil and other locations. Visual: Victor Moriyama / Getty Images

In June, Kofler and Kuzma wrote anopinion piecein The Boston Globe about the EPA approval, critiquing the agencys regulatory system and calling for a better process for evaluating new biotechnologies. The researchers expressed concern that the EPA did not convene an independent, external scientific advisory panel to review Oxitecs claims about its mosquito strategy and that the agency only publicly released its risk assessment after approving the technology. The American public, Kofler and Kuzma wrote, needs to be assured that these decisions are made free of conflicts of interest. The statement from the EPAs Sullivan noted that the agency conducted anextensive risk assessmentbased on the best available science.

Some critics also wanted there to be more public engagement. Kofler and Kuzma say they offered to provide their expertise, along with other outside experts, to the mosquito control district to allow more discussion about the GM mosquitoes with the Keys community. But Kofler says the district wasnt responsive. Oxitec itself launchedwebinarsabout their new product, but not until after the EPA approval. Here we are, like in the final hour, having these conversations that needed to be happening a year ago, says Kofler.

Without public trust and enthusiasm, it doesnt matter whether Oxitecs mosquito technique works, says Guy Reeves, a genetic researcher at the Max Planck Institute for Evolutionary Biology in Germany, who stresses that he doesnt think the companys approach is unsafe. If the population in Florida Keys becomes so sensitized to this issue that they can no longer cooperate with each other thats good for the mosquitoes, not good for the people, he adds.

Based on their first generation mosquito OX513A, Oxitec says it has shown that the approach reduces a targeted mosquito population in trials in bothBraziland theCayman Islands. But theres no evidence that this new OX5034 mosquito release will actually be worth it for mosquito suppression, says Reeves. Oxitec also hasnt explained how their new mosquito will directlycurbhuman diseases, such as dengue. Reducing disease transmission and burden should be measures of efficacy for this technology, says Kofler.

According to Gorman, independent disease suppression data has only been collected by municipalities in Brazil because thats where most of the companys trials have been released in larger scales. These municipalities have shown that Oxitec mosquitoes have reduced dengue cases in areas of release, Gorman says. In order for Oxitec to collect additional data, he adds, the company needs to release and test large areas over sustained periods of time. Gorman maintains that the company is not required to report formal health impact studies.

Reeves adds that Oxitec also hasnt explained what resources are needed to sustain this product, how long it could take to be effective, or the cost. When asked about the cost of the Florida Keys project, Oxitec responded to Undark by email: Oxitec is a pre-commercial, pre-profit company. We will not profit from this pilot project in Florida.We are paying for it ourselves.

OXITEC HAS RELEASEDmore than a billion of their OX513A mosquitoes over the past 10 years. According to independent scientists, some of those experiments did not go well.

For example, researchers at Yale University and collaborators from Brazil analyzed Oxitecs 2015 release of OX513A in Brazil. The scientists confirmed that some offspring of the genetically modified mosquitoes which were supposed to die and not pass new genes to the wild population survived to adulthood and mated with their native counterparts. Between 10 and 60 percent of the native mosquitoes contained genes from Oxitec, according to the Yale study, which published in Nature in2019. The papers authors concluded they do not know what impacts these mixed mosquitoes have on disease control or transmission, but added that their findings underscore the importance of monitoring the genetics of the insects.

Oxitec disagreed with the findings andrespondedon the journals website. Oxitec toldGizmodothat Yales study includes numerous false, speculative, and unsubstantiated claims and statements about Oxitecs mosquito technology. And when Kofler and three other scientistswrote about Oxitecs Brazil trial in The Conversation, Oxitec pushed to have the article retracted, says Kofler.

For this coming release, some Key Largo locals are willing to act on their anger. Daly, for instance, says that if the mosquitoes are deployed in her neighborhood, shell try to put insecticide in any box she finds or send it to an expert to test even if it means getting in trouble with the federal authorities. I already have my arresting officer and she said shes gonna clean her handcuffs for me, she says. I dont care.

Ideally, Daly says, it wont have to come to that. She and other locals hope to stop Oxitec before the latest mosquitos are delivered. Daly says she has been busy organizing protests like one thathappened recentlyin Key Largo and giving out yard signs to residents who dont want their property used in the trial. Locals are pissed off. So I have been busy getting the press to cover the local opposition, Daly wrote in an email to Undark.

The first flying insect or animal that can actually use our human blood for a friggin trial for a product to come to market without my consent, Daly says.

Thats my blood, she adds. Thats my sons blood. Thats my dogs blood.

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Paradise altered: EPA approves first release of genetically modified mosquitoes in Florida Keys - Bulletin of the Atomic Scientists

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Genetic engineering plant genomics refer to the process of development of new plant lines with enhanced genotypic characteristics by crossing two or more plants with the purpose of producing an offspring that shares the required traits of the parent plants. The aim of the method is to characterize, sequence and study of genetic compositions, functions and networks of entire plant genome. The technological advancement is emerging with the increasing demand for better-quality crops.The genetic engineering plant genomics market is expected to witness market growth at a rate of approximately 7.90% in the forecast period of 2021 to 2028. Data Bridge Market Research report on genetic engineering plant genomics market provides analysis and insights regarding the various factors expected to be prevalent throughout the forecast period while providing their impacts on the markets growth. The increasing application of genomics in plant breeding across the globe is escalating the growth of genetic engineering plant genomics market.The increasing demand for improved crop varieties and high quality crop, and surge in plant genome funding fueling the adoption of innovative technologies act as the major factors driving the genetic engineering plant genomics market.

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Genetic Engineering Plant Genomics Market | 2021 | Key Market Indicators, Supply and Demand Analysis And Growth Forecast | Illumina Inc, NRGene,...

A gene is the basic physical and function unity of heredity. Genetic engineering is the changing the structure of the genes of a living things in order to make it healthier, stronger and more useful to human. Changing DNA in cell is to understand their biology. Genetic engineering are currently used in both animal and plant cells this modifications are helps to improve performance of cell.

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Integrated DNA Technologies, IncThermo Fisher Scientific IncMerck KGaAHorizon Discovery Group Plc.Transposagen Biopharmaceuticals Inc.New England BiolabsGenscript Biotech CorporationLonza GroupOrigene Technologies, Inc.Sangamo Therapeutics, Inc.

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Genetic Engineering Market Estimates and Projections by Lonza Group, Origene Technologies, Inc., Sangamo Therapeutics, Inc. The Courier - The Courier

I got into engineering because I wanted to solve problems and to have a positive impact on people. A natural extension of wanting to solve problems at a large scale with efficiency led me to Software Engineering. At first, I majored in Biomedical Engineering, concentrating in bioinformatics at Drexel University. Someone once called me a bad programmer so to prove them wrong, I minored in Computer Science, focusing on artificial intelligence and human-computer interaction. I love solving problems in the biomedical field as much as I love the possibilities of programming.

At Drexel, I had three co-op experiences, which were full-time positions that lasted six to nine months. I worked as a software engineer at a start-up on psychology research, as a data scientist at a pharmaceutical company, and as a bioinformatics cancer researcher at a hospital. Each role cemented a solid foundation in applied Software Engineering on biomedical problems in various contexts.

My most significant experience in college was attending a local hackathon for accessibility, developing solutions for people with special needs. I became a better engineer by learning about the deaf, blind, and aphasic communities, in order to design solutions challenging my own algorithmic biases. Algorithmic biases are unintended aspects of you that sneak into your code. How do I check my algorithmic biases? By writing software with the mindset that software is intended for people who are not me. Continuous life-long learning about the diversity of people still applies to how I write software every day. I follow governmental software standards for accessibility (Section 508) to make software more inclusive for all of us.

I am currently a Software Engineer for a life sciences and technology company, Essex Management, where I develop websites and application programming interfaces (API). I am grateful to be part of an exciting and growing field where I get to build things that make a lasting and positive impact on peoples lives. Genomic information can be very complex, so I am very grateful for my background in biomedical engineering. Im able to leverage my scientific background to better understand scientific researchers and how they expect the software to help them analyze massive amounts of genomic data. One of the projects I worked on was called NCI-MATCH, a clinical trial which used genetic information to match people with cancer to potential treatment options.

I work with an 80/20 balance between technical and people work. This means 20% of my day in the mornings involves communicating with my team, which can include planning, design, and troubleshooting issues. In the afternoons, I focus on writing software or APIs to exchange genomic or clinical data. I also spend my afternoons testing my code by improving upon either software that I wrote or software someone on my team wrote.

To girls interested in engineering, communication is critical for sharing and building upon your innovative engineering ideas, so communicate early and often. Building a network fromprofessional societies, such as the Society of Women Engineers, Women in Computer Science, and American Computing Machinery, will open opportunities for you to try job shadowing or an internship.

Also, choosing your college major may seem like a really big, defining choice, but you can absolutely switch majors or even combine disciplines like I did. You can make this decision by using a gather and reduction approach, which is similar to the path searching algorithm, A*. Gather all of the information that you can and then reduce the problem set. Once you have all of that information and experience, then you can eliminate choices and find out which option is best for you. Some important questions you can ask yourself are what seems practical? What are you good at? What do you really enjoy and can see yourself doing almost every day, at least five days a week? What feels the most authentic to you? Its OK to be uncertain about your decisions. As long as you learn from your experiences and carry that knowledge over into your next choice, youll eventually make better choices over time (human intelligence not artificial intelligence).

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SWE Blog provides up-to-date information and news about the Society and how our members are making a difference every day. Youll find stories about SWE members, engineering, technology, and other STEM-related topics.

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A Day in the Life of Software Engineer Anna - All Together - Society of Women Engineers

Lifesaving vaccines such as Covishield and Covaxin are products of modern biotechnology, as are drugs developed in recent times for treating many ailments. The potential of genetic engineering is immense, with gene editing opening up the possibility of cures to hereditary diseases. Similarly, genetically modified (GM) crops are making big strides in bringing about improvement in crop productivity across farming nations.

By 2019, the area under precision agriculture of GM crops had increased 112 times from 1996, when the first biotech crop was introduced, making it the fastest adopted crop technology in recent years. During 2019, 79 per cent of cotton; 74 per cent of soybean; 31 per cent of maize and 27 per cent of canola acreages globally were under biotech crops, apart from varying acreages under 28 other smaller crops. A number of independent studies are available on the socioeconomic and environmental benefits of biotech crops. One such study estimated that net global farm income increased by $ 186 billion in 20 years. That helped alleviate poverty of over 16.5 million farmers globally and led to a 8.2 per cent reduction in global consumption of pesticides.

Bt Cotton, the only GM crop introduced in India in 2002, transformed Indias cotton sector, as cotton productivity almost doubled in six years. Indias share in the global production of cotton increased from 12 per cent in 2002 to 25 per cent by 2014. From a net importer of cotton, India became the second-largest exporter of cotton.

Following approval for GM cotton, several organisations invested resources and efforts in new crop biotech traits, hoping for similar transformational changes in Indian agriculture. Bt brinjal was one such technology recommended for commercialisation in October 2009, after it completed regulatory evaluation in seven years, and is still under moratorium. Meanwhile, the technology has been adopted in Bangladesh. One study in 2018 stated that net returns of Bangladesh farmers increased six-fold from Bt brinjal, and pesticide usage on brinjal went down by 61 per cent.

Another such stalemate is on GM mustard. India imports over 65 per cent of her edible oil requirement, as Indian oilseed yields are almost stagnant. This costs over $10 billion annually, with imports growing over time. Mustard is one such oilseed crop. But a high yielding mustard variety developed indigenously using biotech is yet to be approved for commercialisation. The regulatory system for crop biotech is inactive, with even periodic meetings of the regulatory committee being avoided. This has resulted in serious reduction in biotech research in recent years.

This impasse is due to irrational opposition to GM crops based on ideology rather than science. India imports over 15 million tonnes of edible oil annually, of which over 25 per cent comprises soy oil and canola oil (a variant of mustard oil), which are from GM soybean and GM canola grown all over America. Over 95 per cent of cotton grown in India being Bt cotton, we consume about 1.4 million tonnes of cotton seed oil produced from GM cotton. However, there is opposition to making available the same technology to mustard growers. On the matter of safety and efficacy of biotech crops, over 100 Nobel laureates collectively issued a statement in 2016, vouching for it.

It is high time Indian agriculture transforms into precision agriculture by using modern tools of biotechnology. The farmers agitation is also a reflection of deep anguish of the farming community about the growing chasm between agricultural income and income from other economic sectors. Farm income is a function of market prices and cost of production. While Indian market prices for major agricultural commodities are influenced by international prices, cost of production is a function of crop productivity. The current productivity of most of our crops is much lower than global averages. It is in this context that apart from reforms in the market and supply chain, we need to make available the best technologies to our farmers. Agriculturally developed countries are rapidly adopting new frontiers of precision agriculture tools, like CRISPR CAS9. It will be most appropriate, as has been the case with the COVID vaccines, if crop biotech, especially Bt Brinjal and GM mustard, is accorded similar sense of priority to improve competitiveness of Indian farmers and boost their income.

This column first appeared in the print edition on April 20, 2021 under the title Biotech boost for farming. The writer is former secretary to government of India and former chairperson, genetic engineering appraisal committee

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Reforms must extend to making available the best technologies to farmers - The Indian Express

GAITHERSBURG, Md., April 23, 2021 /PRNewswire/ --Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced it will report its first quarter 2021 financial results and operational highlights on Monday, May 10, 2021, following the close of U.S. financial markets. Details of the event and replay are as follows:

Conference call details:

Date:

May 10, 2021

Time:

4:30 p.m. U.S. Eastern Time (ET)

Dial-in number:

(866) 652-5200 (Domestic) or (412) 317-6060 (International)

Webcast:

http://www.novavax.com/events

Participants will be prompted to request to join the Novavax, Inc. call.

To ensure a timely connection, it is recommended that participants join at least 10 minutes prior to the scheduled webcast.

Replay details:

Date:

Available starting at 7:30 p.m. ET, May 10, 2021

Dial-in number:

(877) 344-7529 (Domestic) or (412) 317-0088 (International)

Passcode:

10155684

Webcast:

http://www.novavax.com/events, until August 10, 2021

About Novavax

Novavax, 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 and will be advanced for regulatory submission. 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, visit http://www.novavax.com and connect with us on Twitter and LinkedIn.

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Novavax, Inc.

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Novavax to Host Conference Call to Discuss First Quarter Financial Results and Operational Highlights on May 10, 2021 - Herald-Mail Media

In 2009, Time magazine declared cultured meat one of their top 50 inventions of the year for its potential to curb the carbon footprint of industrial farming. This promising idea has since become a booming industry. Ever since Dutch researcher Mark Post debuted the first lab-grown hamburger in 2013 a $325,000 patty with an intense flavor that took two years to dish up nearly 60 companies have sprung up around the globe in pursuit of growing the perfect cut of cultured meat. In the first quarter of 2020 alone, $189 million was poured into these companies. Now that its gone from pipe dream to industry, what is stopping lab-grown meat from being available in a supermarket near you?

The chief hurdle is cost, which is related to what is known in the biz as the scalability problem." Every single slab of meat is an intricate mosaic of billions of cells of different types nerve cells, muscle fibers, fat cells, and more that lend a cut its specific flavor and texture. Researchers have spent years working out how to grow and sustain cultures of cells large enough to make meals at scale. Unfortunately, the mature cells that make up meat are only able to divide a certain number of times before they lose steam, a phenomenon known as senescence. Even if current methods could be expanded, the bulk wouldnt be considered truly clean; the nutritional soup used to grow most meat cultures relies on fetal bovine serum extracted from the blood of unborn cows.

A new ray of hope and innovation has come from a group of researchers taking a very different tack, coupling the raw potential of a special kind of stem cells, known as pluripotent stem cells, with a trick of genetic engineering. Pluripotent stem cells are often called the master cells of the body because they can differentiate into any cell type. Even niftier, these cells can divide endlessly and dont rely on fetal bovine serum to sustain their growth, providing a theoretically limitless supply of cells to serve as precursors to those that make up your favorite cut of meat. Differentiation from a pluripotent stem cell into a mature cell type can take months when left to nature, but neuroscientist Mark Kotter discovered a genetic workaround that cuts the process down to just a matter of days. Kotters technology, dubbed opti-ox, has opened the doors to streamlining the production of billions of cells of your choosing. While opti-ox was first developed to create an unlimited and consistent supply of human neural cells for research, its potential for the clean meat industry caught the eye of Daan Luining, the founder of Dutch-based food tech startup Meatable. The great challenge for them was transforming these animal stem cells into something consumers could eat.

They started a collaboration with a research team led by bit.bio biologist Anne-Claire Guenantin. Guenantin, a pluripotent stem cell expert, had never worked on cultured meat before and was now at the forefront of a massive breakthrough. Right as the project picked up steam, the coronavirus pandemic shut down the world. But Guenantin and her team werent about to let that stop them.

Guenantins entrance into the field was, in her words, by a bit of serendipity. Her roots are in biomedicine, investigating how pluripotent stem cells could be used to treat certain laminopathies, a group of rare genetic disorders resulting from mutations in genes that support the structural integrity of the cells nucleus. During graduate school, she became an expert in cardiac differentiation of pluripotent stem cells, transitioning in her postdoctoral career to a new system: adipocytes, or cells specialized for storing fat. Together with adipocyte expert Nolwenn Briand, she developed and patented one of the first procedures of its kind to derive these fat-storing cells from pluripotent stem cells.

Pluripotent pork cells differentiated into fat (red) and muscle (green) in 7 days.

Meatable

As Guenantin was emerging as a leader in adipocyte differentiation, she became increasingly curious about making the transition from academia to industry. I wanted to do more concrete science, she explains. While a postdoctoral fellow at the University of Cambridge in Prof. Antonio Vidal-Puig's laboratory, she met Thomas Moreau, Head of Research at bit.bio, who introduced her to the opti-ox system. He showed her research group a video of muscle cells differentiating from pluripotent stem cells in just ten days. I knew this is one of the most difficult cell types to [differentiate] from stem cells. I was blown away. The breakthrough made her next career step clear. I knew I wanted work there. That was it.

Luckily for Guenantin, bit.bio was in search of a researcher to work out how to differentiate pluripotent porcine stem cells into the characteristic muscle and fat cells needed to make tasty pork. Guenantin is one of only a few experts in adipocyte differentiation, in part because there is less interest in research around fat stem cell therapies compared to treatments centered on cardiac or neuronal cells. Her expertise in this niche field uniquely positioned her for this monumental task. When she was hired at bit.bio Kotters company holding the opti-ox technology she was tasked with programming the fate of Meatables cells.

Guenantins first challenge was to figure out how to sustain and grow a culture of pluripotent stem cells derived from pork. Its a really different thing to cultivate animal cells than to cultivate human cells, she says. The promise of human stem cell therapies has flooded the research field with standardized protocols and tried-and-true chemical reagents needed to reliably grow a healthy culture of human cells. The same isnt true for culturing stem cells from animals like pigs and cows. Guenantin estimates that the field is 15 years or so behind human cells.

After months of mining the literature, testing various recipes for growth media, and piloting different environmental conditions, Guenantin was able to find the right formula for growing a seemingly endless pool of happy and healthy pluripotent porcine stem cells. It was crazy interesting and really took teamwork, she stresses. Nothing would have happened without all the input from people working in the lab.

The next piece of the puzzle was led by stem cell biologist Sara Gomes, who worked to genetically engineer the opti-ox system into the expectant stem cells. Gomes and Guenantin worked together to figure out how to drive differentiation of the stem cells into the desired muscle and fatty cell fates. While the researchers at bit.bio had a protocol in place for differentiating human muscle from stem cells, it had to be adapted to suit the subtleties of pork muscle. Guenantin recalls, Differentiating the muscle cells was relatively straightforward, but for differentiating adipocytes thats where my expertise came in.

Guenantin and Gomess work at the lab bench was aided by the addition of two new research assistants to the team: Madeleine Garrett and Patrick Thomas. But right as their team expanded, the coronavirus pandemic hit. Guenantin, who was pregnant at the time, had to pull back from her work in the laboratory. As she notes, At this point, we didnt know if it was okay for pregnant women to go to work.

Gomes was left to supervise the work in the lab, which adjusted to staggered shifts to comply with public health guidelines, with Guenantin overseeing and advising on the project from home. The first shifts were stressful and bumpy, Gomes admits, But we quickly reached an efficient way of dividing the workload. The team had daily meetings over Zoom, both to discuss progress on the project and to check in with each other. I wanted to make sure everyone was okay, Guenantin notes. In the beginning, it was okay, but then back in May, [the pandemic] began feeling long and difficult.

The team, from left to right: Anne-Claire Guenantin, Madeleine Garrett, Patrick Thomas, and Sara Gomes.

But COVID-19 did not deter their progress. They worked through the spring and summer of 2020, alternating shifts in and out of the lab, to fine-tune a protocol that would reliably re-program the opti-ox-expressing stem cells into the cells of their choosing. Its a sum of small victories, Guenantin says. We celebrated every step because you have to do that as a scientist. If you dont, you become depressed because basically its never working until its working. To ensure the final cells were up to snuff, the team ran a series of tests to characterize the newly differentiated cells, tapping into Guenantins expertise in fat cell form and function until they were satisfied with the end result. They passed the pork cells over to their colleagues at Meatable who then got to work growing the cultures in bioreactors that provide a three dimensional scaffold for the cells to grow and take shape.

Meatable has continued to raise money to support bringing in $60 million through a combination of Series A funding and support from the Eurostars Programme. In the meantime, Guenantins team and their counterparts at Meatable continue to refine their methods to deliver pork muscle and fat at scale and have begun to turn their attention to stem cells derived from cows.

In the meantime, regulators recognize the demand for a future of clean meat, with Singapore becoming the first country to approve a lab-grown meat product in December 2020. The appeal of cultured meat cuts across a wide swath of consumers, including those passionate about cutting carbon emissions, those seeking to spare animals from the cruel conditions of factory farming, or ones looking for innovative ways to feed the worlds ever-growing population.

This project has raised a lot of questions for me, Guenantin says. It mades me think about the future generations and how this problem of global warming will end up. We need to think about innovative solution to feed the growing planet with tasty and sustainable products.

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This technology was designed to grow human cells. Now it's transforming the cultured meat industry. - Massive Science

Spanish and Libyan researchers met in Andalusia to identify and characterize the most promising cultivars in the North African country.

One of our goals is to investigate the genetic profile of the trees that grow here and to map the most interesting cultivars for olive farming, said Adel Elmagharbi, aleading researcher on the Libyan olive fingerprinting project at the Biotechnology Research Center (BTRC) in Tripoli.

Most of them were propagated during Italian colonization [from 1911 to 1943] and almost 15years ago, we found afew trees carrying white olives about 20kilometers east of Tripoli, he told Olive Oil Times. That is the Tripolitaine cultivar and we are working with our colleagues in Crdoba to investigate its genetic origin.

The meeting took place at the University of Crdoba after bilateral talks between the International Olive Council (IOC) and Libyan authorities in Madrid. The two sides discussed adding the Tripolitaine cultivar to the IOCs World Catalog of Olive Varieties.

Among those in attendance at the talks were Inas Alhudiri, the BTRC genetic engineering department head. She told Olive Oil Times that the Libyan delegation is working with the IOC to add the most interesting Libyan cultivars to the IOCs olive germplasm bank as part of the True Healthy Olive Cultivars 2 project.

We are working on amemorandum of understanding with the University of Crdoba, which might allow us to conduct the genetic investigation into our cultivars, train our students and experts in all areas of olive propagation and farming and optimize production in Libyan orchards, she said.

According to Mohamed Abusanina, aresearcher at the department of plant tissue culture at BTRC, Libyan scientists have already taken DNA samples from local olive cultivars and sent them over to Spanish experts.

We have more than 40 genotypes for cultivars, he told Olive Oil Times. While some of those varieties came from Italy, most of our orchards here have adapted to our dry weather. Some trees are more than 100years old.

Of primary interest to the researchers is discovering the origin of the Tripolitaine cultivar, which yields white olives similar to the southern Italian Leucocarpa cultivar and is also quite rare.

According to the researchers, the trees appear to thrive in Libyas hot and dry climate. Scientists at the BTRC intend to determine whether the Tripolitaine olive is amutation or adifferent variety and the best way to graft the trees.

One of the biggest challenges facing Libyan olive farmers is finding varieties capable of withstanding the low levels of rainfall received by the country. Even the wetter northern regions of Libya receive only slightly more than 250 to 300 millimetres of rain each year.

In this respect, we must count on many varieties that have shown strong resilience to extreme weather conditions over time, Abusanina said.

According to IOC data, Libya produced 16,500 tons of olive oil in the 2020/21 crop year. However, by improving cultivation techniques and selecting suitable varieties, these experts believe that the country could improve its production figures.

With our Spanish counterparts, we hope to identify which cultivars react better to our climate, which are the most interesting commercial cultivars and how to maximize their yields, to possibly suggest to farmers how and where they could invest more in new olive orchards and receive good olive yields, Alhudiri said.

Away from this project, Libyan officials hope that this renewed cooperation with the IOC will lead to further collaboration and, eventually, the official recognition of Libyan chemical and sensory analysis labs.

Researchers also hope to increase cooperation with some of the countrys neighbors, including Tunisia, Algeria and Morocco, to promote olive oil production across North Africa.

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Researchers Investigate Origins of White Tripolitaine Olive in Libya - Olive Oil Times

Quantum computers have been on my mind a lot lately. A friend who likes investing in tech, and who knows about my attempt to learn quantum mechanics, has been sending me articles on how quantum computers might help solve some of the biggest and most complex challenges we face as humans, as a Forbes commentator declared recently. My friend asks, What do you think, Mr. Science Writer? Are quantum computers really the next big thing?

Ive also had exchanges with two quantum-computing experts with distinct perspectives on the technologys prospects. One is computer scientist Scott Aaronson, who has, as I once put it, one of the highest intelligence/pretension ratios Ive ever encountered. Not to embarrass him further, but I see Aaronson as the conscience of quantum computing, someone who helps keep the field honest.

The other expert is physicist Terry Rudolph. He is a co-author, the R, of the PBR theorem, which, along with its better-known predecessor, Bells theorem, lays bare the peculiarities of quantum behavior. In 2011 Nature described the PBR Theorem as the most important general theorem relating to the foundations of quantum mechanics since Bells theorem was published in 1964. Rudolph is also the author of Q Is for Quantum and co-founder of the quantum-computing startup PsiQuantum. Aaronson and Rudolph are on friendly terms; they co-authored a paper in 2007, and Rudolph wrote about Q Is for Quantum on Aaronsons blog. In this column, Ill summarize their views and try to reach a coherent conclusion.

First, a little background. Quantum computers exploit superposition (a particle inhabits two or more mutually exclusive states at the same time) and entanglement (a special form of superposition, in which two or more particles influence each other in spooky ways) to do things that ordinary computers cant. A bit, the basic unit of information of a conventional computer, can be in one of two states, representing a one or zero. Quantum computers, in contrast, traffic in qubits, which are constructed out of superposed particles that embody numerous states simultaneously.

For decades, quantum computing has been little more than a hypothesis, or laboratory curiosity, as researchers wrestled with the technical complexities of maintaining superposition and entanglement for long enough to perform useful calculations. (Remember that as soon as you look at an electron or cat, its superposition vanishes.) Now, tech giants like IBM, Amazon, Microsoft and Google have invested in quantum computing, as have many smaller companies, 193 by one count. In March, the startup IonQ announced a $2 billion deal that would make it the first publicly traded firm dedicated to quantum computers.

The Wall Street Journal reports that IonQ plans to produce a device roughly the size of an Xbox videogame console by 2023. Quantum computing, the Journal states, could speed up calculations related to finance, drug and materials discovery, artificial intelligence and others, andcrack many of the defensesused to secure the internet. According to Business Insider, quantum machines could help us cure cancer, and even take steps to reverse climate change.

This is the sort of hype that bugs Scott Aaronson. He became a computer scientist because he believes in the potential of quantum computing and wants to help develop it. Hed love to see someone build a machine that proves the naysayers wrong. But he worries that researchers are making promises they cant keep. Last month, Aaronson fretted on his blog Shtetl-Optimized that the hype, which he has been countering for years, has gotten especially egregious lately.

Whats new, Aaronson wrote, is that millions of dollars are now potentially available to quantum computing researchers, along with equity, stock options, and whatever else causes ka-ching sound effects and bulging eyes with dollar signs. And in many cases, to have a shot at such riches, all an expert needs to do is profess optimism that quantum computing will have revolutionary, world-changing applications and have themsoon. Or at least, not object too strongly when others say that. Aaronson elaborated on his concerns in a two-hour discussion on the media platform Clubhouse. Below I summarize a few of his points.

Quantum-computing enthusiasts have declared that the technology will supercharge machine learning. It will revolutionize the simulation of complex phenomena in chemistry, neuroscience, medicine, economics and other fields. It will solve the traveling-salesman problem and other conundrums that resist solution by conventional computers. Its still not clear whether quantum computing will achieve these goals, Aaronson says, adding that optimists might be in for a rude awakening.

Popular accounts often imply that quantum computers, because superposition and entanglement allow them to carry out multiple computations at the same time, are simply faster versions of conventional computers. Those accounts are misleading, Aaronson says. Compared to conventional computers, quantum computers are unnatural devices that might be best suited to a relatively narrow range of applications, notably simulating systems dominated by quantum effects.

The ability of a quantum computer to surpass the fastest conventional machine is known as quantum supremacy, a phrase coined by physicist John Preskill in 2012. Demonstrating quantum supremacy is extremely difficult. Even in conventional computing, proving that your algorithm beats mine isnt straightforward. You must pick a task that represents a fair test and choose valid methods of measuring speed and accuracy. The outcomes of tests are also prone to misinterpretation and confirmation bias. Testing creates an enormous space for mischief, Aaronson says.

Moreover, the hardware and software of conventional computers keeps improving. By the time quantum computers are ready for the marketplace, they might lose potential customersif, for example, classical computers become powerful enough to simulate the quantum systems that chemists and materials scientists actually care about in real life, Aaronson says. Although quantum computers would retain their theoretical advantage, their practical impact would be less.

As quantum computing attracts more attention and funding, Aaronson says, researchers may mislead investors, government agencies, journalists, the public and, worst of all, themselves about their works potential. If researchers cant keep their promises, excitement might give way to doubt, disappointment and anger, Aaronson warns. The field might lose funding and talent and lapse into a quantum-computer winter like those that have plagued artificial intelligence.

Lots of other technologiesgenetic engineering, high-temperature superconductors, nanotechnology and fusion energy come to mindhave gone through phases of irrational exuberance. But something about quantum computing makes it especially prone to hype, Aaronson suggests, perhaps because quantum stands for something cool you shouldnt be able to understand.

And that brings me back to Terry Rudolph. In January, after reading about my struggle to understand the Schrdinger equation, Rudolph emailed me to suggest that I read Q Is for Quantum. The 153-page book explains quantum mechanics with a little arithmetic and algebra and lots of diagrams of black-and-white balls going in and out of boxes. Q Is for Quantum has given me more insight into quantum mechanics, and quantum computing, than anything Ive ever read.

Rudolph begins by outlining simple rules underlying conventional computing, which allow for the manipulation of bits. He then shifts to the odd rules of quantum computing, which stem from superposition and entanglement. He details how quantum computing can solve a specific problemone involving thieves stealing code-protected gold bars from a vault--much more readily than conventional computing. But he emphasizes, like Aaronson, that the technology has limits; it cannot compute the uncomputable.

After I read Q Is for Quantum, Rudolph patiently answered my questions about it. You can find our exchange (which assumes familiarity with the book) here. He also answered my questions about PsiQuantum, the firm he co-founded in 2016, which until recently has avoided publicity. Although he is wittily modest about his talents as a physicist (which adds to the charm of Q Is for Quantum), Rudolph is boosterish about PsiQuantum. He shares Aaronsons concerns about hype, and the difficulties of establishing quantum supremacy, but he says those concerns do not apply to PsiQuantum.

The company, he says, is closer than any other firm by a very large margin to building a useful quantum computer, one that solves an impactful problem that we would not have been able to solve otherwise (e.g., something from quantum chemistry which has real-world uses). He adds, Obviously, I have biases, and people will naturally discount my opinions. But I have spent a lot oftime quantitatively comparing what we are doing to others.

Rudolph and other experts contend that a useful quantum computer with robust error-correction will require millions of qubits. PsiQuantum, which constructs qubits out of light, expects by the middle of the decade to be building fault-tolerant quantum computers with fully manufactured components capable of scaling to a million or morequbits, Rudolph says. PsiQuantum has partnered with the semiconductor manufacturer GlobalFoundries to achieve its goal. The machines will be room-sized, comparable to supercomputers or data centers. Most users will access the computers remotely.

Could PsiQuantum really be leading all the competition by a wide margin, as Rudolph claims? Can it really produce a commercially viable machine by 2025? I dont know. Quantum mechanics and quantum computing still baffle me. Im certainly not going to advise my friend or anyone else to invest in quantum computers. But I trust Rudolph, just as I trust Aaronson.

Way back in 1994, I wrote a brief report for Scientific American on quantum computers, noting that they could, in principle, perform tasks beyond the range of any classical device. Ive been intrigued by quantum computing ever since. If this technology gives scientists more powerful tools for simulating complex phenomena, and especially the quantum weirdness at the heart of things, maybe it will give science the jump start it badly needs. Who knows? I hope PsiQuantum helps quantum computing live up to the hype.

This is an opinion and analysis article.

Further Reading:

Will Artificial Intelligence Ever Live Up to Its Hype?

Is the Schrdinger Equation True?

Quantum Mechanics, the Chinese Room Experiment and the Limits of Understanding

Quantum Mechanics, the Mind-Body Problem and Negative Theology

For more ruminations on quantum mechanics, see my new bookPay Attention: Sex, Death, and Science and Tragedy and Telepathy, a chapter in my free online bookMind-Body Problems.

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Will Quantum Computing Ever Live Up to Its Hype? - Scientific American

To aid in the fight against the global Covid-19 pandemic, the past year has seen an urgent rush to develop new and effective vaccines at lightning speed.

Tremendous and collaborative efforts have been made by pharma, governments, scientific experts and patient volunteers to find jabs that will protect the population and slow the disruption that Covid-19 has wrought.

A number of promising candidates from some of the worlds biggest pharma companies have emerged and have already been administered to millions globally.

But, for a number of these vaccines it has been an incredibly bumpy road. With the news of both AstraZenecas vaccine and now Johnson & Johnsons candidate being linked to cases of rare blood clots, governments and their populations are now looking hopefully to candidates further down the pipeline without a reputation for serious adverse events.

With dozens all in different stages of development, and new variants of Covid-19 popping over the last year, the race for the safest and most effective vaccines continues with a new crop of candidates.

Clinical Trials Arena tracks the development of the vaccine candidates at the front of that race for approval.

Candidate name: NVX-CoV2373

Mechanism: Nanoparticle vaccine

GlobalData's TMT Themes 2021 Report tells you everything you need to know about disruptive tech themes and which companies are best placed to help you digitally transform your business.

Trial phase: Phase III

After assessing safety and immunogenicity in Phase I/II clinical trials where the vaccine produced encouragingly high levels of antibodies, NVX-CoV2373 is currently in two pivotal Phase III studies to evaluate vaccine efficacy, safety and immunogenicity.

NVX-CoV2373 clinical trials have enrolled more than 30,000 volunteers around the globe.

NVX-CoV2373 is a protein-based vaccine engineered from the genetic sequence of SARS-CoV-2, the virus that causes Covid-19.

The candidate was created using US-based Novavaxs recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is complemented with the companys patented saponin-based Matrix-M adjuvant to enhance immune response and stimulate high levels of neutralising antibodies.

In March 2021, Novavax reported that its UK trial determined an efficacy rate of 96% against the original coronavirus and 86% against the UK variant. But in South Africa, where volunteers were exposed to variant B.1.351, the efficacy was only 49%.

The company is now developing a new version of the vaccine that is tailored to the South Africa variant. The vaccine has also been brought into a University of Oxford trial to study the potential efficacy of mixing doses of different vaccines, alongside vaccines from Oxford/AstraZeneca, Pfizer/BioNTech and Moderna.

If its own clinical trials succeed, Novavax expects to deliver 100 million doses for use in the United States in 2021.

Candidate name: ZyCoV-D

Mechanism: DNA vaccine (plasmid)

Trial phase: Phase III

ZyCoV-D is India-based Zydus Cadilas plasmid DNA vaccine candidate for Covid-19 that targets the viral entry membrane protein of the virus.

In early animal studies, the firm reported that as well as generating neutralising antibodies post-vaccination, ZyCoV-D also induced T-cell response.

ZyCoV-D can be stored at 2 to 8C for the long term and at 25C for a few months and is administered via Needle Free Injection System (NFIS).

The company has launched an adaptive Phase I/II dose-escalation trial and plans to enrol about 1,000 healthy volunteers. The candidate began Phase II trials in August 2020. The Drugs Controller General of India has granted approval for Zydus Cadila to proceed with Phase III trials which began in January, involving over 30,000 people.

Candidate name: Abdala (CIGB 66)

Mechanism: Protein subunit vaccine

Trial phase: Phase III

Abdala is one of three vaccine candidates for Covid-19 being developed in-house by Cubas Center for Genetic Engineering and Biotechnology (CIGB).

Abdala (CIGB 66) is a protein vaccine that uses yeast as a receptor-binding domain (RBD) protein and alumina as an adjuvant.

The platform used to produce Abdalas RBD is the same one that the centre used in the past to develop HeberNasVac, a therapeutic vaccine against hepatitis B.

Abdala is designed to be administered three times, at 14-day intervals.

The Cuban government reports that 48,000 doses of the first of three shots of the jab were administered to members of CIGB and healthcare workers in the country, reaching the full population of participants proposed for the trial.

The ABDALA trial moved to Phase III at the end of February 2021.

Candidate name: VIR-7831

Mechanism: Plant-based adjuvant vaccine

Trial phase: Phase III

Medicago uses a plant-based platform to develop its vaccines. This approach uses living plants as bioreactors to produce non-infectious versions of viruses (called virus-like particles, or VLPs).

VLPs mimic the native structure of viruses, helping them to be easily recognised by the immune system.

Medicago developed its seasonal recombinant quadrivalent VLP vaccine candidate, VIR-7831, just 20 days after working with the SARS-CoV-2 genome.

A single dose of VIR-7831 in mice generated a positive antibody response after 10 days. Results from a Phase I trial show the vaccine was tolerable and generated an immune response in all participants after two doses.

Based on these results, Medicago received the agreement of regulatory authorities to launch Phase II/III clinical trials on 12 November 2020.

The company is also testing the candidate with two additional vaccine adjuvants from GSK and Dynavax.

On 17 February, the US FDA granted the candidate Fast Track designation.

Candidate name: CVnCoV

Mechanism: mRNA-based vaccine

Trial phase: Phase IIb/III

CVnCoV is German clinical-stage biopharmaceutical company CureVacs mRNA-based vaccine candidate, which started development in January 2020. CVnCoV is being developed in collaboration with British pharma giant GlaxoSmithKline (GSK) and Bayer.

The candidate is being supported by the German federal government and its development is strengthened by a partnership with the UK Government and its Vaccines Taskforce, which CureVac entered in February 2021.

The vaccine is an optimised, non-chemically modified mRNA, encoding the prefusion stabilized full-length spike protein of the SARS-CoV-2 virus, and formulated within lipid nanoparticles (LNPs).

Phase I and IIa clinical trials of CVnCoV began in June and September 2020, respectively, in Germany, Belgium, Peru and Panama. Phase I interim data showed that CVnCoV was generally well tolerated across all tested doses and induced strong antibody responses in addition to first indication of T cell activation. CureVac said the quality of immune response was comparable to recovered Covid-19 patients, closely mimicking the immune response after natural Covid-19 infection.

In December 2020, CureVac initiated the HERALD study, a pivotal Phase IIb/III trial taking place in Germany with 36,000 participants, who will receive a 12g dose of CVnCoV.

A complementary Phase III trial at the University Medical Center Mainz of more than 2,500 healthcare workers is also underway and a Phase III trial in Mexico has also begun.

In February 2021, CureVac initiated a rolling submission with the European Medicines Agency (EMA) for CVnCoV.

Candidate name: Bacillus Calmette-Guerin

Mechanism: Live-attenuated vaccine

Trial phase: Phase II/III

Murdoch Childrens Research Institute in Melbourne, Australia is conducting a Phase III trial of the bacillus Calmette-Gurin (BCG) tuberculosis vaccine to see if it also protects against the coronavirus. The trial, called BRACE, is being run in Australia, Brazil, the Netherlands, Spain and the United Kingdom.

Altogether, the trial will recruit more than 10,000 healthcare staff who will be given either the BCG vaccine (currently given to more than 100 million babies worldwide each year to protect against tuberculosis) or a placebo injection. In the UK, routine BCG vaccination ceased in 2005 because of the low rates of TB in the general population.

The BCG vaccine boosts immunity by training the immune system to respond to other subsequent infections with greater intensity.

Previous studies suggest that the BCG vaccine could reduce susceptibility to a range of infections caused by viruses including those similar to the novel coronavirus. This notion is what will be examined by the researchers working on the BRACE trial.

BRACE has received more than $10m from the Bill and Melinda Gates Foundation to allow its global expansion. The Peter Sowerby Foundation has contributed funding to support the UK Exeter trial site.

Candidate name: INO-4800

Mechanism: DNA vaccine (plasmid)

Trial phase: Phase II/III

Composed of an optimised DNA plasmid, INO-4800 is delivered via a proprietary smart device to produce a robust and tolerable immune response. US drug developer Inovio plans to scale production of the device while awaiting study results.

Inovio said INO-4800 is the only nucleic-acid based vaccine that is stable at room temperature for more than a year, at 37C for more than a month and has a five-year projected shelf life at normal refrigeration temperature. The candidate does not need to be frozen during transport or storage.

Preclinical data published in Nature Communications showed that mice and guinea pigs who received INO-4800 demonstrated neutralising antibodies as well as humoral and T-cell responses. In guinea pigs, researchers observed protein-binding antibody titers and blocking of angiotensin-converting enzyme 2 (ACE2)/SARS-CoV-2 S proteins.

Inovio has been working with Advaccine to advance the clinical development of INO-4800 in China, where 640 subjects have been dosed with the first vaccination of a 28-day, two-dose regimen in a Phase II clinical trial. The trial has enrolled both adults who are 18-59 years old and older adults over 60 with the primary endpoints of evaluating safety and immunogenicity within the Chinese population.

A similar independently-run Phase II segment of INOVIOs Phase II/III clinical trial for INO-4800 in the US, called INNOVATE, has started dosing.

In April 2021, Inovio announced results of a study that showed INO-4800 induced a robust T cell response against all spike protein variants tested, which the firm says will be key in providing protection against SARS-CoV-2 variants, in addition to providing similar levels of neutralising activity against both the UK and Brazilian variants as those against the original strain.

Candidate name: hAd5

Mechanism: Adenovirus-based vaccine

Trial phase: Phase I

ImmunityBio is developing a second-generation Covid-19 adenovirus vaccine candidate that targets both spike and nucleocapsid DNA in SARS-CoV-2.

In May 2020, the firms vaccine candidate, which is being manufactured by NantKwest, was selected to participate in Operation Warp Speed, a national program to accelerate Covid-19 vaccine development.

ImmunityBio believes the key to creating long-term immunity to the SARS-CoV-2 virus and overcoming the variants that are rapidly developing around the world is to design a vaccine that activates antibodies as well as memory B and T cells to multiple antigens.

The vaccine has the potential to provide multiple routes of administration (subcutaneous, intranasal and oral) to potentially generate mucosal IgA antibody barriers to the virus in the upper respiratory tract where it first enters the body.

The firms vaccine demonstrated CD4+ and CD8+ antigen-specific T cell responses in mice and protects nasal and lung airways in non-human primates.

ImmunityBio received authorisation from the US FDA to initiate a Phase I trial of its vaccine candidate last October. Results from the study, and others, will inform the companys swift movement into its Phase II/III trial design.

Currently, a Phase Ib study of the vaccine is progressing to assess the safety and immunogenicity of subcutaneous, oral and sublingual prime-boost combinations.

Candidate name: UB-612

Mechanism: Multitope peptide-based vaccine

Trial phase: Phase II/III

Vaxxinity (formerly COVAXX), a subsidiary of United Biomedical (UBI), is developing UB-612, a multitope protein/synthetic peptide-based vaccine candidate for Covid-19. UB-612 is designed to activate both T-cell and B-cell immunity in the body and has shown neutralising antibody activity in mice, rats, and guinea pigs.

In Taiwan, a Phase I trial of up to 60 participants is underway, and a Phase II trial of 3,850 participants has been initiated.

Results from the Phase I study, which evaluated the safety, tolerability, and immunogenicity of UB-612, showed that the vaccine was generally well-tolerated and elicited robust vaccine-induced CD4+/CD8+ T cell antibody responses.

Vaxxinity is also partnering with medical company Dasa for a Phase II/III trial in Brazil, and with the University of Nebraska for Phase I/II trials in the United States.

Candidate name: GRAd-COV2

Mechanism: Adenovirus-based vaccine

Trial phase: Phase II/III

Biotechnology firms ReiThera (Italy), Leukocare (Germany) and Univercells (Belgium) are partnering to develop GRAd-COV2, an adenovirus-based Covid-19 vaccine.

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10 next-gen Covid-19 vaccines in the race for approval - Clinical Trials Arena