Category Archives: Transhuman News

I spent part of my workday on Wednesday watching a rerun. It was of a Virtual Town Hall meeting entitled Gene Editing: The Future of the Produce Industry?, by the Produce Marketing Association BB #:153708, originally broadcast July 28.

PMA broadcast it again because of its popularity.

It answered one of the proverbial dumb questions that journalists, if no one else, should ask. In this case, whats the difference between genetic engineering and gene editing?

A rigorous answer to this question would depend on your location because various nations define (and regulate) the two differently.

This is essentially the difference: if an organism has been modified by the insertion of foreign DNA, its genetically modified (a GMO, for short).

Gene editing, on the other hand, is modifying genes in a way that could be achieved by plant breeding, except gene editing takes much less time. (For details, see here).

The United States regulates the two methods differently.

USDA issued this statement in March 2018: USDA does not regulate or have any plans to regulate plants that could otherwise have been developed through traditional breeding techniques as long as they are not plant pests or developed using plant pests. This includes a set of new techniques that are increasingly being used by plant breeders to produce new plant varieties that are indistinguishable from those developed through traditional breeding methods.

As an example of gene editing, panelist Haven Baker, cofounder and chief business officer of Pairwise, points to one of his companys current projects: the pitless cherry.

With conventional breeding, it would take 150 years, he remarks. But his company is three years into the project. He predicts that pitless cherries will be on the market by the end of the decade.

Seedless blackberries are further along: Baker estimates they will be available in a couple of years.

Another item: a watermelon that produces a natural zero-calorie sweetener, which panelist Fayaz Khazi, CEO of Bio Life Systems, says is producing to scale now.

Gene editing, panelist Gilad Gershon, CEO of Tropic Biosciences, says, is very specific. You maybe only change one nutrient, or disease resistance.

One example is TR4 Fusarium wilt, which afflicts Cavendish bananas and, if not checked, can destroy the world banana industry as it is now known.

We try to identify genes that affect Fusarium resistance, and try to fit them to consumer needs, Khazi says.

The panel kept returning to one major theme: the importance of consumer wants in gene editing crops. We try not to guess what the market needs, stresses Khazi.

Indeed, the disconnect between real and perceived consumer needs is the biggest bottleneck, Khazi adds. Surprisingly, the biology of the plant is never the bottleneck.

Currently, no produce items are on the market in this country that are products of gene editing, the panelists noted, although Japan has introduced a tomato with a high GABA content that is available there.

Eventually, Khazi predicts, the two categories of GMO and gene editing will merge.

In any case, gene editing is part of the produce industrys present and will become an increasingly important element of its future. Think of it as plant breeding on fast forward.

And never forget to ask dumb questions.

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Editing the produce gene - Produce Blue Book

The UAE the most-vaccinated country in the world against Covid-19 has approved another vaccine from Chinas Sinopharm, to be used as a booster.

As reported in The National, the Ministry of Health and Prevention gave emergency approval this week for the recombinant protein-based vaccine before a roll-out set to begin next month.

State news agency Wam said that clinical trials in the Emirates showed the vaccine stimulated an immune response and did not result in side effects.

Among those involved in the trials were people who had previously received two doses of the Sinopharm inactivated vaccine, which has been widely used in the Emirates.

Here we take a look at the new Sinopharm shot.

The UAE has approved a new vaccine to be used as a booster for anyone who has received two doses of Sinopharm. Pawan Singh / The National

The word recombinant refers to the fact that genetic engineering has been used to produce the new Sinopharm vaccine.

Typically this involves genetic material from the pathogen being inserted into the genetic material of another organism, such as a yeast or a bacterium.

This causes the genetically engineered organism to produce, in this case, coronavirus proteins, which are extracted and purified, and included as part of the active ingredient of the vaccine.

When the vaccine is injected, the immune system recognises the coronavirus proteins -which are antigens as foreign and responds by producing antibodies and other substances to use against them.

If the vaccine recipient is subsequently infected with the coronavirus, the earlier immune response to the vaccine means the immune system is prepared and should be better able to mount a defence against the pathogen.

Unlike messenger RNA (mRNA) vaccines, such as the Moderna and Pfizer-BioNTech shots, recombinant protein-based vaccines were already being given to people before the coronavirus emerged.

The first vaccine based on recombinant DNA methods was one against Hepatitis B, that was approved by the US Food and Drug Administration in 1986.

For this vaccine, the antigen is produced by yeast cells that have had genes for the Hepatitis B surface antigen (HbsAg) inserted into their genetic material.

Some influenza (flu) vaccines are also produced using recombinant technology.

In this case, host cells produce haemagglutinin, an influenza surface protein.

There are other, older forms of technology used to produce vaccines. Inactivated vaccines, for example, have been used for more than a century.

These are often created by producing large numbers of virus particles before they are inactivated with chemicals, heat or radiation. The vaccine may contain the whole virus or just components of it.

Recombinant protein-based vaccines have been extremely useful and extremely innovative, according to Prof John Oxford, emeritus professor of virology at Queen Mary University of London and co-author of the textbook Human Virology.

Ive got nothing but admiration for the whole technology, he said.

Ive got respect for Sinopharm and the other companies in China. Theyre well established.

He added that it was good that vaccines based on several types of technology including mRNA vaccines, inactivated vaccines and recombinant protein-based vaccines, among others had been produced to combat Covid-19.

We dont know all the ins and outs of these different vaccines against Covid, he said.

Some may produce a quick immune response, some a slow immune response.

Some [may produce a] very broad [response], including T cells [a type of immune cell] as well as B cells [which produce antibodies], others a slow but longer-lived response. There are so many variations on the theme. Until the playing field levels, we will not be able to see which is best.

Some influenza (flu) vaccines are also produced using recombinant technology. PA

Sinopharm, the trading name of China National Pharmaceutical Group Corporation (CNPGC), has been one of the key producers of Covid-19 vaccines.

It has two inactivated Covid-19 vaccines, one of which, BBIBP-CorV (sometimes written simply as BIBP), was assessed during clinical trials in the UAE and other countries.

With this vaccine, large numbers of coronavirus particles are produced using vero cells, a type of lab-grown cell line, before the virus particles are rendered harmless or inactivated by chemical treatment.

Many people in the UAE who received this vaccine in the UAE were subsequently given a dose of the Pfizer-BioNTech mRNA vaccine as a booster.

In April media reported that China National Biotec Group Company, a Sinopharm subsidiary, had received approval to begin human trials of its protein-based coronavirus vaccine.

Five months later, in September, Sinopharm unveiled four second-generation Covid-19 vaccines designed to be more effective against the Beta and Delta coronavirus variants.

These four vaccines were of three types: inactivated virus, mRNA and recombinant protein-based, the last of which is the technology behind the vaccine being rolled out in the UAE.

Hayat Biotech is a joint venture between Sinopharm and G42, an Abu Dhabi-based technology company. Photo: G42 Healthcare

As reported in The National, the new Sinopharm vaccine, which will be used from January 2022, is being produced by Hayat Biotech.

Hayat Biotech Hayat is the Arabic word for life is a joint venture between Sinopharm and G42, an Abu Dhabi-based technology company.

In 2020 G42 teamed up with Sinopharm to help administer clinical trials of the BBIBP-CorV vaccine in the UAE.

The two companies joint venture this year began production of BBIBP-CorV in the UAE under the name Hayat-Vax. This made the UAE the first Arab nation to manufacture Covid-19 shots.

Production started in a pharmaceutical plant in Ras Al Khaimah run by Gulf Pharmaceutical Industries PSC (Julphar), before the expected transfer to a new Hayat Biotech facility in Abu Dhabi capable of producing 200 million doses per year.

Updated: December 29th 2021, 3:00 AM

Read more:
What is the new UAE-approved Sinopharm vaccine and how does it work? - The National

GAITHERSBURG, Md. and PUNE, India, Dec. 28, 2021 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, and Serum Institute of India Pvt. Ltd. (SII), the world's largest vaccine manufacturer by volume, today announcedthat the Drugs Controller General of India (DCGI) has granted emergency use authorization (EUA) for Novavax' recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M adjuvant. The vaccine will be manufactured and marketed in India by SII under the brand name Covovax.

"No one is safe until everyone is safe, and today's authorization marks a vital step for India, where additional vaccine options and millions of doses are needed in the country's ongoing efforts to control the pandemic," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "Novavax and SII will not rest in our partnership to deliver our vaccine to those in India and across the globe, as we work to protect the health of people everywhere."

Because the vaccine is stored with standard refrigeration at 2 to 8 Celsius, it may be transported and stored using existing vaccine supply chain, potentially increasing access in hard-to-reach areas.

"The approval of Covovax in India marks a significant milestonein strengthening our immunization efforts across India and LMICs," said Adar Poonawalla, Chief Executive Officer, Serum Institute of India. "We are proud to deliver a protein-based COVID-19 vaccine, based on Phase 3 clinical data demonstrating more than 90% efficacy and a favorable safety profile, to our nation."

The Novavax/SII vaccine recently received EUA inIndonesiaand the Philippines, as well as Emergency Use Listing (EUL) with theWorld Health Organization(WHO). Novavax was also granted Conditional Marketing Authorization by the European Commission and EUL with the WHO for its vaccine, which will be marketed by Novavax as NuvaxovidTM. Novavax has also announced regulatory filings for its vaccine in multiple countries worldwide, while partners SK bioscience and Takeda have submitted regulatory filings inSouth Koreaand Japan, respectively.Novavax expects to submit the complete package to the U.S. FDA by the end of the year.

For additional information on Covovax, please visit the following websites in the coming days:

Authorized Use of Novavax' Covid-19 Vaccine in India

The Drugs Controller General of India (DCGI) has issued Emergency Use Authorization (EUA) for Covovax /Recombinant Spike Protein of SARS-CoV-2 Virus 5 mcgto induce immunity against SARS-CoV-2 to prevent COVID-19 for adults 18 years old and above.

Authorization in the U.S.

NVX-CoV2373 has not yet been authorized for use in the U.S. and the trade name Nuvaxovid has not yet been approved by the U.S. FDA.

Important Safety Information

Covovax is contraindicated in persons who have hypersensitivity to the active substance or to any of the excipients of this vaccine.

About NVX-CoV2373

NVX-CoV2373 is a protein-based vaccine 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 mcg antigen and 50 mcg Matrix-M adjuvant) given intramuscularly 21 days apart. The vaccine is stored at 2- 8 Celsius, enabling the use of existing vaccine supply and cold chain channels. The current assigned shelf-life of the vaccine is 9 months.

Novavax has established partnerships for the manufacture, commercialization and distribution of NVX-CoV2373 worldwide.

About the NVX-CoV2373 Phase 3 trials

NVX-CoV2373 is being evaluated in two pivotal Phase 3 trials.

A trial conducted in the U.K. with 14,039 participants was designed as a randomized, placebo-controlled, observer-blinded study and achieved overall efficacy of 89.7%. The primary endpoint was based on the first occurrence of PCR-confirmed symptomatic (mild, moderate or severe) COVID-19 with onset at least 7 days after the second study vaccination in serologically negative (to SARS-CoV-2) adult participants at baseline. Full results of the trial were published in theNew England Journal of Medicine(NEJM).

PREVENT-19, a trial in the U.S. andMexico, with 25,452 participants, achieved 90.4% efficacy overall. It was designed as a 2:1 randomized, placebo-controlled, observer-blinded study to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373. The primary endpoint for PREVENT-19 was the first occurrence of PCR-confirmed symptomatic (mild, moderate or severe) COVID-19 with onset at least 7 days after the second dose in serologically negative (to SARS-CoV-2) adult participants at baseline. The statistical success criterion included a lower bound of 95% CI >30%. The key secondary endpoint is the prevention of PCR-confirmed, symptomatic moderate or severe COVID-19. Both endpoints were assessed at least seven days after the second study vaccination in volunteers who had not been previously infected with SARS-CoV-2. It was generally well-tolerated and elicited a robust antibody response in both studies. Full results of the trial were published inNEJM.

About Matrix-M Adjuvant

Novavax' 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 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 harnesses the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. NVX-CoV2373, the company's COVID-19 vaccine, received Conditional Marketing Authorization from the European Commission, Emergency Use Listing from the World Health Organization, Emergency Use Authorization inIndia, Indonesiaandthe Philippines, and has been submitted for regulatory authorization in multiple markets globally. NanoFlu, the company's quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Novavax is currently evaluating a COVID-NanoFlu combination vaccine in a Phase 1/2 clinical trial, which combines the company's NVX-CoV2373 and NanoFlu vaccine candidates. These vaccine candidates incorporate Novavax' 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 Twitter,LinkedIn, Instagram and Facebook.

About Serum Institute of India Pvt. Ltd.

Driven by the philanthropic philosophy of affordable vaccines,Serum Institute of India Pvt, Ltd.is the world's largest vaccine manufacturer by number of doses produced and sold globally (more than 1.5 billion doses), supplying the world's least expensive and WHO-accredited vaccines to as many as 170 countries. It was founded in 1966 with the aim of manufacturing lifesaving immunobiological drugs including vaccines worldwide. With a strong commitment towards global health, the institute's objective has been proliferated by bringing down the prices of newer vaccines such as such as Diphtheria, Tetanus, Pertussis, Hib, BCG, r-Hepatitis B, Measles, Mumps and Rubella vaccines. SII is credited with bringing world-class technology toIndia, through its state-of-the-art equipped multifunctional production facility in Manjari,Pune; association with Zipline and government agencies to transform emergency medicine and critical care along with spearheading the race of vaccine development against the COVID-19 pandemic.

Forward-Looking Statements

Statements herein relating to the future of Novavax, its operating plans and prospects, the ongoing development of NVX-CoV2373 and its partnerships, the scope, timing and outcome of future regulatory filings and actions, the role that COVOVAX may play in helping to increase vaccination rates and to control the COVID-19 pandemic in India and across the globe, Novavax' and SII's continued efforts to deliver COVOVAX to those in India and across the globe, and COVOVAX's potential to increase vaccination access in hard-to-reach areas 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:

Investors

Novavax, Inc.

Erika Schultz | 240-268-2022

ir@novavax.com

Solebury Trout

Alexandra Roy | 617-221-9197

aroy@soleburytrout.com

Media

Ali Chartan | 240-720-7804

Laura Keenan Lindsey | 202-709-7521

media@novavax.com

Serum Institute of India

Mayank Sen | +919867974055

mayank.sen@seruminstitute.com

Logo - https://mma.prnewswire.com/media/1506866/Novavax_High_Res_Logo.jpg

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Novavax and Serum Institute of India Receive Emergency Use Authorization for COVID-19 Vaccine in India - KPVI News 6

A researcher in the Madurai Kamaraj University (MKU) has come up with a diagnostic kit to detect COVID-19 infection in 12 seconds. The kit has been patented in India and the researcher has applied for patent at Geneva as well.

T. Arokiyadoss, Assistant Professor and in-charge head of the Department of Physics at the Directorate of Distance Education, developed the diagnostic kit based on lab-on-a-chip technology.

The research team included B. Ashokkumar, Associate Professor, Genetic Engineering Department, and P. Varalakshmi, Assistant Professor in the Molecular Microbiology Department in the School of Biotechnology. The then Vice-Chancellor of the university, M. Krishnan, partly funded the research.

The RT-PCR kit requires 30 minutes to do the test. Our kit can perform the same in just 12 seconds. The kit directly interacts with the virus. When the virus enters the body, it attaches itself to ACE2 (antigen converting enzyme 2) and multiplies. Out kit takes the mRNA from the virus, amplifies and quantifies the virus, explained Mr. Arokiyadoss.

The researchers then sought the support of Madurai Medical College officials, including the then Dean J. Shangumani, and the colleges Viral Research and Diagnostic Laboratory, Institute of Microbiology, to test the kit. The college formed an ethical clearance board to approve the proposal.

We took 200 swab samples from COVID-19 infected patients to assess the performance of the kit. We were given 3 ml from the sample while another 3 ml went for the RT-PCR test. The results from both kits were similar, he said.

Mr. Arokiyadoss filed for a patent for his technology in India as well as in Patent Cooperation Treaty (PCT), Geneva. The PCT patent is pending approval. He has now signed an agreement with a Hyderabad-based private company that makes molecular diagnostics kits for manufacture and commercialisation of the device.

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Madurai Kamaraj University researcher develops kit to diagnose COVID-19 in 12 seconds - The Hindu

In the Charles Dickens novel A Christmas Carol, Ebenezer Scrooges final transformation from miser to philanthropist is marked by the big juicy turkey that he orders for the struggling Cratchit family and which has inspired Christmas menus across Britain and North America ever since.

A family-sized turkey with all the trimmings, including mashed potatoes and stuffing, made for an impressive Christmas dinner centrepiece in Victorian households. Turkeys were also largely within economic reach for those on modest incomes compared with the grander cuts of venison and beef enjoyed by the upper classes meaning festive feasting could be celebrated by all.

Depending on your own personal traditions, it might be hard to imagine Christmas without a turkey. Yet festive menus in the UK looked very different before the 19th century. They often included a variety of meats, cakes and liquors, and there was little to distinguish Christmas food from that of other celebrations and holidays.

Two hundred years on from the Dickensian turkey boom, it seems our festive favourites might be due for another radical rethink. Slaughter-free meat and soilless vegetables are just some of the innovations that are predicted to revolutionise food production. Many of these technologies have emerged in response to turbulent times for traditional agriculture.

In the UK, turkey farmers are currently battling Brexit and COVID disruptions, plus a highly contagious outbreak of avian flu. Globally, meat and dairy producers face mounting pressures from the climate crisis, rising antimicrobial resistance and the growing popularity of plant-based alternatives. Even Christmas vegetables are threatened by drought, floods and the loss of agricultural land to soil erosion.

Weve watched enough sci-fi films to know that predicting exactly what the future will look like is a pretty futile task. Instead, weve served up a menu of possible food futures based on technologies that are currently in development.

According to culinary historian Cathy Kaufman, one of the legacies of A Christmas Carol was an awful slaughter of Christmas turkeys. Now, slaughter-free meat also known as cultured or cultivated meat is under development.

This approach uses animal cells to grow flesh outside the body in bioreactors (artificial systems supporting biological environments). Techniques like precision fermentation and genetic engineering are also being used to reprogramme yeast and bacteria cells to create cow-free milk and chicken-free eggs.

Cell-cultured turkeys probably wont be at the centre of Christmas tables for some time. The first cultured meat product to hit the market was a hybrid chicken nugget, made of a mixture of cultured cells and plant-based ingredients, in 2020. But we dont yet have the technical ability to create the more complex structures of larger joints of meat, though a lot of money is currently being thrown at this challenge.

Were already growing some of our fruit and veg in artificial, sustainable environments using soil-free hydroponic farms its a safe bet that the tomatoes in your fridge were grown hydroponically. This trend is set to continue, with brassicas like broccoli and Brussels sprouts now being grown without soil.

Yet many uncertainties remain over whether these technologies will be able to compete with industrial livestock production, or to deliver on the environmental and ethical leaps their advocates have promised.

Hybrid meat substitutes can offer meaty tastes and textures with a potentially smaller environmental footprint than conventional animal-based products. For a festive example, think hybrid pigs in blankets made from cultured pork and fat cells with added soy or pea proteins.

Hybrid products like these represent incremental steps in meat reduction rather than an immediate radical overhaul of the food system. Yet whether they provide a gateway for a long-term shift away from meat, or simply add to consumers options, remains to be seen.

If theres an overall reduction of meat production and consumption across the worlds biggest meat-eating nations like the UK and US, then high-quality real meat from smaller, climate-conscious producers could be reserved for celebratory occasions like Christmas. For the rest of the year, we could follow a menu of plant-based foods and meat alternatives. But a key challenge is whether people are willing to reduce meat to this extent.

The turkey dinner is, of course, only one version of many seasonal menus enjoyed by different cultures around the world meaning that we dont necessarily have to follow its formula when imagining future Christmas feasts.

We might be dining on insect-based Christmas pies with robot-harvested algae on the side, consuming festive-flavoured nutrient drinks, or eating imitation meats made from air-fed microbes.

Alternatively, we might ultimately reject conventional meat and ultra-processed protein products and embrace a meatless menu of vegetables and legumes as already enjoyed in some Christmas traditions across the world.

Many of these scenarios have far-reaching implications for the future of food and farming from changing agricultural livelihoods and landscapes, to deciding which industries are in control of our food systems.

While turkeys may vote for many of these options, its important to understand who else is set to benefit or lose in each case and what other solutions might be missing from the table. Change in food systems is nothing new. Considering how that change is made is, however, essential if we are to serve up the most sustainable and equitable futures for all.

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What will your Christmas dinner look like in 2050? - The Conversation UK

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In-depth Research on Biohacking Market Forecast Estimation & Approach 2021-2026 | Fitbit, Apple, Synbiota, THE ODIN, HVMN, Moodmetric, and more |...