Category Archives: Genetic Engineering

Where did the virus that changed the world come from?

The prevailing theory for a long time was that wild animals sold as food at a wet market in Wuhan, China, had started the outbreak.

One of the first scientists to seriously question the official narrative was Botao Xiao, who in February 2020 published a pre-print paper arguing that "the killer coronavirus probably originated from a laboratory in Wuhan."

The author pointed out that there was no evidence that the vendors at the wet market in Wuhan sold bat meat. On the other hand, there were two research labs studying bat-borne coronaviruses located in Wuhan, where a virus could have accidentally infected workers, causing them to spread the disease to the general public. Xiao withdrew the paper two weeks later, after Chinese authorities declared that the lab-leak theory had no merit.

The Chinese government proceeded to clamp down on research into the virus's origins and ordered the closure of a lab that had shared the virus's genetic sequence with other scientists in January 2020. The government also forced the lab to destroy its viral samples.

To this day, the Chinese government won't allow outside researchers to test blood drawn from employees of the Wuhan Institute of Virology who, according to a U.S. intelligence report, were hospitalized for a flu-like illness in November 2019weeks before the first documented human-to-human transmission. Chinese authorities cited privacy concerns to the World Health Organization (WHO) team that requested the samples.

There's no direct proof that the virus originated from a lab. But there's also no such proof that humans first became infected by eating bats or through exposure to pangolins, theories that were treated as unimpeachable fact early in the pandemic.

In February 2020, a group of scientists signed a statement published in The Lancet denouncing speculation about potential nonnatural origins of the virus as "conspiracy theories."

Only following the publication of leaked emails did it become clear that the scientist who brought his colleagues together to co-sign the Lancet statement was Peter Daszak, head of EcoHealth Alliance, the nonprofit that secured U.S. government funding for controversial research on bat-borne coronaviruses at the Wuhan Institute of Virology. Daszak assured his co-signers that the EcoHealth logo wouldn't appear on the letter and wrote that he hoped "to avoid the appearance of a political statement."

Daszak also co-authored a June 2020 op-ed in The Guardian headlined"Ignore the Conspiracy Theories: Scientists Know COVID-19 Wasn't Created in a Lab" without disclosing a potential conflict of interest.

Media coverage following the publication of the Lancet letter overwhelmingly framed discussion of the lab-leak hypothesis as a "conspiracy theory," often tying it to former President Donald Trump after he and former Secretary of State Mike Pompeo made public statements promoting the lab-leak theory as the explanation.

"That episode does not reflect well on scientists," says science writer Matt Ridley, co-author of the new book Viral: The Search for the Origin of COVID-19.

Ridley says that White House COVID-19 adviser Anthony Fauci's emails, which were made public through a Freedom of Information Act request, show that behind the scenes scientists were taking the lab-leak theory seriously all along.

"A number of leading virologists were talking to each other and were saying to each other, 'we think this might look a bit like a virus that's been engineered in the laboratory,'" says Ridley, referencing a January 31, 2020, email in which researcher Kristian G. Andersen says that "one has to look really closely at all the sequences to see that some of the features (potentially) look engineered." Fauci replies a day later, "Thanks, Kristian. Talk soon on the call."

"And at the end of that phone call, they all did a very rapid volte-face, and started writing articles almost immediately," says Ridley, referring to an influential article Andersen and his colleagues published in Natureon March 17, 2020, stating that "our analyses clearly show that SARS-CoV-2 is not a laboratory construct or a purposefully manipulated virus." On March 6, Andersen emailed Fauci to tell him the paper had been accepted for publication, to which Fauci replied, "Nice job on the paper."

But Ridley says that it's Daszak's efforts to obscure his connections to the Wuhan Institute of Virology while publishing attacks on the lab-leak hypothesis that are most alarming.

"It does raise very serious concerns that Dr. Daszak needs to answer," says Ridley. "I've tried to correspond with him numerous times. I've never yet had a responseI never said anything rude about him, but he blocked me on Twitter. So I can't get answers out of him."

Daszak did not reply to Reason's interview request.

Ridley's writing partner on the new book is the Broad Institute of MIT and Harvard's Alina Chan, one of the earliest and most outspoken public skeptics of the natural-origin hypothesis. She says that when she and her colleagues published a pre-print paper questioning the consensus, she hadn't been aware of the Lancet letter organized by Daszak. She says she believes it could've had a major chilling effect on the scientific discussion in those early days.

"They were saying that anyone saying that this virus didn't come from nature is a conspiracy theorist," says Chan. "Other people, when they read this letter, they might have thought, 'I'm not going to put my neck out to say that this may have come from a lab.'"

Chan, a molecular biologist, argued in the paper that because SARS-CoV-2 was so well adapted to humans, there was reason to be skeptical that it had recently come from an animal. If it had recently come from bats or pangolins, she would've expected the virus to have been rapidly mutating in the early days of the pandemic to become better adapted to human tissue.

Chan partially credits this insight to her experience in the severe acute respiratory syndrome (SARS) outbreak of 2003, which she lived through in Singapore.

"In that situation and that outbreak, the virus had rapidly picked up dozens of mutations in the early three months," says Chan. "By comparison, for SARS-CoV-2, that had very few of these mutations. So it's suggested to me that this virus had really picked up many useful mutations for infecting and transmitting amongst humans prior to its detection in December 2019."

Another major difference is that during the 2003 outbreak, authorities discovered previous SARS infections among animals being sold at markets in south China within a couple of months. That's not the case with SARS-CoV-2, despite initial suspicions that a wet market was to blame.

"Even though the first class of cases identified was at the seafood market, they never found any signs of animals that were infected by this virus," says Chan. "So up until today, there's no sign of an animal [in Wuhan] that was ever infected by SARS-CoV-2 and then gave it to humans."

When the WHO sent a team to investigate the virus's origins in January 2021, Daszak was the only American member included. The team dismissed the lab-leak hypothesis before WHO leadership later backtracked.

Daszak granted an interview to 60 Minutes following that trip to Wuhan and suggested that farm animals were the likely culprit.

"Now what we've gotta do is go to those farms and investigate. Talk to the farmers. Talk to their relatives. Test them. See if there were spikes in virus there first," Daszak told 60 Minutes.But no farm animals have been identified as the hosts yet.

There's a detail that emerged after the 60 Minutes report that Ridley would like Daszak to explain: Recently-leaked documents show that EcoHealth Alliance applied for a research grant related to inserting what's called a furin cleavage site into SARS-like coronaviruses. This very furin cleavage site may be what makes SARS-CoV-2 so infectious, and it's what distinguishes it from any SARS-like coronaviruses as yet found in the wild. The grant request was rejected. But did the Wuhan laboratory engage in this research even without funding from that grant? Daszak may be able to help answer that question.

"The fact that that is probably the feature that makes the virus sufficiently infectious to start a pandemic means that it is a highly important thing," says Ridley. "So you would think that a scientist who knew that he had put in a grant application in 2018 to put furin cleavage sites into SARS-like viruseswould volunteer that information early in the pandemic."

Ridley and Chan also find it suspicious that when China's premier bat coronavirus expertand Daszak's collaborator in Wuhanpublished her complete analysis of the SARS-CoV-2 genome, she neglected to mention this highly unusual furin cleavage site.

After the 60 Minutes interview, more leaked documents showed that EcoHealth Alliance worked with the Wuhan Institute of Virology to make several bat-borne SARS-like coronavirusesand even Middle East respiratory syndrome (MERS)more infectious to human cells.

Chan and Ridley say that when they started writing the book they didn't have a strong view about which theory was correct, but these recent revelations have shifted their thinking in favor of the lab-leak theory.

"In light of grant proposals and reports released in the past 2 months," Chan wrote on Twitter, "we know novel SARS-like viruses were being synthesized and engineered at unprecedented scale."

"That changed my mind completely, knowing that there actually was a plan, a pipeline, a protocol for doing this work in 2018. So now for me, genetic engineering is very much on the table," says Chan. "If it came from a lab, [the likelihood is] close to a 5050 chance that [genetic engineering] happened."

This question was at the center of a heated exchange between Fauci and Sen. Rand Paul (RKy.) over possible National Institutes of Health (NIH) funding of so-called gain of function research, which involves purposely making a virus more infectious to humans.

But much of the blame for the devastating scope of the pandemic, says Ridley, rests on Chinese authorities, who punished whistleblowers like ophthalmologist Li Wenliang, who tried to get the word out about the emergence of a new SARS-like virus to his colleagues. The government successfully kept human-to-human transmission of the disease under wraps for weeks and maybe longer.

"Communist regimes tend to be secretive," says Ridley. "There tends to be an assumption that you don't talk about things unless you're allowed to, rather than the other way around. But [Chinese President] Xi Jinping, being a much more dictatorial and authoritarian ruler than his immediate predecessors, by 2019 it was more and more the case that scientists in laboratories and doctors in hospitals were under orders not to communicate with theoutside world about things that the regime might not want them toDid that play a part in the epidemic escaping and getting to the rest of the world and turning into a pandemic? You bet it did."

The Wuhan Institute of Virology houses samples of RaTG13, a bat virus that is one of the closest known genetic matches to SARS-CoV-2. But to this day, information about other coronaviruses in the Wuhan lab hasn't been released, so we don't know if the lab was working with a virus that's even more closely related to SARS-CoV-2.

The lab's public database of viral samples could hold some answers, but it was taken offline in February and had been modified in December, which we know because of work by the Dedicated Research and Scientific Team Investigating COVID-19 (DRASTIC), a decentralized group of volunteers who compile and analyze open-source material and leaked documents to investigate the origins of COVID-19.

"Once I realized [the lab-leak hypothesis] was being discredited without any evidence, I just couldn't stay silent," says Yuri Deigin, a biotech entrepreneur and one of the founding members of DRASTIC.

A key revelation uncovered by the group was that the Wuhan Institute of Virology database was first taken down in September 2019, three months before the pandemic became publicly known. A description of the database was modified on December 30, 2019, the day Shi Zhenglitold Chinese state television that her lab first obtained samples of the virus in Wuhan.

Wuhan scientists accessed the database a few times before it was permanently removed in February 2020 for alleged "security concerns."

"For them to take it down is very suspicious. And of course, Shi's explanation that she took it down to prevent hackers from attacking is complete bullshit because it was a public database to begin with," says Deigin.

A member of the DRASTIC team also discovered that the Wuhan team had collected key samplesincluding one of the virus's closest known genetic matchesfrom a mine where some workers had fallen sick and died after clearing out bat droppings. Chinese authorities have denied outsiders any access to examine the mine.

Though there's mounting circumstantial evidence to support the lab-leak theory, government officials maintain that the natural-origin hypothesis is more likely. A U.S. intelligence report declassified on October 29, 2020, said four intel agencies had low confidence that the virus most likely emerged in nature; one agency had moderate confidence that it leaked from a lab; and analysts at three agencies remained "unable to coalesce around either explanation without additional information." The report did conclude that SARS-CoV-2 was unlikely to be a biological weapon.

NIH Director Francis Collins, who didn't reply to Reason's interview request, told computer scientist and podcast host Lex Fridman in early November that he's open to the lab-leak hypothesis but still believes strongly that the virus is of natural origin.

Between July 2020 and January 2021, an international team of scientists captured bats in Laos carrying a newly discovered coronavirus that's the closest known genetic match to SARS-CoV-2even closer than the virus held in the Wuhan lab, which some say supports the natural-origin theory. But Ridley, Chan, and Deigin point out that it lacks the crucial furin cleavage site, which they suspect scientists inserted in a lab.

Supporters of the natural-origin theory point out that no "smoking gun" virus has yet been found in the version of the Wuhan database uncovered by DRASTIC. But Chan points out that this version of the database is years out of date because the Wuhan researchers generally don't enter new viruses until they've had a chance to sequence and publish studies about them.

"So we have barely any concept of what viruses and sequences they might have found after 2016 in the years leading up to COVID-19," says Chan. "So without access to the informationitbecomes very difficult for us to guess whether or not they finally found the precursor of SARS-CoV-2 in the labs and were working with it."

Ridley says that he doesn't want a fear of biotechnology, which he credits for alleviating human suffering, to hamper scientific progress because of what may have happened in Wuhan. But he thinks scientists should convene an international forum to set stricter ethical guidelines prohibiting dangerous types of research, such as harvesting bat viruses from faraway caves and bringing them to large urban centers to run experiments that make them more infectious to human cells. One China-produced documentary released in December 2019 showcases researchers doing this work, some of them without proper protective gear.

"Going out and harvesting viruses in wild places with pandemic potential and bringing them back to cities to work on them, probably isn't very sensible," says Ridley. "If we could get the U.S., the U.K., Australia, Japan, other major countries to sign a treaty saying, 'When there's an outbreak in our country, we promise to open up as far as possible and tell you everything we know,' then the very fact that some countries won't sign that treaty will itself put pressure on them."

He points to the emergence of the International Atomic Energy Agency as a model for nations to follow in terms of preventing future lab leaks of potentially pandemic-causing pathogens.

And Ridley says that despite the months of obfuscation by Chinese authorities, virologists, and even some U.S. media outlets, he's optimistic that the truth will emerge in time.

"It may take a long time," says Ridley. "The fall of the Soviet Union did lead to significant revelations about biological accidents thereI think therefore it may take a change of regime in Beijing before we find out more. But I think there are people who know what happened, whatever happened, even if it's just what happened in a marketThere are plenty of people who say it's too late; we've lost the chance to find out. I'm not one of them, at least not yet."

Produced by Zach Weissmueller; graphic intro and timeline graphics by Tomasz Kaye; additional graphics by Calvin Tran

Images: He Huan / Xinhua News Agency/Newscom; Yin Gang / Xinhua News Agency/Newscom; Imagine China/Newscom; Kyodo/Newscom; Hitoshi Katanoda/Polaris/Newscom; Dickson Lee/SCMP/Newscom; DESIGN CELLS/SCIENCE PHOTO LIBRARY/Newscom; Wang Bingyu/EyePress / EyePress/Newscom; EyePress / EyePress/Newscom; Edwin Remsberg / VWPics/Newscom; SHEPHERD ZHOU/FEATURECHINA/Newscom; Xie Huanchi / Xinhua News Agency/Newscom; Li Xueren / Xinhua News Agency/Newscom; Wang Ye / Xinhua News Agency/Newscom; Imagine China/Newscom; CHINE NOUVELLE/SIPA/Newscom; CHINE NOUVELLE/SIPA/Newscom; CHINE NOUVELLE/SIPA/Newscom; SHI ZHI/FEATURECHINA/Newscom; Xiao Yijiu / Xinhua News Agency/Newscom; Christophe Gateau/dpa/picture-alliance/Newscom; Yin Gang / Xinhua News Agency/Newscom; Andre Malerba/ZUMAPRESS/Newscom; u Peng / Xinhua News Agency/Newscom

Read the original here:
Was It a Lab Leak? The Mysterious Origin of COVID-19 - Reason

The David and Lucile Packard Foundation announced that Princeton's Sarah Kocher is one of 20 early-career researchers to be awarded a 2021 Packard Fellowship for Science and Engineering. Each fellow will each receive $875,000 over five years to pursue their research.

Kocher, an assistant professor of ecology and evolutionary biology and the Lewis-Sigler Institute for Integrative Genomics, investigates the genetic and neurobiological mechanisms behind social living. Herresearch takes advantage of naturally occurring variation in sweat bees, where some species live alone while others build social units like their better-known cousins the honeybees.

Photo by

Denise Applewhite, Office of Communications

"Through this comparative lens, we can examine the genetic factors that shape variation in social behavior within and among species and link these genetic changes with neurobiological and behavioral traits," Kocher said. "My work traverses different levels of biological complexity, from genes to brains to behavior, to gain a comprehensive understanding of the factors that shape the evolution of the social brain.'"

The Packard Fellowships in Science and Engineering are among the nations largest nongovernmental fellowships, designed to allow maximum flexibility in how the funding is used. Since 1988, this program has supported the blue-sky thinking of scientists and engineers whose research over time has led to new discoveries that improve peoples lives and enhance our understanding of the universe.

What a moment for celebration, saidNancy Lindborg, the president and CEO of the Packard Foundation.At a time when we are confronting so many difficult, intertwined challenges, including climate change, a global pandemic and racial injustice, I am buoyed by the determination and energy of these 20 scientists and engineers. Through their research, creativity and mentorship to their students and in their labs, these young leaders have the potential to help equip us all to better understand and address the challenges we face.

The fellowships program was inspired by David Packards commitment to strengthen university-based science and engineering programs in the United States. He recognized that the success of the Hewlett-Packard Company, which he cofounded, was derived in large measure from research and development in university laboratories. Since 1988, the Packard Foundation has awarded $464 million to 657 scientists and engineers from 54 national universities.

The fellowship will be paid over five years, beginning in November 2021. Kocher will join other fellows at an annual conference held online this year and last yearto discuss their research and possibly spark interdisciplinary collaborations. Next years meeting is scheduled for Sept. 7-10 in Monterey, California.

Other Princetonians who have been named Packard Fellows include quantum chemist Leslie Schoop in 2020, mathematicianAleksander Logunov in 2019, biologist Mary "Cassie" Stoddard in 2018, mathematician John Pardon in 2017, physicist Waseem Bakr in 2016, biologist Sabine Petry in 2014, computer scientist Mark Braverman in 2013, astrophysicist Gspr Bakos in 2012, physicist William Jones in 2010, chemical engineer Celeste Nelson and physicist Jason Petta in 2008 and mathematicianManjul Bhargava in 2004.

Originally posted here:
Biologist Sarah Kocher receives Packard Foundation fellowship for early-career scientists for her 'social brain' research with bees - Princeton...

Desmond Edwards was a little kid when first learned about typhoid fever. Fortunately, he didnt have the disease. He was looking at a cartoon public health announcement. The cartoon, produced by the Pan American Health Organization, was designed to educate people in his home country of Jamaica about the importance of immunizations for diseases like typhoid. The typhoid character in the cartoon was so unpleasant it gave him nightmares.

Edwards did have his fair share of hospital visits throughout his childhood. But, his own struggles with infection and illness, and those typhoid cartoon nightmares, became his inspiration for pursuing a career studying human disease. At age 6, Edwards was running impromptu baking soda experiments in repurposed glitter containers in his kitchen. Today, he is a senior at MIT, majoring in biology and biological engineering, thanks to a team of dedicated mentors and an insatiable curiosity about how the human body works or, more accurately, how diseases stop it from working.

Finding a way into research

Edwards knew he wanted to do research but says he assumed that that was something you did after you got your degree. Imagine his surprise, then, upon arriving at MIT in 2018 and meeting classmates who not only had done research, but already had publications. Realizing that he could get a jump-start on his career, he sought out research opportunities and enrolled in the biology class 7.102 (Introduction to Molecular Biology Techniques) for his first-year Independent Activities Period. The class was specifically geared toward first-year students like him with no lab experience.

It was a great first look at how research is done, Edwards says of the class. Students took water samples from the Charles River and were expected to identify the strains of bacteria found in those samples using various biological techniques. They looked at the bacteria under a microscope. They examined how the samples metabolized different sources of carbon and determined if they could be stained by different dyes. They even got to try out basic genetic sequencing. We knew where we were starting. And we knew the end goal, says Edwards. The in-between was up to them.

Class 7.102 is taught by Mandana Sassanfar, a lecturer in biology and the departments director of diversity and science outreach. For Sassanfar, the class is also an opportunity to find lab placements for students. In Edwards case, she literally led him to the lab of Assistant Professor Becky Lamason, walking up with him one evening to meet a postdoc, Jon McGinn, to talk about the lab and opportunities there. After Edwards expressed his interest to Lamason, she responded within 30 minutes. McGinn even followed up to answer any lingering questions.

I think that was really what pushed it over the edge, he says of his decision to take a position in the Lamason lab. I saw that they were interested not only in having me as someone to help them do research, but also interested in my personal development.

At the edges of cells and disciplines

The Lamason lab researches the life cycle of two different pathogens, trying to understand how the bacteria move between cells. Edwards has focused on Rickettsia parkeri, a tick-borne pathogen thats responsible for causing spotted fever. This type of Rickettsia is what biologists call an obligate intracellular pathogen, meaning that it resides within cells and can only survive when its in a host. I like to call it a glorified virus, Edwards jokes.

Edwards gets excited describing the various ways in which R. parkeri can outsmart its infected host. Its evolved to escape the phagosome of the cell, the small liquid sac that forms from the cell membrane and engulfs organisms like bacteria that pose a threat. Once it gets past the phagosome and enters the cell, it takes over cellular machinery, just like a virus. At this point of the life cycle, a bacterium will typically replicate so many times that the infected cell will burst, and the pathogen will spread widely. R. parkeri, though, can also spread to uninfected cells directly through the membrane where two cells touch. By not causing a cell to burst, the bacterium can spread without alerting the host to its presence.

From a disease standpoint, thats extremely interesting, says Edwards. If youre not leaving the cell or being detected, you dont see antibodies. You dont see immune cells. Its very hard to get that standard immune response.

In his time in the lab, Edwards has worked on various projects related to Rickettsia, including developing genetic tools to study the pathogen and examining the potential genes that might be important in its life cycle. His projects sit at the intersection of biology and biological engineering.

For me, I kind of live in between those spaces, Edwards explains. I am extremely interested in understanding the mechanisms that underlie all of biology. But I dont only want to understand those systems. I also want to engineer them and apply them in ways that can be beneficial to society.

Science for society

Last year, Edwards won the Whitehead Prize from the Department of Biology, recognizing students with outstanding promise for a career in biological research. But his extracurricular activities have been driven more by his desire to apply science for tangible social benefits.

How do you take the science that youve done in the lab, in different research contexts, and translate that in a way that the public will actually benefit from it? he asks.

Science education is particularly important for Edwards, given the educational opportunities he was given to help get to MIT. As a high schooler, Edwards participated in a Caribbean Science Foundation initiative called the Student Programme for Innovation in Science and Engineering. SPISE, as its known, is designed to encourage and support Caribbean students interested in careers in STEM fields. The program is modeled on the Minority Introduction to Engineering and Science program (MITES) at MIT. Cardinal Warde, a professor of electrical engineering, is himself from the Caribbean and serves as the faculty director for both MITES and SPISE.

That experience not only kind of opened my eyes a bit more to what was available, what was in the realm of possibilities, but also provided support to get to MIT, Edwards says of SPISE. For example, the program helped with college applications and worked with him to secure an internship at a biotech company when he first moved to the United States.

If education falters, then you dont replenish the field of science, Edwards argues. You dont get younger generations excited, and the public wont care.

Edwards has also taken a leadership role in the MIT Biotechnology Group, a campus-wide student group meant to build connections between the MIT community and thought leaders in industry, business, and academia. For Edwards, the biotech and pharmaceutical industries play a clear role in disease treatment, and he knew he wanted to join the group before he even arrived at MIT. In 2019, he became co-director of the Biotech Groups Industry Initiative, a program focused on preparing members for industry careers. In 2020, he became undergraduate president, and this year hes co-president of the entire organization. Edwards speaks proudly of what the Biotech Group has accomplished during his tenure on the executive board, highlighting that they not only have the largest cohort ever this year, but its also the first time the group has been majority undergraduate.

Somehow, in between his research and outreach work, Edwards finds time to minor in French, play for the Quidditch team, and serve as co-president on the Course 20 Undergraduate Board, among other activities. Its a balancing act that Edwards has mastered over his time at MIT because of his genuine excitement and interest in everything that he does.

I dont like not understanding things, he jokes. That applies to science, but it also extends to people.

Excerpt from:
Investigating pathogens and their life cycles, for the benefit of society - MIT News

The rapid advance of technology has enriched our daily lives. We can take pictures and videos with a cell phone, we can surf the internet, organs can be transplanted, genetic engineering can be utilized to develop vaccines, while windmills and solar panels are altering the way we generate electricity, 5G will revolutionize telecommunications, streaming services allow us to watch movies in our own homes and robots and artificial intelligence are changing the workplace.

There is only one group that rejects the onrush of modernity and technology and that is the organic community of farmers, processors, retailers and marketers (as well as their lobbying organizations), which believes the old ways are the better ways and wishes to turn back the clock to a supposedly idyllic time where small family farms proliferated and produced most of the food we consumed.

Farming has always been a very difficult business, particularly given the vagaries of the weather and crop prices. But it has only been through the application of science and new technologies that farmers have been able to steadily increase productivity and produce more food at a time when the number of people engaged in farming has plunged. This is one of the major reasons organic farming is less productive than conventional farming. It rejects the application of new innovative technologies such as biotechnology which has allowed the expansion of food production.

Many proponents of organic farming even reject hydroponicscrops grown solely in waterbecause they are not grown in soil. In May 2021, the Center for Food Safety and a group of organic farmers appealed a court ruling that the USDA did not act unreasonably when it refused to prohibit the organic certification of hydroponic agriculture. They claimed the USDA is in violation of the Organic Foods Production Act because hydroponic agriculture undermines the laws stipulation that organic farming enhance soil fertility.

There is no reason why organic farming cannot adopt modern biotechnology methods other than stubborn adherence to orthodoxy, which in the long run will undermine the entire industry. This is because organic farming will not be able to compete with the crops that will be grown via genetic engineering, which hold out the promise of creating crops that are insect, browning and drought resistant, make their own nitrogen, are more nutritious, colorful and tastier and have a longer shelf life. These crops can only be created in the laboratory and not through conventional breeding methods.

Pairwise, a biotechnology agriculture company, based in North Carolina, is working on developing via genetic engineering seedless blackberries, pit less cherries and tastier greens.

Calyxt, headquartered in Minnesota, has developed a gene-edited soybean oil that contains approximately 80 percent oleic acid and up to 20 percent less saturated fatty acids compared to commodity soybean oil, as well as zero grams of trans fat per serving.

In 2019, Cibus, another agriculture biotechnology company, headquartered in California, developed via gene-editing three new traits for canola that can increase crop yields and reduce harmful environmental impacts. According to a company press release:

The new traits precisely edit the canola genome to reduce pod shatter, the tendency of canola seed pods to open pre-harvest that can reduce yields by as much 40 percent, build resistance to Sclerotinia, a disease called white mold, that can reduce yields by as much as 50 percent, and introduce an improved weed control system, as competition with weeds for nutrients and sunlight can reduce yield of canola.

The Camelina plant has been genetically modified to produce omega-3 which are normally sourced from fish oil. This development might help to ease overfishing.

Genetic engineering will be able to produce disease resistant crops by manipulating the genetic make-up of plants. The papaya industry in Hawaii was saved from being decimated by ringspot virus by a genetically modified variety that is resistant to the virus. CRISPR/Cas 9 technology has been used to confer late blight resistance to potatoes. Genetic engineering may be the only means of saving the Cavendish banana from being decimated by Panama disease and oranges from citrus greening.

An article in the Phytologist journal entitled, Genetic modification to improve disease resistant crops, noted:

Plant pathogens are a significant challenge in agriculture despite our best efforts to combat them. One of the most effective and sustainable ways to manage plant pathogens is to use genetic modification (GM) and genome editing expanding the breeders toolkit.

Genetic engineered solutions to the scourge of crop diseases that cost farmers billions of dollars of losses would not be available to organic farmers because of the rejection of the use biotechnology in cultivating their crops.

Organic farmers will also not be able to avail themselves of using animals for dairy and meat that have received genetically engineered vaccines. About 20 percent of cows and other livestock are lost to disease every year.

A 1988 article from Critical Reviews in Microbiology that could now be considered a classic entitled, New approaches to animal vaccines utilizing genetic engineering, stated:

Control of infectious diseases in livestock is an important determinant in the success of a nations effort to efficiently meet its need for animal products. Genetic engineering offers many new options in the design of animal vaccines. Monoclonal antibodies, DNA cloning, recombination, and transfection are examples of techniques that facilitate innovative strategies in antigen identification, production, and delivery.

The organic industry will also not be able to take advantage of using animals that have been genetically engineered to be heat tolerate, grow faster like the GMO salmon, and develop more muscle mass.

In December, 2020, the Food and Drug Administration approved genetically engineered pigs for use in food and medical products. The pigs, developed by Virginia-based Revivicor, can be used in the production of drugs, to provide organs and tissues for transplants, and to produce meat thats safe to eat for people with meat allergies.

Meanwhile, a Japanese company is selling a genetically engineered red sea bream that has 20 to 60 percent more meat and whose feed utilization efficiency is 14 percent greater than conventionally grown bream.

In a world in which plant-based meat will garner a growing share of the meat market, the organic good industry will not be able to fully participate in providing basic ingredients, such as soybeans, potatoes and peas, because many of the processes involved in creating such meat use genetic engineering. Impossible Burger, for instance, uses GMO technology to create a soy-based heme which makes its burgers bleed.

An article by IDTechEx Senior Technology Analyst Michael Dent, Emerging Technologies Set to Shape Next Generation of Plant Based Meat, noted:

Genetic engineering technology has great potential for producing new proteins and allowing animal-free production of ingredients usually derived from animals. Perfect Day is using recombinant technologyto create vegan dairy products that contain the exact same proteins as their animal-derived counterparts, creating realistic tastes and textures. Clara Foods is taking a similar route, using genetically engineered yeast to produce vegan egg white proteins. Beyond this, genetic engineering technologies such as CRISPR and TALEN could help create crops optimized for plant-based meat production, such as increased protein content, fewer off-flavors, or boosted nutritional profiles.

The organic food industry remains steadfastly opposed to the use any form of genetic engineering to grow crops. In 2019, for example when U.S. Department of Agriculture undersecretary Greg Ibach suggested that gene-editing should be considered for use in organic food production, The Organic Trade Association issued a statement that said it maintains its long-held position that any gene-editing techniques not be allowed in organic production. Harriet Behar, the chair of the National Organic Standards Board (NOSB) chair, said,

Weve made it very clear, and the organic community has public comment that gene-editing and CRISPR should be an excluded methodThe organic community works with natural systems, and we dont feel the need for this type of genetic engineering.

Despite the long-held and vigorous opposition to genetic engineering, the organic food industry may ultimately have to reassess its position or else it will be digging itself into a grave of obsolesce. Prices for organic food are already much higher than for conventionally grown food. As a result, it has only been able to capture a small percentage of the food market. According to the Organic Trade Association, nearly 6% of all food sold was certified organic in 2020. One of the reasons for the higher costs is the low productivity of organic farming.

A plethora of crops developed by means of genetic engineering will come to the market in the near future that are nutritional, taste and color enhanced, drought tolerant and browning and disease resistant, all of which organic produce will not be able to compete with. The organic food industry needs to set aside its orthodoxy and its devotion to dogma against genetic engineering or else it will never break out of the small niche share it has in the food market and might even slip into irrelevance.

Steven E. Cerier is an international economist and a frequent contributor to the Genetic Literacy Project.

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The organic food industry's rejection of modernity - Genetic Literacy Project

Genetic engineering is a hot topic in current scientific research.

Using methods like the bacterial-inspired CRISPR, multiple countries around the world are hard at work developing ways to detect and change the genes of the organisms around us to better suit our needs. Although these techniques are powerful and impressive, the fact is humans have been altering the genetics of other organisms for thousands of years.

The proof of this ancient human tradition lies not in the pudding, but in the pumpkin pie some of the earliest examples of purposeful genetic engineering by humans are the various types of squash seen on dinner tables and doorsteps throughout the summer and fall.

The word squash is really a blanket term used to describe a wide variety of fruits created by plants in the gourd (cucurbit) family. These have a broad range of types, such as cucumbers, watermelons, pumpkins, acorn squash and even luffas. Many of these plants trace their origins to South and Central America, where they were first brought into human cultivation around 8,000 years ago.

Some of the more delicate fruits are usually defined as summer squash and are eaten soon after they begin growing while their skin and seeds are still supple.

Winter squash, on the other hand, are allowed to grow until their outer skins turn into tough protective coverings. While they take much longer to reach maturity, the thick outer skin of winter squash allows them to be stored for long periods before eating.

Both types of squash have been commonly consumed in America since long before the founding of the United States, however winter squash was especially important to early American colonists as a food source in the colder months.

Luckily for the struggling colonies, early American cultures had established cultivated squash as far north as Canada long before their arrival. As squash was brought north along with migrating groups of people, its preferred pollinator traveled with it. The absolute best (and in some cases only) pollinator of squash is the aptly named squash bee, who makes her nest at the base of squash plants in order to ensure she is always close to her favorite blooms.

The life of a squash bee is finely tuned to that of their beloved squash. Their emergence in spring is perfectly timed to coincide with the first squash blooms, and they tend to forage very early in the morning, which is also the most active time for squash blossoms.

The males of the species even prefer to use roomy squash flowers as a backdrop for courtship dances intended to attract the eyes of nearby females. While their frantic dances dont always end in romance, they still help the flower by dislodging pollen and assisting in pollination.

Studies have shown that squash pollinated by squash bees are much larger than those pollinated by other means, due to the fact that they are so finely tuned to interact with each other.

Most squash bees are specialists who wont move into an area until they find a healthy patch or two of cucurbits. If you have some gourds, pumpkins or other squash that you notice arent being pollinated well, leaving them in place for several seasons might be enough to bring some squash bees closer to your garden.

Bumble bees are also important squash pollinators, so leaving grass tufts and dense brush around where possible will provide habitat for them. Since squash bees nest at the base of plants, avoid heavily disturbing the soil in your cucurbit beds in order to give established nests a chance to survive until the next season.

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Squash family has a fascinating and long history - The Sylva Herald

CAMBRIDGE (CBS) When we all went in to lockdown back in March of 2020, an MIT scientist began studying exactly how the coronavirus pandemic began, and decided that a lab accident in Wuhan, China had to be considered one plausible explanation.

Over the last 18 months, Alina Chan has grown a huge following on Twitter where she tweeted her theories and research and has been attacked by one camp and called a hero by another. Now, shes written a new book on what she says has been an exhausting journey.

This all began because I wanted to ask the question: could this have come from nature or from a lab? Somehow just raising the lab hypothesis offended a whole bunch of people, powerful people, but behind the scenes, in private I have actually received a great deal of support from other scientists, MIT Broad Institute Researcher Alina Chan said.

In fact, after being dismissed as a conspiracy theory at the start of the pandemic, those questions about the possibility of a lab leak have even started to seep in to popular culture. Jon Stewart joked on The Late Show with Stephen Colbert: How did this happen? I dont know maybe a pangolin kissed a turtle, he said.

But Alina Chan warns this is no laughing matter. A postdoctoral researcher in gene therapy at the Broad Institute of MIT and Harvard (but not a virologist), she co-authored the new book Viral, and argues that searching for the origin of COVID-19 is vital to preventing future pandemics.

If we dont say anything, this will happen again and again, Chan said.

The book makes the case for both possibilities: natural transfer of the virus from bats to mammals and then to humans, or from some sort of lab accident at the Wuhan Institute of Virology that spread to the community. She adds this is not about assigning blame.

We make the strongest argument possible for each origin, she explained. And we let the reader decide, so we dont know the answer.

Some have accused Chan of pushing the lab origin theory when there is no evidence to support that claim.There is no evidence whatsoever for a natural origin or a lab origin so all of the existing evidence is circumstantial. Even for natural origin, its completely circumstantial, Chan explained.

So no, there is no hard evidence yet, but as another leading infectious disease expert, Dr. David Relman of Stanford University, told CBS News everything is on the table: The lab leak hypotheses are absolutely legitimate, Dr. Relman said. They are plausible.

Despite personal and professional attacks online questioning her qualifications, Chan insists she wont be deterred: I actually do have a very strong background in handling viruses and engineering them. I have many years of experience in bioengineering, genetic engineering.

And shes not sorry to have started asking questions. I dont regret pushing so hard because the scientific community really needs to step up and rebuild public trust.

Chan said the book catches people up on whats happened so far there has been a lot of confusion, but she points out that no safety changes have been made to the wildlife trade or lab safety. So after millions have died and had their lives turned upside down, we are in the exact same place we were two years ago before anyone ever realized what coronavirus was.

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MIT Scientist Discusses The Importance Of Finding The Source Of The COVID Pandemic - CBS Boston

Climate change is expected to have a big impact on crop yields and food security over the coming decades, as farmers contend with rising temperatures and increasingly abnormal conditions. Scientists working on solutions to this problem continue to demonstrate how gene-editing tools like CRISPR could have a role to play, and a group in Japan has now leveraged the technology to produce a mutant species of barley that avoids premature sprouting.

As one of the world's most widely grown crops, barley is used in everything from breads, cereals, animal fodder and of course as a source of malt for alcoholic beverages including beer and whisky. One problem that barley farmers often run into, however, is known as pre-harvest sprouting, where high humidity due to unexpected rain in the lead up to harvest causes premature germination, significantly devaluing the grain.

Prior research has shown how genetic engineering can be used to extend the dormancy of the grains to prevent this from happening, but this can negatively impact their use in malt production down the track. Scientists have been working to solve this dilemma for years, and through the CRISPR gene editing tool, a team at Okoyama University believe they have landed on a solution.

We recognized the need to strategically manipulate crops to weather the effects of steadily exacerbating climate change," says Dr Hiroshi Hisano, who led the study. "Since our collaborative research group had already developed expertise in precision genome editing of barley, we decided to go with the same initially. Also, previous studies have pinpointed specific grain and seed dormancy genes in barley, called qsd1, and qsd2. Hence, our modus operandi was pretty clear.

The scientists used a species of barley known as Golden Promise as their starting point, and used CRISPR to create genetically engineered versions with mutants of either one or both of these dormancy genes. All of these mutants exhibited a buildup of what's known as abscisic acid, a characteristic in line with delayed germination, but the team's analysis revealed there were a number of other factors at play. Germination could be promoted by treating the mutants with hydrogen peroxide, for example, as it could by exposure to cold temperatures. Qsd1 mutants exhibited partially reduced grain dormancy, while the qsd2 mutants could germinate in the dark, but not in the light.

We could successfully produce mutant barley that was resistant to pre-harvest sprouting, using the CRISPR/Cas9 technology," says Hisano. "Also, our study has not only clarified the roles of qsd1 and qsd2 in grain germination or dormancy, but has also established that qsd2 plays a more significant role.

The research marks an important step forward in efforts to fine-tune the world's most widely-used crops to better handle the effects of climate change, a field of research where we have seen some promising advances of late. This includes editing potato and rice RNA to boost yields by 50 percent, engineering crops to require 25 percent less water, creating broccoli for all seasons and even altering crops so they store more carbon underground.

The study was published in the Plant Biotechnology Journal.

Source: Okayama University via EurekAlert

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Gene-edited barley to bolster beer production in face of climate change - New Atlas

CAMBRIDGE, Mass., Nov. 17, 2021 (GLOBE NEWSWIRE) -- Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced the appointment of Stephen L. Mayo, Ph.D., to its Board of Directors, effective immediately. Dr. Mayo is currently the Bren Professor of Biology and Chemistry at California Institute of Technology (Caltech), and serves on the board of directors for Merck and on the scientific advisory board of Rubryc Therapeutics.

We are delighted to welcome Dr. Mayo to the Sarepta Board of Directors. A world-renowned expert in protein engineering, he will bring significant scientific and business acumen to our board as Sarepta advances its industry leading pipeline of genetic medicines, saidM.Kathleen Behrens, Ph.D., Chairperson of Sareptas Board of Directors.

A trailblazer in science and academia, Dr. Mayos impressive track record of scientific achievement and business success will be vital as we work to deliver on the promise of our pipeline and change the model for treating individuals with rare disease, saidDoug Ingram, Sareptas president and chief executive officer.

Sarepta is at the forefront of a transformative era in genetic medicine and their multi-platform approach across RNA, gene therapy, and gene editing is particularly exciting. It is an honor to join the board at this pivotal juncture, said Dr. Mayo. I look forward to working with the Sarepta team and contributing in a meaningful way to the Companys mission, growth and continued success on behalf of patients.

At Caltech, Dr. Mayo holds joint appointments in the Division of Biology and Biological Engineering and the Division of Chemistry and Chemical Engineering. He joined the Caltech faculty in 1992 and served as Vice Provost for Research from 2007 to 2010 and Chair of the Division of Biology and Biological Engineering from 2010 to 2020. Dr. Mayo's research focuses on the development of computational approaches to protein engineering a field that has broad applications ranging from advanced biofuels to human therapeutics.In 2004, he was elected to the U.S. National Academy of Sciences for his pioneering contributions in the field of protein design.

Dr. Mayo has co-founded several companies: Molecular Simulations Inc. (now Biovia), Xencor, and Protabit, where he serves on the scientific advisory board. In addition to his academic and private-sector work, Dr. Mayo has served as an elected Board Member at the American Association for the Advancement of Science (2010-2014) and served as a presidential appointee to National Science Foundations National Science Board (2013-2018).

Dr. Mayo received an undergraduate degree in chemistry from the Pennsylvania State University, and a Ph.D. in chemistry from Caltech. He completed postdoctoral work at both UC Berkeley and the Stanford University School of Medicine.

About Sarepta TherapeuticsSarepta is on an urgent mission: engineer precision genetic medicine for rare diseases that devastate lives and cut futures short. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limb-girdle muscular dystrophies (LGMDs), and we currently have more than 40 programs in various stages of development. Our vast pipeline is driven by our multi-platform Precision Genetic Medicine Engine in gene therapy, RNA and gene editing. For more information, please visitwww.sarepta.com or follow us on Twitter, LinkedIn, Instagram and Facebook.

Internet Posting of InformationWe routinely post information that may be important to investors in the 'For Investors' section of our website atwww.sarepta.com. We encourage investors and potential investors to consult our website regularly for important information about us.

Forward-Looking StatementsThis press release contains forward-looking statements. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "will," "intends," "potential," "possible" and similar expressions are intended to identify forward-looking statements. These forward-looking statements include statements regarding the potential of Sarepta to advance its industry leading pipeline of genetic medicines and the expectation that Dr. Mayos scientific and business acumen will be vital to Sarepta as Sarepta works to deliver on the promise of its pipeline and change the model for treating individuals with rare disease.

These forward-looking statements involve risks and uncertainties, many of which are beyond Sareptas control. Known risk factors include, among others: Sarepta may not be able to execute on its business plans, including meeting its expected or planned regulatory milestones and timelines, clinical development plans, and bringing its products to U.S. and ex-U.S. markets for various reasons including possible limitations of Company financial and other resources, manufacturing limitations that may not be anticipated or resolved for in a timely manner, and regulatory, court or agency decisions, such as decisions by the United States Patent and Trademark Office with respect to patents that cover Sareptas product candidates; and those risks identified under the heading Risk Factors in Sareptas most recent Annual Report on Form 10-K for the year ended December 31, 2020, and most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) as well as other SEC filings made by the Company which you are encouraged to review.

Any of the foregoing risks could materially and adversely affect the Companys business, results of operations and the trading price of Sareptas common stock. For a detailed description of risks and uncertainties Sarepta faces, you are encouraged to review the SEC filings made by Sarepta. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. Sarepta does not undertake any obligation to publicly update its forward-looking statements based on events or circumstances after the date hereof, except as required by law.

Source: Sarepta Therapeutics, Inc.

Investor Contact: Ian Estepan, 617-274-4052iestepan@sarepta.com

Media Contact: Tracy Sorrentino, 617-301-8566tsorrentino@sarepta.com

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Sarepta Therapeutics Appoints Stephen L. Mayo, Ph.D., to its Board of Directors - GlobeNewswire

Industry interest in regenerative medicines is increasing. In 2019, the US FDA predicted there would be 10 to 20 new cell and gene therapies a year by 2025, based on an assessment of pipelines and clinical success rates.

And, despite COVID-19, this trend has continued according to Melbourne-based Ausbiotech, which reported in September that the global regenerative medicines sector attracted $19.9 billion of investment in 2020.

This sustained industry interest is a significant opportunity for Australian biotech, according to Ausbiotech, which says the country could generate at least $6 billion in annual revenue and create 6,000 new jobs by 2035.

The challenge will be building the manufacturing infrastructure needed to compete on a global scale says Ausbiotech communications director, Karen Parr.

Regenerative medical therapies require highly-specialized GMP capabilities and infrastructure, a highly-skilled workforce, and complex supply chains, she says. The increasing demand for RM therapy manufacturers is growing and a major bottleneck exists at the GMP manufacturing phase of product development, both in Australia and globally.

Capacity for cell and gene therapy production in Australia is limited. According to analysis by Ausbiotech the country has only 34 cleanroomsthe combined cleanroom and QC footprint is 2,982m2and employs just 231 full-time and 45 part-time employees.

To capture a bigger share of the global regenerative medicine (RM) manufacturing market this will need to change, stresses Parr.

There are significant benefits to having manufacturing facilities located onshore in Australia, for patients as well as RM therapy developers: local manufacturing will build resilience for the sector and ensure faster access to cutting-edge therapies for all Australians, she tells GEN.

Sovereign capability facilitates access not only to early phase trials for Australian patients for locally developed products, but also supports access to innovative and cutting-edge international trials.

Sourcing viral vectors is also a challenge for Australian biotechnology companies because, at present, the country has no facilities with the capability to manufacture GMP-grade vectors. However, this will soon change. In 2019, the New South Wales state Government invested A$25 million to expand capacity at the Westmead Viral Vector Manufacturing Facility in Sydney.

The expansion plan will add commercial-scale capacity to the facilitys current small scale production capabilities for gamma retroviruses, adeno-associated virus (AAV), and lentiviral vectors.

Parr sees this investment as a positive sign for the wider regenerative medicine manufacturing sector in Australia and beyond.

This progressive direction demonstrates that Australias capabilities are growing, and greater opportunities are available for the sector if further investment is pledged, she notes. By leveraging Australias reputation for delivering high-quality, complex, and safe medical products, as well as our highly-skilled workforce, we can become the clinical trials and manufacturing hub for the region and deliver potentially life-changing treatments to patients, both in Australia, and the broader Asia Pacific region.

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Australia Needs to Invest to Tap Demand for Cell and Gene Therapy Production - Genetic Engineering & Biotechnology News

GAITHERSBURG, Md. and PUNE, India, Nov. 17, 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 PhilippineFood and Drug Administration (FDA) 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 the Philippines by SII under the brand name COVOVAX.

"With less than a third of the Philippine population fully immunized, we expect the option for a protein vaccine, built on a well-understood technology platform, to contribute substantially to increased vaccination rates," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "Novavax looks forward to SII's delivery of the vaccine to the Philippines, and with additional authorizations expected elsewhere soon, to helping control the COVID-19 pandemic around the globe."

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

"The approval of COVOVAX in the Philippines is another step forward in the global fight against the coronavirus," said Adar Poonawalla, Chief Executive Officer, Serum Institute of India. "We are proud to deliver the first protein-based COVID-19 vaccine to the Philippines."

The Novavax/SII vaccine has recently received EUA in Indonesia and the companies have also filed for emergency authorization in India and for Emergency Use Listing (EUL) with the World Health Organization (WHO). Novavax also announced regulatory filings for its vaccine in the United Kingdom, Australia, New Zealand, Canada and with the WHO, as well as the complete submission of all data and modules in the European Union to support the final regulatory review of its dossier by the European Medicines Agency. Additionally, Novavax and SK bioscience announced a Biologics License Application (BLA) in South Korea.Novavax expects to submit the complete package to the U.S. FDA by the end of the year.

For additional information on COVOVAX, including the Summary of Product Characteristics, Prescribing Information and Important Safety Information, please visit the following websites:

Authorized Use of Novavax' Covid-19 Vaccine in the PhilippinesThe Philippines Food and Drug Administration has issued Emergency Use Authorization (EUA) for Covovax /Recombinant Spike Protein of SARS-CoV-2 Virus 5 mcg for active immunization of individual 18 years of age and older for the prevention of coronavirus disease 2019 caused by SARS-CoV-2

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

About the NVX-CoV2373 Phase 3 TrialsNVX-CoV2373 is being evaluated in two pivotal Phase 3 trials: the PREVENT-19 trial in theU.S.andMexicothat demonstrated 100% protection against moderate and severe disease and 90.4% efficacy overall. It was generally well-tolerated and elicited a robust antibody response. It is also being evaluated in a trial in theU.K.that demonstrated efficacy of 96.4% against the original virus strain, 86.3% against the Alpha (B.1.1.7) variant and 89.7% efficacy overall.

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

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

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

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

For more information, visit http://www.novavax.com and connect with us on Twitter and LinkedIn.

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, its partnerships, the ongoing development of NVX-CoV2373 and other Novavax vaccine product candidates, the scope, timing and outcome of future regulatory filings and actions, the role that COVAVAX may play in increasing vaccination rates in the Philippines, the expected timing of vaccine shipments, and the role that Novavax may play in helping control the COVID-19 pandemic around the globe are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include challenges satisfying, alone or together with partners, various safety, efficacy, and product characterization requirements, including those related to process qualification and assay validation, necessary to satisfy applicable regulatory authorities; difficulty obtaining scarce raw materials and supplies; resource constraints, including human capital and manufacturing capacity, on the ability of Novavax to pursue planned regulatory pathways; challenges meeting contractual requirements under agreements with multiple commercial, governmental, and other entities; and those other risk factors identified in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Novavax' Annual Report on Form 10-K for the year ended December 31, 2020 and subsequent Quarterly Reports on Form 10-Q, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at http://www.sec.gov and http://www.novavax.com, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

Contacts:

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

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

MediaNovavaxLaura Keenan Lindsey | 202-709-7521 Ali Chartan | 240-720-7804[emailprotected]

Serum Institute of India Mayank Sen | +919867974055[emailprotected]

SOURCE Novavax, Inc.

http://www.novavax.com

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Novavax and Serum Institute of India Receive Emergency Use Authorization for COVID-19 Vaccine in the Philippines - PRNewswire