Biotech

New Studies Show Covid-19 Vaccines' Effectiveness Against Variants (cnn.com) 155

CNN recently reported on "a batch" of new studies published Wednesday — with one quantifying how much immunity improves after the second dose, and others showing how well coronavirus vaccines work against new variants of the virus: The first nationwide study of coronavirus vaccination, done in Israel, showed Pfizer/BioNtech's vaccine works far better after two doses. Two shots of the vaccine provided greater than 95% protection from infection, severe illness and death, Dr. Eric Haas of the Israel Ministry of Health and colleagues reported in the Lancet medical journal. "Two doses of BNT162b2 are highly effective across all age groups in preventing symptomatic and asymptomatic SARS-CoV-2 infections and COVID-19-related hospitalizations, severe disease, and death, including those caused by the B.1.1.7 SARS-CoV-2 variant," they wrote. The B.1.1.7 variant, first seen in Britain, has spread widely and is now the most common new variant seen in the US. It was also common in Israel when the study was done...

"By 14 days after vaccination, protections conferred by a second dose [of the Pfizer vaccine] increased to 96.5% protection against infection, 98% against hospitalization, and 98.1% against death," the team wrote. But people who got only one dose of the vaccine were far less protected. One dose alone gave just 57.7% protection against infection, 75.7% against hospitalization, and 77% against death....

Separately, a team in the Gulf state of Qatar looked at the efficacy of Pfizer's vaccine in the population there when B.1.351 and B.1.1.7 were both circulating. They found reassuring results. "The estimated effectiveness of the vaccine against any documented infection with the B.1.1.7 variant was 89.5% at 14 or more days after the second dose. The effectiveness against any documented infection with the B.1.351 variant was 75%," the researchers wrote in a letter to the New England Journal of Medicine...

Vaccine maker Moderna reported Wednesday that a booster shot delivering a half-dose of its current vaccine revs up the immune response against both B.1.351 and P.1. And a booster dose formulated specifically to match B.1.351 was even more effective, Moderna said in a statement...

In another study, vaccine maker Novavax confirmed earlier findings that showed its vaccine protects against B.1.351.

Biotech

Pandora Says Laboratory-Made Diamonds Are Forever (bbc.com) 165

An anonymous reader quotes a report from the BBC: The world's biggest jeweller, Pandora, says it will no longer sell mined diamonds and will switch to exclusively laboratory-made diamonds. Concerns about the environment and working practices in the mining industry have led to growing demand for alternatives to mined diamonds. Pandora's chief executive, Alexander Lacik, told the BBC the change was part of a broader sustainability drive. He said the firm was pursuing it because "it's the right thing to do." They are also cheaper: "We can essentially create the same outcome as nature has created, but at a very, very different price." Mr Lacik explains they can be made for as little as "a third of what it is for something that we've dug up from the ground."

Pandora's lab-made diamonds are being made in Britain, and the UK is the first country where they will be sold. The new diamond jewelry will start at $350. [...] One problem with lab-made diamonds, though, is that they can take a lot of energy to produce. Between 50% and 60% of them come from China, where they are made in a process known as "high-pressure, high-temperature technology." The use of coal powered electricity is widespread. However in the United States, the biggest retail market for lab-grown diamonds, there is a greater focus on using renewable energy. The largest US producer, Diamond Foundry, says its process is "100% hydro-powered, meaning zero emissions." Both types are chemically and physically identical to mined diamonds.

Biotech

Co-Founder of Brain Implant Startup Neuralink Leaves the Company (futurism.com) 32

According to The Byte, the co-founder of brain implant startup Neuralink, Max Hodak, announced he's leaving the company. From the report: Hodak, who started the ultra-ambitious venture with Elon Musk and had until recently served as its president, didn't say why he was leaving the company or on what terms. In other words, it's not currently clear whether he left voluntary or was fired. "I am no longer at Neuralink (as of a few weeks ago)," he wrote in a tweet. "I learned a ton there and remain a huge cheerleader for the company! Onward to new things." Last month, Hodak made headlines when he tweeted that the startup has the technological advances and savvy to create its own "Jurassic Park."
Medicine

How Big Data Are Unlocking the Mysteries of Autism (scientificamerican.com) 68

Scientific American has published an opinion piece by the principle investigator for a project called SPARK, launched five years ago "to harness the power of big data by engaging hundreds of thousands of individuals with autism and their family members to participate in research."

The article calls autism "a remarkably heterogeneous disorder that affects more than five million Americans and has no FDA-approved treatments," arguing that the more people who participate in their research, "the deeper and richer these data sets become, catalyzing research that is expanding our knowledge of both biology and behavior to develop more precise approaches to medical and behavioral issues." SPARK is the world's largest autism research study to date with over 250,000 participants, more than 100,000 of whom have provided DNA samples through the simple act of spitting in a tube. We have generated genomic data that have been de-identified and made available to qualified researchers. SPARK has itself been able to analyze 19,000 genes to find possible connections to autism; worked with 31 of the nation's leading medical schools and autism research centers; and helped thousands of participating families enroll in nearly 100 additional autism research studies.

Genetic research has taught us that what we commonly call autism is actually a spectrum of hundreds of conditions that vary widely among adults and children. Across this spectrum, individuals share core symptoms and challenges with social interaction, restricted interests and/or repetitive behaviors. We now know that genes play a central role in the causes of these "autisms," which are the result of genetic changes in combination with other causes including prenatal factors. To date, research employing data science and machine learning has identified approximately 150 genes related to autism, but suggests there may be as many as 500 or more...

But in order to get answers faster and be certain of these results, SPARK and our research partners need a huge sample size: "bigger data." To ensure an accurate inventory of all the major genetic contributors, and learn if and how different genetic variants contribute to autistic behaviors, we need not only the largest but also the most diverse group of participants. The genetic, medical and behavioral data SPARK collects from people with autism and their families is rich in detail and can be leveraged by many different investigators. Access to rich data sets draws talented scientists to the field of autism science to develop new methods of finding patterns in the data, better predicting associated behavioral and medical issues, and, perhaps, identifying more effective supports and treatments...

We know that big data, with each person representing their unique profile of someone impacted by autism, will lead to many of the answers we seek.

Biotech

How a Researcher 'Clinging To the Fringes of Academia' Helped Develop a Covid-19 Vaccine (nytimes.com) 64

Long-time Slashdot reader destinyland writes: The New York Times tells the story of Hungarian-born Dr. Kariko, whose father was a butcher and who growing up had never met a scientist — but knew they wanted to be one. Despite earning a Ph.D. at Hungary's University of Szeged and working as a postdoctoral fellow at its Biological Research Center, Kariko never found a permanent position after moving to the U.S., "instead clinging to the fringes of academia."

Now 66 years old, Dr. Kariko is suddenly being hailed as "one of the heroes of Covid-19 vaccine development," after spending an entire career focused on mRNA, "convinced mRNA could be used to instruct cells to make their own medicines, including vaccines."

From the article: For many years her career at the University of Pennsylvania was fragile. She migrated from lab to lab, relying on one senior scientist after another to take her in. She never made more than $60,000 a year... She needed grants to pursue ideas that seemed wild and fanciful. She did not get them, even as more mundane research was rewarded. "When your idea is against the conventional wisdom that makes sense to the star chamber, it is very hard to break out," said Dr. David Langer, a neurosurgeon who has worked with Dr. Kariko... Kariko's husband, Bela Francia, manager of an apartment complex, once calculated that her endless workdays meant she was earning about a dollar an hour.
The Times also describes a formative experience in 1989 with cardiologist Elliot Barnathan: One fateful day, the two scientists hovered over a dot-matrix printer in a narrow room at the end of a long hall. A gamma counter, needed to track the radioactive molecule, was attached to a printer. It began to spew data.

Their detector had found new proteins produced by cells that were never supposed to make them — suggesting that mRNA could be used to direct any cell to make any protein, at will.

"I felt like a god," Dr. Kariko recalled.

Yet Kariko was eventually left without a lab or funds for research, until a chance meeting at a photocopying machine led to a partnership with Dr. Drew Weissman of the University of Pennsylvania: "We both started writing grants," Dr. Weissman said. "We didn't get most of them. People were not interested in mRNA. The people who reviewed the grants said mRNA will not be a good therapeutic, so don't bother.'" Leading scientific journals rejected their work. When the research finally was published, in Immunity, it got little attention... "We talked to pharmaceutical companies and venture capitalists. No one cared," Dr. Weissman said. "We were screaming a lot, but no one would listen."

Eventually, though, two biotech companies took notice of the work: Moderna, in the United States, and BioNTech, in Germany. Pfizer partnered with BioNTech, and the two now help fund Dr. Weissman's lab.

Biotech

Scientists Connect Human Brain To Computer Wirelessly For First Time Ever (thenextweb.com) 18

"Scientists have demonstrated the first human use of a wireless brain-computer interface, a potential breakthrough for people with paralysis," reports The Next Web (in a story shared by Slashdot reader Hmmmmmm): While traditional BCIs are tethered to users via cables, the new system — called BrainGate — replaces the cords with a small transmitter affixed atop a users' head. The unit then connects to an electrode array implanted in the brain's motor cortex. In a clinical trial, two participants with paralysis used the system to point, click, and type on a standard tablet computer. They both achieved similar typing speeds and point-and-click accuracy as those attained with wired systems.

The researchers say it's the first time a device has transmitted the full spectrum of signals recorded by a sensor in the brain's motor cortex.

Biotech

Will CRISPR Offer Hope For Controlling African Swine Fever? (cornell.edu) 26

"New vaccine trials hold great promise in the management of an East African strain of African swine fever, one of the most devastating diseases to afflict pigs," writes Cornell's Alliance for Science (a group who gives its mission as correcting misinformation and countering conspiracy theories slowing progress on issues including synthetic biology and agricultural innovations).

Slashdot reader wooloohoo shares their report: Scientists at the International Livestock Research Institute (ILRI) are employing CRISPR Cas9 editing and synthetic biology to modify the ASFV genome in order to attenuate the virus for a live vaccine to help reduce deaths from African swine fever. Up to 10 vaccine candidates have been lined up for tests, in a project that commenced in 2016...

African swine fever is present in 26 African countries, Steinaa observed, as well as in parts of Asia and Europe. An effective vaccine could be a breakthrough for pig farmers across the globe... With a 100 percent fatality rate and a highly contagious nature, African swine fever poses a potent threat to the global pig farming industry. The rapid spread of the disease portends social and economic disruptions wherever it strikes.

Biotech

How CRISPR Can Create More Ethical Eggs (cornell.edu) 91

Slashdot reader wooloohoo shares a new article from Cornell's Alliance for Science, a group who gives its mission as correcting misinformation and countering conspiracy theories slowing progress on issues including synthetic biology and agricultural innovations: There are two types of chickens: the broilers that we eat and the layers that produce the eggs. The layers don't have enough meat to make them useful for human consumption and since only hens can lay eggs, that leaves the male layers useless. As a result, billions of newly hatched male layer chicks are killed each year.

Now the Israeli ag-tech startup eggXYt has found a way to humanely address this dilemma through the use of CRISPR — the gene editing technique that allows scientists to make targeted, specific genetic tweaks...

By using CRISPR, eggXYt's scientists can edit the genes of chickens to make them lay sex-detectable eggs... The global egg industry saves the costs and the ethical conundrum of killing half of its product and billions of additional eggs are added to the global market to help meet growing demand.

Biotech

Beyond Meat Signs Global Supply Deals With McDonald's, KFC and Pizza Hut (agfundernews.com) 109

U.S. plant-based protein company Beyond Meat has signed global supply deals with fast food firms McDonald's and Yum! Brands, which includes KFC, Pizza Hut, Taco Bell and others. AgFunderNews reports: The three-year strategic agreement with McDonald's will see Beyond Meat become the 'preferred supplier' of patties for the fast food chain's new McPlant plant-based burger. Under their separate strategic partnership, Beyond Meat and Yum! Brands will co-develop a range of exclusive plant-based protein menu items for the latter's KFC, Pizza Hut, and Taco Bell chains.

Bruce Friedrich, executive director of the Good Food Institute, said in comments sent to AFN that the two deals represent "the clearest sign yet that the future of meat will be plant-based." "The world's largest restaurant chains are placing plant-based meat directly on the plates of millions of customers around the world," he said. "With more restaurants and revenue than any other food chains on the planet, McDonald's and Yum! Brands will bring plant-based meat onto the mainstream menus of millions of people. When these restaurant chains move, the entire food industry takes notice."

Biotech

Researchers Try Using CRISPR To Genetically Engineer Zika-Resistant Mosquitoes (cornell.edu) 31

A new research study at the University of Missouri is using CRISPR gene-editing technology to produce mosquitoes that are unable to replicate Zika virus and therefore cannot infect a human through biting. Slashdot reader wooloohoo shared an announcement from Cornell's Alliance for Science: Alexander Franz, an associate professor in the MU College of Veterinary Medicine, collaborated with researchers at Colorado State University... Their work was recently published in the journal Viruses. Franz added that the genetic modification is inheritable, so future generations of the altered mosquitoes would be resistant to Zika virus as well... "[W]e are simply trying to expand the toolbox and provide a solution by genetically modifying the mosquitoes to become Zika-resistant while keeping them alive at the same time."

Franz' research is designed to help prevent another outbreak of Zika virus disease from occurring while also addressing concerns that have some have raised about reducing populations of mosquitoes, which are a food source for some animals...

The study was funded by the National Institutes of Health.

China

US Intelligence Officials Say Chinese Government Is Collecting Americans' DNA (cbsnews.com) 95

schwit1 shares a report from CBS News: The largest biotech firm in the world wasted no time in offering to build and run COVID testing labs in Washington, contacting its governor right after the first major COVID outbreak in the U.S. occurred there. The Chinese company, the BGI Group, made the same offer to at least five other states, including New York and California, 60 Minutes has learned. This, along with other COVID testing offers by BGI, so worried Bill Evanina, then the country's top counterintelligence officer, that he authorized a rare public warning. "Foreign powers can collect, store and exploit biometric information from COVID tests" declared the notice. Evanina believes the Chinese are trying to collect Americans' DNA to win a race to control the world's biodata. Jon Wertheim speaks to Evanina and others for an investigation into how personal data, particularly biodata, has become a precious commodity and in the wrong hands, poses threats to national security and the economy.
Government

Joe Biden Promotes 'Science Advisor' to US Cabinet-Level Position (apnews.com) 146

"President-elect Joe Biden announced Friday that he has chosen a pioneer in mapping the human genome — the so-called 'book of life' — to be his chief science adviser," reports the Associated Press, "and is elevating the top science job to a Cabinet position." Biden nominated Eric Lander, founding director of the Broad Institute of MIT and Harvard, who was the lead author of the first paper announcing the details of the human genome, as director of Office of Science and Technology Policy and adviser on science. He is the first life scientist to have that job. His predecessor is a meteorologist.

Saying "science will always be at the forefront of my administration," Biden said he is boosting the science advisor post to Cabinet level, a first in White House history.... "Elevating (the science adviser) role to member in the President's Cabinet clearly signals the administration's intent to involve scientific expertise in every policy discussion," said Sudip Parikh, chief executive officer of the American Association for the Advancement of Science, the world's largest general scientific society.

Biotech

Theranos Destroyed Crucial Subpoenaed SQL Blood Test Database, Can't Unlock Backups (theregister.com) 148

An anonymous reader quotes a report from The Register: Failed blood-testing unicorn Theranos trashed vital incriminating evidence of its fraud, prosecutors said on Monday. The imploded startup's extensive testing data over three years, including its accuracy and failure rate, was "stored on a specially-developed SQL database called the Laboratory Information System (LIS)," according to a filing [PDF] in the fraud case against Theranos's one-time CEO Elizabeth Holmes and COO Sunny Balwani. The database "even flagged blood test results that might require immediate medical attention, and communicated this to the patient's physician," we're told.

Theranos claimed to have perfected technology that would allow industry standard blood tests to be run at great speed and with just a drop of blood, revolutionizing the health industry, and causing the business to be valued at $10bn. The reality, however, was that for one set of tests, the failure rate was 51.3 per cent. What does that mean? Prosecutors explain: "In other words, Theranos's TT3 blood test results were so inaccurate, it was essentially a coin toss whether the patient was getting the right result. The data was devastating."

So devastating that the database was subpoenaed by a grand jury digging into fraud claims against Holmes and Balwani. But when investigators turned to take a copy of the database, guess what? From the filing: "On or about August 31, 2018 -- three months after a federal grand jury issued a subpoena requesting a working copy of this database -- the LIS was destroyed. The government has never been provided with the complete records contained in the LIS, nor been given the tools, which were available within the database, to search for such critical evidence as all Theranos blood tests with validation errors. The data disappeared."

Science

The First Pig-to-Human Organ Transplants Could Happen This Year (medium.com) 88

Every day in the United States, 17 people die waiting for a lifesaving organ transplant. To address this crisis, one biotech company is turning to an unlikely source: pigs. Maryland-based United Therapeutics says it plans to begin transplanting organs from genetically modified pigs into people as soon as this year. From a report: "We're right on that cusp. We're looking to get into humans within the next year or two," said David Ayares, PhD, in an exclusive interview with Future Human. Ayares is the chief scientific officer of Revivicor, a subsidiary of United Therapeutics that's developing the pigs. "We think we have the pig that is going to be what we bring forward into humans in 2021 or 2022." For decades, scientists have been hopeful that organs from other species could be used to replace faulty ones in humans, known as xenotransplantation. But animal organs trigger immediate and severe immune reactions when transplanted into humans.
Biotech

Can mRNA Biotechnology be Adapted to Improve Flu Vaccines and Fight Cancer? (reuters.com) 75

Reuters notes the "miraculous speed" of mRNA vaccines, while also calling it "a glimpse of what's possible if it can be applied post-pandemic to treat cancer or rare diseases."

The vaccine market alone is worth about $35 billion each year, and investors apparently believe mRNA companies will capture around two-third of that, leading market researcher Bernstein to evalaute the combined worth of mRNA companies at nearly $180 billion. The technology is the closest thing yet to making medicine digital. MRNA vaccines essentially inject genetic code that instructs a recipients' cells to construct a part of the virus. The body recognizes the produced protein as foreign and mounts a future immune response when exposed. Moderna and BioNTech's vaccines show the technology works fast. Vaccines typically take a decade to develop. They took less than a year...

The speed of mRNA therapeutics is a big advantage. For example, flu vaccines only reduce the risk of illness by up to 60% because makers must guess which strains will be prevalent each season. Sometimes they're wrong. Shaving months off means better guesses, and higher efficacy.

The bigger opportunity comes from the validation of the mRNA "platform". Instructing cells to produce desired proteins could lead to multiple advances. Perhaps they can instruct the body to more vigorously attack cancerous cells or repair damaged tissue. Producing missing proteins might fight inherited diseases...

Success against Covid-19 means these companies will be flush with cash from sales and attract partnerships and scientific talent. That should make 2021 a watershed.

Medicine

How the Bill and Melinda Gates Foundation Fought the Pandemic (fastcompany.com) 144

In a long article titled "Gates versus the Pandemic," Fast Company looks at the many mitigation efforts launched by the Bill & Melinda Gates Foundation.

- It's one of the largest funders of the World Health Organization.

- It's partnered with the governments of Norway and India, the World Economic Forum, and the research-charity Wellcome Trust to launch an important group called the Coalition for Epidemic Preparedness Innovations (CEPI).

And then Fast Company breaks down the specifics: - The Gates Foundation invested $52 million in a German mRNA startup named CureVac in 2015; a year later, it gave Massachusetts-based Moderna a $20 million grant to support its development of mRNA-based HIV therapeutics, which helped the company further its underlying platform that can also be used to make vaccines.

- The foundation made an initial equity investment of $55 million in BioNTech, another German startup working on mRNA technology, in 2019. (While the foundation typically makes grants, it sometimes invests in companies to negotiate terms that require a funded product be globally accessible and affordable.)

The goal of all of this spending, in part, was to encourage these companies to focus on mRNA vaccines for communicable illnesses. "If you're looking at where the money is," in medical funding, "it's in oncology and cancer immunotherapy," says Lynda Stuart, deputy director of vaccines and host-pathogen biology at the Gates Foundation. Without a push, companies working in the space "wouldn't necessarily gravitate to infectious disease vaccines."

As the virus was beginning to spread, the Gates Foundation encouraged its other vaccine development partners to turn to COVID-19.

- Researchers at Oxford University started work on a coronavirus vaccine made from a weakened, altered form of a chimpanzee cold virus, a platform that CEPI had supported for other vaccines such as MERS.

- Novavax, a biotech startup the foundation had previously funded, also entered the race to create a vaccine.

By October, more than 200 COVID-19 vaccines were in development, but only 11 had reached Phase III clinical trials (human efficacy tests, the last step before regulatory approval). Of those, four vaccine platforms — from Moderna, BioNTech, Novavax, and the University of Oxford — had received early backing from CEPI or the Gates Foundation. In November, BioNTech-Pfizer, Moderna, and Oxford-AstraZeneca all announced that their respective vaccines had proved highly effective in preliminary study results. On December 11, the FDA approved the BioNTech-Pfizer vaccine, which represents a huge victory for the Gates Foundation. (In addition, the foundation is funding contenders that are at an earlier stage of development, such as Icosavax's nanoparticle vaccine construct.)

"Without the efforts of the Bill & Melinda Gates Foundation, the Covid-19 crisis would almost certainly be worse," writes Fast Company. "But its extensive role raises questions about how much we rely on philanthropy."

Their article includes this quote from a Northeastern University law professor focused on intellectual property rights and universal access to treatments for HIV/AIDS and COVID-19. "A fundamental question is, Well, because you have the money, should you be able to control the architecture of global health?"

A former director of vaccine delivery at the Gates Foundation counters that "they add value in helping to design very effective programs."
Biotech

Boston Biotech Conference Led To 245,000 COVID-19 Cases Across US (cnn.com) 43

An anonymous reader quotes a report from CNN: A biotech conference in Boston last February that's already been flagged as a Covid-19 superspreading event led to at least 245,000 other cases across the US and Europe, a new genetic fingerprinting study shows. One single case seems to have been responsible for many of the other eventual cases, the team at the Broad Institute in Massachusetts reported. Their study finds two particular genetic fingerprints of viruses associated with the conference and then tracks those lineages across the US. One "was exported from Boston to at least 18 US states as well as to other countries, including Australia, Sweden, and Slovakia," the team, led by Bronwyn MacInnis, director of pathogen genomic surveillance at the Broad Institute, wrote in the journal Science.

One was especially bad. A virus carrying one mutation -- a small genetic change they've flagged as C2416T -- was apparently carried to the conference by a single person, and ended up infecting 245,000 people. A subset of the viral strain with a mutation known as G26233T ended up in 88,000 of these cases. "A single introduction had an outsize effect on subsequent transmission because it was amplified by superspreading in a highly mobile population very early in the outbreak, before many public health precautions were put in place," the team wrote. "While Massachusetts accounted for most early spread related to the conference, Florida accounted for the greatest proportion of cases overall," they added.

Biotech

Singapore Becomes First Country To Approve Lab-Grown Meat (cnn.com) 78

Singapore has granted San Francisco start-up Eat Just Inc. regulatory approval to sell its laboratory-grown chicken in the city-state -- the world's first government to allow the sale of cultured meat. CNN reports: The product, created from cultured chicken cells, has been approved as an ingredient in chicken bites following Singapore Food Agency (SFA) approval, Eat Just said Tuesday. Initially, the chicken bites will debut in a Singapore restaurant, with plans for wider expansion into dining and retail establishments in the country, Josh Tetrick, co-founder and CEO of Eat Just told CNN Business. The product will be priced at parity with premium chicken, he added.

The cultured meat is created in a bioreactor -- an apparatus in which a biological reaction or change takes place -- Eat Just said. It has a high protein content and is a rich source of minerals, according to the company, which plans to sell the product under the GOOD Meat brand. For now, with manufacturing hubs in Singapore and Northern California, the company only has approval to sell the meat in Singapore, but it hopes to expand sales of cultured meat -- including cultured beef -- into the US and Western Europe, Tetrick said.

Medicine

No One Who Got Moderna's Vaccine In Trial Developed Severe COVID-19 (sciencemag.org) 177

An anonymous reader quotes a report from Science Magazine: Continuing the spate of stunning news about COVID-19 vaccines, the biotech company Moderna announced the final results of the 30,000-person efficacy trial for its candidate in a press release today: Only 11 people who received two doses of the vaccine developed COVID-19 symptoms after being infected with the pandemic coronavirus, versus 185 symptomatic cases in a placebo group. That is an efficacy of 94.1%, the company says, far above what many vaccine scientists were expecting just a few weeks ago.

More impressive still, Moderna's candidate had 100% efficacy against severe disease. There were zero such COVID-19 cases among those vaccinated, but 30 in the placebo group. The company today plans to file a request for emergency use authorization (EUA) for its vaccine with the U.S. Food and Drug Administration (FDA), and is also seeking a similar green light from the European Medicines Agency. The data released today bolster an interim report from the company two weeks ago that only analyzed 95 total cases but produced similarly impressive efficacy. "I would still like to see all of the actual data, but what we've seen so far is absolutely remarkable," says Paul Offit, a vaccine researcher at the Children's Hospital of Philadelphia who is a member of an independent committee of vaccine experts that advises FDA.

United States

Experimental Antibody Treatment for Covid-19 Patients Wins 'Emergency Approval' in America (msn.com) 81

America's Food and Drug Administration granted emergency authorization Saturday to an experimental antibody treatment (for people already experiencing Covid-19), reports the Washington Post: The drug, made by Regeneron Pharmaceuticals, is designed to prevent infected people from developing severe illness. Instead of waiting for the body to develop its own protective immune response, the drug imitates the body's natural defenses. It is the second drug of this type — called a monoclonal antibody — to be cleared for treating covid-19. The FDA authorized Eli Lilly & Co.'s drug on Nov. 9.

Regeneron's drug is a cocktail of two monoclonal antibodies, called casirivimab and imdevimab. The FDA said in authorizing the cocktail that it may be effective in treating mild to moderate covid-19 in adults and children 12 or older, and is indicated for those at high risk of developing severe illness. Doctors hope the drugs will keep those patients from being hospitalized... Regeneron executives said on the company's earnings call in early November that they project having enough doses for 80,000 patients by the end of November, and 300,000 total doses by the end of January...

In a clinical trial, the Regeneron drug reduced hospitalizations or emergency room visits when given to people at high risk of developing severe disease. It was also shown to reduce the amount of virus in people's bodies... The safety and effectiveness of the drug will continue to be studied. It is not authorized for use in hospitalized patients... In a study published Oct. 28 in the New England Journal of Medicine, researchers said the Lilly cocktail lowered the risk of follow-up medical visits and reduced levels of virus in people with mild to moderate symptoms of covid-19.

The progress on monoclonal antibodies comes as pharmaceutical and biotech companies are racing to produce coronavirus vaccines... The antibody treatments can play an important role in making the disease less dangerous.

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