We have another highly effective COVID vaccine, based on different tech

Image of a man receiving an injection.

Enlarge / A participant gets his second dose of the Novavax vaccine during the clinical trial. (credit: Karen Ducey / Getty Images)

Today, a company called Novavax announced that it had completed a large efficacy trial of its COVID-19 vaccine, and the news was good. The vaccine is highly effective, it blocked severe disease entirely, and it appeared to work against some of the more recently evolved virus variants. The company says it can produce 150 million doses per month by the end of the year, and the vaccine is stable when stored in a normal freezer, so it could play a big part in the effort to administer vaccines outside of industrialized nations.

Different tech

So far, US citizens have had the choice of RNA-based vaccines, like the offerings from Moderna and Pfizer/BioNTech, or a vaccine based on a harmless virus engineered to carry the coronavirus spike protein, as used in the Johnson & Johnson vaccine. (The AstraZeneca and Sputnik vaccines are similar to J&J’s.) Outside the US, many countries have used vaccines based on an inactivated coronavirus, although these have turned out not to be very effective.

The Novavax vaccine uses an entirely different technology. Vaccine production starts by identifying a key gene from the pathogen of interest—the SARS-CoV-2 spike protein, in this case—and inserting it into a virus that infects insect cells. Insect cells can easily be grown in culture, and they process any proteins they make in the same way that human cells do. (This processing can involve chemically linking sugars or cleaving off superfluous parts of the protein.) The activity ensures that the purified protein will be chemically identical to the spike protein found on the surface of the SARS-CoV-2 virus itself.

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#biology, #medicine, #novavax, #science, #vaccines, #virology

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Trailblazing Transgender Doctor Saved Countless Lives

After transitioning in 1917, Alan L. Hart helped alter medical history

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#behaviorsociety, #medicine, #mind

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Landmark Alzheimer’s Drug Approval Confounds Research Community

Many scientists say there is not enough evidence that Biogen’s aducanumab is an effective therapy for the disease

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New Technique Grows Realistic Bone in a Dish

It’s one of the most challenging organs to re-create

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Researchers add sense of touch to robotic arm via brain implant

A robotic arm grasps a white spherical object.

Enlarge (credit: University of Pittsburgh Medical Center)

One of the most astonishing examples of the promise of brain implants is shown in a video in which a paralyzed person controls a robotic arm with nothing but her thoughts. The technology alone is impressive, but the joy on the participant’s face as she grabs herself a drink for the first time in over a decade really drives home just how important this technology can be.

While we’re still decades away from widespread implant use, there are continued signs of progress in making implants more functional. Last week, we saw a neural implant that could turn imagined writing into real text. This week, the research community has followed up with an implant-controlled robotic arm that sends touch feedback to the user via a second implant.

Adding senses

When we go to pick up an object, we locate the object primarily through vision. From there, other senses take over. Humans have a sense called proprioception, which helps us know where are body parts are, even when they’re not visible. Our sense of touch tells us when we’ve made contact with the object, and pressure sensation gives us an indication of how firmly we’ve grasped the object. The visual system quickly becomes secondary to the process.

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#biology, #brain-implants, #brain-computer-interface, #medicine, #neuroscience, #robotics, #science

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Should Your Child Get the COVID Vaccine?

A pediatric infectious disease expert answers questions about whether the vaccine is safe, and why children need it

— Read more on ScientificAmerican.com

#health, #medicine, #public-health

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Mix-and-Match COVID Vaccines Trigger Potent Immune Response

Preliminary results from a trial of more than 600 people are the first to show the benefits of combining different vaccines

— Read more on ScientificAmerican.com

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Researchers show neutralizing antibodies correlate with COVID protection

Cartoon of a virus surrounded by small, Y-shaped molecules.

Enlarge / Illustration of antibodies (red and blue) responding to an infection with the new coronavirus SARS-CoV-2 (purple). (credit: Getty Images)

From the start of the COVID-19 pandemic, many of researchers’ nagging questions involved trying to understand what constitutes immunity to future infections. People who had been infected by the virus produced varying amounts of antibodies, and it wasn’t clear what levels were needed to provide protection. Similar issues applied to figuring out how long protection lasted, given that antibody levels appeared to decline over time. Those questions have implications for whether we will eventually need booster shots to maintain our immunity.

The most common way of looking at immunity at the beginning of the pandemic was to check for neutralizing antibodies, which could block the virus’s ability to infect new cells. But we’ve gone through much of the pandemic without knowing exactly how levels of these antibodies relate to protection.

Evidence has been building that neutralizing antibodies directly correlate with protection, and a new paper provides some of the most decisive evidence yet. The authors also provide some hints about the sort of decline in immunity we might expect.

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#antibodies, #biology, #covid-19, #immunology, #medicine, #pandemic, #sars-cov-2, #science

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Delaying a COVID Vaccine’s Second Dose Boosts Immune Response in the Elderly

People older than 80 who waited 11 to 12 weeks for their second jab had higher peak antibody levels than did those who waited only three weeks

— Read more on ScientificAmerican.com

#health, #medicine, #public-health

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Vaccinated people can now go maskless in most indoor locations

A masked woman walks along a treelined city street.

Enlarge / If you’ve been vaccinated, the CDC now says you can skip the mask and spacing. (credit: Luis Alvarez / Getty Images)

As part of an ongoing press conference, the Centers for Disease Control and Prevention responded to recent data on the effectiveness of vaccines and updated its guidance on mask use and physical distancing. Under the new guidance, anyone who is fully vaccinated (meaning two weeks after the final dose of their vaccine) can now skip mask use and social distancing both indoors and outdoors.

“Anyone who is fully vaccinated can participate in indoor and outdoor activities—large or small—without wearing a mask or physical distancing,” said CDC Director Rochelle Walensky. There are some exceptions; vaccinated people should still mask up in places like hospitals, airplanes, and other forms of public transport. But for the most part, people who have been vaccinated can return to normal activities.

The press conference is ongoing, and we’ll update this story once it’s over.

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Adolescents Can Finally Get Vaccinated against COVID

Pfizer-BioNTech vaccine approval is younger teens’ shot at freedom

— Read more on ScientificAmerican.com

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CDC advisory committee recommends COVID vaccine for 12- to 15-year-olds

A masked child watches a healthcare worker perform an injection.

Enlarge / With new data, we’re able to expand vaccinations to ever-younger populations. (credit: Roberto Jimenez Mejias / Getty Images)

On Wednesday, the CDC’s Advisory Committee on Immunization Practices recommended that the CDC approve the use of the Pfizer/BioNTech COVID-19 vaccine for the 12- to 15-year age group. The decision comes two days after the FDA granted an emergency use authorization for the same age group and will help the US further limit the pool of people who can spread infections or foster the evolution of new viral variants. Formal CDC approval could come quickly, given recent history.

Given the FDA’s earlier decision, the move might seem anticlimactic. But having the FDA and CDC officially on the same page is reassuring, and several state-run vaccination programs are awaiting the CDC’s OK before expanding into that age group. Private providers and insurance companies were also varied in their response to the FDA’s decision and were waiting for the CDC.

The data that supported the approval was pretty decisive, as a small Phase III clinical trial of 2,260 adolescents saw 16 cases of COVID-19, with every single one occurring in the placebo group. Side effects were similar to those experienced by older people, with a brief period of flu-like symptoms. The committee was tasked with considering whether the benefits outweighed the risks; given the minor side effects and the increasingly obvious benefits of vaccination, it’s not a surprise that the vote in favor of approval by the committee was 14 in favor, none opposing, and a single recusal. The CDC director, Rochelle Walensky, is overwhelmingly likely to follow the committee’s recommendation, most likely before the day is over. (We’ll update this story if and when this occurs.)

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Neural implant lets paralyzed person type by imagining writing

An artist's schematic of the system.

Enlarge / An artist’s schematic of the system. (credit: Nature)

Elon Musk’s Neuralink has been making waves on the technology side of neural implants, but it hasn’t yet shown how we might actually use implants. For now, demonstrating the promise of implants remains in the hands of the academic community.

This week, the academic community provided a rather impressive example of the promise of neural implants. Using an implant, a paralyzed individual managed to type out roughly 90 characters per minute simply by imagining that he was writing those characters out by hand.

Dreaming is doing

Previous attempts at providing typing capabilities to paralyzed people via implants have involved giving subjects a virtual keyboard and letting them maneuver a cursor with their mind. The process is effective but slow, and it requires the user’s full attention, as the subject has to track the progress of the cursor and determine when to perform the equivalent of a key press. It also requires the user to spend the time to learn how to control the system.

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#biology, #brain-computer-interface, #medicine, #neural-implants, #neuroscience, #science

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MDMA Shows New Promise for Trauma, but the Drug Alone Is Not a Cure

The illegal substance—paired with intensive therapy and hard work—dramatically improves PTSD symptoms

— Read more on ScientificAmerican.com

#medicine, #mind

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Failure of Genetic Therapies for Huntington’s Devastates Community

Hopes were high for drugs designed to lower levels of a mutant protein, but development has stalled

— Read more on ScientificAmerican.com

#health, #medicalbiotech, #medicine

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In Shocking Move, U.S. Backs Waiving Patents on COVID Vaccines

The development from the Biden administration draws cheers from public health researchers and ire from drugmakers

— Read more on ScientificAmerican.com

#health, #medicine, #policyethics, #public-health

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Few Would Fear COVID Vaccines if Policy Makers Explained Their Risks Better

Clear messaging and transparency are vital, say some experts on risk assessment and decision-making

— Read more on ScientificAmerican.com

#health, #medicine, #policyethics, #public-health

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COVID Innovations: Vaccines for Variants, Drone Deliveries, Print-Your-Own Shots, and More

Next-generation COVID-19 vaccines will not only tackle different versions of the virus but will provide solutions across the world at a fraction of the cost

— Read more on ScientificAmerican.com

#biotech, #health, #medicine

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Blood Test Gives Early Warning of Failing Heart Transplant

The new DNA-based test predicts transplant rejection

— Read more on ScientificAmerican.com

#advances, #health, #medicine

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Malaria Vaccine Shows Promise–Now Come Tougher Trials

Preliminary results suggest the vaccine is up to 77 percent effective in young children, but researchers await larger studies

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Penicillin Wasn’t Alexander Fleming’s First Major Discovery

It was lysozyme, an enzyme that attacks the cell walls of bacteria—and just as with the celebrated antibiotic, he found it through pure serendipity

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Blood Clots and the Johnson & Johnson Vaccine: What We Know So Far

Infectious disease physician-scientist Wilbur Chen discusses the rare cases of blood clots linked to the immunization

— Read more on ScientificAmerican.com

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‘Conscience laws’ endanger patients and contradict health tech’s core values

Recent laws allowing healthcare providers to refuse care because of conscientious beliefs and denying care to transgender individuals might not seem like an issue for the tech industry at first blush, but these types of legislation directly contradict the core values of health tech.

Arkansas Governor Asa Hutchinson last month signed into law S.B. 289, known as the “Medical Ethics and Diversity Act,” which allows anyone who provides healthcare services — not just doctors — to refuse to give non-emergency care if they believe the care goes against their conscience.

Arkansas is one of several states in the U.S. that have been pushing laws like this over the past several years. These “conscience laws” are harmful to all patients — particularly LGBTQ individuals, women and rural citizens — especially because over 40% of available hospital beds are controlled by Catholic institutions in some states.

While disguised as a safeguard that prevents doctors from having to participate in medical services that are at odds with their religious beliefs, these laws go far beyond that and should be repealed.

While disguised as a safeguard that prevents doctors from having to participate in medical services that are at odds with their religious beliefs, these laws go far beyond that and should be repealed.

“Non-emergency” service is open to interpretation

The Arkansas legislation is one giant slippery slope. Even beyond the direct effects that the law would have on reproductive rights and the LGBTQ community, it leaves open questions about the many different services that medical professionals could decline simply by saying it goes against their conscience.

Broadly letting healthcare providers decide which services they will perform based on religion, ethics or conscience essentially eliminates protections patients have under federal anti-discrimination regulations.

What constitutes an “emergency” to one doctor or EMT may be deemed a “non-emergency” by another. By allowing medical professionals to avoid performing some services, the bill can be interpreted as allowing anyone involved in the provision of healthcare services to avoid performing any kind of service, as long as they say they believed it wasn’t an emergency at the time.

The law also allows individuals to refuse to refer patients to someone who would provide the desired service for them. This places an undue burden on patients with physical or mental health issues and causes delays in treatment as the patient searches for an alternate provider. In cases of health and life-threatening issues, for example, women have been refused treatment at Catholic medical institutions and forced to ride to the closest emergency care center.

The health tech community is working to improve the health of all

The Arkansas law runs counter to the values of the businesses that are working hard to develop and improve medical technologies. Health tech startups at their core are fighting to provide more and better services to more patients — whether it’s by building platforms to make healthcare accessible to all, developing specific medical devices to improve the quality of service or researching new treatments and vaccines.

Imagine developing a vaccine for a global pandemic and then allowing doctors the right to refuse to administer it because it’s open to interpretation whether the virus represents an emergency to specific people. Or imagine a hospital pharmacist who deliberately tries to spoil hundreds of vaccine doses because of the conspiracy theories he believes. Laws like the one in Arkansas open up the healthcare system to abuse by conspiracy theorists, and it is already the case that many wellness providers are basing their advice and services on QAnon falsehoods.

The health tech community is not just developing medications and devices for patients whose beliefs are similar to their own. Equally, medical professionals should not be making it harder for people to get needed medical care based on personal feelings. On the contrary, the ultimate goal of health tech businesses and healthcare providers alike should be a singular focus on improving the quality of care for all.

“Medical ethics” and anti-LGBTQ laws are unethical

As the health tech community continues to work tirelessly to bring new solutions to the marketplace to improve the health of everyone, it must also stand against laws like this, which threaten to eradicate the important gains that have been made in enhancing the lives and health of patients.

The Arkansas law — and others like it — place the burden of finding appropriate care on the patient instead of on the medical community, where it belongs. These laws must be repealed.

#arkansas, #column, #diversity, #health, #healthcare, #healthcare-industry, #healthtech, #lgbtq, #medicine, #opinion, #tc, #united-states

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Psilocybin Therapy May Work as Well as Common Antidepressant

For the first time, a randomized controlled trial shows the psychedelic offers potent, if short-term, relief in comparison with an SSRI

— Read more on ScientificAmerican.com

#health, #medicine, #mental-health

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Johnson & Johnson Vaccine Suspension–What This Means For You

An infectious disease doctor answers questions about the CDC’s and FDA’s decision to pause the vaccine’s use over a possible link with blood clots

— Read more on ScientificAmerican.com

#health, #medicine, #public-health

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J&J COVID vaccine use paused due to one-in-a-million complication

Image of a woman receiving a vaccine.

Enlarge / A nurse practitioner named Heidi Johnson administers a vaccine from Johnson & Johnson. (credit: Tom Williams / Getty Images)

On Tuesday morning, the US Food and Drug Administration and the Centers for Disease Control and Prevention issued a release acknowledging an extremely rare clotting disorder was associated with the use of the Johnson & Johnson COVID vaccine. The problem is actually less than a one-in-a-million issue; in data from the US, where 6.8 million doses of this vaccine have been used, there have only been six instances of the clotting problem detected.

Because the clots call for an unusual treatment, however, the organizations are calling for a pause in administering the shot. This will provide them with time to ensure the medical community is aware of the appropriate treatment.

This is not the first vaccine to create extremely rare clotting issues. They’ve also been seen following use of the AstraZeneca vaccine. The problem appears to be caused by the harmless virus (an Adenovirus) that carries a single gene from SARS-CoV-2 in order to elicit an immune response.

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#astrazeneca, #cdc, #clotting, #covid-19, #fda, #johnson-johnson, #medicine, #science, #vaccine

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Memic raises $96M for its robot-assisted surgery platform

Memic, a startup developing a robotic-assisted surgical platform that recently received marketing authorization from the U.S. Food and Drug Administration, today announced that it has closed a $96 million Series D funding round. The round was led by Peregrine Ventures and Ceros, with participation from OurCrowd and Accelmed. The company plans to use the new funding to commercialize its platform in the U.S. and expand its marketing and sales efforts outside of the U.S., too.

The company previously raised a total amount of $31.8 million, according to Crunchbase, including about $12.5 million raised through crowdsourcing platform OurCrowd.

Memic team photo

Image Credits: Memic

The Hominis, as the company calls its platform, has been authorized for use in “single site, natural orifice laparoscopic-assisted transvaginal benign surgical procedures including benign hysterectomy.” It’s worth noting that the robot doesn’t perform the surgery without human intervention. Instead, surgeons control the device — and its robotic arms — from a central console. The company notes that the instruments are meant to replicate the motions of the surgeon’s arms. And while it’s currently only authorized for this one specific type of procedure, Memic is looking at a wide range of other procedures where a system like this could be beneficial.

“The Hominis system represents a significant advancement in the growing multi-billion-dollar robotic surgery market. This financing positions us to accelerate our commercialization efforts and bring Hominis to both surgeons and patients in the months ahead,” said Dvir Cohen, co-founder and CEO of Memic.

It’s worth noting that there are a wide range of similar, computer-assisted surgical systems on the market already. Only last month, Asensus Surgical received FDA clearance for its laparoscopic platform to be used in general surgery, for example. Meanwhile, eye surgery robotics startup ForSight recently raised $10 million in seed funding for its platform.

Memic’s Hominis is the first robotic device approved for benign transvaginal procedures, though, and the company and its investors are surely betting on this being a first stepping stone to additional use cases over time.

“Given the broad potential of Hominis combined with a strong management team, we are proud to support Memic and execution of its bold vision,” said Eyal Lifschitz, managing general partner of Peregrine Ventures.

#general-partner, #hardware, #health, #medicine, #ourcrowd, #recent-funding, #startups, #surgery, #telemedicine, #united-states

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How Could a COVID Vaccine Cause Blood Clots?

Researchers are searching for possible links between unusual clotting and the Oxford-AstraZeneca coronavirus vaccine

— Read more on ScientificAmerican.com

#health, #medicine, #public-health

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Want to worry about the next pandemic? Spillover.global has you covered

Researchers with Franceville interdisciplinary Medical Research Centre (CIRMF, Centre Interdisciplinaire Medical de Recherches de Franceville) collect samples from a bat on November 25, 2020 inside a cave in the Zadie region in Gabon. - Working in remote recesses in the hearth of the Gabonese forest, scientists scour caves populated by bats, animals suspected of being at the origin of many epidemics transmitted to humans in recent years: the SARS in 2003, MERS in 2012, Ebola and now SARS-CoV-2 or novel coronavirus Covid-19. (Photo by STEEVE JORDAN / AFP) (Photo by STEEVE JORDAN/AFP via Getty Images)

Enlarge / Researchers with Franceville interdisciplinary Medical Research Centre (CIRMF, Centre Interdisciplinaire Medical de Recherches de Franceville) collect samples from a bat on November 25, 2020 inside a cave in the Zadie region in Gabon. – Working in remote recesses in the hearth of the Gabonese forest, scientists scour caves populated by bats, animals suspected of being at the origin of many epidemics transmitted to humans in recent years: the SARS in 2003, MERS in 2012, Ebola and now SARS-CoV-2 or novel coronavirus Covid-19. (Photo by STEEVE JORDAN / AFP) (Photo by STEEVE JORDAN/AFP via Getty Images)

We didn’t know about the SARS-CoV-2 virus until it showed up in humans. But previous experience with other coronaviruses that had jumped into humans (SARS and MERS) had told us that something like COVID-19 could pose a risk. Coronaviruses are prevalent in a number of species that have frequent contact with humans, and they have a clear history of being able to adapt themselves to human cells.

Being aware of which viruses have similar properties can help us recognize threats for future pandemics among the ones we find circulating in animals. Now, researchers are taking the results of a massive virus survey and releasing a public database of hundreds of viruses, all rated for how much risk the viruses pose to humans. And any viruses that we discover can be plugged into the framework they’ve developed so that we can get quick information on whether they’re threatening.

What’s out there?

The effort grew out of a USAID-sponsored program called PREDICT, which was part of a set of efforts focused on zoonotic diseases, those who can cross species barriers and infect humans. Collectively, the PREDICT project did a massive survey of animal viruses, taking over a half-million individual samples taken from 75,000 animals. Out of that data, the project identified over 700 new viruses and another that had never been seen in the animal in which it was found.

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The Deadly Lung Disease You’ve Probably Never Heard Of

Pulmonary fibrosis is diagnosed in about 50,000 new patients annually, and as many as 40,000 Americans die from it each year

— Read more on ScientificAmerican.com

#health, #medicine

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COVID Showed How Trials for New Drugs Could Be Faster and Better

The pandemic has spotlighted ways to make clinical trials easier on patients and better for science, a heart drug researcher says

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If You Don’t Have COVID Vaccine Side Effects, Are You Still Protected?

Reactions reflect unique features of an individual’s immune system, not the strength of a response

— Read more on ScientificAmerican.com

#health, #medicine, #public-health

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Which COVID Vaccine Is ‘Best’? Why Do Some People Have Side Effects? Experts Answer These Questions and More

Scientific American talked to scientists about everything from what efficacy means to protection against the new coronavirus variants

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“Are schools safe?” is the wrong question to be asking

Image of mask-wearing students in a classroom.

Enlarge (credit: MediaNews Group/Reading Eagle via Getty Images )

Is it safe to open schools? From the moment it became clear that the COVID-19 pandemic had set up shop in the US, answers to that question have been scrutinized, analyzed, and even politicized. Lost in all of this is the realization that it’s a terrible question—because there’s no single answer to it.

Instead, any answer to that question only applies to individual communities and, in many cases, individual schools. It’s also subject to change with the evolving dynamics of the pandemic, including the appearance of new variants. Fortunately, a detailed understanding of why the question is bad can help people understand which questions they should be asking instead.

Schools are part of a community

A couple things that are relevant to school safety have become clear over the course of the pandemic. One is that school-aged children are the least likely to be hospitalized or die of any age group tracked by the Centers for Disease Control and Prevention. Out of the over half-million COVID-19 deaths in the US, only a few hundred have been kids under the age of 17. In addition, in a few cases where new infections were tracked in detail, schools that adopted adequate safety measures saw lower infection rates than the surrounding community.

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#cdc, #covid-19, #health, #medicine, #pandemic, #sars-cov-2, #schools, #science

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Better Health raises $3.5M seed round to reinvent medical supply shopping through e-commerce

The home medical supply market in the U.S. is significant and growing, but the way that Americans go about getting much-needed medical supplies, particularly for those with chronic conditions, relies on outdated and clumsy sales mechanisms that often have very poor customer experiences. New startup Better Health aims to change that, with an e-commerce approach to serving customers in need of medical supplies for chronic conditions, and it has raised $3.5 million in a new seed round to pursue its goals.

Better Health estimates the total value of the home medical supplies market in the U.S., which covers all reimbursable devices and supplies needed for chronic conditions, including things like colostomy bags, catheters, mobility aids, insulin pumps and more, is around $60 billion annually. But the market is obviously a specialized one relative to other specialized goods businesses, in part because it requires working not only with customers who make the final decisions about what supplies to use, but also payers, who typically foot the bill through insurance reimbursements.

The other challenge is that individuals with chronic care needs often require a lot of guidance and support when making the decision about what equipment and supplies to select — and the choices they make can have a significant impact on quality of life. Better Health co-founder and CEO Naama Stauber Breckler explained how she came to identify the problems in the industry, and why she set out to address them.

“The first company I started was right out of school, it’s called CompactCath,” she explained in an interview. “We created a novel intermittent catheter, because we identified that there’s a gap in the existing options for people with chronic bladder issues that need to use a catheter on a day-to-day basis […] In the process of bringing it to market, I was exposed to the medical devices and supplies industry. I was just shocked when I realized how hard it is for people today to get life-saving medical supplies, and basically realized that it’s not just about inventing a better product, there’s kind of a bigger systematic problem that locks consumer choice, and also prevents innovation in the space.”

Stauber Breckler’s founding story isn’t too dissimilar from the founding story of another e-commerce pioneer: Shopify. The now-public heavyweight originally got started when founder Tobi Lütke, himself a software engineer like Stauber Breckler, found that the available options for running his online snowboard store were poorly designed and built. With Better Health, she’s created a marketplace, rather than a platform like Shopify, but the pain points and desire to address the problem at a more fundamental level are the same.

Better Health Head of Product Adam Breckler, left, and CEO Naama Stauber Breckler, right

With CompactCath, she said they ended up having to build their own direct-to-consumer marketing and sales product, and through that process, they ended up talking to thousands of customers with chronic conditions about their experiences, and what they found exposed the extend of the problems in the existing market.

“We kept hearing the same stories again, and again — it’s hard to find the right supplier, often it’s a local store, the process is extremely manual and lengthy and prone to errors, they get the surprise bills they weren’t expecting,” Stauber Breckler said. “But mostly, it’s just that there is this really sharp drop in care, from the time that you have a surgery or you were diagnosed, to when you need to now start using this device, when you’re essentially left at home and are given a general prescription.”

Unlike in the prescription drug market, where your choices essentially amount to whether you pick the brand name or the generic, and the outcome is pretty much the same regardless, in medical supplies which solution you choose can have a dramatically different effect on your experience. Customers might not be aware, for example, that something like CompactCath exists, and would instead chose a different catheter option that limits their mobility because of how frequently it needs changing and how intensive the process is. Physicians and medical professionals also might not be the best to advise them on their choice, because while they’ve obviously seen patients with these conditions, they generally haven’t lived with them themselves.

“We have talked to people who tell us, ‘I’ve had an ostomy for 19 years, and this is the first time I don’t have constant leakages’ or someone who had been using a catheter for three years and hasn’t left her house for more than two hours, because they didn’t feel comfortable with the product that they had to use it in a public restroom,” Stauber Breckler said. “So they told us things like ‘I finally went to visit my parents, they live in a town three hours away.’”

Better Health can provide this kind fo clarity to customers because it employs advisors who can talk patients through the equipment selection process with one-to-one coaching and product use education. The startup also helps with navigating the insurance side, managing paperwork, estimating costs and even arguing the case for a specific piece of equipment in case of difficulty getting the claim approved. The company leverages peers who have first-hand experience with the chronic conditions it serves to help better serve its customers.

Already, Better Health is a Medicare-licensed provider in 48 states, and it has partnerships in place with commercial providers like Humana and Oscar Health. This funding round was led by 8VC, a firm with plenty of expertise in the healthcare industry and an investor in Stauber Breckler’s prior ventures, and includes participation from Caffeinated Capital, Anorak Ventures, and angels Robert Hurley and Scott Flanders of remote health pioneer eHealth.

#8vc, #advisors, #caffeinated-capital, #health, #healthcare-industry, #humana, #medicare, #medicine, #oscar, #oscar-health, #pain, #port, #robert-hurley, #shopify, #software-engineer, #surgery, #tc, #united-states

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Scarcity of COVID Shots Might Boost Demand among the Vaccine-Hesitant

Willingness is rising, even among skeptical groups, at a time when there are still not enough doses to go around

— Read more on ScientificAmerican.com

#health, #medicine, #public-health

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COVID Antibody Treatments Show Promise for Preventing Severe Disease

Uptake by patients and physicians has been low in the U.S., even though some therapies have been authorized for months

— Read more on ScientificAmerican.com

#health, #medicine, #public-health

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Serimmune launches new immune response mapping service for COVID-19

Immune intelligence startup Serimmune hopes to better understand the relationship between antibody epitopes (the parts of antigen molecules that bind to antibodies) and the SARS-CoV-2 virus.

The company’s proprietary technology, originally developed at UC Santa Barbara, provides a new and specific way of mapping the entire array of an individual’s antibodies through a small blood sample. They do this through the use of a bacterial peptide display—a sort of screening mechanism that can isolate plasmid DNA from antibody-bound bacteria in the sample. This DNA can then be sequenced to identify epitopes, which provide information about both which antigens someone may have been exposed to, as well as how his or her immune system responded to them.

“It’s a very highly multiplexed and exquisitely specific way of looking at the epitopes found by antibodies in a specimen,” said Serimmune CEO Noah Nasser, who has a degree in molecular biology from UC San Diego and has previously worked for several diagnostics companies.

This week, Serimmune announced the launch of a new application of their core technology to help understand the disease states of and immune responses to SARS-CoV-2, or the virus that causes COVID-19.

“So what we do is we take these antibody profiles we build, and we’re able to then map those back with about a 12 amino acid specificity to the SARS-CoV-2 proteome,” said Nasser. “And what we find is that antibody expression is highly correlated to disease state, so we can distinguish mild, moderate, severe and asymptomatic disease on the basis of antibodies that are present in the specimen.”

The more patient data Serimmune can collect, the better its core technology becomes at finding patterns across different antigen exposure and disease severity. Noticing those patterns sooner won’t only help physicians and researchers to better understand how the SARS-CoV-2 virus operates, but can also inform new approaches to diagnostics, treatments, and vaccines for any antigen.

Serimmune’s launch of its new COVID antibody epitope mapping service is a way of making this data more accessible to customers like vaccine companies, government agencies, and academic labs that have shown interest in better understanding the immune response to SARS-CoV-2.

“The key was to zero in on the information that researchers wanted to know and standardize that,” said Nasser. “We can actually now provide these results back in as few as two days from sample receipt.”

Beyond this new service, Serimmune also has plans to launch a longitudinal clinical study on immunity to SARS-CoV-2. Using a painless at-home collection kit, study participants send in small blood samples to Serimmune, which then uses its core technology to outline an individual immunity map.

“We provide their results back to them in the form of a personal immune landscape to COVID,” said Nasser. “And what we’re trying to do is to understand over time how that immune response changes, and what happens to that immune response on repeated exposure to COVID.”

The mapping technology is now so specific that it can tell whether or not a patient has antibodies from natural exposure to the SARS-CoV-2 virus or from a vaccine, he added.

While the primary focus for Serimmune remains these applications to the COVID-19 pandemic for now, Nasser also mentioned that the company has plans to move into personalized medicine, potentially offering their mapping service directly to interested patients.

“We believe that this has value to individual patients in understanding their immune status and what antigens they’ve been exposed to,” he said. Until then, Serimmune plans to continue growing its database with more patient samples.

#biotech, #covid, #disease, #health, #immunology, #mapping-technology, #medicine, #science, #startups

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Could Valo Health become one of Flagship Pioneering’s biggest companies yet?

The investment firm Flagship Pioneering has incubated a lot of life sciences companies since it was founded in 2000. In fact, while a general partner with Flagship Pioneering over the last 15 years, David Berry has started more than 30 companies, five of which trade publicly right now: Seres Therapeutics, Sensen Bio, Evelo Biosciences, T2 Biosystems, and Axcella Health.

Berry is often a company’s first CEO, then transitions out of the company within 18 months. But he has no plans to leave his post as CEO of Valo Health, a three-year-old, Boston-based, 110-person drug discovery company that Berry and Flagship seem to think could become one of the firm’s most important companies yet. That’s notable, considering that Flagship incubated 11-year-old Moderna, which currently boasts a $50 billion market cap thanks in large part its coronavirus vaccine.

Perhaps it’s no surprise, given Berry’s and Flagship’s track record that Valo has attracted believers. Notably, today it is announcing a fresh $110 million in extended Series B financing from Koch Disruptive Industries that brings the round total to $300 million and the overall amount the young company has raised to more than $450 million.

Still, given that there are hundreds of drug discovery companies in the world seizing on the latest advancements in AI, machine learning and computation, it’s easy to wonder what’s so special about this one. We got Berry’s take during a chat with him yesterday, parts of which we are featuring below edited for length and clarity.

TC: Valo is trying to accelerate the creation of drugs, and it has a computational platform called Opal to do it faster and more effectively than many rivals. Is there a way to make it clearer to outsiders why this platform is so unique? 

DB: First, from day one, we were operating on a different scale [than past Flagship Pioneering companies]. Typically, when you look at Flagship companies, there’s an [exclusive] initial commitment by Flagship of plus or minus $50 million. But because of the scale of the opportunity that we saw ahead of us with Valo, we actually started out by bringing in external financing partners as part of a Series A that was right around $100 million.

[Also unique is the] breadth of what we’re trying to achieve through our systematic approach to R&D, as opposed to a targeted approach to thinking about it. There’s been an historical challenge in life sciences in that companies are primarily viewed based on what their lead therapeutic asset looks like. But if you have the potential to change the scope, the scale, the potential, the speed, the probability of success, [and] the cost of developing drugs, you’re not going to look like a typical therapeutics company.

TC: So your focus on multiple therapeutic areas at once — oncology, neurodegenerative, and cardiovascular diseases — is a distinguishing element of the company. How are you tackling so much simultaneously?

DB: The legacy biopharma model is basically this point-to-point system [where up to 15 groups] do some work, and then they basically take the result of it and they throw it over a wall to another group that has its own framework. The model is intrinsically disintegrated. They use mice. They use cell lines. They use extracted organs. And those just don’t represent what a full, intact living human actually looks like, and they don’t reflect what the disease looks like in the context of that human.

What we’re doing is what I would call that next transformation . . enabled by high-quality human-centric data [that we analyze] in an end-to-end, but componentized manner. What I mean by that is we’ve created a single underlying architecture so that we’re using the same species, we’re using the same decision-making criteria. we’re using the same KPIs throughout the entirety of the R&D cascade, [and] we’re using the same bases of the core computation. We’re using the same self-reinforcing model to learn as we go. We have a local expression, because we have to perform a certain set of tasks in order to comply with the regulatory environment. But by doing it in this way as we do those tasks, we’re learning a lot more and we’re keeping that human centricity, so when we uncover for example, a new target in cardiovascular disease or neurodegenerative disease, it’s based on our human data. It’s not based on a dog model or mouse model or something along those lines. It’s not based on cells adapted to plastic in a lab.

TC: Where is that human data coming from? Is the data you’re feeing into Opal somehow better or different than what others are using?

DB: We haven’t we haven’t yet disclosed where our datasets are coming from, but we have reason to believe that the scale and quality of the data sets are substantially high. We have not seen data sets that compare in scope and size. We have announced one subset of our data lake, but I would call it a small subset through a data partnership we announced earlier. [Editor’s note: this is with a company called Global Genomics Group, which gives Valo access to a cardio-metabolic dataset.]

TC: You’ve been at this for a few years. Have you had any major breakthroughs?

DB: I believe what we’ve done over the last two years is build an incredibly strong technology basis and foundation [for] transformation. We’ve announced four therapeutic programs that we’ve launched thus far, and each represents not only something where we’ve been able to develop a therapeutic candidate in very short periods of time, but we’ve also been able to overcome issues that were historical barriers things that made developing those sorts of candidates much more difficult, and we were able to overcome those barriers in weeks.

TC: Can you elaborate on one of those therapies to underscore your point?

DB: One of the programs we announced is called NAMPT. What was really interesting about it is it’s a very powerful cancer target. The downside of it is it’s known to cause a very particular toxicological effect — it causes retinal toxicity — and what we wanted to figure out was whether we could get the benefit of the molecule by targeting the target but avoiding getting that molecule into the retina, which required a very specific design. Long story short, in a couple of weeks, we were able to achieve a molecule that had enough differentiation between the blood in the eye that it shouldn’t have any substantial effects.

TC: Are any of these four candidates heading into the market any time soon?

DB: I would love them to be in the market soon but they’re not yet there. We are expecting that with the financing in hand, we should ultimately have molecules in clinical trials, and ultimately we’re very excited to be able to transition some of the drugs that we’re developing into [viable offerings in the market].

TC: Would you sell then sell these to a big pharma company, or would Valo be marketing these itself?

DB: Both are viable potential paths. Because we’re developing a number of different therapeutics, it gives us flexibility in the way we think about our ultimate business model.

#biotech, #drug-discovery, #flagship-pioneering, #machine-learning, #medicine, #moderna, #recent-funding, #startups, #tc, #venture-capital

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New Johnson & Johnson Shot Prevents Severe COVID As Well As Existing Vaccines Do, Experts Say

Trials of all three vaccines came up with different efficacy numbers, but all offer crucial protection in this health emergency

— Read more on ScientificAmerican.com

#health, #medicine, #public-health

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The genetics of relatively healthy obesity

Image of an overweight individual

Enlarge (credit: Matthew Horwood / Getty Images)

In general, obesity is linked with a large range of health problems—for most people, at least. But for a substantial minority of those who are overweight, obesity is accompanied by indications of decent health, with no signs of impending diabetes or cardiovascular disease. These cases have probably received unwarranted attention; who doesn’t want to convince themselves that they’re an exception to an unfortunate rule, after all? But the phenomenon is real, and it’s worth understanding.

To that end, a large international team of researchers has looked into whether some of these cases might be the product of genetic influences. And simply by using existing data, the team found 61 instances where a location in our genomes is associated with both elevated obesity and signs of good health, cardiovascular or otherwise.

Good and bad

The team’s method of searching the genome is remarkably straightforward, and it relies on the fact that many research groups have already done so much work to look for factors associated with obesity, diabetes, and cardiovascular health. This work includes searching for areas of the genome associated with measures of obesity, like body mass index, body fat percentage, and waist-to-hip ratio. Insulin and glucose levels have also been studied genetically, as these numbers give some indication of how the body is responding to weight and food intake. Cardiovascular health measures, including things like cholesterol, triglyceride levels, and blood pressure, have also been explored.

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#biology, #genetics, #genomics, #health, #medicine, #obesity, #science

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7 Ways to Reduce Reluctance to Take COVID Vaccines

Trusted messengers and repeated reminders can overcome hesitancy, social science shows

— Read more on ScientificAmerican.com

#health, #medicine, #public-health, #the-science-of-health

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Pfizer-BioNTech’s COVID-19 vaccine just got a lot easier to transport and distribute

The COVID-19 vaccine developed by Pfizer and BioNTech now has less stringent and extreme transportation requirements than it debuted with. Originally, the mRNA-based vaccine had to be maintained at ultra-low temperatures throughout the transportation chain in order to remain viable – between -76°F and -112°F. New stability data collected by Pfizer and BioNTech, which has been submitted to the U.S. Food and Drug Administration (FDA) for review, allow it to be stored at temps between 5°F and -13°F – ranges available in standard medical freezers found in most clinics and care facilities.

The vaccine should remain stable for up to two weeks at that temperature, which vastly improves the flexibility of its options for transportation, and last-mile storage in preparation for administration to patients. To date, the vaccine has relied largely on existing “cold-chain” infrastructure to be in place in order for it to be able to reach the areas where it’s being used to inoculate patients. That limitation hasn’t been in place for Moderna’s vaccine, which is stable at even higher, standard refrigerator temperatures for up to a month.

This development is just one example of how work continues on the vaccines that are already being deployed under emergency approvals by health regulators across the U.S. and elsewhere in the world. Pfizer and BioNTech say they’re working on bringing those storage temp requirements down even further, so they could potentially approach the standard set by the Moderna jab.

Taken together with another fresh development, study results from Israeli researchers that found just one shot of the ordinarily two-shot Pfizer-BioNTech vaccine could be as high as 85 percent effective on its own, this is a major development for global inoculation programs. The new requirements open up participation to a whole host of potential new players in supporting delivery and distribution – including ride-hailing and on-demand delivery players with large networks like Amazon, which has offered the President Biden’s administration its support, and Uber, which is already teamed up with Moderna on vaccine education programs.

This also opens the door for participation from a range of startups and smaller companies in both the logistics and the care delivery space that don’t have the scale or the specialized equipment to be able to offer extreme ‘cold-chain’ storage. Technical barriers have been a blocker for some who have been looking for ways to assist, but lacked the necessary hardware and expertise to do so effectively.

#amazon, #articles, #biden, #biontech, #biotech, #clinical-trials, #covid-19, #covid-19-vaccine, #health, #medical-research, #medicine, #moderna, #pfizer, #president, #tc, #uber, #united-states, #vaccine

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Experts Answer the Biggest COVID Vaccine Questions

What does “95 percent effective” mean? Should you get vaccinated if you have had COVID? Is there a best vaccine? 

— Read more on ScientificAmerican.com

#health, #medicine, #public-health

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Booster Shots Against Scary COVID Virus Variants Are In the Works

Vaccine makers are designing follow-up shots, based on new mutations, to keep the disease at bay

— Read more on ScientificAmerican.com

#health, #medicine, #public-health

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COVID Vaccines Are Safe and Effective–What the Research Says

As more coronavirus vaccines are rolled out, researchers are learning about the extent and nature of side effects

— Read more on ScientificAmerican.com

#health, #medicine, #public-health

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Why It’s So Hard to Make Antiviral Drugs for COVID and Other Diseases

Antibiotics abound, but virus-fighting drugs are harder to come by. Fortunately, scientists are getting better at making and finding them

— Read more on ScientificAmerican.com

#health, #medicine

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Past coronavirus infections don’t seem to help with SARS-CoV-2

Image of small blue spheres above a larger yellow surface.

Enlarge / False color image of viruses attached to a cell’s surface. (credit: NIAID)

While the SARS-CoV-2 virus is new to humans, coronaviruses in general aren’t. There have been earlier members of this group of viruses that have raised pandemic fears, while another group regularly circulates widely in humans, causing symptoms of the common cold.

Early on, there were some indications that prior exposure to cold-causing viruses could produce a degree of protection against COVID-19. But back in December, researchers published results indicating that any cross-reactivity against related viruses by T cells was likely to be ineffective. Now, additional results have been published that indicate antibodies raised against cold viruses fail to neutralize SARS-CoV-2.

Memories

The SARS-CoV-2 virus has a number of features that distinguish it from other coronaviruses that have circulated within humans. But it also has plenty of things in common, like its use of RNA as a genetic material and the general layout of its genome. Some of its genes have also picked up very few changes over the course of evolution. As a result, there are some stretches of genes that are identical in cold viruses and SARS-CoV-2.

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#antibodies, #biology, #covid-19, #immunology, #medicine, #sars-cov-2, #science, #t-cells

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Is It Safe to Delay a Second COVID Vaccine Dose?

Some evidence indicates that short waits are safe, but there is a chance that partial immunization could help risky new coronavirus variants to develop

— Read more on ScientificAmerican.com

#health, #medicine, #public-health

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Mount Sinai study finds Apple Watch can predict COVID-19 diagnosis up to a week before testing

A new study from Mount Sinai researchers published in the peer-reviewed Journal of Medical Internet Research found that wearable hardware, and specifically the Apple Watch, can effectively predict a positive COVID-19 diagnosis up to a week before current PCR-based nasal swab tests.

The investigation dubbed the ‘Warrior Watch Study,‘ used a dedicated Apple Watch and iPhone app and included participants from Mount Sinai staff. It required participants to use the app for health data monitoring and collection, and also asked that they fill out a day survey to provide direct feedback about their potential COVID-19 symptoms, and other factor including stress.

During the course of the study, the research team enlisted “several hundred health care workers” to participate, and collected data over several months, between April and September. The primary biometric signal that the study’s authors were watching was heart rate variability (HRV), which is a key indicator of strain on a person’s nervous system. This information was combined with information around reported symptoms associated with COVID-19, including fever, aches, dry cough, gastrointestinal issues, loss of taste and smell, among others.

The Warrior Watch Study was not only able to predict infections up to a week before tests provided confirmed diagnoses, but also revealed that participants’ HRV patterns normalized fairly quickly after their diagnosis, returning to normal roughly one to two weeks following their positive tests.

As to what the study could lead to in terms of actual interventions, the study’s authors note that it can help anticipate outcomes and isolate individuals from others who are at risk. Most importantly, it provides a means for doing so remotely, allowing caregivers to anticipate or detect a COVID-19 case without even doing a physical exam or a administering a nasal swab test, which can help take precautionary measures in high-risk situations when cases are suspected, possibly preventing any spread before someone is highly contagious.

The study is ongoing, and will expand to examine what else wearables like the Apple Watch and their onboard sensors can tell us about other impacts of COVID-19 on the health of care workers, including what factors like sleep and physical activity can have in association with the disease.

#apple, #biotech, #coronavirus, #covid-19, #disease, #fever, #health, #iphone, #medicine, #tc

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