AstraZeneca says it will likely do another study of COVID-19 vaccine after accidental lower dose shows higher efficacy

AstraZeneca’s CEO told Bloomberg that the pharmaceutical company will likely conduct another global trial of the effectiveness of its COVID-19 vaccine trial, following the disclosure that the more effective dosage in the existing Phase 3 clinical trial was actually administered by accident. AstraZeneca and its partner the University of Oxford reported interim results that showed 62% efficacy for a full two-dose regimen, and a 90% efficacy rate for a half-dose followed by a full dose – which the scientists developing the drug later acknowledged was actually just an accidental administration of what was supposed to be two full doses.

To be clear, this shouldn’t dampen anyone’s optimism about the Oxford/AstraZeneca vaccine. The results are still very promising, and an additional trial is being done only to ensure that what was seen as a result of the accidental half-dosage is actually borne out when the vaccine is administered that way intentionally. That said, this could extend the amount of time that it takes for the Oxford vaccine to be approved in the U.S., since this will proceed ahead of a planned U.S. trial that would be required for the FDA to approve it for use domestically.

The Oxford vaccine’s rollout to the rest of the world likely won’t be affected, according to AstraZeneca’s CEO, since the studies that have been conducted, including safety data, are already in place from participants around the world outside of the U.S.

While vaccine candidates from Moderna and Pfizer have also shown very strong efficacy in early Phase 3 data, hopes are riding high on the AstraZeneca version because it relies on a different technology, can be stored and transported at standard refrigerator temperatures rather than frozen, and costs just a fraction per dose compared to the other two leading vaccines in development.

That makes it an incredibly valuable resource for global inoculation programs, including distribution where cost and transportation infrastructures are major concerns.

#astrazeneca, #biotech, #ceo, #coronavirus, #covid-19, #fda, #health, #medical-research, #moderna, #oxford, #pfizer, #pharmaceutical, #tc, #united-states, #vaccine, #vaccines


US Fertility says patient data was stolen in a ransomware attack

U.S. Fertility, one of the largest networks of fertility clinics in the United States, has confirmed it was hit by a ransomware attack and that data was taken.

The company was formed in May as a partnership between Shady Grove Fertility, a fertility clinic with dozens of locations across the U.S. east coast, and Amulet Capital Partners, a private equity firm that invests largely in the healthcare space. As a joint venture, U.S. Fertility now claims 55 locations across the U.S., including California.

In a statement, U.S. Fertility said that the hackers “acquired a limited number of files” during the month that they were in its systems, until the ransomware was triggered on September 14. That’s a common technique of data-stealing ransomware, which steals data before encrypting the victim’s network for ransom. Some ransomware groups publish the stolen files on their websites if their ransom demand isn’t paid.

U.S. Fertility said some personal information, like names and addresses, were taken in the attack. Some patients also had their Social Security numbers taken. But the company warned that the attack may have involved protected health information. Under U.S. law, that can include information about a person’s health or medical conditions, like test results and medical records.

A spokesperson did not immediately respond to a request for comment about the incident. (Thursday is a national holiday in the U.S..)

U.S. Fertility didn’t say why it took more than two month to publicly disclose the attack, but said in the notice that its disclosure was not delayed at the request of law enforcement.

This is the latest attack targeting the healthcare sector. In September, one of the largest hospital systems in the U.S., Universal Health Services, was hit by the Ryuk ransomware, forcing some affected emergency rooms to close and to turn patients away. Several other fertility clinics have been attacked by ransomware in recent months.

Read more:

#california, #crimes, #cybercrime, #health, #ransomware, #security, #spokesperson, #united-states


Pandemic of Hunger

COVID-19 is straining African food security, but also presents an opportunity for change

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#health, #public-health


Scientists Are Becoming More Politically Engaged

Here’s what that means beyond the 2020 elections

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#behaviorsociety, #health


Gift Guide: Smart exercise gear to hunker down and get fit with

Welcome to TechCrunch’s 2020 Holiday Gift Guide! Need help with gift ideas? We’re here to help! We’ll be rolling out gift guides from now through the end of December. You can find our other guides right here.

Home exercise gear is always a nice holiday gift choice for anyone who has expressed interest in staying healthy and getting more fit, but during the ongoing COVID-19 pandemic it’s more relevant than ever. Luckily, smart exercise and health gear is smarter than ever, making it perfect for the gift list this season.

Big machines

Bowflex Velocore bike

Image Credits: Bowflex

Bowflex’s latest excercise bike is a great follow-up to their solid C6, and it has a unique trick up its sleeve – leaning. The Velocore unlocks to allow side-to-side leans during workouts, which adds a good amount of core stabilization to your existing spin exercises.

The Velocore also offers an integrated display in either 16″ or 22″ sizes, and that provides access to Bowflex’s own JRNY video fitness instruction. It’s a great subscription service, though it doesn’t include live classes like Peloton. Luckily, Bowflex supports Peloton’s software as well, so you can also use that with the Velocore if that’s your preference.

Price: $1,699 (16-inch) or $2,199 (22-inch) from Bowflex direct or Best Buy

Hydrow rower

Image Credits: Hydrow

Rowers are a great way to get in some indoor cardio, and a nice change-up from treadmills and bikes that also works out your upper body. The Hydrow is the most technologically advanced of these out there, with a large, high-quality display that provides access to both live and on-demand classes via its virtual service. It’s also engineered to really feel like you’re getting the same kind of resistance you would from actual water.

Price: $1,995 (price as of publication) from Hydrow direct

Peloton Tread

Image Credits: Peloton

If you’re looking for a treadmill with smart features, Peloton’s is easily the best option available. The new Tread is the way to go for most, since it’s nearly $2,000 cheaper than the original which is now the Tread+, and it still offers a huge display for those interactive and on-demand peloton classes, and everything you need for a full-body workout as well. It’s not available in retail across the U.S. until March, but it’s a good advance gift if a treadmill is on the list.

Price: From $2,495 from Peloton direct

Smart and small

JAXJOX KettlebellConnect 2.0

Image Credits: JAXJOX

Smart weights come in a variety of shapes and sizes, but JAXJOX’s next-generation smart kettlebell is one of the all-around best and most convenient smart weights out there. The selectable weight ranges from 12 to 42 lbs, and the smart features on board provide real-time reporting on performance, along with the ability to sync with the JAXJOX mobile app for on-demand guided workouts.

Price: $229 from JAXJOX

Tangram Factory SmartRope Rookie

Image Credits: Tangram Factory

If you’re even more space constrained, a jump rope is essentially a whole-body gym in a tiny, portable package. The Tangram Factory Rookie is a more affordable, smaller and higher version of their original SmartRope, with built-in activity tracking, long-lasting battery, and a fully-adjustable rope length that allows it to be used by both children and adults of all sizes.

Price: Starting at $39.95 from Tangram Factory direct or Apple Store

Activity and health monitoring

Withings BPM Core wireless blood pressure monitor

Image Credits: Withings

The Withings BPM Core is a connected blood pressure monitor that provides a lot of extras, including measurement of your heartbeat with a digital stethoscope, and an electrocardiogram (ECG) feature to monitor for any potential atrial fibrillation. Withings is building all their hardware these days to clinical validation standards, so this is a surefire way to keep on top of these key signals of health.

Price: $250 from Withings (coming soon)

Withings Body Cardio

Image Credits: Withings

Withings is really nailing it with home health monitoring equipment these days, which is why the Body Cardio smart scale is another recommendation in this list. The Body Cardio not only measures weight, but also provides you with a body composition breakdown giving you approximate body fat percentage and body mass index for even more detailed fitness tracking. Plus, it monitors heart rate as well.

Price: $119.96 (price at publication) from Withings



#gadgets, #gift-guide-2020, #health, #tc


COVID Models Show How to Avoid Future Lockdowns

The models could help inform policy on everything from mask mandates to social distancing

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#health, #public-health


Amazon’s Echo Buds get new fitness tracking features

I wasn’t super impressed when I reviewed the Echo Buds around this time last year, but Amazon’s first shot at Alexa-powered fully wireless earbuds was passable. And while they’ve already been on the market for a while now, the company’s continuing to deliver some key updates, including today’s addition of new fitness features.

Say “Alexa, start my workout” with the buds in, and they’ll begin logging steps, calories, distance, pace and duration of runs. Like many new software additions, this one will take a few days to roll out for everyone. This one also requires users to enable the new tracking feature using the Alexa app.

Once enabled, you can state/ask follow-ups, like:

  • “Alexa, start my run”
  • “Alexa, pause my walk”
  • “Alexa, end my workout”
  • “Alexa, how far have I run?”
  • “Alexa, what’s my pace?”
  • “Alexa, how was my workout?”

Asking, “Alexa, how was my workout?” After the fact will pull up your historical running stats.

As I noted previously, the Echo Buds didn’t really do much to set themselves apart from myriad other earbuds, though there certainly was a lot to be said for the price — then $130. At the moment, they’re discounted much further, now running $80 — which makes them a solidly competitive deal.

#alexa, #amazon, #echo, #echo-buds, #hardware, #health, #wearables, #wireless-earbuds


Mental health startups are raising spirits and venture capital

A spate of startups focused on mental health recently made enough noise as a group that they caught the eye of the Equity podcast crew. Sadly, the segment we’d planned to discuss this topic was swept away by a blizzard of IPO filings that piled up like fresh snow.

But in preparation, I reached out to CB Insights for new data on the mental health startup space that they were kind enough to supply. So this morning we’re going to dig into it.

Regular readers of The Exchange will recall that we last dug into overall wellness venture capital investment in August, noting that it was mental health startups inside the vertical that were seeing the most impressive results.

The Exchange explores startups, markets and money. Read it every morning on Extra Crunch, or get The Exchange newsletter every Saturday.

I wanted to know what had happened even more recently.

After all, Spring Health recently raised $76 million for its service that helps companies offer their workers mental health benefits, Mantra Health disclosed that it has raised $3.2 million to help with college-age mental health issues and Joon Care announced $3.5 million in new capital to “grow its remote therapy service for teens and young adults,” per GeekWire.

Sticking to theme, Headway just raised $32 million to build a platform that “helps people search for and engage therapists who accept insurance for payments,” according to our own reporting, and online therapy provider Talkspace is pursuing a sale — it looks like an active time in the mental health startup realm.

So, let’s shovel into the latest data and see if the signals that we are seeing really do reflect more total investment into mental health startups, or if we’re over-indexing off a few news items.

The state of mental health venture investing

To prepare the ground, let’s talk about the general state of healthcare investing in the venture capital world. Per CB Insights’ Q3 healthcare VC report, venture capital deal volume and venture capital dollar volume reached new record highs in the sector during Q3 2020.

The quarter’s 1,539 rounds and $21.8 billion in invested capital were each comfortably ahead of prior records set in Q2 2018 for round volume (1,431) and Q2 2020 for dollar volume ($18.4 billion) for healthcare startups.

#calm, #cb-insights, #fundings-exits, #headspace, #health, #startups, #tc, #the-exchange


Oxford University’s COVID-19 vaccine shows high efficacy, and is cheaper to make and easier to store

Oxford University’s COVID-19 vaccine, being developed in partnership with drugmaker AstraZeneca, has shown to be 70.4% effective in preliminary results from its Phase 3 clinical trial. That rate actually includes data from two different approaches to dosing, including one where two full strength does were applied, which was 62% effective, and a much more promising dosage trial which used one half-dose and one full strength dose to follow – that one was 90% effective.

Oxford’s results may not have the eye-catching high efficacy headline totals of the recent announcements from Pfizer and Moderna, but they could actually represent some of the most promising yet for a few different reasons. First, if that second dosage strategy holds true across later results and further analysis, it means that the Oxford vaccine can be administered in lower amounts and provide stronger efficacy (there’s no reason to use the full two-dose method if it’s that much less effective).

Second, the Oxford vaccine can be stored and transported at standard refrigerator temperatures – between 35° and 45°F – whereas the other two vaccine candidates require storage at lower temperatures. That helps obviate the need for more specialized equipment during transportation and on-site at clinics and hospitals where it will be administered.

Oxford’s COVID-19 vaccine also uses a different approach to either Moderna’s or Pfizer’s, which are both mRNA vaccines. That’s a relatively unproven technology when it comes to human therapeutics, which involves using messenger RNA to provide blueprints to a person’s body to build proteins effective at blocking a virus, without any virus present. The Oxford University candidate is an adenovirus vaccine, which is a much more established technology that’s already been in use for decades, and which involves genetically altering a weekend common cold virus and using that to trigger a person’s own natural immune response.

Finally, it’s also cheaper – in part because it uses tried and tested technology for which there’s already a robust and mature supply chain, and in part because it’s easier to transport and store.

The Phase 3 trial for the Oxford vaccine included 24,000 participants, and it’s expected to grow to 60,000 by the end of the year. Safety data so far shows no significant risks, and among the 131 confirmed cases in the interim analysis that produced these results, none of those who received either vaccine dosage developed a severe case, or one requiring hospitalization.

This is great news for potential vaccination programs, since it introduces variety of supply chain into an apparently effective vaccine treatment for COVID-19. We’re much better off if we have not only multiple effective vaccines, but multiple different types of effective vaccines, in terms of being able to inoculate widely as quickly as possible.

#astrazeneca, #biotech, #health, #medical-research, #medicine, #messenger, #moderna, #oxford-university, #pfizer, #tc, #unproven-technology, #vaccination, #vaccine, #vaccines


Doing the Touchy Math on Who Should Get a COVID Vaccine First

Mathematicians model pandemic scenarios by plugging thorny ethical and logistical issues into calculations

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#health, #math, #medicine, #public-health, #the-sciences


Pfizer and BioNTech to submit request for emergency use approval of their COVID-19 vaccine today

Two of the companies behind one of the leading COVID-19 vaccine candidates will seek approval from the U.S. Food and Drug Administration for emergency use authorization (EUA) of their preventative treatment with an application to be delivered today. Pfizer and BioNTech, who revealed earlier this week that their vaccine was 95% effective based on Phase 3 clinical trial data, are submitting for the emergency authorization in the U.S., as well as in Australia, Canada, Europe, Japan and the U.K., and says that could pave the way for use of the vaccine to begin in “high-risk populations” by the end of next month.

The FDA’s EUA program allows therapeutics companies to seek early approval when mitigating circumstances are met, as is the case with the current global pandemic. EUA’s still require that supporting information and safety data are provided, but they are fast-tracked relative to the full, formal and more permanent approval process typically used for new drugs and treatments that come before they’re able to actually be administered broadly.

Pfizer and BioNTech’s vaccine candidate, which is an mRNA-based vaccine that essentially provides a recipient’s body with instructions on how to produce specific proteins to block the ability of SARS-CoV-19 (the virus that causes COVID-19) to attach to cells. The vaccine has recently been undergoing a Phase 3 clinical trial, that included 43,661 participants so far. The companies are submitting supporting information they hope will convince the FDA to grant the EUA, including data from 170 confirmed cases from among the participants, and safety information actively solicited from 8,000 participants, and supplementary data form another 38,000 who that was passively collected.

While production is ramping globally for this and other vaccines in late stage development, and EUA will potentially open up access to high-risk individuals including frontline healthcare workers, it’s worth pointing out that any wide vaccination programs likely aren’t set to begin until next year, and likely later in 2021.

#australia, #biontech, #biotech, #canada, #coronavirus, #covid-19, #europe, #health, #japan, #medical-research, #medicine, #pfizer, #tc, #united-kingdom, #united-states, #vaccination, #vaccines


Medable raises $91 million for its clinical trial management software

The clinical trial management software developer Medable has raised $91 million in a new round of financing as life sciences companies struggle with how to conduct the necessary validation studies of new drugs and devices in a pandemically challenged environment.

Digital and decentralized clinical trials are becoming a necessity given the health and safety guidelines that have been adopted to respond to the COVID-19 pandemic, the company said. And those changes are driving a shift to services like Medable’s as companies move through the approval process, the company said in a statement.

The company’s new $91 million financing was led by Sapphire Ventures, with follow-on investment from existing investors GSR VenturesPPD, Inc. and Streamlined Ventures.

Medable’s software manages recruitment, remote screening, electronic consent, clinical outcomes assessment (eCOA), eSource, telemedicine, and connected devices, the company said.

Its software is already being used to work on vaccines and therapeutics targeting COVID-19 specifically in addition to facilitating the development of other potentially life-saving therapies and treatments.

“The pandemic has made the world aware of the importance of clinical drug development,” said Dr. Michelle Longmire, CEO and co-founder of Medable, in a statement. “We need transformative technologies that break down critical barriers to improve patient access, experience and outcomes. This new funding will enable Medable to continue our aggressive pursuit of new technologies that improve clinical trials to benefit all patients.”

Trials underway in more than 60 countries are using the service and Medable has inked partnerships with companies like Datavant, to integrate multiple data sources for decentralized trials; MRN, to handle home and remote visits, and AliveCor, to track in-home health with electrocardiograms. 


#alivecor, #articles, #drug-development, #gsr-ventures, #health, #medable, #sapphire-ventures, #streamlined-ventures, #tc, #telehealth, #telemedicine


Evaluating COVID Risk on Planes, Trains and Automobiles

Stay safer on different forms of transportation

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#health, #public-health


Slow Gains against the Virus

Multiple and complex underlying factors determine why some people get terribly sick from COVID-19

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#from-the-editor, #health, #public-health


Diagnoss launches its coding assistant for medical billing

Diagnoss, the Berkeley, Calif.-based startup backed by the machine learning-focused startup studio The House, has launched its coding assistant for medical billing, the company said.

The software provides real-time feedback on documentation and coding.

Coding problems can be the difference between success and failure for hospitals, according to Diagnoss. Healthcare providers were decimated by the COVID-19 outbreak, with hospitals operating below 60% capacity and one-fourth of them facing the potential for closing in a year if the pandemic continues to disrupt care.

The cost pressures mean that any coding error can be the financial push that forces a healthcare provider over the edge.

“For every patient encounter, a physician spends an average of 16 minutes on administration, which adds up to several hours every single day. In addition, codes entered are often wrong – up to a 30% error rate – resulting in missed or delayed reimbursements. We believe that, with the great progress we’ve seen with artificial intelligence and machine learning, we can finally address some of these inefficiencies that are leading to physician burnout and financial strain,”  said Abboud Chaballout, founder and chief executive of Diagnoss, in a statement.

Diagnoss acts like a grammar checking tool, but its natural language processing software is focused on reading doctor’s notes. The company’s tools can provide evaluation and management code for patient encounters; point out missing information in doctors’ notes; and provide predictions about the diagnosis and procedure codes that could apply after reviewing a doctor’s notes.

In a study of 39,000 de-identified EHR charts, the company found that its machine coding service was about 50% more accurate than human coders, according to a Diagnoss review.

Physician practices are already using Diagnoss’ service through a previously announced partnership with the mobile EHR vendor, DrChrono .

#assistant, #california, #coding, #drchrono, #electronic-health-records, #health, #healthcare, #knowledge, #machine-learning, #natural-language-processing, #physician, #tc


The COVID Cold Chain: How a Vaccine Will Get to You

A vaccine logistics expert explains how millions of frozen vials will be widely distributed

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#health, #medicine, #public-health


Your Tears Might Save Your Life Someday

They could ultimately be used to find diseases the way blood tests do now—but cheaper and more easily

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#health, #medicine


Device that combines air circulation with UV-C light deployed in first U.S. homes to help decrease COVID-19 transmission risk

Now that we know the virus that causes COVID-19 can be transmitted via aerosol (tiny particles in the air that can hang around for a long time), researchers and engineers globally have turned their attention to helping promote air circulation where risk exposure is high, and also to kill any active viral particles that might be in the air. One such effort is the Nanowave Air, a device created by Pittsburgh-based Dynamics, Inc. (via NEXT Pittsburgh) which uses UV-C light in a safe and contained way to inactivate the virus in enclosed spaces.

The Nanowave Air operates on basically the same principal as any air purifier you might have in your home, using a fan to take in air and then passing it through a filter before putting it back out into the room. The difference is that the filter in this case is actually exposure to ultraviolet light – and specifically UV-C light, the type that has been proven to be effective in killing the SARS-CoV-2 virus that leads to COVID-19.

UV-C light differs from the more common UV-A light that we’re all generally exposed to in significant quantities from sunlight, and direct exposure to UV-C is harmful to humans. It has been used in indoor viral surface sterilization in the past, but typically the rooms where it’s used can’t be occupied at the time, and obviously it’s not effective once it’s no longer in use and people are allowed back in.

The Nanowave Air was created by the Carnegie Mellon spinout Dynamics when its CEO realized that the technology they were working on around UV-C light sources already for large-scale industrial applications could be adapted to address the COVID-19 crisis. That led to the portable design of the Air, which is roughly the size of a hobbyist telescope, and which works by containing the UV-C light within, and funneling air through it at high speeds using fans in order to be able to neutralize any active virus present while also allowing people to still continue to occupy the spaces where it’s in operation.

Nanowave Air is now shipping, with a $3,450 retail price. It’s intended for use in spaces like primary care facilities, dental offices, and other shared locations where people have to occupy the same space despite current guidance around social distancing and especially indoor exposure. The company, which has tested its technology at a number of labs across the U.S. including the University of Pittsburgh’s Center for Vaccine Research, also announced that it’s now being used in some homes with a COVID-19-positive individual, in order to reduce the exposure potential for other members of the household who haven’t yet contracted the illness.

This week saw the announcement of positive news for two of the larger efforts to develop a vaccine for COVID-19, but even if those end up providing long-term protection and ramp distribution quickly, the effort to contain COVID-19 globally will still include a lot of necessary preventative steps to avoid contraction among the unvaccinated populace. Managing airborne presence of the virus is sure to be a key ingredient, and solutions like the Nanowave Air could help to spur those efforts.

#air-purifier, #articles, #carnegie-mellon, #ceo, #health, #occupational-safety-and-health, #pittsburgh, #tc, #ultraviolet, #united-states, #vaccine, #virus


Bond Vet raises $17 million to be the CityMD of veterinary care

Bond Vet, the NYC-based tech-forward veterinary startup, has announced the close of a $17 million Series A financing. The round was led by Talisman Capital Partners.

The startup has clinics across NYC that are meant to fill the gap between veterinary ERs and the veterinary equivalent of a primary care physician, modeling the business after CityMD. Unlike some other new veterinary startups, Bond doesn’t require a membership to book an appointment. Pet parents can either walk in or make an appointment on the website or mobile app.

The startup also provides both urgent care and primary care, including regular vaccinations and check-ups.

Bond puts a particular focus on the design of the clinic itself, with high-friction floors so puppies don’t slip and examination tables that give pet parents the ability to remain close to their furry friend during procedures or examinations when appropriate.

The company also has technology on the back-end for vets and nurses that make the process of providing care more efficient (like with note taking, for example) so that they can spend more time with the patients.

Bond has its own telehealth platform as well, to let pet parents text with their vet before and after appointments, or potentially even replace an appointment and solve the issue remotely.

Cofounder and CEO Mo Punjani explained that the efficiencies built in to Bond Vet allow the company to pass on savings to customers. While primary care services are on par with other vets, according to Punjani, emergency services can be rendered at a much lower cost than a traditional veterinary ER.

Pet spending is set to top $100 billion next year, according to the American Pet Products Association, as millennials opt to use higher-quality products for their animals. Startups across the pet ecosystem have capitalized on this new trend, and Bond Vet is among them.

The Bond Vet team, which includes in-clinic staff and HQ, is about 100 people, and 20 percent of employees are female.

Since launch in June of 2019, Bond has seen upwards of 15,000 unique pets in its clinics. The company plans to use the funding to keep building out its technology stack and expand its physical footprint, with plans to launch clinics in suburban areas next year.

#health, #recent-funding, #startups, #tc


Mysteries of COVID Smell Loss Finally Yield Some Answers

Explanations begin to arise at the molecular level for this vexing but commonplace symptom

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#health, #public-health


Pfizer says its COVID-19 vaccine is 95% effective in final clinical trial results analysis

Drugmaker Pfizer has provided updated analysis around its COVID-19 vaccine Phase 3 clinical trial data, saying that in the final result of its analysis of the 44,000-participant trial, its COVID-19 vaccine candidate proved 95% percent effective. This is a better efficacy rate than Pfizer reported previously, when it announced a 90% effectiveness metric based on preliminary analysis of the Phase 3 trial data.

This result also follows a preliminary data report from Moderna about their own Phase 3 trial of their vaccine candidate, which they reported showed 94.5% effectiveness. Pfizer and partner BioNTech’s vaccine is an mRNA-based preventative treatment, similar to the Moderna one, and now it looks like they should be roughly similar in efficacy – at least in the early offing, based on a limited sample of total cases and prior to peer review by the scientific community, which is yet to come.

The Pfizer data in its final analysis shows that among a total of 170 confirmed COVID-19 cases so far among the 44,000 people who took part in the study, 162 cases came from the placebo group while only eight were from the group of those who received the actual vaccine candidate. The company also reported that 9 out of 10 of the severe cases among those who were infected occurred in the placebo group, suggesting that even in the rare occasion that the vaccine didn’t prevent contraction of COVID-19, it helped reduce its severity.

This should help Pfizer make its case that it be granted an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) to be able to provide the vaccine early pending full and final approval as an emergency measure. Earlier this week, the company reported that it has already collected two months’ worth of follow-up data about participants in its trial, which is a required component for said approval, and it’s pursuing it with hopes of seeking that EUA “within days.” The company intends to ramp production of its vaccine beginning later this year, and achieving a run rate of up to 1.3 billion doses by next year.

#biontech, #biotech, #coronavirus, #covid-19, #health, #medical-research, #medicine, #moderna, #pfizer, #tc, #vaccine, #vaccines


For Billion-Dollar COVID Vaccines, Basic Government-Funded Science Laid the Groundwork

Much of the pioneering work on mRNA vaccines was done with government money, though drugmakers could walk away with big profits

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#health, #medicine, #public-health


Why are telehealth companies treating healthcare like the gig economy?

Telehealth has taken off.

Spurred by the pandemic, many doctors in the U.S. now offer online appointments, and many patients are familiar with getting live medical advice over the internet. Given the obvious benefits, many experts have concluded that telehealth is here to stay. “It’s taken this crisis to push us to a new frontier,” said Seema Verma, administrator of the Center for Medicare and Medicaid Services. “But there’s absolutely no going back.”

Now the question is, where are we going? Telehealth has played an essential role during the pandemic, and it could do even more good in the years to come. But we are still in the very early days of its development. And if we are to realize telehealth’s full potential, then we must first reckon with the fact that there are serious flaws in the predominant way it is delivered today — flaws that endanger patients themselves.

Legacy telehealth services like Teladoc and others were built for a time when telehealth was a fringe phenomenon, mostly used to support acute needs like a bad cold or a troubling rash. They largely offer, in effect, randomized triage care. Patients go online, wait in a queue and see the first doctor who happens to be available. These companies market this as a virtual house call, but for patients, the experience may feel more like being stuck on a conveyor belt. Too often, they get funneled through the system with little to no choice along the way.

Insurance companies love this model because it is cheap to operate. But patients bear the cost. Doctors, in this arrangement, get paid to work the assembly line. Every minute they spend listening to patients — learning about their lives, building a personal relationship — is a minute they’re not moving them down the line, seeing the next patient and earning their next fee. The system doesn’t reward doctors for providing care; it rewards them for churning through patients.

As we build telehealth’s future, doubling down on this model would be a worrisome mistake since it is antithetical to how our healthcare system should operate. Healthcare has long been premised on the idea that you should have an ongoing relationship with a local care provider — someone with a holistic, longitudinal view of your health, who you trust to help navigate difficult or sensitive medical issues.

The randomized triage model breaks this bond and replaces it with a series of impersonal interactions that feel more like ones you have with an Uber driver — polite but transactional, brief and ephemeral. Healthcare, however, should not be treated in the same way as the gig economy.

As a physician, I am troubled by the prospect of what happens when you scale this model up. Every time a patient gets passed from one doctor to the next, there is a chance that critical information is lost. They won’t understand your baseline mood, your family context or living situation — all critical “intangibles” for informed treatment. That lack of longitudinal data leads to worse outcomes. This is why the healthcare system has long been designed to minimize patient handoffs — and why it would be a mistake for us to choose a telehealth infrastructure that increases them.

What, then, does a better approach look like?

We are at the very dawn of telehealth’s integration into our country’s healthcare system, and I won’t claim to know the full answer. But I do know that patients are far better stewards of their own health than a random doctor generator. A more effective approach to telehealth puts the power in patients’ hands. Because when we give them choices and then listen to them, patients tell us what they prefer.

Data gathered by my company makes clear that by a substantial margin, people want to make this decision themselves: Nine out of 10 telehealth patients prefer to schedule an appointment with a provider of their choosing rather than see a randomly assigned doctor after waiting in a digital queue.

Not only that: When given this choice, most patients — about seven in 10 — make an appointment with a nearby doctor when booking a virtual visit. Patients instinctively know that at some point, they’ll want or need to physically be in the same room with their doctor. And they know that choosing a local provider makes it possible to pick up the conversation in-person right where it left off online. They don’t want to be forced to choose between telehealth and an ongoing relationship with a trusted provider. And they’re right — they shouldn’t have to.

None of the legacy telehealth companies focus on this imperative. Instead, while the pandemic rages on, they are rushing to scale while their randomized triage model is still viable. And the markets may reward them in the near term for being in the right place at the right time. But long-term value will be derived from listening to, responding to and iterating on what patients want.

Experience suggests patients will reward whoever can give them the most control over their healthcare. That’s where I’m placing my bet, too.

#column, #gig-economy, #health, #healthcare, #opinion, #physician, #startups, #telecommunications, #telehealth, #telemedicine


Levels raises $12M from a16z and others to bring its biowearable to market

Levels today is announcing a large seed round to help bring its biowearable metabolic sensor to market. The innovative platform pairs continuous glucose monitoring (CGM) with an impressive software suite to provide the wearer with deep insights about their health. The company’s founders strongly feel that this approach helps users close the loop between food, exercise and well-being.

Levels provides actionable health information by constantly monitoring the wearer’s blood sugar using proven technology. This isn’t a wearable worn around the wrist; Levels uses medical hardware that’s attached to the wearer’s arm for two weeks. It sounds scarier than it is. I have one on right now, and it’s painless.

The $12 million seed round was led by Andreessen Horowitz with other notable investors participating, including Marc Randolph (co-founder and first CEO of Netflix), Dick Costolo (former CEO of Twitter), Michael Arrington (founder of TechCrunch), and Matt Dellavedova (NBA, Cleveland Cavaliers).

Levels says there are 45,000 people on its waitlist, and with this funding, the company expects to fulfill all pre-orders and millions more. The company expects customers will be able to purchase Levels starting in early 2021.

“Levels is ultimately a behavior change mechanism,” CEO and co-founder Josh Clemente said. “We will continue to establish product development milestones that are focused on achieving that end state before we fully launch. This funding will allow us to grow the team and perform the research necessary to understand specifically which mechanisms to focus on and translate those into the product. Once we reach that degree of efficacy, we’ll launch.”

The founders of Level are passionate about this cause. Over several phone calls with TechCrunch, Levels’ founders Josh Clemente and Dr. Casey Means explained the company’s targets.

“Optimizing metabolic function can improve energy, endurance, memory, mood, and cognitive performance. Seven of the ten leading causes of death in the US are strongly related to metabolic dysfunction,” said Dr. Casey Means, Co-founder of Levels. “Levels helps you improve metabolic fitness by alerting you to foods that negatively impact glucose levels. Armed with this information, you can take control of your metabolic health and make healthier lifestyle decisions.”

Image Credits: Levels

#health, #levels, #tc


Amid Research into Vaping, a Whiff of a Familiar Tactic Emerges

To understand the battle over e-cigarettes, one must look to history, and big tobacco

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#health, #public-health


Vaping Industry Echoes Big Tobacco’s Misleading Call for Science

To understand the battle over e-cigarettes, one must look to history—and big tobacco

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#health, #public-health


Twentyeight Health partners with Healthify to expand its reproductive and sexual health services

Targeting the population that’s most underserved with new treatment options has been part of the mission fro Twentyeight Health since its launch. Now a new partnership with the venture-backed startup, Healthify, means that the company will be able to expand its reach. 

Healthify works with managed care organizations and case workers to integrate social determinants of health into the healthcare system.

Social factors have a significant role to play in patient outcomes, according to new research, and both Twentyeight Health and Healthify are trying to do their part to ensure that access to care becomes less of an issue.

Twentyeight Health sells and delivers birth control pills, patches, rings, shots and emergency contraception prescriptions at a low-cost — or covered by insurance including Medicaid.

Through the Healthify integration, the company will be able to offer its services through health plans and providers that use Healthify to determine social factors that may influence treatment, the companies said.

“This partnership comes at a time when many women in vulnerable communities are in need of prescription delivery or virtual healthcare services due to COVID-19,” said Amy Fan, Co-Founder of Twentyeight Health. “By working with Healthify, we can strengthen our efforts to ensure that all women who want birth control are able to access it.”

Since its launch two years ago, Twentyeight Health is now operating in six states including Florida, Maryland, New Jersey, New York, North Carolina and Pennsylvania.

“Together, we can expand Twentyeight Health’s impact by offering their services to help individuals receive the low- or no- cost birth control that is right for them,” said Manik Bhat, Founder and Chief Executive Officer of Healthify.

To date, Healthify has raised $25.5 million from investors including Primary Venture Partners and BlueCross Blue Shield Venture Partners. Twentyeight Health recently announced a $5 million early stage round of funding and is backed by investors including Third Prime and Town Hall Ventures.

#health, #public-health, #reproductive-health, #tc, #twentyeight-health


Health Care AI Systems Are Biased

We need more diverse data to avoid perpetuating inequality in medicine

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#health, #policyethics


COVID Vaccine Excitement Builds as Moderna Reports Positive Result

Preliminary data show that the immunization is 94 percent effective and seems to prevent severe infections

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#health, #medicine, #public-health


3 growth tactics that helped us surpass Noom and Weight Watchers

Many consumers might think Noom or Weight Watchers are industry leaders with their nonstop commercials, but neither is the fastest-growing weight management program.

Over the past year, nutrition app Lifesum has acquired users at nearly twice the rate of both Noom and Weight Watchers, according to statistics from Sensor Tower, the independent market intelligence for the mobile app economy.

Over this past summer, we surpassed Noom on the global scale with 45 million users. More impressively, we accomplished this without any TV buys. That’s right — no multimillion dollar ad campaigns, allowing us to redistribute precious marketing dollars to other growth projects.

Here’s a closer look at the three growth marketing tactics I credit with helping us scale Lifesum over the last 36 months. It’s a strategy any startup can use, regardless of size or budget.

Understand the different generational lenses

Generations approach products differently. It’s important for startups to understand the different generational approaches of their customers. Startups that spend time thinking and strategizing about where generational trends are going will scale faster.

Here’s a closer look at the three growth marketing tactics I credit with helping us scale Lifesum over the last 36 months. It’s a strategy any startup can use, regardless of size or budget.

Millennials and Generation Z are now the largest consumer market in the world, so you can’t ignore them if you want to scale. With Lifesum these generations have helped our brand surpass the older and well-established competitors. We achieved this by intimately understanding how they view health and fitness.

Gen Z and millennials are all about empowerment. They grew up with Google and Facebook, having information at their fingertips. They are far less likely to be moved by a TV commercial since they desire to discover the world on their own.

In our industry, we’ve learned millennials and Gen Z don’t want a one-size-fits-all weight loss program or to count calories like their parents did 20 years ago. As millennials and Gen Z started embracing keto, intermittent fasting and pescatarian diets, our nutrition team had already created tailored programs to help them stick with it.

Bypass traditional marketing methods

As a brand, it’s important to look ahead and anticipate what is coming next. This also applies to marketing your product. If you get in early with emerging marketing platforms, you will save money and potentially reach more early adopters.

#apps, #column, #entrepreneurship, #growth-marketing, #health, #noom, #startups, #tc, #weight-loss


Strava raises $110 million, touts growth rate of 2 million new users per month in 2020

Activity and fitness tracking platform Strava has raised $110 million in new funding, in a Series F round led by TCV and Sequoia, and including participation by Dragoneer group, Madrone Capital Partners, Jackson Square Ventures and Go4it Capital. The funding will be used to propel the development of new features, and expand the company’s reach to cover even more users.

Already in 2020, Strava has seen significant growth. The company claims that it has added over 2 million new “athletes” (how Strava refers to its users) per month in 2020. The company positions its activity tracking as focused on the community and networking aspects of the app and service, with features like virtual competitions and community goal-setting as representative of that approach.

Strava has 70 million members already according to the company, with presence in 195 countries globally. The company debuted a new Strava Metro service earlier this year, leveraging the data it collects from its users in an aggregated and anonymized way to provide city planners and transportation managers with valuable data about how people get around their cities and communities – all free for these governments and public agencies to use, once they’re approved for access by Strava.

The company’s uptick in new user adds in 2020 is likely due at least in part to COVID-19, which saw a general increase in the number of people pursuing outdoor activities including cycling and running, particularly at the beginning of of the pandemic when more aggressive lockdown measures were being put in place. As we see a likely return of many of those more aggressive measures due to surges in positive cases globally, gym closures could provoke even more interest in outdoor activity – though winter’s effect on that appetite among users in colder climates will be interesting to watch.

Strava’s app is available free on iOS and Android, with in-app purchases available for premium subscription features.

#android, #apps, #health, #jackson-square-ventures, #madrone-capital-partners, #mobile-software, #recent-funding, #software, #startups, #strava, #tc


Scientists Failed to Use Common Sense Early in the Pandemic

The WHO’s initial advice not to wear masks in the fight to contain COVID sowed dangerous confusion

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#health, #observatory, #policyethics, #public-health, #the-sciences


Moderna reports its COVID-19 vaccine is 94.5% effective in first data from Phase 3 trial

Following fast on the heels of Pfizer’s announcement of its COVID-19 vaccine efficacy, Moderna is also sharing positive results from its Phase 3 trial on Monday. The biotech company says that its COVID-19 vaccine candidate has shown efficacy of 94.5% in its first interim data analysis, which covers 95 confirmed COVID cases among its study participants, of which 90 were given the placebo, and only 5 received Moderna’s mRNA-based vaccine. Further, of 11 severe cases of COVID-19, none were found among those who received the actual vaccine candidate.

This is another very promising sign for the potential of having effective vaccines available to the public in some kind of significant volume at some point next year. As mentioned, it’s worth pointing out that this is just a first interim report, but it is data that comes from the safety board overseeing the trial appointed by the National Institutes of Health, which is an independent body not affiliated with Moderna, so it’s a reliable result that provides hope for continued and final analysis.

Moderna says that it will be submitting for an Emergency Use Authorization of its vaccine candidate based on the results within the coming weeks, looking to get approval from the FDA to use it in emergency circumstances ahead of a full and final approval. That EUA, should it be granted, will be based on data from 151 confirmed cases among the Phase 3 participant group (which included 30,000 participants in total), and data from follow-ups extending on average over two months after case confirmation.

All final data will also be submitted to the scientific community for independent peer review, which is a standard part of the ultimate vaccine trial and approval process.

Both these and Pfizer’s vaccine candidate, which it developed in partnership with BioNTech, are mRNA-based vaccines. These are relatively new in terms of human use, and differ from traditional vaccines in that they use messenger RNA to instruct a recipient’s cells to generate effective antibodies, without actually exposing them to any virus, whereas more traditional vaccines in general use typically use either small, safe doses of active or inactive virus in order to trigger a patient’s immune system to generate their own antibodies.

#biontech, #biotech, #coronavirus, #covid-19, #fda, #health, #medical-research, #medicine, #messenger, #moderna, #pfizer, #tc, #vaccination, #vaccine, #vaccines


Vision and Breathing May Be the Secrets to Surviving 2020

Stanford neurobiologist Andrew Huberman discusses the two things we can always control, even during a high-stress election and scary COVID pandemic

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#health, #mental-health, #public-health


Virtual Reality and the COVID Mental Health Crisis

Depression and anxiety have risen amid the pandemic; immersive therapeutics can help

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#health, #mental-health


Coronavirus News Roundup, November 7-November 13

Pandemic highlights for the week

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#health, #public-health


Dating During the Pandemic: Can You Trust an ‘Antibody Positive’ Claim?

Testing positive for COVID antibodies is not a pass to date freely

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#behaviorsociety, #health, #public-health


Microsoft says hackers backed by Russia and North Korea targeted COVID-19 vaccine makers

Microsoft has revealed that hackers backed by Russia and North Korea have targeted pharmaceutical companies involved in the COVID-19 vaccine development efforts.

The technology giant said Friday that the attacks targeted seven companies in the U.S., Canada, France, India, and South Korea. But while it blocked the “majority” of the attacks, Microsoft acknowledged that some were successful.

Microsoft said it had notified the affected companies, but declined to name them.

“We think these attacks are unconscionable and should be condemned by all civilized society,” said Tom Burt, Microsoft’s customer security and trust chief, in a blog post.

The technology giant blamed the attacks on three distinct hacker groups. The Russian group, which Microsoft calls Strontium but is better known as APT28 or Fancy Bear, used password spraying attacks to target their victims, which often involves recycled or reused passwords. Fancy Bear may be best known for its disinformation and hacking operations in the run-up to the 2016 presidential election, but the group has also been blamed for a string of other high-profile attacks against media outlets and businesses.

The other two groups are backed by the North Korean regime, one of which Microsoft calls Zinc but is better known as the Lazarus Group, which used targeted spearphishing emails disguised as recruiters in an effort to steal passwords from their victims. Lazarus was blamed for the Sony hack in 2016 and the WannaCry ransomware attack in 2017, as well as other malware-driven attacks.

But little is known about the other North Korea-backed hacker group, which Microsoft calls Cerium. Microsoft said the group also used targeted spearphishing emails masquerading as representatives from the World Health Organization, charged with coordinating the effort to combat the COVID-19 pandemic.

A Microsoft spokesperson acknowledged it was the first time the company had referenced Cerium, but the company did not offer more.

This is the latest effort by hackers trying to exploit the COVID-19 pandemic for their own goals. Earlier this year, the FBI and Homeland Security warned that hackers would try to steal coronavirus vaccine research.

Today’s news coincides with the Paris Peace Forum, where Microsoft president Brad Smith will urge governments to do more to combat cyberattacks against the healthcare sector, particularly during the pandemic.

“Microsoft is calling on the world’s leaders to affirm that international law protects health care facilities and to take action to enforce the law,” Burt said. “We believe the law should be enforced not just when attacks originate from government agencies but also when they originate from criminal groups that governments enable to operate — or even facilitate — within their borders.”

#coronavirus, #covid-19, #government, #hacking, #health, #microsoft, #nation-state, #national-security, #security


Why Polls Were Mostly Wrong

Princeton’s Sam Wang had to eat his words (and a cricket) in 2016. He talks about the impacts of the pandemic and QAnon on public-opinion tallies in 2020

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#behaviorsociety, #health, #public-health, #the-sciences


For COVID Drugs, Months of Frantic Development Lead to Few Outright Successes

There have been mixed results as researchers try to stop a disease they are still trying to understand

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#health, #medicine, #public-health


Scientists and Health Experts Need to Be Advocates

Amid multiple crises, science and medicine cannot stand aloof from politics

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#health, #policyethics


Divide and Conquer Could Be Good COVID Strategy

COVID might be fought efficiently with fewer shutdowns by restricting activities only in a particular area with a population up to 200,000 when its case rate rises above a chosen threshold.  

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#health, #math, #public-health, #the-sciences


An Emerging Tool for COVID Times: The Portable MRI

Bedside imaging holds vast potential as a diagnostic tool, especially during the pandemic

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#health, #medicine, #public-health


Pfizer’s Early Results Bode Well for a COVID Vaccine Approval This Year

The data are preliminary, however, and it is not yet clear whether the vaccine protects against severe disease

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#health, #medicine, #public-health


Early COVID Vaccine Results Bode Well for an Approval This Year

The data are preliminary, however, and it is not yet clear whether the vaccine protects against severe disease

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#health, #medicine, #public-health


Cutting Diesel Exhaust Could Lessen COVID Spread in Cities

Fewer particulates in the air would carry less virus to unsuspecting residents

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#health, #public-health


We Finally Have a COVID Strategy

The Biden-Harris plan is vastly better than Trump’s “you’re on your own” approach—but it’s not perfect

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#health, #policyethics


How We Can Avoid a ‘Twindemic’ of COVID and Flu

There’s no vaccine against the coronavirus yet, but we have influenza vaccines—and we need to use them

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#health, #public-health


The Real Danger Posed by Coronavirus-Infected Mink

A new SARS-CoV-2 strain in mink has infected about a dozen people in Denmark, but it is not known whether the mutation makes the virus more dangerous

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#health, #public-health


Virtual Patients Could Revolutionize Medicine

Replacing humans with digital simulations could make clinical trials faster and safer

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#computing, #health, #medicine, #tech