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.

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.

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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

 

 

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.

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.

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.

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.

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.

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.

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.