A Food and Drug Administration official said COVID-19 vaccine makers won't need to carry out fresh clinical trials to receive approval for booster shots they're updating for newer Omicron variants. Dr. Peter Marks, who runs the FDA's Center for Biologics Evaluation and Research, told Reuters the agency will use data from trials for vaccines that target BA.1 — the Omicron variant that caused a huge surge in infections last winter — as well as manufacturing data to assess the vaccines. Safety data and preclinical data from animal studies may also be used.
This week, the FDA asked vaccine manufacturers to modify booster shots to target the Omicron BA.4 and BA.5 variants in addition to the original strain of the virus. The agency hopes the updated boosters will be ready by the fall. "It's going to be really critical as we move into this fall where we've seen this evolution into BA.4/5, where we could see further evolution, to try to get as many people boosted as we can," Marks said.
The Centers for Disease Control and Prevention says BA.1 isn't circulating in the US anymore, but BA.4 and BA.5 now account for over 52 percent of COVID-19 infections in the country. Combined, they made up just 0.5 percent of cases in the US at the end of April.
Pfizer and Moderna this week released clinical trial data which suggests versions of their shots that target BA.1 offered a stronger immune response than the initial COVID-19 vaccines. Those boosters did not perform quite as well against BA.4 and BA.5. However, the data showed that the immune response was still robust.
The Food and Drug Administration has asked COVID-19 vaccine makers to update booster shots to tackle newer omicron variants that are on the rise. It says the manufacturers should add a spike protein component to shots to target the omicron BA.4 and BA.5 variants in addition to the original strain.
An "overwhelming majority" of the FDA's advisory committee voted this week in favor of updating shots with an omicron component, in the hopes of starting to use those modified boosters in the fall. The advisory is only for booster shots and not primary inoculations.
Vaccine makers are essentially playing whack-a-mole with the various strains of COVID-19. Pfizer and Moderna have created versions of their vaccines that target BA.1, the omicron variant that caused a significant upswing in COVID-19 cases during the winter.
However, that strain isn't circulating in the US anymore, according to the Centers for Disease Control and Prevention. Earlier this week, the CDC said BA.4 and BA.5 now account for over 52 percent of COVID-19 infections in the US. That figure is expected to rise in the coming weeks.
As CNBCnotes, Pfizer and Moderna released clinical trial data this week showing that the current omicron shots performed better against BA.1 than the original versions of their vaccines in terms of offering a stronger immune response. While the immune response against BA.4 and BA.5 was still said to be robust, the omicron inoculations were less effective against those strains. It's unclear how long it will take vaccine makers to develop shots that take aim at BA.4 and BA.5.
"Vaccine manufacturers have already reported data from clinical trials with modified vaccines containing an omicron BA.1 component and we have advised them that they should submit these data to the FDA for our evaluation prior to any potential authorization of a modified vaccine containing an omicron BA.4/5 component," the FDA said. "Manufacturers will also be asked to begin clinical trials with modified vaccines containing an omicron BA.4/5 component, as these data will be of use as the pandemic further evolves."
If you post about being able to mail abortion pills to those who need it on Facebook, don't be surprised if you get a warning — or even get your account restricted. A tipster told Motherboard that they were notified a minute after posting "I will mail abortion pills to any one of you" that their status update had been removed. When they tried to post about it again later, they were banned for it. Motherboard was able to replicate the scenario, and we were able to confirm it, as well. We tried posting "abortion pills can be mailed" on Facebook and were quickly notified that we violated the website's Community Standards.
Facebook
In the next slide explaining our infraction, Facebook said doesn't allow users to buy, sell or exchange things such as tobacco, marijuana, recreational drugs and non-medical drugs. To test it out, we posted "I'm selling cigarettes," "cigarettes can be mailed," "anti-depressants can be mailed" and "painkiller pills can be mailed." None of them got flagged. General posts such as "abortion is healthcare" didn't get flagged either. As for our post that did get flagged, we were asked if we would like to accept Facebook's enforcement action or not. After choosing to accept it, our post got removed but we didn't get banned. According to Motherboard, their account got restricted for 24 hours after making several posts that got flagged.
It's unclear when the website started removing posts about mailing out abortion pills and whether it only began after the Supreme Court overturned Roe v. Wade. The Supreme Court's decision made all types of abortion illegal in several states with trigger laws, but people in those states can still get abortion pills shipped to them from international groups like Aid Access. Facebook could be preventing that information from getting to some people who need it, though, especially since it flags posts with "mail" and "abortion pills" even for international users. We posted from outside the US and still got a warning. "Some items aren't regulated everywhere," the slide explaining our violation reads, "but because Facebook is borderless we have global standards that apply to everyone."
The New York Times also recently reported that Facebook's parent company, Meta, told employees not to discuss the Supreme Court ruling within the workplace. Moderators would reportedly swoop in and quickly remove posts about abortion in the company's internal Workplace platform. Meta did, however, tell employees that it would reimburse them for travel expenses if they need to access out-of-state healthcare and reproductive services "to the extent permitted by law."
The Food and Drug Administration has banned e-cigarette maker Juul from selling and distributing its products in the US. It ordered the company to remove its wares from the market or face enforcement actions.
Reports earlier this week suggested that an FDA ban on Juul products was imminent. After a two-year review, the FDA rejected Juul's application to keep selling tobacco- and menthol-flavored pods as well as its vape pen.
The decision doesn't apply to Juul pens and pods that are already in the possession of the company's customers. However, it'll be difficult, if not impossible, to find those products in the near future.
In 2020, the FDA began a comprehensive review of all e-cigarette products sold in the US. It weighed up the potential benefits of vaping vs. cigarettes for adult smokers against the popularity of e-cigarettes among underage users. The agency has permitted other manufacturers to continue selling vape products, including NJOY and Vuse parent Reynolds American. To date, the agency has authorized 23 "electronic nicotine delivery systems" (to give vape pens their formal name).
In Juul's case, though, the FDA said the company's application "lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing of the products would be appropriate for the protection of the public health. In particular, some of the company’s study findings raised concerns due to insufficient and conflicting data – including regarding genotoxicity and potentially harmful chemicals leaching from the company’s proprietary e-liquid pods – that have not been adequately addressed and precluded the FDA from completing a full toxicological risk assessment of the products named in the company’s applications."
The agency went on to say that it doesn't have clinical information that suggests there is "an immediate hazard" linked to Juul's pen or pods. "However, the [marketing denial orders] issued today reflect FDA’s determination that there is insufficient evidence to assess the potential toxicological risks of using the Juul products," the FDA said. It noted that it's not possible to grasp the possible harms of using other pods in a Juul vape pen or the company's pods in third-party devices.
“The FDA is tasked with ensuring that tobacco products sold in this country meet the standard set by the law, but the responsibility to demonstrate that a product meets those standards ultimately falls on the shoulders of the company,” said Michele Mital, acting director of the FDA’s Center for Tobacco Products. “As with all manufacturers, Juul had the opportunity to provide evidence demonstrating that the marketing of their products meets these standards. However, the company did not provide that evidence and instead left us with significant questions. Without the data needed to determine relevant health risks, the FDA is issuing these marketing denial orders.”
Juul can appeal the decision or challenge it in court. Engadget has contacted the company for comment.
The company became the leader in the US e-cigarette market in 2018. However, sales have dropped following a string of controversies. Juul slipped to second place behind Vuse in terms of US market share. The vast majority of the company's revenue comes from the US, The Wall Street Journal noted this week.
Juul had been accused by federal agencies, state attorneys general and other officials of marketing its products to teens. The company agreed to pay eight-figure settlements related to lawsuits in North Carolina and Washington state, and faced suits in several other states.
The company halted sales of mint- and fruit-flavored vape pods in 2019 before the FDA banned most flavored variants in early 2020. According to the Centers for Disease Control and Prevention, nearly 85 percent of young people who had used e-cigarettes said they used flavored varieties. However, vaping has become less popular among teens overall. In 2019, Juul revealed a new, connected version of its vape pen that can verify a user's identity in an attempt to prevent underage use.
Early in the pandemic, scientists tried training dogs to detect COVID-19 infections in humans. The results were predictable. Man’s best friend proved adept at sniffing out the disease, but the question researchers kept asking themselves was how they would scale that approach. After all, training a dog is expensive, and taking care of one can be a handful.
Still, the idea of using animals to spot sick humans is a good one and one that a team of researchers from Michigan State University approached in a novel way. In a recent study published in the journal bioRXiv, they detailed a locust-based cancer screening system. Per MIT Technology Review, the tech involves surgically-altered locusts with electrodes implanted into the lobes of their brains by Professor Debajit Saha and his colleagues. Those electrodes were there to capture signals from each insect’s antennae, which they use to sense smells.
Additionally, the team grew three different types of cancerous human mouth cells – in addition to a separate set of healthy ones – and built a device for capturing the gases emitted by those tissues. They then used that device to give the insects a whiff of the gases. They found that the locusts' brains responded to each type of tissue differently and that they could correctly identify sick cells with only the recording of the gasses.
It’s hard to say if you’ll ever see your local clinic uses insects for cancer screenings. The study hasn’t been peer-reviewed yet, and it’s difficult to know if regulators like the Food and Drug Administration would ever approve such a procedure. People could also find the treatment of the locusts questionable. “The insect is dead in terms of its body function,” Saha told MIT Technology Review. “We are just keeping its brain alive.”
Saha and his team plan to continue work on the project. Their current system requires between six and 10 locust brains to function. He hopes new electrodes will allow his team to record more neurons, thereby making a single locust brain sufficient for an individual screening. He also wants to make the device holding the brain and antennae portable, which would allow the team to use the system outside of a lab.
A group of Democratic lawmakers led by Sen. Mark Warner (D-Va.) and Rep. Elissa Slotkin is urging Google to "crack down on manipulative search results" that lead people seeking abortions to anti-abortion clinics. In a letter addressed to Alphabet CEO Sundar Pichai, the lawmakers reference a study conducted by US nonprofit group Center for Countering Digital Hate (CCDH). The organization found that 1 in 10 Google search results for queries such as "abortion clinics near me" and "abortion pill" — specifically in states with trigger laws that would ban the procedure the moment Roe v. Wade is overturned — points to crisis pregnancy centers that oppose abortion instead.
"Directing women towards fake clinics that traffic in misinformation and don't provide comprehensive health services is dangerous to women's health and undermines the integrity of Google's search results," the lawmakers wrote. CCDH also found that 37 percent of results on Google Maps for the same search terms lead people to anti-abortion clinics. The lawmakers argue in the letter that Google should not be displaying those results for users searching for abortion and that if the company's search results must continue showing them, they should at least be properly labeled.
In addition, CCDH found that 28 percent of ads displayed at the top of Google search results are for crisis pregnancy centers. Google added a disclaimer for those ads, "albeit one that appears in small font and is easily missed," the lawmakers note, after getting flak for them a few years ago. "The prevalence of these misleading ads marks what appears to be a concerning reversal from Google’s pledge in 2014 to take down ads from crisis pregnancy centers that engage in overt deception of women seeking out abortion information online," the letter reads.
Warner, Slotkin and the letter's other signees are asking Google what it plans to do to limit the appearance of anti-abortion clinics when users are explicitly searching for abortion services. And, if Google chooses not to take action to prevent them from appearing in results, the group is asking whether Google would add user-friendly disclaimers clarifying whether the clinic is or isn't providing abortion services. You can read the whole letter below:
NEW: @RepSlotkin and I are leading a group of lawmakers to push on the Google CEO to crack down on manipulative search results that lead to scammy “crisis pregnancy centers.”
It’s time for them to limit or label results and ads that lead to fake abortion clinics. pic.twitter.com/LlkTueI2QP
A Supreme Court draft obtained by Politico in May showed that SCOTUS justices have voted to reverse Roe v. Wade, the landmark case that protected the federal rights to abortion across the country. Senator Ron Wyden and 41 other Democratic lawmakers also previously asked Google to stop collecting and keeping users' location data. They said the information could be used against people who've had or are seeking abortions in states with trigger laws.
Facebook is collecting data about people who visit the websites of pregnancy crisis centers, according to a report from Reveal. The findings raise questions about how that data could be misused, and Meta’s ability to enforce its advertising rules.
In an investigation conducted with The Markup, Reveal found that hundreds of crisis pregnancy centers were using the Meta Pixel on their websites. The Meta Pixel allows companies to keep tabs on who visits their websites so they can create targeted ads on Facebook. As the report notes, so-called crisis pregnancy centers typically aren't licensed medical establishments and are not bound by HIPAA and other privacy regulations. Instead, they are "mostly run by religiously aligned organizations whose mission is to persuade people to choose an option other than abortion."
Under Meta’s rules, the Meta Pixel is supposed to filter out “sensitive” health data, like much of what Reveal found was being collected. “In many cases, the information was extremely sensitive – for example, whether a person was considering abortion or looking to get a pregnancy test or emergency contraceptives,” Reveal reports. In some cases, the social network also received data about specific appointments that were requested. The report also found that third-party anti-abortion marketing companies were able to gain access to data collected by the Meta Pixel, even though their websites had not been visited.
In a statement provided to Reveal, Meta said that “It is against our policies for websites and apps to send sensitive information about people through our Business Tools,” referring to the Meta Pixel. “Our system is designed to filter out potentially sensitive data it detects, and we work to educate advertisers on how to properly set up our Business Tools.”
The issue of online platforms collecting data from people seeking abortion services has taken on a new urgency in recent weeks following a leak of a draft Supreme Court opinion that would overturn Roe v. Wade. Privacy advocates have warned that the information could be used to prosecute people seeking abortions in areas where it's been outlawed. Lawmakers have also raised concerns about the issue, calling on Apple, Google and other platforms to bar apps that collect data targeting people seeking abortion services.
Researchers have 3D-printed hearts using silicone and even a patient's own cells, but they haven't matched the full functionality of the real thing and aren't much good for repairing hearts. There's some progress on that front, however, as a team at Harvard's Wyss Institute has developed a technique for 3D-printing long cardiac macrofilaments that develop into muscle-like filaments which contract. The new method mimics the complex alignment of a heart's contracting elements (a difficult feat so far) while producing tissue thick enough to use in regenerative heart treatments.
The system is a refinement of Wyss' existing SWIFT (Sacrificial Writing in Functional Tissue) bioprinting technology. Their approach created a platform with 1,050 wells, each with two microscopic pillars. Scientists filled the wells with human-induced pluripotent stem cells (that is, young cells capable of developing into multiple forms) as well as a protein collagen and the cells used to form connective tissue. The combination forms a dense tissue that aligns along the axis linking the micropillars. The team then lifts the resulting organ building blocks off the pillars, uses that to create a bioprinting ink and uses the motion of the 3D printer head to further help with alignment.
This is just a small piece of the heart. While the technology produces a relatively high output, there's much more work to be done before a fully functional, 3D-printed organic heart is available.
The research group believes their work could still be useful long before reaching the whole-heart milestone. The 3D-printed filaments could be used to replace scars following heart attacks, or to create improved disease models. They might even patch holes in newborns with congenital heart defects, and would grow with those child patients. Simply put, a damaged heart might not be the permanent problem it tends to be today.
Apple is at last promising better sleep tracking for Apple Watch as part of watchOS 9. The Sleep app will add a sleep stage function. It will be able to detect the REM, core and deep sleep stages and track those over time. Those who participate in the Apple health research program will be able to submit their sleep stage data to researchers for a new study.
One of the more notable health features for watchOS 9 is that it will show how long a wearer is in a state of atrial fibrillation (AFib) if they have been diagnosed with the condition. The new feature will show the time of day or week that AFib is most active.
You'll receive weekly notifications to help you gain a better insight of AFib frequency. The Health app will show a detailed history, along with indicators of lifestyle factors that may impact the condition, such as exercise, sleep and alcohol intake. You'll be able to download a PDF that includes your aFib history and possible lifestyle factors to share with your healthcare professionals.
Apple Watch's electrocardiogram (ECG) tool can look for signs of an irregular heartbeat or AFib. The US Food and Drug Administration just granted Apple approval last week for an ECG history feature.
In addition, Apple is introducing a Medications app to help users keep track of when to take their meds.
A lot of us have been on post-pandemic health kicks or just relishing a return to the sports and fitness regimens we enjoyed before COVID-19 derailed everything. Subsequently, many of us (raises hand) might have overexerted ourselves.
Unfortunately, a few minutes of post-workout stretching isn’t always enough to relieve the aches and pains of a Couch to 5K excursion. While several popular massage gadgets have hit the market over the last few years, the pandemic has led to many seeking out recovery methods that don’t require coming face to face with a massage therapist. These gadgets might not measure up to a professional’s hands, but they may help. We’ve researched and tested all of the following picks, including percussive therapy guns, compression therapy tech, and even some analog accessories that don’t require charging.
About me
I’m not an athlete, but I’ve had several chapters in my fitness journey over the years. I have a black belt in Judo, and am currently trying to perfect a backflip. I sweat my way through HIIT and weight training classes five times a week. And because of all these things, I have my own particular aches and pains, especially with my knee, neck and shoulders.
When testing some of these devices, I used them daily for over a week. Depending on what kind of recovery gadget it was, I would spend at least 15 minutes targeting stiff areas, alongside stretches. I’ve intermittently been using some of these accessories, like a foam roamer, for years.
The basics
Foam roller
Trigger Point
There’s no vibrating function here, just a cylinder-shaped piece of foam (sometimes plastic or rubber) for you to gingerly roll yourself across. I’ve personally enjoyed some relief from knee issues (combined with recovery exercises and guidance from my physio) and found that it helped loosen up tight quads.
The great thing about a foam roller is its versatility. There are exercises for the shoulders, back muscles, the iliotibial (IT) band and every other part of your leg. Many rollers come with basic diagrams to try out, but you can also follow along with many YouTube videos; just search for a specific tight area.
If you’re new to foam rolling, I’d suggest this one from Trigger Point, which is gentler on your tender muscles than some of the plastic-molded options.
These rigid massage balls, usually the size of a tennis ball, offer a trigger point massage that helps tackle knots in your shoulder blade, or that tight corner of your glutes. Place the ball on a yoga mat (or carpet) and position your problem area over the ball, using your body weight to apply force. Relief isn’t just limited to the floor either. Try positioning the ball between your back – or shoulder – and a wall. There are several guides online, but this set of balls, with differing levels of stiffness, should ensure you feel the pressure at just the right level.
This recommendation comes from my colleague Valentina Palladino, who loves this bolster for improving her yoga habit. Bolsters are firm pillows that come in several shapes and sizes which help many yoga practitioners maintain proper posture in certain movements, due to lack of flexibility or minor injuries.
According to Valentina: “While I definitely don’t stretch as much as I should, this bolster that I originally bought solely for yoga practice has come in handy when I do sit on the mat for a 10-minute, post-run stretch. I mostly use it for back extensions, placing the bolster underneath my lower back so I can get a gentle spinal decompression.
She adds: “There are dedicated back stretchers you can buy that do something similar, but I have come to prefer the bolster for its supportive comfort and its versatility. I still use it during yoga sessions as a tool to get deeper into certain movements, and it provides extra support in sitting poses.”
Should you splurge on something a little more powerful and expensive, though? There is established evidence that manual hand massage helps to reduce pain, but there’s less supporting data for many of the benefits claimed by percussive therapy devices.
Depending on the company and the device, some claims (like improved performance or range of motion) are backed up by small studies, but others (including reduced cellulite and sped-up muscle recovery) are not.
Dr. Kelly Starrett, Athlete Performance Advisor for Hyperice (and founding mobility expert for CrossFit) told Engadget: “When we are trying to change how the brain interprets information from the body’s tissue systems as threatening or unsafe; vibration, percussion, and even heat can help us feel better.”
My own experience tracks with this: using one with a targeted approach to tight areas feels good and can help you prime your body ahead of a workout without overexerting yourself.
If you’ve seen the Instagram ads, you already know there are many massage guns to choose from, but our picks come from two of the most prominent players in the field, Therabody’s Theragun and Hyperice’ HyperVolt series.
Theragun Prime
Mat Smith/Engadget
We’ve touched on the benefits of the Theragun Prime before, but it’s the company’s unique triangle design that helps its devices stand out. It offers multiple ways to grip the Theragun and help target trickier parts of the body. As one of the more premium massage devices, you get 16mm amplitude (typically only beaten by devices several hundred dollars more) and speeds of up to 2,400 percussions per minute.
The Prime comes with three extra attachments in addition to the standard ball: a cone, a dampener with a flattened head, and a thumb attachment, which can help dig deeper.
Therabody’s latest family of percussive therapy devices is also quieter than older Theraguns – and most of the competition – but it certainly isn’t silent.
The HyperVolt 2 Pro has a more conventional design, but I prefer its dial for switching between different speeds. It, too, comes with extra head attachments, including a fork attachment, a flat wedge and a cushioned head.
This is the premium flagship Hypervolt, so it offers the fastest speeds (faster than even the Theragun Prime). However, while it's also quieter than the Prime, it is a little trickier to maneuver into difficult tight spots without assistance from someone else.
These devices are generally safe in most use cases, but check out each company’s safety guideline pages. It’s sensible to talk to your doctor before use if you’re pregnant, have had recent surgery or have any existing skin or nerve system conditions.
Hyperice has also combined its vibration tech with the targeted relief of a massage ball. The Hypersphere (and HyperSphere mini) include three levels of vibration and an easy-to-understand LED read-out to gauge battery life and intensity levels. In addition, the shape adds a different degree of versatility, as you don’t need to reach with your arm to where you might need relief.
It’s also got a rubber coating that helps it stay in place if you’re not stretching or massaging on a yoga mat. Notably, the smaller Mini has a more powerful motor and is more comparable in size to a lacrosse ball. Despite a more powerful motor and roughly identical battery life, it's more affordable than the bigger model. Most will find the Mini the better option, but the larger Hypersphere, I found, worked well on my lower back and chest, as it raised my body further off the ground, increasing the targeted pressure.
Therabody, the company behind Theragun, has branched out into several additional recovery products. The company also offers a vibrating foam roller and ball, but its RecoveryAir series is entirely different, using controlled compression to massage your legs or arms gently.
The RecoveryAir system is split into a lower (for your legs, from foot to hip) and upper body system, but the “trousers” seem like the best device for most, massaging some of the biggest muscle groups in your body. They feel particularly good after a heavy session of squats or a lengthy run.
While Therabody might be new to compression therapy, science and research into it has continued for decades, with medical compression garments as far back as the 1950s used for treating conditions following the end of World War II.
The AirRecover squeezes at your legs, stimulating your body’s circulation like – and this is a quote from a Therabody’s spokesperson – “squeezing a toothpaste tube.” It’s a relaxing sensation: the AirRecover cycles through squeezing at your feet, calves, knees, hamstrings and thighs. You can adjust both the strength of the compression and the length of the massage up to an hour. Compared with massage guns and static tissue massage, you get to be a little lazier and let the AirRecover do the work.
You can just chill on your sofa or favorite chair, watching Netflix, while it squeezes away. That ease of use comes at a high price, though: $1,299. It’s rather expensive compared to the other devices we’ve included here, but it’s also a very different experience and one that steers itself.
