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Why is it so hard to review the Johnson & Johnson vaccine? Data.

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Why is it so hard to review the Johnson & Johnson vaccine? Data.


“We’ll never have perfect data, and there will always be uncertainty,” said Grace Lee, a professor at Stanford University and chair of the advisory panel’s Covid-19 Vaccine Safety Technical Subgroup, when the group met on Wednesday. “It’s really, for me, about getting better risk estimates.” 

Committee members agreed to reconvene once they’ve had more time to gather and assess data about who might be most at risk of complications, and how that compares with the risk of catching and spreading covid.

All six of the cases reported after the vaccine became widely available occurred in women; one additional case—a man—was reported during clinical trials. All patients were between 18 and 48, and several were treated with the blood thinner heparin, which is typically used for clots but worsened the condition of these patients. The symptoms appear very similar to ones associated with AstraZeneca’s covid vaccine, which many European countries have limited or even stopped using. The active components of both are delivered to cells by adenoviruses that have been modified so they can’t replicate.

But because there are other treatments available that use totally different methods, experts say it is sensible to hold off to see if more information becomes available. The Johnson & Johnson vaccine counts for only 7.5 million of America’s 195 million shots delivered; the Pfizer-BioNTech and Moderna vaccines, which use mRNA rather than adenoviruses, are responsible for the rest.

“We’ll never have perfect data, and there will always be uncertainty. It’s really, for me, about getting better risk estimates.” 

“The risks and benefits of continuing to administer the J&J vaccine can’t be looked at in isolation,” says Seema Shah, a bioethicist at Lurie Children’s Hospital in Chicago. “If people have alternatives, at least while the FDA is figuring things out, it makes sense to steer people in the direction of those alternatives.”

Resumption of Johnson & Johnson shots may not mean that it becomes available to everybody, however. Ensuring the safety of vaccines is especially important because they’re given to healthy people, rather than treating people who are already sick, and successfully figuring out which groups might see the most benefit—or most harm—could lead to tiered recommendations. Several EU countries, for instance, have said the AstraZeneca vaccine should be given to older people at higher risk of complications from covid, rather than younger people who might be at higher risk of vaccine complications.

“At the end of the day, the critical issue is if I’m a 30-year-old woman and I get this vaccine, how much will that increase my risk of this bad thing?” says Arthur Reingold, chair of California’s Covid-19 Scientific Safety Review Workgroup and a former member of the CDC’s vaccine advisory panel. 

A more complicated question is what data the committee will review to make a final decision.

No comprehensive data

Information may be limited because the issue was caught quickly, and because the Johnson & Johnson vaccine is so far being deployed only in the US (the company said it was delaying delivery to European Union countries). But making a determination may also prove difficult because America’s medical data is highly fragmented.

Without a national health-care system, there’s no comprehensive way to assess risks and benefits for different groups that have received the vaccine. There is no routine federal capability to connect patient data with vaccine records. Instead, regulators hope clinicians will hear about the pause and proactively report cases they hadn’t previously connected to vaccinations. 

“It might stimulate some clinician to say, ‘Oh my God, Mrs. Jones had that three weeks ago,’” says Reingold. In addition, he says, “there’s still quite a few people who have gotten a dose within the last two weeks, and some of them could develop this rare side effect.”

The voluntary system may seem archaic, but that is how the six cases under review came to the attention of the authorities. They were reported to the CDC through an online database called the Vaccine Adverse Events Reporting System, or VAERS. It is an open website that medical staff, patients, and caregivers can use to notify the government about potential vaccine side effects. 

Because the system is so open, and requires opt-in participation, it’s impossible to calculate exact risks using VAERS data. Epidemiologists generally think of it as a place to look for hypotheses that tie vaccines to side effects, rather than a source that can be used to confirm their suspicions.

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A nonprofit promised to preserve wildlife. Then it made millions claiming it could cut down trees

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A nonprofit promised to preserve wildlife. Then it made millions claiming it could cut down trees


Clegern said the program’s safeguards prevent the problems identified by CarbonPlan.   

California’s offsets are considered additional carbon reductions because the floor serves “as a conservative backstop,” Clegern said. Without it, he explained, many landowners could have logged to even lower levels in the absence of offsets.

Clegern added that the agency’s rules were adopted as a result of a lengthy process of debate and were upheld by the courts. A California Court of Appeal found the Air Resources Board had the discretion to use a standardized approach to evaluate whether projects were additional.

But the court did not make an independent determination about the effectiveness of the standard, and was “quite deferential to the agency’s judgment,” said Alice Kaswan, a law professor at the University of San Francisco School of Law, in an email.

California law requires the state’s cap-and-trade regulations to ensure that emissions reductions are “real, permanent, quantifiable, verifiable” and “in addition to any other greenhouse gas emission reduction that otherwise would occur.”

“If there’s new scientific information that suggests serious questions about the integrity of offsets, then, arguably, CARB has an ongoing duty to consider that information and revise their protocols accordingly,” Kaswan said. “The agency’s obligation is to implement the law, and the law requires additionality.”

The recipe

On an early spring day, Lautzenheiser, the Audubon scientist, brought a reporter to a forest protected by the offset project. The trees here were mainly tall white pines mixed with hemlocks, maples and oaks. Lautzenheiser is usually the only human in this part of the woods, where he spends hours looking for rare plants or surveying stream salamanders.

The nonprofit’s planning documents acknowledge that the forests enrolled in California’s program were protected long before they began generating offsets: “A majority of the project area has been conserved and designated as high conservation value forest for many years with deliberate management focused on long-term natural resource conservation values.”

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Meet Jennifer Daniel, the woman who decides what emoji we get to use

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Meet Jennifer Daniel, the woman who decides what emoji we get to use


Emoji are now part of our language. If you’re like most people, you pepper your texts, Instagram posts, and TikTok videos with various little images to augment your words—maybe the syringe with a bit of blood dripping from it when you got your vaccination, the prayer (or high-fiving?) hands as a shortcut to “thank you,” a rosy-cheeked smiley face with jazz hands for a covid-safe hug from afar. Today’s emoji catalogue includes nearly 3,000 illustrations representing everything from emotions to food, natural phenomena, flags, and people at various stages of life.

Behind all those symbols is the Unicode Consortium, a nonprofit group of hardware and software companies aiming to make text and emoji readable and accessible to everyone. Part of their goal is to make languages look the same on all devices; a Japanese character should be typographically consistent across all media, for example. But Unicode is probably best known for being the gatekeeper of emoji: releasing them, standardizing them, and approving or rejecting new ones.

Jennifer Daniel is the first woman at the helm of the Emoji Subcommittee for the Unicode Consortium and a fierce advocate for inclusive, thoughtful emoji. She initially rose to prominence for introducing Mx. Claus, a gender-inclusive alternative to Santa and Mrs. Claus; a non-gendered person breastfeeding a non-gendered baby; and a masculine face wearing a bridal veil. 

Now she’s on a mission to bring emoji to a post-pandemic future in which they are as broadly representative as possible. That means taking on an increasingly public role, whether it’s with her popular and delightfully nerdy Substack newsletter, What Would Jennifer Do? (in which she analyzes the design process for upcoming emoji), or inviting the general public to submit concerns about emoji and speak up if they aren’t representative or accurate.

“There isn’t a precedent here,” Daniel says of her job. And to Daniel, that’s exciting not just for her but for the future of human communication.

I spoke to her about how she sees her role and the future of emoji. The interview has been lightly edited and condensed. 

What does it mean to chair the subcommittee on emoji? What do you do?

It’s not sexy. [laughs] A lot of it is managing volunteers [the committee is composed of volunteers who review applications and help in approval and design]. There’s a lot of paperwork. A lot of meetings. We meet twice a week.

I read a lot and talk to a lot of people. I recently talked to a gesture linguist to learn how people use their hands in different cultures. How do we make better hand-gesture emoji? If the image is no good or isn’t clear, it’s a dealbreaker. I’m constantly doing lots of research and consulting with different experts. I’ll be on the phone with a botanical garden about flowers, or a whale expert to get the whale emoji right, or a cardiovascular surgeon so we have the anatomy of the heart down. 

There’s an old essay by Beatrice Warde about typography. She asked if a good typeface is a bedazzled crystal goblet or a transparent one. Some would say the ornate one because it’s so fancy, and others would say the crystal goblet because you can see and appreciate the wine. With emoji, I lend myself more to the “transparent crystal goblet” philosophy. 

Why should we care about how our emoji are designed?

My understanding is that 80% of communication is nonverbal. There’s a parallel in how we communicate. We text how we talk. It’s informal, it’s loose. You’re pausing to take a breath. Emoji are shared alongside words.

When emoji first came around, we had the misconception that they were ruining language. Learning a new language is really hard, and emoji is kind of like a new language. It works with how you already communicate. It evolves as you evolve. How you communicate and present yourself evolves, just like yourself. You can look at the nearly 3,000 emoji and it [their interpretation] changes by age or gender or geographic area. When we talk to someone and are making eye contact, you shift your body language, and that’s an emotional contagion. It builds empathy and connection. It gives you permission to reveal that about yourself. Emoji can do that, all in an image.

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Product design gets an AI makeover

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Product design gets an AI makeover


It’s a tall order, but one that Zapf says artificial intelligence (AI) technology can support by capturing the right data and guiding engineers through product design and development.

No wonder a November 2020 McKinsey survey reveals that more than half of organizations have adopted AI in at least one function, and 22% of respondents report at least 5% of their companywide earnings are attributable to AI. And in manufacturing, 71% of respondents have seen a 5% or more increase in revenue with AI adoption.

But that wasn’t always the case. Once “rarely used in product development,” AI has experienced an evolution over the past few years, Zapf says. Today, tech giants known for their innovations in AI, such as Google, IBM, and Amazon, “have set new standards for the use of AI in other processes,” such as engineering.

“AI is a promising and exploratory area that can significantly improve user experience for designing engineers, as well as gather relevant data in the development process for specific applications,” says Katrien Wyckaert, director of industry solutions for Siemens Industry Software.

The result is a growing appreciation for a technology that promises to simplify complex systems, get products to market faster, and drive product innovation.

Simplifying complex systems

A perfect example of AI’s power to overhaul product development is Renault. In response to increasing consumer demand, the French automaker is equipping a growing number of new vehicle models with an automated manual transmission (AMT)—a system that behaves like an automatic transmission but allows drivers to shift gears electronically using a push-button command.

AMTs are popular among consumers, but designing them can present formidable challenges. That’s because an AMT’s performance depends on the operation of three distinct subsystems: an electro-mechanical actuator that shifts the gears, electronic sensors that monitor vehicle status, and software embedded in the transmission control unit, which controls the engine. Because of this complexity, it can take up to a year of extensive trial and error to define the system’s functional requirements, design the actuator mechanics, develop the necessary software, and validate the overall system.

In an effort to streamline its AMT development process, Renault turned to Simcenter Amesim software from Siemens Digital Industries Software. The simulation technology relies on artificial neural networks, AI “learning” systems loosely modeled on the human brain. Engineers simply drag, drop, and connect icons to graphically create a model. When displayed on a screen as a sketch, the model illustrates the relationship between all the various elements of an AMT system. In turn, engineers can predict the behavior and performance of the AMT and make any necessary refinements early in the development cycle, avoiding late-stage problems and delays. In fact, by using a virtual engine and transmissions as stand-ins while developing hardware, Renault has managed to cut its AMT development time almost in half.

Speed without sacrificing quality

So, too, are emerging environmental standards prompting Renault to rely more heavily on AI. To comply with emerging carbon dioxide emissions standards, Renault has been working on the design and development of hybrid vehicles. But hybrid engines are far more complex to develop than those found in vehicles with a single energy source, such as a conventional car. That’s because hybrid engines require engineers to perform complex feats like balancing the power required from multiple energy sources, choosing from a multitude of architectures, and examining the impact of transmissions and cooling systems on a vehicle’s energy performance.

“To meet new environmental standards for a hybrid engine, we must completely rethink the architecture of gasoline engines,” says Vincent Talon, head of simulation at Renault. The problem, he adds, is that carefully examining “the dozens of different actuators that can influence the final results of fuel consumption and pollutant emissions” is a lengthy and complex process, made by more difficult by rigid timelines.

“Today, we clearly don’t have the time to painstakingly evaluate various hybrid powertrain architectures,” says Talon. “Rather, we needed to use an advanced methodology to manage this new complexity.”

For more on AI in industrial applications, visit www.siemens.com/artificialintelligence.

Download the full report.

This content was produced by Insights, the custom content arm of MIT Technology Review. It was not written by MIT Technology Review’s editorial staff.

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