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Covid-19 vaccines shouldn’t get emergency-use authorization

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I really want a covid-19 vaccine. Like many Americans, I have family members and neighbors who have been sickened and killed by the new coronavirus. My sister is a nurse on a covid-19 ward, and I want her to be able to do her job safely. As a health-care lawyer, I have the utmost confidence in the career scientists at the US Food and Drug Administration who would ultimately determine whether to issue an emergency-use authorization for a covid-19 vaccine. But I am deeply worried about what could happen if they do. 

The pace of covid-19 vaccine research has been astonishing: there are more than 200 vaccine candidates in some stage of development, including several that are already in phase 3 clinical trials, mere months after covid-19 became a global public health emergency. In order for the FDA to approve a vaccine, however, not only do these clinical trials need to be completed—a process that typically involves following tens of thousands of participants for at least six months—but the agency also needs to inspect production facilities, review detailed manufacturing plans and data about the product’s stability, and pore over reams of trial data. This review can easily take a year or more.

That’s why, for several months now, the FDA has been considering criteria for initially deploying a covid-19 vaccine under an emergency-use authorization, or EUA, before the FDA has all the information normally required for full approval. At least a few of the manufacturers currently in phase 3 trials have publicly stated their intent to request an EUA. Pfizer plans to do so later this month in light of the exciting preliminary results for its vaccine.

EUAs allow the FDA to make unapproved products available during public health emergencies. While the FDA has issued EUAs sparingly for diagnostics and therapies aimed at other infectious diseases, such as H1N1 and Zika, a vaccine has never been used in civilians under an EUA. Vaccines are different from other medical products in that they are deployed broadly and in healthy people, so the bar for approving one is high.

The FDA’s Vaccines and Related Biological Products Advisory Committee, a group of outside experts who advise the FDA on vaccines, met for the first time to discuss covid-19 vaccines on October 22. Some committee members questioned whether the FDA had set the bar for a vaccine EUA high enough. Members also expressed several important concerns about authorizing a vaccine through an EUA.

One concern is that once a vaccine is authorized in this manner, it may be difficult—for ethical and practical reasons—to complete clinical trials involving that vaccine (and thus to collect additional safety data and population-specific data for groups disproportionately affected by covid-19). It could also hamper scientists’ ability to study other covid-19 vaccine candidates that may be “better” in various ways than the first across the finish line.

But the most important consideration in my view relates to public trust.

Public health experts caution that vaccines don’t protect people; only vaccinations do. A vaccine that hasn’t gained enough public trust will therefore have a limited ability to control the pandemic even if it’s highly effective.

Data from the Pew Research Center show declining trust in a covid-19 vaccine across all genders, racial and ethnic categories, ages, and education levels, with many people citing safety and the pace of approval as key factors in their skepticism. Information presented to the advisory committee by the Reagan-Udall Foundation similarly showed significant distrust in the speed of vaccine development, likely exacerbated by recent political interference with the FDA and the US Centers for Disease Control and Prevention (CDC) and some politicians’ promises that a vaccine would be available before the end of the year. People of color have expressed additional concerns with vaccine research.

Judging from their written and verbal comments to the advisory committee, major vaccine manufacturers recognize the potential disruptions to subsequent clinical trials and are seeking the FDA’s advice to address them. While those considerations are daunting, I suspect that manufacturers and the FDA could create workable responses. But even then, the public trust issues associated with EUAs—which most of the public first heard about through the hydroxychloroquine debacle and again in the context of the convalescent plasma controversy—still make this tool a poor fit for vaccines.

Instead, if vaccine trial data are promising enough to warrant giving some people pre-approval access to a covid-19 vaccine, the FDA should do so using a mechanism called “expanded access.” While the FDA ordinarily uses expanded access to make experimental treatments available to sick patients who have no alternative treatment available, it has been used for vaccines before and could be used now to avoid disrupting ongoing clinical trials or fostering public perceptions that a vaccine was being rushed because of an “emergency.” Expanded-access programs are also overseen by ethics committees and have informed consent requirements for patients that go beyond those associated with products authorized by EUA.

Not only must the public trust a covid-19 vaccine enough to seek out the first wave of authorized vaccines, but that trust must be resilient enough to withstand potential setbacks: protection below 100% (and perhaps below 50%), significant side effects (or rumors of them), and possible recalls. That level of trust takes time to rebuild if it has been eroded. And the stakes here are not just the slowing of this pandemic. As former senior health official Andy Slavitt recently said, “Done right, vaccines end pandemics. Done wrong, pandemics end vaccines.”

Clint Hermes, a former academic medical center general counsel, has advised universities, teaching hospitals, and life sciences companies on global health problems. He has helped set up vaccination, treatment, and surveillance projects for infectious diseases in North and South America, Africa, Asia, and the Middle East. The views expressed here are his own and not those of any organization with which he is affiliated, including his employer. The information presented here should not be construed as legal advice.

Lyron Foster is a Hawaii based African American Musician, Author, Actor, Blogger, Filmmaker, Philanthropist and Multinational Serial Tech Entrepreneur.

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Databand raises $14.5M led by Accel for its data pipeline observability tools

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DevOps continues to get a lot of attention as a wave of companies develop more sophisticated tools to help developers manage increasingly complex architectures and workloads. In the latest development, Databand — an AI-based observability platform for data pipelines, specifically to detect when something is going wrong with a datasource when an engineer is using a disparate set of data management tools — has closed a round of $14.5 million.

Josh Benamram, the CEO who co-founded the company with Victor Shafran and Evgeny Shulman, said that Databand plans include more hiring; to continue adding customers for its existing product; to expand the library of tools that its providing to users to cover an ever-increasing landscape of DevOps software, where it is a big supporter of open source resources; as well as to invest in the next steps of its own commercial product. That will include more remediation once problems are identified: that is, in addition to identifying issues, engineers will be able to start automatically fixing them, too.

The Series A is being led by Accel with participation from Blumberg Capital, Lerer Hippeau, Ubiquity Ventures, Differential Ventures, and Bessemer Venture Partners. Blumberg led the company’s seed round in 2018. It has now raised around $18.5 million and is not disclosing valuation.

The problem that Databand is solving is one that is getting more urgent and problematic by the day (as evidenced by this exponential yearly rise in zettabytes of data globally). And as data workloads continue to grow in size and use, they continue to become ever more complex.

On top of that, today there are a wide range of applications and platforms that a typical organization will use to manage source material, storage, usage and so on. That means when there are glitches in any one data source, it can be a challenge to identify where and what the issue can be. Doing so manually can be time-consuming, if not impossible.

“Our users were in a constant battle with ETL (extract transform load) logic,” said Benamram, who spoke to me from New York (the company is based both there and in Tel Aviv, and also has developers and operations in Kiev). “Users didn’t know how to organize their tools and systems to produce reliable data products.”

It is really hard to focus attention on failures, he said, when engineers are balancing analytics dashboards, how machine models are performing, and other demands on their time; and that’s before considering when and if a data supplier might have changed an API at some point, which might also throw the data source completely off.

And if you’ve ever been on the receiving end of that data, you know how frustrating (and perhaps more seriously, disastrous) bad data can be. Benamram said that it’s not uncommon for engineers to completely miss anomalies and for them to only have been brought to their attention by “CEO’s looking at their dashboards and suddenly thinking something is off.” Not a great scenario.

Databand’s approach is to use big data to better handle big data: it crunches various pieces of information, including pipeline metadata like logs, runtime info, and data profiles, along with information from Airflow, Spark, Snowflake, and other sources, and puts the resulting data into a single platform, to give engineers a single view of what’s happening better see where bottlenecks or anomalies are appearing, and why.

There are a number of other companies building data observability tools — Splunk perhaps is one of the most obvious, but also smaller players like Thundra and Rivery. These companies might step further into the area that Databand has identified and is fixing, but for now Databand’s focus specifically on identifying and helping engineers fix anomalies has given it a strong profile and position.

Accel partner Seth Pierrepont said that Databand came to the VC’s attention in perhaps the best way it could: Accel needed a solution like it for its own internal work.

“Data pipeline observability is a challenge that our internal data team at Accel was struggling with. Even at our relatively small scale, we were having issues with the reliability of our data outputs on a weekly basis, and our team found Databand as a solution,” he said. “As companies in all industries seek to become more data driven, Databand delivers an essential product that ensures the reliable delivery of high quality data for businesses. Josh, Victor and Evgeny have a wealth of experience in this area, and we’ve been impressed with their thoughtful and open approach to helping data engineers better manage their data pipelines with Databand.”

The company is also used by data teams from both large Fortune 500 enterprises to smaller startups.

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WhatsApp is upping its wallpapers and stickers game

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WhatsApp is finally upping its wallpapers and stickers game.

The instant messaging service said on Tuesday that it will now allow users to set custom wallpapers for different chats in a bid to make it easier for users to easily distinguish the dozens or hundreds of chats they are simultaneously engaging with. There’s no limit on how many custom wallpapers a user could choose to assign to different chats, it said.

“Make your chats personal and distinguishable by using a custom wallpaper for your most important chats and favorite people, and you never need worry about sending the wrong message in the wrong chat ever again,” the Facebook -owned service said.

WhatsApp, used by over 2 billion users, is also rolling out doodle wallpaper — the default wallpaper currently — in more colors, and is bulking up the selection of wallpapers with more images of nature and architecture from around the world, it said. Additionally, users can now also set a separate wallpaper which activates when their phone switches from light to dark mode.

Moving on from wallpapers, the messaging app said it is also making it easier for users to quickly search and find stickers with text or emoji, or browse through common categories.

The firm urged sticker creators to tag their stickers with emojis and text moving forward so that their stickers become more easily searchable for WhatsApp users. A company spokesperson declined to share the kind of traction stickers have received on WhatsApp, or how many sticker creators have contributed.

But if stickers are something you enjoy, there are some additional ones you will spot today. The World’s Health Organization’s “Together at Home” sticker pack is now available as animated stickers. (The two began collaborating earlier this year to raise more awareness about the coronavirus pandemic.)

“Together at Home has been one of the most popular sticker packs across WhatsApp, and will now be even more expressive and useful in its animated form. The ‘Together at Home’ sticker pack is available within WhatsApp, including with text localized for 9 languages – Arabic, French, German, Indonesian, Italian, Portuguese, Russian, Spanish and Turkish,” WhatsApp said.

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Google Play’s Best of 2020 Awards highlight the stressful year it’s been

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Continuing its annual tradition, Google today announced its Best of 2020 awards — the company’s list of the best apps, games, movies and books for the year. Not surprisingly, the top apps picked by both Google Play users and editors reflect the stressful year that 2020 has been, with a top sleep app, Loóna, winning the title of “Best App” of 2020. Meanwhile, Google Play users picked streaming service Disney+ as their choice.

Loóna is a fitting app to win the award this year. The sleep aid promises a mood-altering experience that helps its users deal with the negative emotions that accumulate during the day and are then processed during sleep. As anxiety and stress grow, people’s sleep patterns and REM sleep be disrupted, Loóna explains. To combat this, its app offers nightly “sleepscapes,” that combined activity-based relaxation, storytelling and sounds to help people shut out their stress and relax.

Unlike other sleep or meditation apps where users close their eyes and drift off, Loóna is intended to help people wind down while still on their phones. Users tap to color images while the sleep story plays. The company also this year introduced music playlists, called soundscapes.

Image Credits: Loóna

In October, the company reported its app — which is also available on iOS — was seeing daily average time spent of 34 minutes from its subscribers. And its average conversion rate from trial to paid subscriber was 52.5%. With version 2.0, Loóna plans to reposition its app from being solely focused on bedtime relaxation to become a broader mood management app that also covers the sleep to wake up cycle, among other things. It also plans to add personalized content recommendations.

In addition to Loóna, Google Play editors selected the free-to-play action role-playing game Genshin Impact as the year’s best game for giving players a “wondrous world to explore” while unraveling mysteries. The game, miHoYo’s first-ever open-world game, features battles with elemental magic, character switching, and gacha game monetization for obtaining new characters, weapons, and other additions.

Google Play users, however, selected SpongeBob: Krusty Cook-Off as the year’s best game.

Another app that benefitted from coronavirus lockdowns was Disney+, which won this year’s User’s Choice award for Best App. The streaming service helped families stuck at home to keep their kids entertained. Plus, with new shows like the “The Mandalorian,” the service has been a hit for adults in the family, too.

In addition to the top winners, Google gave a shout-out to a few other notable titles in its announcement, including Chris Hemsworth’s training app Centr, behavioral modification app Intellect, as well as games like The Gardens Between, Harry Potter: Puzzles & Spells, and Sky: Children of the Light.

The Play Store also awarded various gaming subgenres with awards of their own, like best competitive games, best indies, best pick up and play, and best game changers. These winners include Brawlhalla, Bullet Echo, GWENT: The Witcher Card Game, Legends of Runeterra, The Seven Deadly Sins: Grand Cross, Cookies Must Die, GRIS, inbento, Maze Machina, Sky: Children of Light, Disney Frozen Adventures, DreamWorks Trolls Pop, EverMerge, Harry Potter: Puzzles & Spells, SpongeBob: Krusty Cook-Off, Fancade, Genshin Impact, Minimal Dungeon RPG, Ord., and The Gardens Between.

Other top apps won awards in categories like best everyday essentials, best for personal growth, best hidden gems, best for fun, and best apps for good. These app winners include Calmaria, Grid Diary, The Pattern, Whisk, Zoom, Centr, Intellect, Jumprope: How-to Videos, Paird: Couples App, Speekoo, Cappuccino, Explorest, Loóna, Paperless Post, Tayasui Sketches, Bazaart, Disney+, Dolby On, Reface, Vita, GreenChoice, Medito, and ShareTheMeal.

Movies that won “Best of” for 2020 included Bill & Ted Face the Music, Just Mercy, Miss Juneteenth, Onward, and Parasite; while book winners included A Promised Land by Barack Obama, The City We Became by N.K. Jesmin, Riot Baby by Tochi Onyebuchi, Solutions and Other Problems by Allie Brosh, and You Had Me at Hola by Alexis Daria,

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