November
16, 2020

13 min read

This story originally appeared on Business Insider

A second experimental coronavirus vaccine has successfully prevented COVID-19 in the final stage of clinical research, marking a victory in the fight against the pandemic.

Moderna announced the success Monday morning in a press release, saying its vaccine was 94.5% effective in preventing COVID-19 , the disease caused by the new coronavirus. An independent group of experts found clear signs of effectiveness after reviewing preliminary data from an ongoing study of 30,000 people, Moderna said.

The Moderna injection is the second major vaccine program to announce success in an advanced stage trial. Pfizer and its German partner BioNTech said on November 9 that their vaccine was found to be more than 90% effective in preventing COVID-19 in a preliminary review of an ongoing study.

Both announcements provide much-needed good news as the pandemic spreads across the globe, though it could be weeks before regulators review vaccines and decide whether to make them more accessible. The United States now averages more than 140,000 new coronavirus cases a day, and the healthcare system is showing worrying signs of strain as hospitalizations and deaths rise.

Moderna’s share price gained more than 10% before markets opened on Monday and was about to hit an all-time high. US equity futures also rose, with the S&P 500 and the Dow Jones Industrial Average gaining between 1.4% and 1.8% to trade around session highs.

^{Pfizer and its German partner BioNTech said on November 9 that their vaccine was found to be more than 90% effective in preventing COVID-19 / Image: NurPhoto | Getty Images}

Pair of ‘excellent shots’

“Those are two great vaccines that will help a lot of Americans and help a lot of people around the world,” Moderna CEO Stéphane Bancel said in a video interview with Business Insider.

Moderna’s release indicates that its vaccine is very similar to Pfizer’s. Moderna said its vaccine appeared to be 94.5% effective, while Pfizer said its injection was more than 90% effective. Moderna’s analysis was based on 95 COVID-19 cases, while Pfizer’s review included 94 cases. The data from neither company has been published in a scientific journal and both are still gathering more information on the safety of their vaccines.

Moderna’s study begins counting coronavirus cases two weeks after volunteers receive their second vaccine, while Pfizer’s study records illnesses one week after volunteers complete the vaccination course.

It would be “naive to compare 90% to 94.5%,” Bancel told Business Insider, saying it’s too early to compare the shots.

Volunteers in the Moderna trial were randomly given a two-dose regimen of the experimental Moderna injection or placebo injections. The expert panel’s conclusion is based on 95 cases of the disease observed in the study.

Of those 95 illnesses, 90 people who took placebo became ill compared to five who received Moderna’s vaccine. The vaccine also appeared to prevent serious diseases. The researchers found 11 cases of severe COVID-19 among the placebo group and zero among the people who received the vaccine.

Moderna’s vaccine has a crucial advantage over Pfizer’s injection: it can be stored for one month at typical refrigerator temperatures (2 to 7 degrees Celsius), while Pfizer’s injection must be stored at -34 degrees Celsius, which requires dry ice and special containers.

Moderna’s vaccine has yet to be evaluated by the FDA

Both vaccines are still experimental and must obtain regulatory clearance before being released to the public. Both companies plan to apply for the emergency use authorization at the end of November. It is unclear how long it will take the US Food and Drug Administration to evaluate the vaccines and decide whether to approve them.

Even if approved by regulators, the vaccine supply will be extremely limited at first, although it would be helpful to have two vaccines.

Moncef Slaoui, the senior advisor to the US government’s vaccine initiative Operation Warp Speed, recently estimated that 20 million Americans could be immunized in December if both vaccines were approved.

^{Even if the regulators approve it, the vaccine supply will be extremely limited at first / Image: Depositphotos.com}

Moderna was a key component of Warp Speed’s vaccine plan, with the United States government investing up to $ 2.48 billion to fund its development and secure a supply.

Pfizer has said it expects to produce up to 50 million doses by the end of 2020, and Moderna should have 20 million doses available in the United States by the end of the year. Both injections are given in two-dose regimens.

Manufacturing will expand in 2021, with Pfizer saying it will have enough of its vaccine to immunize up to 650 million people and Moderna aiming to produce enough injections for 500 million worldwide. Vaccines from other drug manufacturers could also be available next year if they are successful in clinical trials that are now underway.

Bancel predicted that a coronavirus vaccine would be widely available in the United States by Memorial Day in late May, based solely on results from Pfizer and his company.

“Even if no other vaccine would make it, worst case scenario, I think by Memorial Day, at the end of June, any American who wants a vaccine will get their hands on a vaccine,” Bancel said.

Early success should bode well for other vaccine pioneers

The effectiveness of the Moderna injection should bode well for other vaccine pioneers. All of these experimental injections target the same part of the new coronavirus, the spike protein.

Slaoui told Business Insider in October that he anticipated three waves of approvals over the next few months.

Moderna and Pfizer would make up the first wave. They could quickly be followed by shots from Johnson & Johnson and AstraZeneca. Slaoui said he expected results in December or January from those companies.

The third wave includes two more takes, one from Novavax and the other from Sanofi and GlaxoSmithKline. Those programs are expected to begin the final phase of clinical trials in the United States in the coming weeks.

Leading government scientists have said that a vaccine should be widely available to Americans in April. Slaoui predicted in August that if people agreed to get the injections, we could be back to normal in the second half of 2021.

The announcements that both vaccines are effective is a validation of the new technology they both use, called messenger RNA. The technology platform uses only the genetic code of the virus to create a vaccine. The approach is promising but novel: to date, there are no federally approved mRNA vaccines.

Key questions remain unanswered, despite promising news

It is too early to draw conclusions about whether one vaccine is more effective or safer than the other. Although Moderna provided much more detailed results than Pfizer, neither has published data in medical journals from its trials, which are still ongoing.

Both companies are still collecting and analyzing data, which means that the exact effectiveness of the shots could differ from these preliminary results.

Moderna provided an overview of preliminary data on safety and side effects, while Pfizer did not provide that information.

Most of the side effects from Moderna injections were mild or moderate, but some volunteers had serious side effects, which are medically significant but not life-threatening. These happened mainly after the second injection. The most common serious side effects were fatigue (9.7%), muscle aches or pains (8.9%), joint pain (5.2%), headache (4.5%), pain (4.1%), and redness in the injection site (2.0%).

While Moderna said these side effects were “generally short-lived,” the specifics will be important, particularly in terms of how severe and long-lasting the side effects were.

^{Most of the side effects of Moderna injections were mild or moderate / Image: Depositphotos.com}

There are some other unanswered questions

In terms of efficacy, it is not clear whether any of the vaccines prevent asymptomatic infections. Studies are likely not able to answer that question definitively, as volunteers were not tested for coronavirus unless they developed symptoms.

No company has provided detailed results by age group. Historically, some vaccines have been less protective in older people.

Finally, we don’t know anything about how long the protection might last. That information will only come with more time, as the study volunteers are followed for many more months. People may need booster shots, although no one knows if they will be needed six months, a year, or several years later.

A transformative moment for Moderna

While Pfizer is a pharmaceutical giant known for treatments like Viagra and Lipitor, Moderna is a much smaller biotech upstart who has never developed an approved drug.

Still, Moderna, which has been around for only a decade, has quickly become one of the most vibrant startups in the pharmaceutical industry.

Bancel, the CEO, has had great insights into the potential of mRNA to work on a wide range of diseases. That has driven record levels of fundraising for Moderna, including the largest biotech IPO in history in December 2018.

The Cambridge, Massachusetts company is working on several other candidate vaccines for Zika, influenza, cytomegalovirus, and respiratory syncytial virus.

Moderna hopes its success with the coronavirus will show that the company’s core technology works, Bancel said.

“It’s copy and paste,” he said. “So the Zika vaccine, the CMV vaccine, if this vaccine shows high efficacy, they are going to have high efficacy. It’s just science.”

Responding to the pandemic has accelerated the company’s progress, and Moderna has worked closely with the US National Institutes of Health since January to develop and test a candidate vaccine for COVID-19. Moderna’s candidate vaccine was the first in the world to begin human testing in March.

Being able to have positive efficacy results from an advanced stage study in less than a year is a scientific feat so far equaled only by Pfizer and BioNTech.

^{Moderna’s candidate vaccine was the first in the world to begin human testing in March / Image: Depositphotos.com}

Investors have taken notice. Moderna’s stock has quadrupled this year, driven by the progress of the coronavirus vaccine. The company has hired hundreds of new employees, especially to help operate its Norwood, Massachusetts, manufacturing plant 24 hours a day.

“It’s just the beginning”

The company’s success has also drawn criticism. The company’s top executives and board members sold $ 236 million worth of stock during the first nine months of 2020 as some corporate governance experts criticized insider sales as a poor view.

And some infectious disease experts criticized earlier press releases on positive early data as “science by press release.” The eventual data was later published in one of the major medical journals and was in line with Moderna’s initial description.

Despite criticism, Moderna’s late success is the clearest validation of its technology to date.

“It is just the beginning of a great wave of products,” said Bancel.

While there are significant logistical challenges ahead in the fight against the pandemic, having effective vaccines will go a long way in defeating the virus.

November
15, 2020

4 min read

Disclosure: Our goal is to feature products and services that we think you’ll find interesting and useful. If you purchase them, Entrepreneur may get a small share of the revenue from the sale from our commerce partners.

You don’t have to wait until Black Friday to bring home must-have products at impressive prices, including electronics. In the market for new audio accessories? You can get all of these on-sale items at an additional 15 percent discount for a limited time.

Apple Powerbeats3 Wireless Earphones

The product of collaboration between Apple and Beats by Dre, the Powerbeats are the perfect headphones for people who love Bluetooth audio but are worried about losing their individual earbuds. They deliver crystal-clear sound through top-tier Bluetooth but come with a more secure fit and a wire to ensure they don’t fall apart. No more shaking your earbuds out of your ear while you’re running.

Get the Apple Powerbeats3 Wireless Earphones for $66.30 (Reg. $129) with promo code SAVE15NOV.

RokBlok: The World’s Smallest Wireless Record Player V1.5

Meet the world’s smallest record player, RokBlok. This Shark Tank favorite lets you play your vinyl collection anywhere you have a flat surface. Just put RokBlok on top of a record and let it play with its integrated speaker.

Get the RokBlok: The World’s Smallest Wireless Record Player V1.5 for $76.46 (Reg. $99) with promo code SAVE15NOV.

TREBLAB XFIT Bluetooth Sports Headphones

These Bluetooth headphones are designed to fit an active lifestyle. They offer up to 30 hours of wireless audio with the included portable charging case while delivering True-HD sound. You’ll have all the music you need to power through your workout.

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Soundfreaq SFQ-07 Sound Spot Compact Bluetooth Speaker

Enjoy custom Bluetooth audio everywhere with this compact speaker. It fits comfortably in your pocket and can deliver up to seven hours of playtime on a single charge. Plus, you can adjust the audio to your musical taste with built-in Tone Control settings.

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Gotek Wireless Charging Music Station

Upgrade your nightstand with this clever 3-in-1 device. The Gotek combines a Bluetooth 5.0 speaker, a wireless phone charger, and a digital clock. It may look like a classic digital clock from the ’90s, but it’s so much more.

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TUNAI Wand Bluetooth Transmitter for TV

This 2018 CES Innovation Awardee upgrades your TV, game consoles, and home stereos into Bluetooth devices. The aptX Low Latency Support prevents lags and lip-sync delays, and you won’t have to worry about dead batteries because the transmitter is USB-powered. Plus, it connects two sets of headphones so you can listen with a friend.

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HyperGear Wave Water-Resistant Wireless Speaker

Looking for a more adventure-ready speaker for the slopes this season? This IPX4 waterproof Bluetooth speaker provides up to four hours of playtime on a single charge and is built tough for whatever you throw at it. It’s the perfect way to bring your soundtrack to the slopes.

Get the HyperGear Wave Water Resistant Wireless Speaker for $29.75 (Reg. $39) with promo code SAVE15NOV.

Zulu Audio Alpha Wearable Speakers

No, they’re not headphones. The Zulu Audio Alpha Wearable Speakers are the perfect audio solution for running, riding, or working if you don’t like headphones. They attach to your body using magnets and work just like Bluetooth headphones.

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TREBLAB Z2 Bluetooth 5.0 Noise-Canceling Headphones

They call them the Z2’s because they offer twice the sound, twice the noise-cancellation, and twice the flexibility of competitor headphones. These noise-canceling headphones are great for traveling or when you’re trying to get into the work zone. They’re designed to be extremely comfortable, no matter how long you wear them.

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TaoTronics Hybrid Active Noise-Canceling Headphones

These high-quality headphones are an Amazon’s Choice product with a 4.3/5-star rating. They feature a Sony Digital Noise-Cancellation Chip that blocks out ambient noise whenever you want to focus on what you’re listening to and features three different modes to complement the environment you’re in. Plus, they have a CVC 8.0 noise-canceling microphone, so you’ll be able to take calls even in the busiest areas.

Get the TaoTronics Hybrid Active Noise-Cancelling Headphones for $76.50 (Reg. $107) with promo code SAVE15NOV.

October
24, 2019

7 min read

Days after 9/11, while many Americans were watching the news in a state of shock and horror, a team of 12 Green Berets took action. They covertly entered Afghanistan and began to wage war against the Taliban … on horseback.

It wasn’t until 48 hours before their insertion that the men were informed they would have to traverse the steep and treacherous landscape of Afghanistan on horses. It was the first of many aspects of this mission, code-named Task Force Dagger, that they would have to figure out as they went along. 

Despite being often cut off from communications with command headquarters and outnumbered forty to one, these men, The Horse Soldiers, fought in a series of intense battles side-by-side with militia allies and successfully captured the city of Mazar-i-Sharif from the Taliban, a strategic stronghold.

The Horse Soldier’s story inspired a book, a movie and a monument that can be seen at the 9/11 Memorial in New York. Nearly 20 years after Task Force Dagger’s success, retired Special Operators Scott Neil, Rob Schaefer, Mark Nutsch, Bob Pennington, Tyler Garner and John Koko, along with Elizabeth Pritchard-Koko, found a new mission: they founded American Freedom Distillery. The all-American company’s signature offering is the award-winning Horse Soldier Bourbon, which is sold in bottles pressed in molds made from steel salvaged from the World Trade Center site. 

Related: How To Get Into The Whiskey Business When You Don’t Know Anything About the Whiskey Business

Co-founder and branding manager Elizabeth Pritchard-Koko took some time to explain the group’s incredible journey from elite warriors to elite spirits makers.

Entrepreneur: What inspired you all to band together as bourbon makers?

Pritchard-Koko: My husband John and I and our friend Scott Neil were on a trip out west on horseback a couple of years ago. We were trying to figure out what the next phase of our lives was going to look like, what we would do next. We stopped at a little craft distillery in Driggs, Idaho, called the Grand Teton Distillery. The husband-and-wife team let us back into the operation, and this was sort of our “aha!” moment. We spent the next three weeks hitting every craft distillery we could find all the way back to Tampa, Florida, where we’re from. We knew this was what we wanted to do.

(Credit: Sunship Films) From left to right: Co-founders Scott Neil, Bob Pennington, Mark Nutsch and John Koko speak at an event held at the World Trade Center

What was your next step?

We learned everything we could in regards to the craft. We went to Scotland and visited a friend who was a Royal Marine and had started Wolfburn Distillery. He let us train there for a while. Then we moved on to Ireland where we trained with one of the oldest distilling families in the world. We’ve traveled the bourbon trail up and down Kentucky and spent time perfecting the craft. Some of us attended a distilling school there. Everyone in this community has been nothing but welcoming in sharing information with us. Bottom line: We didn’t launch until the product met the standards we set for ourselves early on. It had to be exactly what we loved to drink ourselves.

Related: How to Be Your Own Boss and Drink on the Job

There are many craft bourbons. How does yours stand out from the pack? 

There is a very special differentiator to our bourbon and that is our story. We are authentic. Behind Horse Soldier Bourbon are the men that went into Afghanistan — days after 9/11 — on horseback, and the Horse Soldier moniker on our bottle is the statue at Ground Zero dedicated to them, America’s Response Monument. The story behind it is a differentiator, but so is the product itself. It’s award-winning. This is a completely American-made product, from the packaging to the people who make it.

Can you explain the design elements on the bottle? 

The bottle itself has a lot of symbolic meaning, and it truly is reflective of who we are. Each bottle is pressed by a mold that was forged from steel from the Twin Towers. The bottle has broad shoulders like the men who carried the burden in America’s darkest days. The hatchet and arrow are symbols of the Green Berets and Army Rangers. I felt it was important to use metal as an element that also spoke to our history. The bottle is absolutely beautiful and elegant and striking enough to be considered jewelry for any bar. It stands out on the shelf and is equally as feminine as it is masculine.

What did it feel like when you saw the first case that was ready to be sold?  

The first bottles we distilled were filled and labeled by hand using wooden gigs. Those were long, physically grueling days, which made it so much more rewarding. We felt it was important to understand every angle of the business. Our children and family members were often in the hand-bottling runs, and as a mother, this was one of my proudest moments. Growing something from a concept to a product on the shelves is an indescribable feeling, especially when you see the crooked neck labels on some of the bottles that were put on by our kids, families, and friends. 

Related: From MMA Champ to Whiskey Entrepreneur: a Conversation With Conor McGregor

What has been the biggest lesson you’ve learned in producing and marketing it?

Nothing comes easy. You make mistakes, learn to grow from them and push forward. We’ve changed a lot in regards to design and brand, and it keeps getting better. We make what we love to drink. This is our passion, and we hope it shows.

In terms of funding, what did you learn that you can share with other startups? 

We were not prepared for the early success of the brand — which is a great problem to have, but it is, in fact, a problem. We thought we would do 1,000 cases the first year but sold through that in the first month, and then the reserve of another 1,000 cases sold, and we really had to start thinking about seriously upping our production and building our brand. It was moving fast — faster than we ever imagined. 

In the beginning, the capital was all the co-founders’ personal money. We decided to recapitalize ourselves. We did a round of funding and that allowed us to grow nationally; it took a long time to complete. The biggest advice is to stay true to your core values and to your family and team. No amount of money is worth the loss of your fundamental brand values. Seeking capital is exhausting and can get met with many “close but not there yet” moments. If you stay true to yourselves, in the end, the capital raise is so much more rewarding. 

What does the word “entrepreneur” mean to you?

To believe in something so much that you manifest it. You don’t measure it by how much you make but how much you love the journey — mistakes and all.  To be able to define your own success however you want, whatever “success” may mean to you.

Is there a particular quote or saying that you use as personal motivation?

“If you want to go fast, go alone. If you want to go far, go together.”

(Credit: Sunship Films) Replica of the America’s Response Monument