FDA Approves Genetically Altered Pigs for Potential Organ Transplants

Jeff Brown
|
Jan 5, 2021
|
Bleeding Edge
|
10 min read
  • This is the largest spectrum auction in history…
  • Amazon wants to compete with Uber…
  • These genetically altered pigs could save the day…

Dear Reader,

Vaccines.

This was one of the hottest topics over the holidays following the approval of a second COVID-19 vaccine in the U.S. for emergency use on December 18.

Both Pfizer and Moderna had been manufacturing tens of millions of doses over the last six months in advance of the approvals from the Food and Drug Administration (FDA) for emergency use. In fact, in the weeks that led up to the authorizations, doses were already being distributed in advance to various states and their health care facilities.

That’s why I was surprised to see the media writing about shortages in the availability of the COVID-19 vaccines.

After digging in, here’s what I found. Nothing could be farther from the truth.

Based on data from the Centers for Disease Control and Prevention (CDC), as of January 4th, 15,418,500 doses of COVID-19 vaccines have already been distributed to states and their health care facilities. Better yet, Pfizer and Moderna have already manufactured millions more doses, which are on standby for distribution when the states need more.

But what I found much more interesting and enlightening is what percentage of the doses have been administered. Again, from the CDC directly, only 30.2% of the 15,418,500 doses have been administered. Almost 70% are just sitting unused on a shelf. Incredible.

Here are some examples at the state level:

  • California has administered only 24.3% of its vaccines

  • New York has administered only 33.5% of its vaccines

  • Pennsylvania has administered only 27.6% of its vaccines

  • Virginia has administered only 23.2% of its vaccines

  • Arizona has administered only 19.5% of its vaccines

In fact, of all 50 states, only five states have administered more than 50% of the doses they’ve already received: Tennessee (50.8%), Connecticut (50.7%), Maine (50.5%), South Dakota (62.2%), and North Dakota (58.7%). We should remember that states had more than half a year to prepare for the administration of the vaccines. So what’s going on?

We’re too early in the process to have a definitive understanding, but here are some anecdotal explanations of what might be going on:

  • Somewhere between 20–40% of Los Angeles County health care workers are refusing to get a vaccine shot

  • In Ohio, 60% of nursing home workers have declined the COVID-19 vaccine

  • In Riverside County, CA, 50% of health care workers are refusing the shot

It goes on and on…

And some health care facilities are already resorting to “bonuses” to incentivize workers to take the vaccine. For example, Houston Methodist has offered up a $500 “hope bonus” for taking the COVID-19 vaccine.

The vaccine is certainly safe enough for the healthy part of the population. But it’s clear that many people have deep concerns about potential side effects.

And many are probably like me – people who have already had COVID-19 and have developed a natural T cell immunity to the virus.

Either way, I’m happy to say that availability of the vaccines is not a problem at all thanks to the incredible public-private partnership to develop several vaccines in record time.

For investors, this incredible achievement by the biotechnology industry is going to fuel even more fantastic investment opportunities for us in 2021.

Now let’s turn to today’s insights…

The 5G spectrum auction shattered expectations…

Early last month, the Federal Communications Commission (FCC) began to auction off what’s called C-band spectrum. This is mid-band spectrum that will be the cornerstone of 5G wireless networks in the U.S.

As we discussed last month, this spectrum sits in between the lower frequency bands that AT&T and T-Mobile are using and the millimeter wave frequency bands that Verizon has focused on. C-band spectrum enables a great balance between performance, coverage of an individual cell tower, and overall cost of wireless network infrastructure.

As a reminder, 5G over a lower-band spectrum can cover wider geographic areas with fewer towers. That makes it much cheaper to build. But the performance isn’t great. In fact, low-band 5G offers speeds comparable to 4G.

On the other hand, 5G deployed over the millimeter bands delivers ultra-fast speeds above one gigabit per second (Gbps). This is the 5G I tested on my tour across the American Heartland last year. But the downside is that this approach requires more towers and infrastructure. That makes it economical in the short term only in very dense urban areas.

C-band spectrum is right in the middle. It offers performance that is superior to 4G. Yet it does not require as many towers as 5G deployed over the millimeter bands.

The industry expected this auction to raise between $35 billion and $40 billion because of how desirable this spectrum is to the wireless operators. It turns out those estimates were far too low.

The auction has already exceeded $69 billion in bidding through the holidays, and it’s not over yet. This will be the largest spectrum auction in history when it’s all said and done.

And the fact that the operators are pouring so much money into C-band spectrum gives us some great insights.

For starters, this tells us that the existing 5G deployments over low bands are not attractive to consumers. And that’s not really a surprise. Since the performance is the same as 4G, why bother?

The aggressive bidding on mid-band spectrum gives us a clear picture of what nationwide 5G networks will look like in the United States.

They will consist of ultra-fast 5G over millimeter wave bands in dense urban areas. And the rest of the country will be covered by 5G deployed over C-band spectrum. The speeds won’t be quite as fast as they are in the millimeter wave bands, but they will still be superior to 4G. Speeds will be faster, capacity will be increased (more simultaneous users possible), and the latency (delay) will drop dramatically.

And here’s the best part…

The fact that the wireless operators are going to pour over $70 billion into C-band spectrum tells us that these mid-band 5G networks will get built as quickly as possible. After all, this is a major expense that will not generate revenue until the network is completed. If it isn’t built, it can’t be monetized.

So the incredible success of this auction is very bullish for 5G. We’ll see 5G network coverage expand rapidly throughout 2021.

Amazon just launched its self-driving ride-hailing service…

While the rest of the world was focused on the much needed holidays, Amazon officially rolled out an autonomous ride-hailing service featuring Zoox’s self-driving cars.

We talked about Zoox last July when Amazon entered negotiations to acquire the company. Zoox is an autonomous vehicle company with an approach that is quite unique.

Most other self-driving cars have been developed with the assumption that a safety driver would be needed at first. Not Zoox. It developed a vehicle without a steering wheel right from the beginning.

And this approach allowed Zoox to develop a smaller, more mobile vehicle that is optimized for passengers and urban travel.

Have a look at the inside of the vehicle:

Zoox’s Car Design

Source: Zoox

There are no front and back seats. All four passengers sit comfortably in the same chamber.

What’s more, the vehicle doesn’t even have a front and a back. It can drive in both directions – there is no front or rear of the vehicle. That is completely different from the other self-driving cars in development today.

Here’s a look at the entire vehicle:

Zoox’s Vehicle

Source: Zoox

And get this – Zoox installs two light detection and ranging (lidar) sensors on every corner of the vehicle. Lidar is 3D-sensing technology that allows the vehicle to “see” its surroundings and perceive distance.

One of these sensors on each corner looks down to get a good view of the street and any objects close to it. The other one looks outward to “see” any objects around the vehicle.

We should keep in mind that these lidar sensors are very expensive. The fact that Zoox equips its vehicles with eight of them tells us that safety is a top priority. These vehicles will know what’s going on around them at all times.

Also interesting is the fact that the lidar sensors only have a range of about 150 meters. That tells us that these vehicles are not really designed for highway travel.

Instead, they are optimized for short-distance urban travel in close quarters. And unlike other self-driving cars, they will be able to easily navigate driveways or even narrow alleyways.

This gives us insight into how Amazon envisions its ride-hailing service. It will focus on dense urban areas. Amazon will directly compete with Uber and Lyft, with convenience and mobility as its competitive advantages.

So this is a major development in the world of autonomous vehicles. We can expect Amazon to announce which cities it plans to start with in the coming months.

And let’s not forget that Amazon is the master at creating marketplaces. With Amazon’s incredible backing and customer base, Zoox could quickly become a front runner in urban ride hailing. And imagine if Amazon tied in Zoox’s ride sharing into its Amazon Prime service somehow. That would be a fantastic way to accelerate adoption.

This isn’t the endgame for Amazon, though. This kind of technology is what will likely be used for Amazon’s last-mile delivery of packages to consumers. It won’t be long before we see these roll up to our homes to drop off our packages.

The FDA just approved genetically engineered pigs…

The Food and Drug Administration (FDA) approved genetically engineered pigs for both food and medical applications. This is a first.

I know this sounds like a strange topic on the surface, but this is incredibly important work. We talked about this way back in January of last year.

There are more than 100,000 people in the U.S. waiting on an organ transplant right now. And 20 of those people die every single day because they didn’t receive an organ in time. There just aren’t enough human organs available for the people who need them.

One answer to this problem is xenotransplantation. That is the transplantation of cells, tissue, or organs from one species to another – typically from animals to humans.

And it turns out that pig organs are in many cases the most compatible in humans. However, the human body often rejects pig organs because it detects foreign genes.

And that’s where genetically engineered pigs come into play.

The FDA approved GalSafe pigs. These are pigs that have been altered so that they do not have alpha-gal sugar. That is what often causes the human body to reject pig organs.

So the theory is that the medical community will be able to use organs and body parts from GalSafe pigs for patients in need without having to worry about rejection.

And that theory is already being put to the test.

An early stage company called XenoTherapeutics is testing skin grafts from GalSafe pigs to treat burn victims in a Phase 1 clinical trial right now.

If the trial goes well, we can expect to see more extensive xenotransplantation trials to follow. And we will likely see GalSafe pork products start to pop up as well. They will be targeted at those consumers who get sick if they consume meat that has alpha-gal sugar.

I know it may seem a little strange, but this will be a big topic in the gene editing space this coming year. eGenesis, which was founded by geneticist George Church, is a company that I’m watching closely in this space. It’s a great example of how bleeding-edge technology can be used in unconventional ways to save lives.

Regards,

Jeff Brown
Editor, The Bleeding Edge

P.S. For readers who have been looking for a way to get shares of companies before they go public – before the truly massive gains happen – you don’t want to miss my first presentation of the year.

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So please mark your calendar for Wednesday, January 13, at 8 p.m. ET. As always, my presentation will be free to all readers of The Bleeding Edge.

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