Friday, November 27, 2020

BREW AND REAL TIME HEADLINES

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Special Report

TOGETHER WITH

SimpliSafe

Good morning and Happy Belated Thanksgiving. Since you’re probably taking a break from your day-to-day routine, so are we. Which means that today and tomorrow, we’re excited to present special reports on one of the greatest challenges of our time: The incredibly complex and incredibly fascinating Covid-19 vaccine supply chain. 

  • Day 1 (today) will break down the material logistics of vaccines: How they’re made, how they’re distributed, who’s doing the distributing, etc. 
  • On Day 2 (tomorrow), we’ll focus on the human element: Who will get a vaccine? And how many people even want one? 

P.S.: This newsletter is best enjoyed with leftovers.

Francis Scialabba

Maybe Thanksgiving is getting us sentimental, but the concept of a vaccine is kind of...amazing? Someone injects a distorted version of a virus into you and then your body learns how to defend against it. It’s not not magical. 

Here’s how those painful miracles of science come to be

The process that generates the lifesaving poky boys is grounded in cold, hard science and logistics. But, it’s mind-numbingly complicated; think Christopher Nolan film plus Gillian Flynn novel times your flightiest friend’s romantic status. 

From a business POV, it’s also extremely risky. Regulators license the process behind making a vaccine in addition to the biological product itself. That means that any major tweaks to that process trigger another round of tire-kicking. As a result, the failure rate in vaccine manufacturing is high and supply often runs short. 

  • Plus, it’s not cheap. The total costs of vaccine development can run up to $500 million, one study found. 

Methodologies vary, but the overall breakdown goes something like this: 

Step 1: Create an antigen (a substance that provokes your immune system). Scientists do this by literally growing it in a cell—like the basil plant on your window, but tiny. 

Step 2: Take the baby antigen out of the cell where it was grown. Basil’s gotta become pesto at some point. 

Step 3: Next, the antigen is purified through processes that sound like words you’d make up when lying about doing science homework: chromatography and ultrafiltration. 

Step 4 (optional): In some cases, some extra spices are added to strengthen the antigen, or to add shelf life. 

Step 5: Distribution—mix up all the components in vials or syringes, load those suckers on trucks, and get them in some arms. 

Vaccine manufacturing is Isla de Muerta 

It’s an island that cannot be found, except by those who already know where it is. The field is dominated by legacy players, because only those with significant existing scale can foot the bill for the necessary raw material, facilities, regulatory compliance, and labor. 

  • Did you know there’s currently a shortage of sand needed to make glass vials for vaccine storage? Or that one ingredient used in vaccines comes from the bark of the Quillaja saponaria Molina tree in South America that’s only harvested two months of the year? Probably not, but Pfizer does. 

Zoom out: The companies currently vying to get a Covid-19 vaccine to market are pursuing different biological methods, in the hopes that a “throw everything against the wall” approach will lead to a few sticking. 

        

U.S. Dept. of Defense

...but it’s pretty dang fast. After the Manhattan Project and training dolphins to locate sea mines, Operation Warp Speed (OWS) could go down as one of the most successful government initiatives in recent memory. So what is it exactly? 

The goal: To deliver 300 million doses of a safe and effective vaccine by Jan. 2021. It was created as a sort of “project manager” to coordinate all the moving parts between government agencies and private companies. 

Budget: Up to $18 billion. More than $12 billion has already been doled out in vaccine-related contracts.

Why it matters: As you can see in the graphic above, OWS is trying to squeeze what’s typically a 73-month process into just 14 months. So far, it appears to be working. 

Looking ahead...OWS leadership has said they can deliver a Covid-19 vaccine to every state less than 24 hours after FDA approval. 

        

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Giphy

Leading vaccine candidates are more temperature-sensitive than your dad who doesn’t let anyone touch the thermostat. 

  • To avoid spoiling, Pfizer-BioNTech’s vaccine must be transported and stored at -94°F, while Moderna’s prefers a balmier -4°F. 

Maintaining these below-freezing temps puts enormous strain on distribution. Here’s what goes into the “cold chain:" 

  • Airlines deliver doses in temperature-controlled holds. This could be the biggest bottleneck in the supply chain, given that one-in-four passenger airplanes (which actually ship the majority of air freight) has been grounded during the pandemic. Expect cargo companies to pick up the slack. 
  • Storage is tight. UPS and Lufthansa have been scrambling to build massive "freezer farms" near airports to receive vaccines. Drug companies will also make use of existing cold storage facilities, but according to a JLL report, 78% of U.S. cold storage warehouses are at least 20 years old and don’t meet modern standards. 
  • Dry ice is the cold chain’s best friend. Pfizer has designed temperature-controlled dry ice boxes that can maintain a roughly -94° Fahrenheit temperature for up to 10 days. Each box can hold about 5,000 doses. 

Bottom line: Even with distributors and drug companies beefing up their cold chain capacity, pharma experts still expect a spoilage rate between 5% and 20%.

        

STATS

Covid-19 Vaccine: By the Numbers

Here's a look at some of the stats that illustrate one of the largest logistical challenges in human history. 

Vaccine candidates

  • 67 vaccine candidates are currently in various stages of clinical trials around the world. 
  • 10 billion single doses could be available by the end of 2022 if all the frontrunner vaccine candidates are approved.

Purchase agreements

  • Five—the number of individual doses the U.K. has pre-bought for each citizen, which is the highest per-capita amount in the world.
  • $21—the difference in price between Moderna’s vaccine ($25/dose) and AstraZeneca’s vaccine ($4/dose), according to U.S. purchase agreements.

Sourcing

  • 850 million syringes will be required for Covid-19 vaccine delivery in the U.S.
  • 2% of the required amount of anticipated needles and syringes in the U.S. are located in the Strategic National Stockpile, the country’s repository of critical medical supplies.

Distribution

  • 8,000 fully filled 747 cargo planes would be needed to distribute a single vaccine dose to the world's 7.8 billion people, per the International Air Transportation Association.  
  • 15,000 total cargo flights would be required to vaccinate the entire planet, according to a DHL study. 
        

Justin Sullivan/Getty Images

While a global pandemic has put many companies in “unprecedented situations," for others, like McKesson, it’s given them an opportunity to step up. 

McKesson, based out of Irving, TX, is the country’s largest drug distributor. It handles the behind-the-scenes logistics of getting drugs and medical supplies—from flu shots to generics—to the places that need them: pharmacies, hospitals, and more.

  • It’s a lucrative business. With revenues of $231 billion last fiscal year, it ranked eighth on the Fortune 500 list...just ahead of AT&T. 

Put me in, coach

Through Operation Warp Speed, the government has made McKesson the central distributor of Covid-19 vaccines (outside of Pfizer-BioNTech’s, which needs to live in sub-Arctic temps). 

  • The company will not make decisions on where to send the vaccines, however. That’s up to local and state officials. 

Because of McKesson’s expertise in schlepping life-saving material, the country has tapped it for similar programs before. In 2009, the U.S. government hired the company to distribute H1N1 vaccines (which was then the largest public health project in the CDC’s history). 

Zoom out: McKesson’s playing Superman now, but it’s also been accused of participating in one of the darkest episodes of the U.S. pharmaceutical industry’s history. Along with two rival distributors, McKesson said they could collectively pay up to $21 billion to resolve lawsuits alleging they fueled the opioid crisis. 

        

Giphy

We just spit a lot of information at you about the vaccine supply chain. To tie everything together, let’s explore the hypothetical journey of a single dose of a Moderna coronavirus vaccine from manufacturing → arm. 

Our quest begins in the quaint New England town of Portsmouth, NH, where about 100 workers at Lonza Biologics are busy concocting Moderna’s vaccine. 

  • Lonza signed a contract with Moderna in July to make the vaccine in small batches, and now it’s ramping up production in anticipation of emergency use authorization.

Where to next? The vaccine will fly in those Elsa-approved containers to a McKesson distribution facility in Irving, TX. There, they’ll be paired up with goody bags full of needles, syringes, and alcohol swabs in a process known as “kitting.” 

Then, they're on the road, this time to a regional distribution center. This could just be a local hospital, because the main requirement is enough freezer space to keep the vaccine cold.

And now, the final leg. The vaccine will head to an administration site like a mobile clinic or a Costco, where injectees will get a shot, a chicken bake, six gallons of salsa, and be on their way. 

But not so fast: Moderna’s vaccine requires two doses 28 days apart. So hurry up on that salsa. 

        

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GAMES

Friday Puzzle

A kangaroo word contains another word (a joey) within themselves. A joey word is a synonym of the kangaroo word, and the letters must be in the same order.

Example: "rapscallion" contains the word "rascal": RApSCALlion

See if you can find the joey words in these kangaroo words:

  1. exists
  2. deceased
  3. barren
  4. precipitation
  5. prematurely
  6. feasted (there are two joey words in here) 

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ANSWER

1. is (exISts)
2. dead (DEceAseD)
3. bare (BARrEn)
4. rain (pRecipitAtIoN)
5. early (prEmAtuReLY)
6. fed / ate (FEasteD / feAsTEd)

Source

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Latest Columnists and Tipsheet


Bearing Arms

1. Trump Recommends GSA “Do What Needs To Be Done” For Initial Transition Protocols


Trump, Tasos KatopodisGetty Images

Tasos Katopodis/Getty Images

Emily W. Murphy serves as the administrator of the federal General Services Administration (GSA). Under the Presidential Transition Act of 1963, she has the authority to make post-election resources and services available to assist in presidential transitions. Although President Trump and his team of lawyers continue legal challenges in several states, the president said this week that "in the best interest of our country, I am recommending that Emily and her team do what needs to be done with regard to initial protocols, and have told my team to do the same."

But Murphy made clear that she has no real role in deciding who won the election, even though several news agencies have deemed Joe Biden the winner. "As you know, the GSA Administrator does not pick or certify the winner of a presidential election. Instead, the GSA Administrator’s role under the Act is extremely narrow: to make resources and services available in connection with a presidential transition."

"As stated, because of recent developments involving legal challenges and certifications of election results, I have determined that you may access the post-election resources and services described in Section 3 of the Act upon request. The actual winner of the presidential election will be determined by the electoral process detailed in the Constitution," she wrote. That makes more than $6 million available to Biden and his team.

But Trump declared that he's not yet done. "Our case STRONGLY continues, we will keep up the good fight, and I believe we will prevail!" he wrote on Twitter.

 

2. Key States Certify Biden Wins


Trump and Biden, JIM WATSON,BRENDAN SMIALOWSKIAFP via Getty Images

JIM WATSON,BRENDAN SMIALOWSKI/AFP via Getty Images

Three states this week certified results from the Nov. 3 election, and Biden won all three. In Michigan, the statewide canvassing board, made up of two Republicans and two Democrats, voted 3 to 0 to approve the results, with one Republican abstaining.

Republicans throughout the state and nationally had pushed the GOP members to resist certifying vote over questions of the veracity of the vote count, especially in Wayne County, which includes Detroit. The Trump campaign and others have claimed that a number of irregularities and alleged misconduct could have impacted the result of the presidential election. President Trump is trailing Democratic presidential nominee Joe Biden by more than 154,000 votes in the state.

Then the Pennsylvania State Department certified the results of the presidential election in favor of Biden. "Today @PAStateDept certified the results of the November 3 election in Pennsylvania for president and vice president of the United States," Democratic Gov. Tom Wolf wrote on Twitter. "As required by federal law, I’ve signed the Certificate of Ascertainment for the slate of electors for Joe Biden and Kamala Harris."

The certification came as the Trump campaign is appealing a federal judge’s dismissal of his team's effort to block the certification.

Nevada, too, certified its election results without fanfare, giving Biden the win over Trump by more than 33,000 votes.

But again, Team Trump said the certifications don't mean diddly. "Certification by state officials is simply a procedural step," Trump campaign senior legal adviser Jenna Ellis said in a statement. "We are going to continue combatting election fraud around the country as we fight to count all the legal votes. Americans must be assured that the final results are fair and legitimate."

 

3. Biden Names Top-Level Members of His Administration


Win McNameeGetty Images-1

Win McNamee/Getty Images

Biden is moving forward, naming members to his Cabinet and others to be top White House aides. Progressives weren't particularly pleased because Biden picked longtime Establishment players, including:

Antony Blinken, Secretary of State — Blinken was a member of President Clinton’s National Security Council and served most recently as President Obama’s Deputy Secretary of State. Blinken was a staunch defender of the Iran deal, and spoke out in support of an increased military presence in Syria.

John Kerry, Climate Envoy — Kerry served as Secretary of State from 2013 to 2017 under Obama, and played an integral part in the United States’ participation in the Paris climate agreement, an agreement Biden plans on rejoining "on day one." In response to the announcement of his nomination, Kerry tweeted "America will soon have a government that treats the climate crisis as the urgent national security threat it is.”

Janet Yellen, Treasury Secretary — Yellen served as Federal Reserve Chair from 2014 to 2018. A familiar face in Washington politics, she broke traditional Fed protocol by joining the Biden campaign as an adviser after her tenure.

Alejandro Mayorkas, Homeland Security — Mayorkas served previously as Deputy Secretary of Homeland Security and Director of Citizenship and Immigration Services. Mayorkas played an integral role in the implementation of the Deferred Action for Childhood Arrivals program under the Obama administration, and has signaled his intention to soften the Department of Homeland Security’s stance towards refugees and "Dreamers."

Jake Sullivan, National Security Adviser — Sullivan is best known for his ties to Hillary Clinton, serving as her deputy chief of staff at the State Department, and her senior policy adviser during the 2016 presidential campaign. A graduate of Yale University, Sullivan served also as Obama’s director of policy planning. In 2011, Sullivan reportedly played a key role in the United States’ ousting of Libyan dictator Muammar Gaddafi, a move that sparked tensions that resulted in the death of Ambassador Chris Stevens and three other Americans 11 months later.

Avril Haines, Director of National Security — Haines served most recently as Obama’s deputy national security adviser. She faced criticism for her role in Obama’s secretive use of drones in the Middle East and Africa. Haines, a former Deputy Director of the CIA, was “sometimes summoned in the middle of the night to weigh in on whether a suspected terrorist could be lawfully incinerated by a drone strike.” According to Human Rights leaders, those drone strikes resulted in the deaths of hundreds of civilians, including women and children. 

 

 

FRIDAY 11.27.2020
BREAKING NEWS










Pro-gun Groups Counting on Justice Barrett

FRIDAY 11.27.2020
BREAKING NEWS











Pro-gun groups hope Justice Barrett will lead the charge to remove restrictions on the 2nd Amendment. Learn how > CLICK HERE

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