What you need to know about the vaccine supply chain

February 8, 2021
We start the week with an exclusive look at vaccine manufacturing, as well as news on legislation that would advance biofuels. Also, meet the Black surgeon and scientist who developed the blood bank and fought racial discrimination. (1000 words, 5 minutes)
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We start the week with an exclusive look at vaccine manufacturing, as well as news on legislation that would advance biofuels. Also, meet the Black surgeon and scientist who developed the blood bank and fought racial discrimination. (1000 words, 5 minutes)

 
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What you need to know about vaccine manufacturing

 
 

There have been a lot of questions lately about the COVID-19 vaccine supply chain and when vaccines will be distributed. To help us understand what’s happening and why, we spoke with Phyllis Arthur, BIO’s VP for Infectious Disease and Diagnostics Policy, for an exclusive look inside the vaccine supply chain.

Ongoing supply issues are to be expected, given unprecedented demand for COVID-19 vaccines and the complexities of manufacturing them.

Development has gone quickly, but manufacturing biologics is a uniquely delicate process requiring consistency in quality control. “The currently available COVID-19 vaccines do not contain any live material, but you still have all the different rules of the manufacturing process,” explained Phyllis Arthur, BIO’s VP for Infectious Diseases and Diagnostics Policy.

For example, mRNA vaccines need to be kept at extremely cold temperatures. The Pfizer-BioNTech COVID-19 vaccine must be stored at -70 degrees Celsius, and the Moderna vaccine at -20 degrees Celsius. These temperature requirements must be factored into the quality control process.

There’s also a conflation of supply chain management and vaccine distribution. To a large extent, this is a challenge with communicating and managing expectations regarding vaccine distribution, rather than one of supply chains. 

What many in the public perceive as delays in production are actually ongoing challenges in distribution. “Companies are making doses as quickly as they can in three shifts over 24 hours,” said Arthur, delivering “30 to 40 million doses a month.” This is an entirely separate issue from distribution in the states.

It’s also important to understand failures in integrating equity into the decision-making process. “Some states skipped some of the populations in the [Advisory Committee on Immunization Practices] recommendations where communities of color were a focus,” explained Arthur. “So, if you skipped the essential worker category and went from frontline workers immediately to 65+, you skipped the equity issue that was embedded inside why essential workers were put at the front of the line. They were put at the front of the line for several reasons: One, they are essential. Two, those jobs are predominantly held by Black and brown people who cannot work from home.”

Want to know more about the development of COVID-19 vaccines? Visit www.COVIDVaccineFacts.org.

 

More Health Care News: 

Biopharma Dive: Bristol Myers wins FDA approval for cancer cell therapy
“Breyanzi…is cleared for use in adults with certain types of large B-cell lymphoma whose cancer has progressed after at least two prior treatments.” 

The Washington Post: U.K. coronavirus variant spreading rapidly through United States, study finds
“The report, posted on the preprint server MedRxiv and not yet peer-reviewed or published in a journal, comes from a collaboration of many scientists and provides the first hard data to support a forecast issued last month by the Centers for Disease Control and Prevention that showed the variant becoming dominant in the United States by late March.” 

 
 
 
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This bill would advance biofuel innovation

 
 

With last week’s Agriculture and EPA nomination hearings, we skipped over this news: three U.S. Senators reintroduced legislation from 2020 that would advance biofuel innovation and help solve our climate and economic crises. 

Last Thursday (February 4), U.S. Sens. John Thune (R-SD) and Jeanne Shaheen (D-NH) reintroduced legislation that would approve certain advanced biofuel registrations. 

If passed, EPA would be “required to render a decision within 90 days on any registration application that has been pending for at least 180 days, as well as take action within 180 days for completed pathways petitions pending for at least 180 days,” says the press release.

This is the same bill they introduced in June 2020, which we covered here

What Sen. Shaheen’s saying: “I’m proud to reintroduce this bill along with Senator Thune to tackle the backlog of advanced biofuel registrations, empowering producers to utilize the latest technology and research in fuel production.” 

What Sen. Thune’s saying: “This bill will permit biofuel producers to capitalize on the research and facility investments they have made to bring this technology to scale, improve their operating margins, and further lower lifecycle greenhouse gas emissions.”

Sen. Thune also reintroduced the Adopt GREET Act with Sen. Amy Klobuchar (D-MN), which requires EPA to update GHG modeling for ethanol and biodiesel using measurements from the Argonne National Laboratory. 

What Sen. Klobuchar's saying: “It is critical that the EPA’s decade-old greenhouse gas modeling for ethanol and biodiesel be updated to fully reflect the newest science and technology. This legislation will allow us to fully understand how biofuels can help contribute to our emissions reduction goals while expanding and promoting the use of clean energy and rural jobs across the country.”  

What BIO member POET is saying“Senator Thune and Senator Klobuchar’s bill is a critical step in restoring integrity to the RFS, encouraging higher blends of biofuels and formally recognizing what ethanol producers and corn farmers have known all along: the power of biofuels and agriculture are some of the best tools available to grow our rural economies while staying in sync with nature.”

Learn more about sustainable biofuels.

 

More Agriculture and Environment News: 

E&E News: Five takeaways from the Michael Regan hearing
“There were few fireworks at the hearing but rather kudos for the nominee, so it's likely now a question of when, not if, Regan will be confirmed as EPA's 16th administrator.” [Read Good Day BIO’s coverage of Regan’s hearing.]

 
 
 
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BIO Celebrates Black History Month
Charles Drew.jpg

Washington, D.C. native and Howard University professor Dr. Charles R. Drew is known for his pioneering work to develop blood banks and fight racial discrimination in blood donation. 

In 1940, Dr. Drew became the first Black student to earn a Doctorate of Science in Surgery at Columbia, where his thesis, “Banked Blood,” would prove essential during World War II. He was recruited by Blood for Britain, where “he supervised the successful collection of 14,500 pints of vital plasma for the British,” says his namesake medical school

In 1941, Dr. Drew led the first American Red Cross blood bank for the U.S. military—where he, as a Black man, was prohibited from donating. He resigned when the armed forces decided African Americans could donate blood, but that their blood would be kept separate from blood donated by white people—a policy kept in place until 1950. 

Dr. Drew passed away on April 1, 1950, at the age of 46, after being injured in a car accident.

 
BIO Beltway Report
BIO Beltway Report
 
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President Biden’s Monday: The COVID-19 Response Team will hold a briefing at 11 AM ET. This afternoon, President Biden and VP Harris will virtually tour the State Farm Stadium vaccination site in Glendale, Arizona.

What’s Happening on Capitol Hill: “Democrats are plowing forward with plans to pass a massive COVID-19 relief package. And if Republicans don't join them, they won’t forget it,” reports POLITICO. Former President Trump’s second impeachment trial begins tomorrow.

 
 
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