LET’S START PLAYING OFFENSE IN OUR FIGHT AGAINST COVID-19

Washington, DC 6 December 2020

Dear family, friends and the public at large,

I write this letter with all sincerity and gratitude that you and your families remain healthy and well. As I write this letter, my wife’s college roommate’s mother is sedated, on high oxygen and in the ICU with severe COVID-19—and it is not looking good. We are sending her an overnight shipment to rural Pennsylvania one of our family’s Apple IPADs so she can see her mom possibly for the last time since the medical staff in this small rural farming community only uses Apple Face Time to connect w/families and their loved ones in intensive care. Unfortunately, she only has an Android phone and is currently suffering what unfortunately hundreds of thousands of families have had to cope with this past year in the US including ours—not being able to visit their hospitalized loved ones while front line medical professionals scramble to use limited defensive tools and to preserve life. These Americans, unfortunately die with no family around and even worse, their funerals and memorial services go unnoticed by their communities and many indefinitely postponed. Dying alone without family is one of the very worst things we must resolve to do better as a society and my letter to you is about joining this fight against COVID-19 by taking one of the soon to be FDA authorized vaccines.

A DEADLY GAME

If the COVID-19 pandemic was the Super Bowl, our team has been playing defense against a formidable opponent, the SARS COV2 (virus), for two quarters and using limited tools and plays. The defensive tools and plays such as face coverings, PPE, distancing, closures, travel restrictions, diagnostic testing, therapeutics and incremental improvements in clinical care to defeat our opponent (SARS-COV2) is truly limited. Problem is, we can never score points or defeat anything by playing defense—we can just buy time, run out the clock a bit or mitigate our losses. We are now on the verge of bringing new players into the game—vaccines—in order to turn the tide in our favor and start playing offense. Vaccines have been used for a couple of hundred years to control or eradicate deadly diseases and within public health, are considered the number one most effective achievement of the 20th Century in preventing illness and premature death in humans.  https://www.cdc.gov/mmwr/preview/mmwrhtml/00056803.htm 

REASSESSING AND LAUNCHING A NEW GAME STRATEGY

As we enter our locker room for half-time, we ought to re-assess our strategy, game plan and strongly consider putting in the first year “rookie” quarterback and wide-receiver walk-ons who’ve been showing great promise during practice games as their styles, speed and dynamic execution of plays make a great fit against our opponent’s weaknesses. Both rookies had stellar college careers, but no one believed they had the experience to win at the Super Bowl level so soon, but we are putting them in the game anyways as we need to turn the tide and begin defeating our opponent and do so now.

 THE NEW PLAYERS ON THE FIELD

Very soon, two COVID-19 vaccines—the rookies--will be coming to your states and they will first be offered to older populations living and/or working in congregant care facilities and our dedicated healthcare workers who have been fighting against COVID-19 since March 2020 and some earlier. If you are or know someone who is considered high risk for COVID-19, please strongly consider learning more about and taking one of these messenger ribonucleic acid (mRNA) vaccines or encouraging your loved ones and friends to do so as well.  

Although the CDC and the Advisory Committee on Immunizations Practices (ACIP) will make their recommendations on who first gets the initial limited doses of vaccine, your state level leaders will implement vaccination programs in accordance with your state needs. Our Operation Warp Speed leaders have been working closely with them for several months now. The best part is there are open forums for the public to understand the authorization process of these vaccines with the FDA through the Vaccine and Related Biological Products Advisory Committee (VRBPAC) on 10 and 17 Dec 2020. The USA is one of the few if not only country that has this level of public transparency upon the authorization and/or approval of new vaccines. https://www.fda.gov/advisory-committees 

WHO’S THIS GUY?  

How do I know? I am the Program Manager of the Moderna Product Coordination Team (PCT) at Operation Warp Speed and have also seen the studies, data with a skeptical eye on not only the Moderna vaccine, but on the mRNA platform technology that are coming to all of us very soon. I know some people have been saying, “How is it possible? “It must be rushed to get these two "unproven" and “never approved" vaccines out so quickly.” I am not a physician, or lab researcher, but someone who has actually worked in the pharmaceutical management/development/health care devices/material and healthcare arena for over 24 years and for the last 7 years in the advanced vaccine development space. I have been privileged that the US Army has sent me to post graduate level education or certification programs in public health, program management, science and technology management, pharmacology, drug/biologics, cGMP (manufacturing), healthcare supply chain, regulatory science, risk science and pharmaceuticals management. 

I’ve been an Institutional Official (IO) and Chief of Staff for the DOD’s Largest Biomedical Research Lab with subordinate labs in four continents all doing human subjects and animal research in infectious diseases as well as in neuro science. I’ve not only done public health research as a resident fellow at GWU’s School of Public Health, but did graduate level research on the management of pharmaceuticals and its associated supply chains. I have taken almost every vaccine offered to the military including the Anthrax, Small pox, Rabies and even the Shingles vaccine! I have taken an annual flu vaccine consistently since 1996 and have travelled extensively, lived in or been deployed to places like Kenya, Nigeria, Thailand, Cambodia, Japan, Germany, Qatar, Afghanistan, Iraq, and Kuwait to ensure our global infectious diseases research, pharmaceutical and medical supply and medical device capabilities in the US military were well supported.

I was heavily involved along with formidable teams at the Joint Program Executive Office for Chemical and Biological Defense (JPEO-CBD Medical), the Defense Threat Reduction Agency and the US Army Medical Research and Development Command (USAMRDC) and many others in the rapid manufacture and emergency deployment to West Africa of the experimental Ebola vaccine in 2014-2015.  These teams played a large role in the emergency manufacturing of this vaccine in late 2014 under a quick DTRA letter contract and subsequent storage and transfer of tens of thousands of doses to Merck where it received FDA licensure in 2019; the second fastest FDA approval for a vaccine in US history. This vaccine too was stored at sub-zero temperatures and we moved this vaccine all over the world and in the US albeit in smaller quantities than the COVID-19 response will require. This rapid manufacturing and deployment of the investigational Ebola vaccine, at great career risk (story I will tell you in person), enabled organizations like the NIH/NIAID/CDC/WHO and others to use this experimental vaccine in large Phase 2/3 ring vaccination trials in West Africa and ultimately led to the defeat of that deadly outbreak in 2015. The WHO and other partners used this Ebola vaccine again as recently as this year in the Democratic Republic of Congo (DRC) to crush another deadly outbreak of Ebola which flared up in June and was declared over just last month in Nov 2020!  https://www.who.int/csr/don/18-november-2020-ebola-drc/en/    

You likely didn’t hear about it because of the actions many scientists, program officers and others did many years back at places like the Public Health Agency of Canada, USAMRIID/WRAIR, JPEO/DTRA, NIAD/VRC, Battelle, UTMB, Marburg, Germany, WHO, GAVI, commercial biopharma companies (Merck, Newlink Genetics/Lumos Pharma), non-profits, NGOs and of course the venerable BARDA/ASPR teams. It would have surely been huge news without COVID-19 and likely would have continued to ravage Africa without this relatively new (rarely used in humans) vaccine from Merck/GAVI.   

Since 2006, I’ve been fortunate to be mentored by one of the world’s most successful giants in the biotech industry. He retired in 2008 after a 40+ year career in the military and industry and brokered the sale of a Fortune 500 biotech he founded in 1988 for over $15 billion.  His company delivered FDA approved life-saving treatments and biologics against some of the world’s most harmful diseases, especially to pre-mature born children and was an attractive acquisition by one of the world’s largest pharma companies—one that is advancing one of the six leading COVID-19 vaccine candidates right now. He taught me most of all in biotech, it’s about instilling a sense of trust in the people you recruit, lead and take care of to get the best medical countermeasures through to FDA approval and about setting up a culture of success and winning, something I have personally witnessed in my 6 months at Operation Warp Speed (OWS). We don’t admire problems at OWS, we figure them out and solve them through trusted teams of experts where pushing back and asking tough questions are welcome—even to a FOUR STAR GENERAL. All-in. Every day. Every Hour matters. Leave your drama and ego at door.

THE WHY

I say these things NOT to impress, but to inform you that the information presented here is coming from a place as a fellow human who cares about others health and well-being and from being a career military officer with no agenda other than trying to help prevent unnecessary illness and death.  

Part of my duty it is to help lead, manage and track the various development efforts and importantly, hold ourselves and our contracted companies and product development teams accountable for the delivery of safe and effective vaccines to protect Americans and our Nation. I have been fortunate during the past 6 months to support our PCT lead, a career BARDA scientist and our Warp Speed Lead on Vaccine Development, a former senior military physician/scientist who was the Medical Director at DARPA. They are both as focused on accountability and delivering safe and effective vaccines with no agenda other than saving lives.

HOW SO FAST?

Let me assure you, these mRNA vaccines aren’t some “rushed” lab experiment started in January 2020 to cash in profits during a pandemic, but rather a whole of country effort by people 100% committed to saving lives and getting our country and world back to some sense of normalcy. I have already personally advised my 80 year-old 100% disabled, COVID-19 high risk Vietnam Veteran Dad and others at risk who I love to take these vaccines as soon as they are offered. It’s okay and normal to be skeptical, but don’t regret passing on this opportunity so do your research now if you’re not sure on reputable sites such as the DOD’s and CDC’s at: https://www.defense.gov/Explore/Spotlight/Coronavirus/Operation-Warp-Speed/

https://www.cdc.gov/coronavirus/2019-ncov/vaccines/index.htm 

Messenger RNA (mRNA) vaccine basic and applied research has been going on for decades and has been painstakingly developed with safety foremost in mind. Moderna, for example, has been solely focused on their mRNA platform since 2010---that is ten “All-In” years of developing and nearly perfecting this platform for human use in close partnership with the NIH/NIAID/Vaccine Research Center and DARPA/DOD and others worldwide.

The beauty of this new vaccine platform is how efficiently scientists and bio-manufacturing facilities can create and use it to defeat some of the hardest to defeat diseases (including cancers and rare disorders) by adding the genetic sequence (the software of life) needed for "our bodies" to make the necessary protein to illicit an effective and comprehensive immune response.

CHALLENGE FINITE THINKING WITH CREATING POSSIBILITIES

The shock factor is that we're all "used to the status quo” of new vaccines always taking 10-15+ years to make and use that extended time frame to collect safety data. Well, the truth is, this mRNA platform has been used in Phase 1 (Safety) and Phase 2 (Safety & Immunogenicity) human studies for a few years now (CMV, Zika, RSV, EBV, Flu H7N9) with no severe adverse events, but we don’t hear about these other trials. Basic and applied research and development is rarely newsworthy, especially among the general public.  

Did you know that these industries as well as academia and the federal government have been working on this platform technology for 30+ years? All three areas in a true public private partnership have been figuring out how to make it work safely and effectively in monotonous lab experiments. These partnerships and extreme focus during the past decade led to cracking the code to safely encapsulate and modulate the mRNA in just the past few years! This pandemic created the perfect storm “opportunity” for science, industry, academia, government, bold and decisive leadership, to achieve an unmet need—to rapidly counter a NEVER before seen virus in humans in months, not years or decades—a truly historic and once in a century innovation of significant global impact.

Our dedicated lab research scientists and clinicians will be truly deserving of the highest accolades in support of all of humanity when this fight is won. I hope we will continue to support their research both financially and programmatically going forward and always remain prepared for future pandemics with appropriate stockpiles of PPE, testing materials and readied platform technologies.

These vaccines have also been extensively studied for toxicity and reproduction in animals and have been deemed safe and highly efficacious (~95%) relative to other licensed vaccines. There will always be anomalies when you begin using anything in hundreds of millions or billions of people, not unlike a few people out of millions who just don't digest a bowl of leafy green/romaine salad all that well or even a banana. I’d bet you my house more people will get illnesses and/or die within days/weeks of bad food borne diseases in the US than any of these new vaccines in a given year by far; want to bet your house?  I can assure you, these vaccines are safety tested and intensively managed in a global supply chain a lot more than your local side of romaine lettuce or favorite foods that millions consume nation-wide without thought. Did you know that millions fall ill and thousands die from food borne diseases each year in the US? Yes normal, everyday food.  

https://www.cdc.gov/foodborneburden/2011-foodborne-estimates.html

LUCKY TO SOME, PREPARED FOR MANY

These mRNA platforms present an "Innovative" or “Warp Speed” leap into the future because the pandemic created the opportunity, urgency, funding and dedicated focus to capitalize on these technologies in an otherwise status quo environment.

Just think back to January 1990 when you were at your local Blockbuster video renting your favorite movies on VHS cassette tapes. Imagine if someone in Dec 1990 gave you a hand held smartphone that streamed all the movies you ever wanted to see on demand--you'd be shocked! Probably in disbelief. Likely apprehensive. Thinking is this possible or is some sort of prank? Well, my friends, the biotechnology and medical industries just literally leaped past CDs, DVDs and Blue Ray and went right to "5K" Ultra HD/super high speed digital streaming in 11 months—literally at the “speed of relevance” to keep you disease free and your more at risk loved ones from falling ill or dying of COVID-19.

Consider this: The USA and the world will benefit from something already paid for by your hard working tax dollars so in essence; you are all part of the solution and have been all along.

Please strongly consider taking one of these vaccines when available to you and your loved ones. 

We now find ourselves in the 3rd quarter of the Super Bowl and ready to start scoring touchdowns with these rookie wunderkind players. Let’s pump up the music, stand-up, start cheering them on and doing our part to help the home team defeat our opponent and take home the victory by taking one of the FDA authorized COVID-19 vaccines. It just may make the difference in enabling you to attend sporting events in stadiums next year or preventing another loved one from dying alone in some cold ICU room.

If you want to learn more about this mRNA platform technology, please take 15 min and read this article in Nature: https://www.nature.com/articles/nrd.2017.243#citeas 

COL Victor A. Suarez, MS, CMRP

Vaccine Program Manager

Moderna Product Coordination Team

Operation Warp Speed

[email protected]