We Need Challenge Studies for COVID-19 Vaccines

Combined with standard testing protocols, challenge studies could accelerate development of a safe and effective vaccine.

Challenge studies involve giving a developmental vaccine to volunteers followed by infecting those volunteers with the SARS-CoV-2 virus. Challenge studies are rare but the National Institutes of Health has been doing them for a few years for a mild strain of influenza.

From 1954-1973, during The Cold War, the U. S. Army conducted a series of challenge studies on more than 2000 Seventh-day Adventist volunteers. Operation Whitecoat was created to protect against the threat of Soviet bioweapons. The studies were conducted at Ft Detrick MD and set the gold standard for the use of human volunteers in medical experiments. In 2018, I directed & produced a documentary film about these incredibly patriotic young men.

Looking forward, after a COVID-19 vaccine completes Phase I safety testing, volunteers for a challenge study would be vaccinated and later infected with the COV-SARS-2 virus. Initially, only young, healthy volunteers would be selected. They would be closely monitored in a medical facility.

Donna Shalala (D-FL), a former secretary of Health and Human Services, along with 33 other members of Congress from both parties, have expressed support for the use of human challenge trials. The World Health Organization and National Institutes of Health are currently examining the issue.

This is not a common procedure for vaccine development.

These are not common times.

Who Should Be in Charge of the COVID-19 Response?

During the past few months, how many times have you heard a pundit on TV say, “We must listen to the experts.”  Every time I hear this, I wonder if the pundit has ever sat around a conference table with a group of scientists—or for that fact, lawyers, economists, senior military leaders or other such “experts”. 

I have.  

During the past two decades I have spent many hours—in fact, entire days, listening to distinguished experts engage in exhausting, ferocious debates while failing to reach consensus on a wide variety of national security issues. This is in no way a criticism–it is the essence of policy debates. Such “real-time peer review” is even more pronounced when dealing with the COVID-19 pandemic. There is so much we don’t yet know about the virus, the disease and the social and economic consequences–and no one dealing with the current pandemic has ever faced such a challenging crisis–at least not in the “real world”.

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Reopening is a Critical Health Issue

When we began this blog, our lead article was written by A. J. Kay stating the ban on elective procedures (which includes things like heart valve replacements, bone marrow transplants, organ donations, and cancer screenings) could kill more Americans than COVID-19. Today’s op-ed in the Washington Post by the Secretary of Health and Human Services adds even more information to this argument.

Since the stay-at-home orders and ban on elective procedures began—which we fully supported at the time to prevent the potential overloading of the healthcare system—the unintended consequences have grown at an alarming rate.

  • mammograms down 87 %
  • colonoscopies down 90%
  • breast cancer surgeries reduced by 66%
  • vaccinations down 60%

These are all classed as elective procedures.

Additionally, many hospitals have experienced a 60% reduction in revenue due to the cancellation of elective procedures resulting in the furloughing of healthcare providers and creating a situation in which many rural hospitals are on the brink of bankruptcy and may be forced to close—permanently.

One has to wonder if the epidemic modelers add these and other unemployment heath risks (increases in suicides, opioid deaths and spousal abuse plus loss of healthcare benefits) to their equations?

There are not any “no-risk” solutions, but Secretary Azar makes it very clear—this is not an argument about health vs the economy. It is about health vs health.

We recommend you read Secretary Azar’s op-ed.

A Good War Needs You

We created A Good War to help inform you and your family during the epic battle against COVID-19. America’s top public health leaders will be among the contributors, along with heroes working on the frontlines.

I am Randy Larsen. For the past 25 years, I have held various executive positions, inside and outside of government, working with my fellow public health warriors to try and convince America’s leaders that public health preparedness is a critical element of national security.

I have been working with Jay Lavender since 2008. Jay is a writer and producer with a great passion for protecting America’s national security. For the past dozen years, we have been telling stories in film and print celebrating unsung heroes.

Jay and I are honored to be working with a world-class team to edit this site and produce the podcast, A Good War. Our mission is to help tell the inspiring stories of public health heroes—past and present—in the battles between the human race and infectious diseases.

Look for the podcast to debut in the coming weeks.

Please reach out with ideas for posts or questions and share with everyone who wants to help play their part.

Thank you for spending your valuable time with us. We need each of you to help Win A Good War.

Smallpox is Dead!

Written by Leigh Henderson

One of the most significant anniversaries in human history passed recently with little fanfare. Forty years ago, on May 8, 1980, the World Health Assembly declared that smallpox had been eradicated.

WHO Smallpox Identification Card

Smallpox had been transmitted in an uninterrupted chain from person to person for at least 3,000 years. Unlike bubonic plague, it was endemic—always present—killing some 20-30% of those infected and leaving many of the survivors blind and most horribly scarred. Children bore the brunt of smallpox—many adults had survived the disease or been successfully vaccinated. Children under 15 could account for 75% of all deaths in an epidemic.

Images of men with Smallpox

On January 1, 1967, the World Health Organization (WHO) started a global smallpox eradication program. Smallpox control efforts had ended endemic smallpox in much of the world, but epidemics introduced by travellers were rife. Smallpox was conservatively estimated to infect 10 million people annually, causing 2 million deaths.

On October 26, 1977, a Somali man became the last victim of smallpox in the world. Two years of exhaustive searches for any remaining smallpox reservoirs followed. A global commission reviewed the evidence and concluded that smallpox had indeed been eradicated.

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Pandemic Wave Scenarios: What You Need to Know About COVID-19, Today and Tomorrow

Dr. Mike Osterholm has been a colleague and good friend for 20 years. He is not only a world-class epidemiologist, but also a fabulous communicator. You have probably seen him on TV during the past few months, but in this podcast he has the time to explain the details behind the headlines and sound bites. I will be listening to his weekly podcasts, and so should you.

Episode 7: Pandemic Wave Scenarios

Interview with Dr. Luciana Borio – Part 1

Dr. Luciana Borio (LB) 
Randy Larsen (RL)
May 4, 2020

Part 1 – Testing for COVID-19

RL  We’re very happy to have with us, Dr. Luciana Borio, a vice president at In-Q-Tel. She previously served as the Director of Medical and Biodefense Preparedness Policy at the National Security Council in the White House. Prior to that, she was the acting Chief Scientist at the Food and Drug Administration. 

And in the spirit of full disclosure, I should say that Dr. Borio and I have been good friends and professional colleagues for 20 years. Dr. Borio it is a pleasure to have you join us today.

LB  My pleasure to be here Randy. 

RL  Dr. Borio, can you tell us why is it taking us so long to develop diagnostic tests for COVID-19?

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Interview with Dr. Luciana Borio – Part 2

Dr. Luciana Borio (LB)
Randy Larsen (RL)
May 4, 2020

Part 2 – Vaccines for COVID-19

RL  I’ve been hearing people say we can have a vaccine within a year to 18 months, but others are not so optimistic. What is your prediction?

LB  Well … we’ve never developed a vaccine from start to finish in 18 months. It’s certainly going to take a concerted effort by major pharmaceutical companies. But it is worth remembering that the science of vaccine development has progressed a lot in the last decade. All of the candidates that are in development right now are the result of years and years of funding and support for biomedical research. 

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Interview with Dr. Luciana Borio – Part 3

Dr. Luciana Borio (LB)
Randy Larsen (RL)
May 4, 2020

Part 3 – Therapeutics for COVID-19

RL  So one last topic for today … therapeutics … and I think that you will agree with me .. I’ve been telling people that we will have a therapeutic … maybe more than one effective and safe therapeutic long before we have a vaccine. Do you agree with that?

LB  I do. As of last week, we have an effective therapy for COVID-19, one that has been established to benefit patients with advanced (or serious) COVID-19. It is called Remdesivir, it is produced by Gilead, and it received an Emergency Use Authorization by the FDA. 

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Warning: Do Not Wear the Wrong Type of N-95 Mask

There are many types of N-95 masks available, but do not use one with an exhalation valve during this pandemic.  For those of us not in a medical setting, but just wanting to help prevent the further spread of COVID-19 while in public, particularly as some states ease up on stay-at-home orders, a face covering is a very important public health procedure when outside your home.

The purpose is not so much to protect the person wearing a mask or scarf, but to prevent the wearer, who may be infected with COVID-19 but have no symptoms, from spreading the disease.  And it does not require a cough or sneeze to spread the virus—talking or just breathing may be sufficient to infect others in close proximity.

The N-95 mask with exhalation valve was designed only for industrial use and never authorized for use in a medical setting . It does a great job preventing small particles from entering the masks, but a really bad job of preventing particles from exiting the masks.

UPDATE: On May 2nd, two reporters on ABC World News Tonight wore N-95 masks with exhalation valves while one wore an N-95 mask more suited to prevent the spread of the virus:

Wrong N-95 Mask = Exhalation Valve = Might not protect others if wearer is infected.
Wrong N-95 Mask = Exhalation Valve = Might not protect others if wearer is infected.
Right N-95 Mask = No Exhalation Valve = Can protect others if wearer is infected.

For more information, read this article:

Mark Wilson – What is a Mask Valve and Why are Cities Banning Them – Fast Company