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.

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.

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

The Ban on Elective Procedures is Killing More People Than COVID-19

Written by A. J. Kay

On March 15th, Janet Mills of Maine became the first US Governor to recommend statewide cancellation of all elective medical procedures. Governor Mills proclaimed that such action would, “relieve the strain on the healthcare system as Maine prioritizes COVID-19-related cases.”

That same day, the American Hospital Association (AHA), in cooperation with three other healthcare advocacy organizations, published an open letter to the Surgeon General rejecting the idea that the COVID response necessitated such sweeping measures. They stated declaratively,

Our ability to respond to patients must not be prevented by arbitrary directives.”

In the following weeks, a cascade of 35 states included similar restrictions on elective procedures in their stay-at-home and shelter-in-place (commonly known as “lockdown”) orders. These directives ranged from instruction on the prioritization of “grey area” elective surgeries to compulsory cancellation and postponement of all non-emergent procedures. Orders in seven of those states outlined explicit civil and criminal penalties (some including imprisonment) for doctors who failed to comply.

In the weeks since the unprecedented multi-state lockdowns, the US Healthcare system has been left with an opaque patchwork of the very same ‘arbitrary directives’ against which the AHA cautioned. The lockdown orders and elective procedure bans were instituted with the intent to save lives. However, our failure to safely and quickly resume elective surgeries when lockdowns helped blunt the impending crisis has financially crippled our hospitals and private practices, led to mass furloughs, and denied healthcare to those who need it most. 

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How to Win the War on Coronavirus

Written by Col Randy Larsen, USAF (Ret)

I remember the first time I thought about World War III. It was October 22, 1962. As President John Kennedy addressed the nation about the “unmistakable evidence” of nuclear-tipped Soviet missiles in Cuba, my dad whispered to my mom, “This may be World War III.”

Thankfully, Dad was wrong. But during the first two decades of my military service, the possibility of WWIII between the U.S. and the Soviets remained a serious threat until the collapse of the Soviet empire. By the time I became a professor and department chairman at the National War College (NWC) in 1998, I had become convinced that the most serious threat to national security was not Russian or Chinese missiles, but a pandemic — either man-made or naturally occurring. I was so convinced, I hired Dr. Robert Kadlec — the first physician to serve on the faculty at NWC. Several of the “old cold warriors” on the faculty could not understand. They asked, “What is he going to do? Give us flu shots?” (Dr. Kadlec continued his work on the national-security aspects of pandemic preparedness during two tours on the National Security Council, and he now serves as the assistant secretary of preparedness and response at the Department of Health and Human Services.)

Since the 1970s, scholars have defined national security with the acronym DIME: diplomacy, intelligence, military, and economics. (With the onset of the information age, some modified it to intelligence/information.) During the past several decades, many of my colleagues in the biosecurity and public-health communities, plus a bipartisan group of political leaders including senators Bob Graham (D., Fla.), Jim Talent (R., Mo.), Gary Hart (D., Colo.), Richard Burr (R., N.C.), and Joe Lieberman (I., Conn.), have argued to include public health as a key element in national security. Unfortunately, most national leaders failed to listen. I suspect that may be changing, albeit, a bit late.

Not since WWII have all Americans been engaged in a war requiring a national mobilization. Not only did 12 million serve in uniform, but virtually every man, woman, and child in America was involved in one way or another. From war-bond drives, victory gardens, and ration cards, to women taking on completely new roles outside the home — building airplanes, tanks, and battleships — the entire nation participated in a united effort.

Compare that with the nearly two decades following 9/11. Shortly after that tragic day, President Bush told Americans, “Go back to the malls.” Understandable at the time. We could not let 19 hijackers destroy our economy. But as the war on terrorism dragged on, only the military and their families made the sacrifices. Less than a fraction of 1 percent of the U.S. population have been asked to sacrifice.

Suddenly, everything has changed. We are once again back to a reality like that of 1943. All Americans are once again involved. WWIII has begun. And it is not just a war against COVID-19, it is a war against infectious disease. WWIII will be a “good war” — a war between the human race and infectious diseases.

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