Solving the Flu-Meets-Coronavirus Crisis (I)
The Urgent Need for a Self-Administered Vaccination Solution
Public health officials are starting to urge people even more than usual to get flu shots. But many seniors and other vulnerable people will find the conventional arrangements for flu vaccination too risky, and won’t comply.
What’s needed to avert an even more acute public health crisis is a way to protect seniors and others against the flu without increasing their risk of contracting covid-19.
An ideal solution would be one that allows seniors and others to self-administer flu vaccination at home.
While no suitable product for self-administered vaccination (SAV) is currently available, there are several technologies now in various stages of research and development that could potentially solve the SAV problem.
The same kind of accelerated, “warp speed” effort invested in covid-19 vaccines and therapeutics should be applied to developing and deploying one or more safe and effective SAV solutions.
When the next flu season comes, the roughly 50 million Americans age 65+ (and millions of others in the high-risk category) will still need to be practicing social distancing — and self-quarantining — to protect them from a covid-19 pandemic that is still out of control and rapidly growing in the United States. So going out to a clinic or pharmacy to get a flu shot poses a risk of coronavirus infection that many seniors won’t want to take.
Evidence that the covid-19 pandemic has caused major declines of in-person healthcare includes:
- a sharp, 40–50% decline of emergency room visits and a corresponding rise of “DOA” deaths of people suffering heart attacks, strokes, or other life-threatening illnesses who have been afraid to go to the ER during the pandemic
- a decline of up to 90% of cancer screening tests such as mammograms, especially among the elderly
- a nearly full stop of childhood vaccinations in the United States following the declaration of the coronavirus pandemic emergency
The confluence of coronavirus and flu poses a particularly dire threat to seniors, who account for 75–80% of all deaths from either disease. And while over 200,000 Americans have died to date from covid-19, still an estimated 24,000 to 62,000 people died from influenza in the United States in the 2019–2020 flu season.
The director of the Center for Disease Control and Prevention and other epidemiologists are now warning that hospitals and other US healthcare facilities will be even more stressed than they have been by the overlap of the next flu season with a covid-19 pandemic that is not declining but growing faster — and that scientists worry could accelerate further when colder weather arrives. So public health officials are starting to urge people even more than usual to get flu shots. But many seniors and other vulnerable people will find the conventional arrangements for flu vaccination too risky, and won’t comply.
What’s needed to avert an even more acute public health crisis is a way to protect seniors and others against the flu without increasing their risk of contracting covid-19.
An ideal solution would be one that allows seniors and others to self-administer flu vaccination at home. Among the requirements for such a solution are that it (A) not require refrigeration, (B) be needle-free, (C) can be obtained by mail or other direct delivery service, and (D) not require special skill or training to administer correctly.
Unfortunately, no suitable product meeting all those requirements for self-administered vaccination (SAV) is available for current use.
However, there are several technologies now in various stages of research and development that could potentially solve the SAV problem.
A massive, “warp speed” effort is underway worldwide to develop vaccines and therapeutics for covid‑19. As Bill Gates has noted, the billions of dollars and array of research teams, companies, and other organizations devoted to this task seem like a bargain compared to the trillions of dollars the novel coronavirus poses in economic disruption. (Estimates of the economic cost of the pandemic to the US economy alone range from $550 billion to nearly $20 trillion. For the world economy the estimated loss ranges from $3.3 trillion to a staggering $82 trillion over the next five years.)
There should be a comparably urgent effort to develop and deploy an SAV technology before flu season peaks next winter. There are two key reasons for such a crash program.
First, an SAV solution would blunt the threat to seniors and other vulnerable people posed by the confluence of the covid‑19 pandemic and the coming fall–winter flu season. Second, if a safe and effective coronavirus vaccine can be developed and approved in record time, by January, there will then be the immense challenge of vaccinating billions of people worldwide, many in poor countries with limited healthcare resources. So helping to meet that challenge would be a collateral benefit of an SAV crash program, by providing a cost-effective means to vaccinate people in poor and remote areas (as well as many people who are simply averse to hypodermic injections).
There are some fallback measures that in the near term can make it safe enough to get a flu shot to overcome the fears of seniors and others at high risk of coronavirus infection. (See the Fallback section below and then Part II for details.) But the sooner a safe and effective SAV solution can be created and approved, the better off everyone will be.
SAV Technology Options
A nasal spray for flu vaccination is available. Since many people already are familiar with using nasal sprays for common over-the-counter medications — such as for colds or allergies — that would seem to be a practical mechanism for self-administered vaccination. However the flu vaccine spray uses live virus, requires refrigeration, and is authorized only for people age 2 to 49. Even within the allowed age group, use of the live virus spray may be restricted in case of particular health conditions, such as allergies or pregnancy, and it may interact negatively with a variety of medicines. So a nasal spray would not be a feasible solution for the problem described here without significant re-engineering to overcome those hurdles.
One possible candidate that has engaged a number of researchers is some kind of patch that is simply stuck on like a band-aid, and that delivers the flu vaccine through the skin over a few hours. Some technical approaches use microscopic needles that just penetrate the outer layer of skin. Others aim to use nanoparticles or biochemical means to allow vaccine to be absorbed through the skin. The patch would not require refrigeration and could be shipped to the home by mail or some other delivery service. While simple in concept, some of these types of solutions may not be easy to apply correctly or to assure a consistently correct dosage. Several prototypes are in development, but none yet has been approved for human use.
Another possible SAV solution that could satisfy the four criteria listed above would be a vaccine that could be taken orally, as in a pill. A flu pill tested in a limited phase 2 trial was shown to be as effective as the standard hypodermic injection. But the oral vaccine is believed to be at least five years away from market readiness.
A promising, novel approach is a system that uses a spring-loaded, needle-free device that, when pressed firmly against the skin, shoots a tiny projectile of solidified vaccine (about 4 mm long and 0.85 mm in diameter) a few millimeters into the skin, where the solid dose dissolves and is absorbed. The solid dose vaccine is packaged in a disposable, single-use cassette that is inserted in the end of the hand-held actuator. The actuator itself can be re-used multiple times. This system satisfies all four criteria for an effective SAV solution noted earlier: no refrigeration is needed, no needle is used, it can be easily delivered to the home, and no special skill or training is required to administer it. Moreover, the subcutaneous placement of the solid dose appears to prompt an enhanced immune response compared to conventional hypodermic injection. (The enhanced immune response may be particularly significant for seniors, who typically have reduced immune activity and thus require a higher dose of conventional flu vaccine to achieve adequate immunity.)
Costs and Benefits
The total investment in the intense efforts by private companies, universities, nonprofit organizations, and governments worldwide to develop vaccines and therapeutics for covid‑19 is hard to gauge exactly, but is on the order of $10 billion. That is spread across more than 140 projects. History indicates that most of those will fail to yield a useful product (though all will contribute valuable knowledge about what works or doesn’t, and why). Experts expect that out of this massive activity will emerge more than one vaccine as well as several therapeutics that pass the regulatory requirements for safety and effectiveness.
By comparison, the cost of developing one SAV solution to being market-ready, and passing it through various phases of clinical trials to be ultimately approved as safe and effective, may be on the order of $100–200 million. A program to pursue several potential solutions would be some multiple of that, so on the order of $1 billion.
In addition to the financial cost, the cost of time also warrants consideration. Following the normal path of procedures from basic research through to market readiness and regulatory approval, a safe, effective, and deployable SAV solution probably would not be available until the fall of 2021.
But the quest for covid-19 vaccines and therapeutics has aggressively pushed against the envelope of normal procedures. Aiming for a deployable vaccine in as little 18 or even 12 months may be considered either heroic or radical, but in any case defies precedent: No vaccine for any coronavirus has yet been developed. And the speed record for vaccine development is held by the one for mumps, which took four years.
The accelerated pace and cost of the attack on the coronavirus is justified by the trillions of dollars of costs the pandemic is imposing on the global economy. By comparison, the average annual economic burden of seasonal influenza in the United States has been estimated to be about $11 billion. That figure includes the cost of healthcare, the cost of lost productivity, and the economists’ valuation of lives lost. (Philosophically we may believe that human lives are priceless, but both private and public business finds the need to put a price on them.)
It’s hard to say how much of that average figure would be saved by a safe and effective SAV solution. At first it might seem arguable whether the billion dollars or so needed to create one solution (or several) is worth what that saving could be. But that flu cost is just for the United States. The global cost of seasonal flu is several times greater, estimated to be $60 billion a year by the World Health Organization.
And those figures are only for a normal flu season. The coronavirus pandemic is a multiplier that raises the usual ante. It multiplies the chances that people who contract either flu or covid-19 would be more vulnerable to contracting the other as well, becoming much sicker and more likely to die, while also magnifying the total burden on a possibly over-stretched healthcare system.
To be added to that is the potential, as noted earlier, for an SAV solution to be applied also to vaccinating people against covid‑19. That could significantly increase the cost-effectiveness of a global vaccination campaign to curtail the coronavirus — a benefit that brings back into the equation the trillions of dollars of economic costs of the pandemic.
In that light, the cost of a crash program to create a safe and effective SAV solution can be justified just as much as the all-out effort to find coronavirus vaccines and treatments.
Fallback
In the absence of a means to self-administer flu vaccination at home, what might be a fallback option for protecting seniors 65+ and other people with high risk factors for coronavirus infection (notably, hypertension, obesity, and diabetes) from contracting influenza? See Part II for a full discussion of that question.
For the moment though, consider that, since the coronavirus is significantly more infectious than influenza, seniors and others sheltering and practicing other measures to avoid covid‑19 infection (washing hands, wearing a mask, and so on) would seem to be even less likely to contract the flu. And in fact, countries in the southern hemisphere have reported markedly fewer influenza cases during fall and winter than usual.
While there is no assurance that the flu season in the northern hemisphere will be as mild as it was in the southern hemisphere, skipping the flu shot and waiting for a better, safer means for SAV is one option to consider.
The other option would be to organize the way the usual hypodermic flu shot is administered to minimize or even eliminate the risk of coronavirus infection, especially for the elderly and others at high risk.
Sources/Links
Problem
“Dr. Robert R. Redfield, the director of the Centers for Disease Control and Prevention, called the pandemic ‘the greatest public health crisis our nation and world have confronted in a century,’ and warned that the outbreak would coincide with flu season later this year, straining hospitals and health workers. Getting a flu shot, he said, would be even more important this year.” https://bit.ly/RdfldPandFlu
“Slowing the Coronavirus Is Speeding the Spread of Other Diseases” https://bit.ly/LsCovMrDis
“COVID-19 Fears May Have Led to Rise in D.O.A. Calls in NJ Town, Officials Say” https://bit.ly/Cov19frDOA
“Adults With Serious Conditions Are Avoiding Emergency Rooms Because of COVID-19” https://bit.ly/DocDntavdER
“Americans’ Fear of Seeking Medical Care During Covid-19” https://bit.ly/AmFrMDpndmc
“COVID-19 Pandemic Is Negatively Impacting Cancer Screening” https://bit.ly/NegCncrScr
“Routine vaccinations for U.S. children have plummeted during the Covid-19 pandemic” https://bit.ly/ChldVacUS
“WHO and UNICEF warn of a decline in vaccinations during COVID-19” https://bit.ly/WHOvacc
“Comorbidities the rule in New York’s COVID-19 deaths” https://bit.ly/CmdtNYcov
SAV Technology
“Needle-free flu vaccine patch effective in early study” http://j.mp/URMCptch
“Investigators Exploring Microneedle Patch As Universal Influenza Vaccine Candidate” http://j.mp/GSUmnptch
“Microneedle patch for flu vaccine” http://j.mp/GTmnptch
“Current Progress in Particle-Based Systems for Transdermal Vaccine Delivery” https://bit.ly/ParBasSTDV
“Flu vaccine in pill form on horizon” https://bit.ly/FluPill
“Enesi Pharma Platform” https://bit.ly/EnesiPhPlt
Costs and Benefits
“The coronavirus pandemic could cost the global economy a nightmarish $82 trillion over 5 years, a Cambridge study warns” https://bit.ly/CorPanCst
“Economic burden of seasonal influenza in the United States” https://bit.ly/EconBrdFluUS
“How Economists Calculate The Costs And Benefits of COVID-19 Lockdowns” https://bit.ly/EconCalCBcov
Fallback
“Flu in the Southern Hemisphere has ‘practically disappeared.’ What does that mean for America’s flu season?” https://bit.ly/SthHemFlu
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© 2020, Lewis J. Perelman. Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
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Published 08/14/20; updated 10/02/20.
