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<p>As the continuing global pandemic threatens to overwhelm the medical response, there are tempered expectations about an imminent SARS-CoV-2 vaccine to protect the battered healthcare workforce. The Food and Drug Administration is not expecting a magic bullet, saying it would accept a vaccine with 50% efficacy as long as they are confident it would be no lower than 30% effective.</p>
COVID-19 Vaccine Imminent, but No Magic Bullet Expected
December 1, 2020 9 minutes read
By Gary Evans, Medical Writer
As the continuing global pandemic threatens to overwhelm the medical response, there are tempered expectations about an imminent SARS-CoV-2 vaccine to protect the battered healthcare workforce. Immunization with a safe and effective vaccine could give mental health benefits as well as biological protection, as healthcare personnel work daily in the fear of some unforeseen exposure to COVID-19.
The Food and Drug Administration (FDA) is not expecting a magic bullet, saying it would accept a vaccine with 50% efficacy as long as they are confident it would be no lower than 30% effective. Given that and other factors, there is emerging epidemiological consensus the virus will not be vanquished easily, and may even become globally endemic. Addressing the widespread public mistrust in the vaccine development at “warp speed,” an immunization expert and FDA advisor said pressures political and otherwise to rush the process will not undermine stringent review for safety and efficacy.
“There has been so much attention on that fear that I just don’t think it’s going to happen,” Paul Offit, MD, said recently at the IDWeek 2020 infectious disease conference. “I am optimistic that there are things in place now between the data safety monitoring boards and the FDA Vaccine Advisory committee that it’s not going to happen.”
Offit is director of the Vaccine Education Center and an infectious disease physician at Children’s Hospital of Philadelphia. “I am a member of the FDA’s Vaccine Advisory Committee as well as the data safety monitoring board,” he said. “Both [boards] are composed of people who are academicians, clinicians, and researchers. These people are not associated with the government or the pharmaceutical industry. I think they will give a clear, unvarnished, honest opinion of what they think about these vaccines. I really don’t think that a vaccine that is inadequately tested for safety and efficacy will be given to the American public.”
As Hospital Employee Health previously reported, healthcare workers have been designated by the CDC’s Advisory Committee on Immunization Practices (ACIP) as the first group to receive a safe and effective COVID-19 vaccine cleared for use in the United States.1 About 10% of healthcare workers with COVID-19 develop serious infections, with outcomes including hospitalizations, intensive care, and death. Beyond the clinical consequences, healthcare workers report for duty knowing they may be endangering their own lives, and those of their families, colleagues, and patients.
Given this backdrop, Hospital Employee Health asked ACIP member Grace Lee, MD, MPH, a frontline pediatrician and professor at Stanford University, a hypothetical question: What would it mean to a healthcare worker to be immunized with a safe and effective COVID-19 vaccine?
“I feel it will be extremely helpful,” Lee says. “Our healthcare workforce is exhausted. The constant worry about COVID is just hanging over us as we are caring for patients and [interacting with] their family members. It’s going to be one really important strategy, and it will give us a sense of enhanced protection. It won’t take away the need for us to continue to use PPE [personal protective equipment], but I feel like it will give me an extra layer of confidence that if I don’t do everything perfectly all of the time then I am putting myself and my family at risk. I think that is what gets exhausting. I was on clinical service last week and I have to tell you, I was exhausted by the end of the day. I couldn’t think.”
Razor’s Edge
PPE shortages and other healthcare delivery issues have exacerbated the situation, particularly in hot spots of community spread as demand for ICU beds increase. Under such conditions, the margin for error is razor thin.
“We cannot afford to lose more healthcare workers. We have to protect those on the frontlines of this battle,” said Tom Frieden, MD, MPH, former director of the Centers for Disease Control and Prevention (CDC). Delivering a keynote address at IDWeek 2020 on Oct. 22, Frieden said other diseases may arise if COVID-19 overwhelms the healthcare systems in third-world countries.
“Perhaps my biggest fear in this entire pandemic is that there will be millions of preventable deaths in Africa from measles, malaria, HIV, and tuberculosis,” he said. “We must protect healthcare, and we must use data to drive progress.”
That said, COVID-19 will not be driven out any time soon, and may never completely disappear, he emphasized.
“The reality is that even with a vaccine, we will be dealing with the risk of ongoing explosive cases and clusters,” Frieden said. “We are guardedly optimistic about vaccination, and management and treatment is improving. We are learning more about prevention, but also we are not going back to the old normal.”
Indeed, medical history may eventually draw a line of demarcation of before COVID-19 emerged (BC), but we may remain in “during COVID” (DC) indefinitely, he added.
“I don’t think we see an after — a COVID AC,” Frieden said. “I don’t see this being eradicated anytime soon. Who knows, there could be drift in the genetic characteristics of it. We could figure out a way to find a low-variance, low-virulence strain to immunize people. We don’t know what the future will hold. What we do know is the cards we have to play today — and those cards are to knock down spread where it is spreading explosively and then work to control cases and clusters rapidly.”
One troubling sign is that the virus has been found in minks and other species, raising the possibility that coronavirus will eventually become endemic through an animal reservoir — much as the Middle East Respiratory Syndrome (MERS) coronavirus has done via camels in Saudi Arabia. In addition, vaccine-preventable viruses still emerge in cases and outbreaks because vaccines are not 100% effective and there are susceptible populations of unvaccinated people.
“The question is going to be, can we ever truly eradicate SARS-CoV-2 from the human population?” Michael Ryan, MD, MPH, director of the World Health Organization’s Health Emergencies Programme, asked at IDWeek. “That’s going to be a tough one. We have had effective vaccines against measles and yellow fever for decades and decades. We have [nearly] eradicated those diseases, and they devastate children every single year.”
Rather than eradication, the goal should be reining in the virus with vaccines, therapies, and other public health measures, he added.
“If health systems can recover, maybe we can reach a point where this virus may enter the pantheon of all those viruses that can affect us from time to time, but we have the therapeutics and we absolutely have control over what it does to us,” Ryan said. “If we get there, I will consider that to be a public health success. Then, we will decide whether we can eradicate this disease or not.”
Permanent Change
As Albert Camus wrote, “though the plague had ended, we continued to live by its standards.”2 In that vein, some of the changes made to accommodate COVID-19 are likely permanent for the foreseeable future.
“We have all realized that there are a lot of virtual meetings we can do that save airfare and are good for our carbon footprint, so why go back?” Frieden asked. “There are people who have realized, ‘We didn’t need that office space — we like working from home.’ We hope reimagining cities will make bicycling and walking more attractive and appealing, and will be helpful for our lungs and planet. Regardless what happens with COVID, there are changes that are going to be long term because we have realized that we were doing some things that could be done differently and better.”
In the divisive times of an election year, Frieden expressed hope that by this time next year people will realize they are connected for good or ill with others in a global village.
“Communities, families, individuals, may have an impact — positive or negative — on anyone else in the world,” he said. “Interconnectivity has huge implications for our health and society — for our economic, educational, and environmental systems. Ultimately, the world is up against a common enemy. We weren’t invaded from outer space; we were invaded from the microbial world. That should call to our better natures, a better ability to collaborate, to think together, to be essentially one world in unison against the microbial world.”
Frieden reviewed a severity assessment framework of the 1918 H1N1 flu pandemic with COVID-19 superimposed by age groups.
“For those who are 70 or older who have underlying conditions, [COVID-19] is the 1918 pandemic,” he said. “For those 50-69, it is a moderately severe pandemic. For those who are 20-49, it’s behaving like a moderate-to-high-severity pandemic. For children, it’s behaving like a low-to-moderate severe pandemic. It’s a different pandemic in different populations.”
While these broad strokes show greater risk of mortality in countries with larger elderly populations, there is much that is not completely understood about this virus.
“We don’t really understand the epidemiology of transmission,” Frieden said. “We don’t know why [some] people get so much sicker than others. We don’t know whether mutations are associated with the severity or to what extent it’s driving these distances. We don’t know why women and children are less likely to get severe disease, nor do we know the optimum way to balance reducing spread with limiting economic damage.”
With the response already complicated by these unknowns, the virus has attacked chronically underfunded public health systems and clinical care facilities designed to run with little surplus capacity.
“Our systems are not elastic,” Ryan said. “They are operating at 95% to 97% all the time. They find it very hard to expand and absorb extra work that may come in a shock wave. We have seen the effects of that with overcrowded emergency rooms, lack of ICU beds, lack of PPE. These are inevitable outcomes of a rigid and inelastic system that cannot move resources around when it needs to. It cannot expand quickly.”
Periodic lockdowns are a blunt weapon against a virus, but the greater problem is that many countries squandered the time gained by such severe measures, Ryan said.
“This is the opportunity we all lost, particularly in the Northern Hemisphere,” he said. “Many countries [locked down] and got this disease down to a low level. [But] did we invest in public health surveillance, hiring contract tracers, making our hospitals more resilient, educating our population, and building community resilience?”
The question was rhetorical, but the answer clearly is “no.”
“We didn’t do all of that homework, and now we are upset that what was predictable is happening?” Frieden added. “I mean, that is the reality. The countries that were able to crush the curve and not have a simmering, ongoing spread are able to reopen without an explosion. In Europe and the U.S., we haven’t crushed the curve. There is a lot of [transmission] and we don’t know where it’s coming from. At best, we are diagnosing one out of five patients in the U.S., even though we are doing a million tests per day. The problem is, the more cases you have, the more tests you have to do. It is not a solution, it is part of a strategy. When we think about lockdowns we have to become more granular in how we consider this.”
In a larger sense, it is a “false dichotomy” as grocery stores and other essential services never completely shut down, Frieden said.
“It’s not about open vs. closed,” he explained. “For the foreseeable future masks are in and handshakes are out. We’re going to have to get used to that reality. The three Ws: Wear a mask, watch your distance, wash your hands. What we don’t know is how much of our society can you resume if you knock the levels down and take those kinds of measures. ‘Lockdown’ is a really bad term, but you take that action only to prepare your healthcare and public health systems.”
Despite unknowns like long-term effects and neurological complications, these basic measures to reduce COVID-19 transmission are not a mystery.
“We know that this virus can only reproduce effectively in the human biologic system,” Ryan said. “It can only survive for a very short time outside that system. This disease moves from person to person. We can argue about how easily and exactly what circumstances are most efficient, but we know there are many circumstances, situations, and modes of transmission. We know how to break those. We know how to break the chains of transmission.”
For all its negative outcomes — including killing more than 1 million people worldwide as this report was filled — COVID-19 has shed a damning light on social injustice.
“It has been the great revealer,” Ryan said. “It has revealed issues with health justice, social justice, climate justice — God knows what else. The world is out of balance, our civilization is out of balance. Our children deserve a better world. I think we need to start moving forward. Not to a new normal; we need to move forward to a ‘better’ normal. We need to use COVID-19 as one of the lessons to move us toward a more sustainable and better normal in the future.”
REFERENCES
- Evans G. CDC: Healthcare workers first in line for COVID-19 vaccine. Hospital Employee Health, Nov. 1, 2020. https://www.reliasmedia.com/articles/146963-cdc-healthcare-workers-first-in-line-for-covid-19-vaccine
- Camus, A. The Plague. London: Hamilton, 1948.
As the continuing global pandemic threatens to overwhelm the medical response, there are tempered expectations about an imminent SARS-CoV-2 vaccine to protect the battered healthcare workforce. The Food and Drug Administration is not expecting a magic bullet, saying it would accept a vaccine with 50% efficacy as long as they are confident it would be no lower than 30% effective.
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