Will You Roll Up Your Sleeve?
It was summer. A very active and healthy 39-year-old gentleman was on a family yacht vacation in Canada when he suddenly came down with general malaise, severe back pain, and ultimately weakness and paralysis of his legs in a matter of days. He would lose the ability to walk on his own for the rest of his life. He was diagnosed with a virus that was extremely contagious, especially in summer; however, the overwhelming majority of people who caught it either had no symptoms or what they thought was a mild “bug” with fever, sore throat, headache, and feeling bad for several days before recovering. Those who went on to have the more severe symptoms of backpain, stiff neck, weakness, nausea and vomiting still often recovered but a small percentage developed permanent paralysis, some to where they could not breath without a machine and many of those eventually died. The virus had the most profound effect on infants and children, to the point where when epidemics peaked, mothers would keep their kids at home and out of camp or playgroups for fear of illness or transmission to adults…. sound a little familiar?
By now you may have recognized that this disease was polio and the gentleman was FDR. The history of the polio virus is simultaneously tragic, fascinating, and inspiring. Polio existed for thousands of years, was/is transmitted through contact with contaminated water, food, hand to mouth, or by ingesting contaminated substances and became rampant. As sewage treatment and personal hygiene improved in the 1900s in developed countries, fewer people caught it and “herd” immunity lessened. Generations later in the 1940s and 1950s, polio came roaring back with many adults and children infected. It was probably the one-word parents feared most in the early and mid-20th century. The point of this narrative is that polio, and smallpox for that matter – this scourge of legitimate fear, illness and death - are now basically nonexistent because of primarily one thing…. vaccines. In the case of polio, vaccinations starting in the late 50s have eradicated 99% of polio throughout the world.
If you accept that “around the corner” means two to six months from now, we will probably have one or more FDA approved COVID-19 vaccines around the corner. There will be many reasons why people don’t receive the COVID-19 vaccine: slow ramp-up of production; early vaccines are logistically intensive requiring cold storage; and access - which will further highlight the racial, ethnic, and demographic disparities that exist around the globe. However, compared with the 1950s there is now a much larger percentage of folks who just say they don’t trust the government, the scientists, or the companies to field a safe and effective vaccine. In fact, some polls show that one third to one half of people asked said they will not initially take the vaccine if available or offered. There are various reasons given. Some of which include…
People believe that COVID-19 is a hoax or myth, possibly perpetuated by one political party to undermine another. I’m guessing that some of these folks also believe we did not go to the moon or that we walk around with injected alien DNA and illnesses stem from dreams with demons; which would certainly be “interesting” except that the President has quoted these very people and sources on occasion as foundations for his assertions.
People worry that early vaccines may not be safe; as in they could do more harm to you than good. This is unlikely, given the number of people being tested. Statistically speaking, these large numbers should uncover safety issues. If your point is it usually takes five to ten years to develop and observe the effects of vaccines, that is a good point. Science (there is “that” word again) has come a long way to expedite technology for vaccine development. Technology has sped up vaccine development in the same way it has made gall bladder removal an out-patient procedure vs. the seven to ten-day admission required not that long ago.
One of the biggest game changers in the vaccine development could be breaking the genomic code, so in short order the gene/amino acid sequence of the virus has been identified and that can be manufactured and carried on a harmless virus to trigger the body’s immune system. That said all eyes and ears should be on what’s called the COVID-19 vaccine “Phase 3 Studies.” Once the vaccine has reached Phase 3 enough basic science and indications of no-harm and a presumed immune effect allow it to be administered to the masses in a highly monitored and controlled study to obtain a statistically valid random sample that will be large enough to enable the trial to prove safety and efficacy.
This is the tough call the FDA has to make…. they will probably be in one of those “damned if they do or damned if they don’t” scenarios as some will say the enemy of good is perfect so just approve a COVID-19 vaccine! Others will remember the drug Thalidomide in the 1960s. At the time it was one of the largest prescribed tranquilizers in Europe, and more than that, it worked well for pregnancy morning sickness. There would have been a huge market in the States for this drug. The FDA’s Dr. Frances Kelsy who had final say, disapproved its use (and she pretty much saved the day) for the United States based on lack of adequate clinical trials in the face of blistering pressure from big Pharma and some senior FDA administrators to approve Thalidomide. The rest is history in that tragically many babies born to moms on the drug had horrible congenital defects. This experience cemented the FDA’s ‘raison d’etre’ and created regulations to require what we now know as Phase 0 - 3 trials.
Another improvement born out of error in vaccine manufacture came in 1955 as a result of “The Cutter Incident” where a laboratory creating the polio vaccine did not sufficiently inactivate the virus and infected thousands of children. Almost all of the children recovered (and were immunized) yet tragically some lost muscle function and ten died. Now juxtapose this incident with the United States and global epidemics at the time where thousands died and many more were paralyzed to the point where pools and theaters closed in the summer out of fear of infection. That vaccine error appropriately halted the program. Yet, when the vaccine program restarted the line was still around the block with no apparent loss of interest by parents. Contrast this rebound of interest in vaccination with what might happen today with any COVID-19 vaccine.
Finally, COVID-19 Phase 3 studies need to prove efficacy of the vaccine. You can give it to 40,000 people and deem it safe - but does it actually work? To do that you can measure antibodies and other laboratory indicators but the best proof of efficacy is to test the vaccine on a population you expect may become infected with COVID-19 and then see if they don’t. This is why (volunteers with informed consent) college students and nursing home residents could be desirable test subjects given how fast the virus spreads and its prevalence. However trials need to tread gently around the highest risk patients who may lack the ability to appreciate all risks.
And then there are simply (and it is not so simple) the anti-vaxxers. These are folks who in whole or in part refuse vaccinations for themselves or for their children. For some it is on a religious basis dealing with a fundamental belief in faith – and that faith is all that is allowed. For some it is a true (but generally unrealistic) fear of side effects. While we shake our heads at parents who won’t vaccinate their children, it has been my experience that they love and care for their children immensely. They are often good parents making bad decisions that put their children and others at risk. Often when told that children can die from the flu, but not from the flu shot or the measles, mumps, rubella (MMR), or diphtheria, pertussis, and tetanus (DPT), they will say even if there is a very small risk from “a shot”, if nature harms my child then at least I did not do it. It can get very emotional and deep very fast. Sometimes it is just an unawareness or playing the odds to forgo or not get around to a flu shot. I have been present on the (fortunately rare) occasion a child has died from the flu and nobody wants to ask the anguished parents if the child got their flu shot.
Perhaps we are victims of our own success. People have grown complacent without knowing any kids or adults experiencing MMR, polio, smallpox, diphtheria or pertussis. Transport a nurse or a doctor from the 1940s to today and tell them a school has an outbreak of diphtheria and watch the look on their face. Can’t happen? Measles is now coming back because of aggregate refusal to vaccinate.
In my past role in the Navy as Surgeon General, I was the final appellate authority on those requesting waiver from immunizations. In the Service refusal to comply with immunizations is grounds for discipline and/or separation, as it is in many civilian healthcare systems. We approved only a handful of waiver requests and then only with very convincing proof and history of religious affiliation or a rare medical condition/allergy. The reason is vaccinations for the flu and most likely for COVID-19, will not be 100% effective but will reduce the number of infections, lessen the severity, keep you productive, and reduce the time you are infective and thereby protect those around you. All of that lessens the chance you give this disease to someone else, especially infecting patients under your care. So, if we can keep you from catching it we can keep you from giving it to others which is critical in so many settings.
But now we even have a political statement being made by some who will likely refuse vaccination for the same reason they refuse to wear a mask or to stay a safe distance apart. They believe it is a political statement or support of exercising their freedoms (that is, the freedom to become ill and to give it to others) or to support leaders who continue to either deny the severity of COVID-19 or consider it to be the cost of doing business while keeping all businesses up and running. Not willing to accept or compromise with a hybrid approach to reducing risks through masks and distancing to allow more businesses to open under those conditions. Some who throw an absolute public fit over masks are just revealing anxiety and fear boiling over with an endogenous and irrational belief that if there are no masks then there is no deadly illness. I feel for these folks at some level but do not excuse their actions or behaviors. Others really do believe that COVID-19 is a hoax or “just the flu”. If only that were true. By the way, in a very bad year “just the flu” can kill over 50,000 people in the United States alone - so go get a flu shot - particularly this year. COVID-19 killed that many people in just April 2020 alone. We need a COVID-19 vaccine.
Ironically, the President’s not-so-subliminal message that masks are optional is not only fueling the fire of anti-maskers but also could keep many from getting vaccinated which would hamper achieving the herd immunity he and all of us so desperately want which in his words, “will make this all go away soon.” There is such widespread cynicism for government manipulation of data, intent, and pressure on our scientific institutions that nine major companies all competing for a vaccine issued an unprecedented joint statement saying they will not release a vaccine based on political deadlines but only scientific guidelines. The aperture of institutional skepticism continues to increase. Many support the President’s agenda specifically because he is NOT a politician…fair enough as a debatable concept. However, many of those folks also support his personal take and advocacy on infectious disease, its origins, and how best to treat it specifically because he is NOT a scientist or doctor…. yeesh. We have seen the enemy, and it is us.
The COVID-19 vaccine(s) fielded will be scrutinized like never before as a result of the erosion of trust in the Executive Branch on all things COVID. The head of the FDA has gone on record saying he will resign if he feels a vaccine is released without reasonable confidence. The FDA has a good track record over the last 20 years per a review in September’s “Annals of Internal Medicine,” over 50 vaccines approved in that time were found to be “remarkably safe” with close follow-up through any issues in VAERS (Vaccine Adverse Event Reporting System) stating “These findings confirm the robustness of the vaccine approval system and post marketing surveillance.” Unlike Russia, where the state system non-transparently disseminates a vaccine that may or may not be ready for prime time, that will not likely be the case in the United States. Apparently, Russia’s President didn’t take the vaccine, but said his daughter did. With President Trump’s apparent affinity for his Russian counterpart, Ivanka should be prepared to roll up her sleeve.
All that said, when the first vaccines are available, I will take one given the opportunity. I am confident enough that the risk profile will be in my favor that I will take my chances with a vaccine rather than COVID-19. I will not assume it is the magic fix but time will tell. The vaccine may require booster shots, or annual shots (like the flu) and maybe only 50 - 70% effective until more and more come on line. The challenge with the fact that there will be limited doses available initially is the triage required to determine who gets it. Better to give the dose to the 70-year-old grandmother or her 20-year-old grandson who attends college and visits her? Clearly the frontline healthcare provider and essential worker will be encouraged and/or required to take it and most will willingly I believe. As to the algorithm for remaining distribution that will be art and science.
I recognize the emotional volatility of this to many people. It is a combination of visceral fear as well as hope - trying not to let one irrationally overpower the other. Truth be known, very few things, including medicines and vaccines have absolutely zero risk, but I will roll up my sleeve. I will do so because I want to do my part to be an example for others, to lessen my chance of illness, to lessen my chance to be a source of infection, and perhaps most of all because my thoughts will be of the over 200,000 people in the U.S. and one million globally who have died from COVID-19 so far and who never had this choice to make.
About the Author:
Matt Nathan, M.D. is a Harvard ALI 2020 Fellow, previously the 37th Surgeon General of the Navy and most recently a Senior Vice President for a large tertiary care healthcare system.