Critical Decisions: To Vaccinate, or Not to Vaccinate, Part 2

My Mom has a wonderful way of dispelling fear, anxiety and trouble with just a few words. I guess when you make it to 82 (don’t tell her I told you how old she is!), you pick up a few things along the way.

About things in the future that could be problematic: “Don’t borrow trouble! Today has enough!”

About when things go wrong: “Hey, I never promised you a rose garden!” (We always hated that one growing up).

And about fear: “Everybody gets afraid. Not everybody runs away.”

Looking forward in our current battle with COVID-19, I’m starting to see the clouds breaking a bit, and a light at the end of this particularly dark tunnel. Both are going to require all of us to play ball for it to come true. And step one in our part of the solution is going to be getting vaccinated.

I know many of you out there have lots of excuses and fears to justify in your own mind not getting a vaccine. I’m here today to give you the Straight Talk on your fears and anxieties regarding getting one of the new COVID-19 vaccines. I know you might be afraid; everybody gets afraid. But not everybody runs away.

Let’s start knocking those excuses off your list:

“Mike, what if I can’t afford these new vaccines? So high-tech, surely they will be expensive!”

Two things are working together to make SURE everybody can get this vaccine. First the federal government has pre-funded the first year of the vaccine. It’s already bought and paid for in 2021. CMS also has ordered Medicare and Medicaid to pay 100% of the vaccine’s cost. Health insurance companies will be doing the same; every health insurance company in the U.S. will have to provide the vaccine at least once per year with $0 copays. In other words, for all of 2021, FDA-approved COVID-19 vaccines will be FREE.

Going forward, I expect the U.S. Preventive Services Task Force to grade the vaccines “A,” which means they will be included as essential benefits on your plan. The ONLY groups that would be able to get away with not providing COVID-19 vaccines for free to their members are going to be grandfathered plans.

“Ok, Mike, where the heck do I get this vaccine once they are out there?”

The first two companies out of the box, Moderna and Pfizer, will be manufacturing billions of doses of their vaccines over the next two years. The President has assigned the United States Military to handle the logistics of making sure the vaccines get distributed. If you’ve ever served, or know anybody who’s ever served, you know NOBODY moves material more efficiently and at scale better than the U.S. Army.

The government is pre-buying vaccines and setting up payments so that many, many different places will be able to administer the vaccine – like drug stores, doctors’ offices, urgent care clinics and, ultimately, community centers. I fully expect mobile health centers to patrol under-served areas offering vaccines to anyone who wants one. Think bookmobile with vaccines.

It will be like nothing you have ever seen before, once these COVID-19 vaccines go into full production. It might be February, March or even April before all this gets up and running, but it will. Count on it.

“Fine, but are they SAFE? And do they WORK?”

These are quality questions and deserve a complete answer. Let’s talk about the development process and how we know the vaccines are already working at such an early stage. It’s fascinating stuff to me.

Starting back in May 2020, several drug companies had a COVID-19 vaccine advanced to the point where the research and development was essentially over, and they were ready to go into the large-scale testing stage called Phase 3. This meant recruiting over 40,000 volunteers, making sure that group was as diverse as possible in terms of race, gender, age, and health conditions, and then giving them a couple of shots, 30 days apart. Half the group got shots of salt water. The other half of the group got the actual vaccine.

And then these 40,000 people agreed to get a COVID-19 infection test every single week going forward. Their health was VERY closely monitored during this Phase 3 trial, and every few weeks, the company compiled their results and made them public, in what was the most transparent drug testing process in the history of pharmaceutical development. I’ve never seen anything like it.

For example, on Nov. 18, 2020, Pfizer announced that of their 44,000 test subjects, 170 of them so far had tested positive for COVID-19. Remember these people in the trial weren’t hiding, or doing anything special, they were just wandering around living their normal lives, so they would get exposed to COVID-19 just like you or I would.

Of the 170 who got infected, 162 of them had received saltwater shots (called “placebos”), not the actual vaccine. Only eight of the infected had received the actual vaccine. If the vaccine didn’t work at all, we would have expected 85 people in each bucket — vaccine and salt water. But 162 being in the saltwater group was very statistically significant and meant the vaccine was well over 90% effective in stopping C19 infection completely.

Even more importantly, of the eight vaccinated folks who caught COVID-19, seven of them had very mild symptoms, almost unnoticeable symptoms. Of all the people vaccinated in the trial, over 44,000 people, now in their third month since their shots, only one person who got the vaccine has caught a bad case of COVID-19. By vaccine standards, that is unheard-of success.

Yes, a few people are still going to get sick and that’s unfortunate. I never promised you a rose garden.

The Moderna vaccine is just a few weeks behind the Pfizer vaccine in distribution in their Phase 3 trial and their effectiveness is holding at over 94% too. So, we may have choices soon.

So far, these vaccines seem to work VERY well, far better than regular flu shots, for example. Conventional vaccines lose effectiveness as the patient gets older. A flu shot works much better for a 10-year-old, than a 70-year-old. But these new vaccines are showing NONE of that “age deterioration.” So far, they are just as effective for older folks as for younger folks. We’ll be watching that result very closely.

As far as safety goes, it’s important to understand that the rules of Phase 3 clinical trials mean if anybody in the trial gets seriously ill after getting the vaccine, the trial must be stopped and re-evaluated from scratch to see if they should continue it. In both trials so far, of over 80,000 people, only one person got seriously ill. The trial was paused, and they discovered that person was in the saltwater group and had never received the vaccine.

Disclaimer – these vaccines have not been widely studied in children and it is unclear when they might be available for the primary school crowd. I’ve heard of one study for adolescents ages 12-17 that is underway.

“Mike, I heard these new vaccines use some kind of RNA stuff and will alter my DNA! Is that true?”

Ah, the internet. Bringer of all knowledge, and so, so much bad data. This rumor even made it into the medical community! Let’s be clear about this right now.

The vaccines from both Pfizer and Moderna use “messenger” RNA, or mRNA. That mRNA contains a set of instructions to your cells, and, for a few hours, orders them to produce a replica of parts of the COVID-19 virus. Not the actual virus, but a replica so close that your immune system can’t tell the difference between that replica and real COVID-19. That replica of various parts of the virus is close enough to educate your immune system on what’s coming, but not the actual virus to make you sick.

Think of it as watching a preview of a movie. You’ll learn enough to think “hey, I might want to see that movie,” and so you start paying attention to when it will be released, so you can catch it when it comes out.

Messenger RNA creates a “preview” of COVID-19, so that your immune system knows what it looks like, can see it coming, and then kill it before it takes hold. It turns out that our immune systems are actually “trainable” in this way, and the process to create a “preview” vaccine is quick and efficient. It does not, in any way, alter your DNA. But don’t take my word for it:

“This cannot change your genetic makeup. The time that this mRNA survives in the cells is relatively brief in the span of hours. What you are really doing is sticking a recipe card into the cell making protein for a few hours, train the immune system, and then it’s gone.”

Dr. Dan Culver, pulmonary researcher, Cleveland Clinic USA

Agreed, it’s early in the game, but mRNA vaccines have been in development for years, they just needed a financial push to get them going, and the federal government’s “Operation Warp Speed” provided billions of dollars for research and development into a vaccine for COVID-19. It removed the financial risk, and vaccines went ahead much faster than normal.

“This all sounds too easy. Aren’t there ANY problems?”

My mom would say, “don’t borrow trouble.” But yes, there are some challenges that need to be overcome. For example, we still don’t know how long the protection lasts in these vaccines. Every month we are gathering more data about that particular variable, and if we start to notice a bigger percentage of people getting COVID-19 in the vaccine groups, we can start making assumptions about how long they work. At this point, with only three months of data, everything still looks very good. But people like me, who’ve already had COVID-19, have no idea how long our immunity will last anyway. Nobody is measuring or testing us for that. At least with the vaccine population, we’ll know exactly how long protection will last.

mRNA vaccines like Pfizer’s are actually much easier to make in a lab than the other vaccines we’ve used historically, and they need to be. To vaccinate the U.S. population to a “herd immunity” point will require at least 60% of residents to get vaccinated, maybe as often as once per year. That’s 384 million doses produced and distributed in the U.S., potentially every single year (320 million people times 60%, times two shots/year). That’s a ton of vaccines. We will have to monitor VERY closely going forward production quality and costs and the FDA will be very, very busy. To get the planet 60% vaccinated? Try 8.4 BILLION doses per year! Big jobs ahead.

mRNA vaccines are relatively fragile once they are produced. Pfizer’s, for example, needs to be stored frozen at -176 to -103 degrees to keep long-term! Your average household freezer only goes down to about 0 degrees. These special freezers run between $10,000 and $20,000 each, and lots of rural hospitals and clinics will struggle to afford them. That’s a problem that will need solving, but further editions of the vaccines will be more robust and won’t require such lavish freezing. In the interim, I expect mobile “freezer boxes” to become more and more common.

But all this work, money and effort will be wasted if each of us doesn’t make the decision to get vaccinated. If you don’t believe me, at LEAST ask your doctor.

We have to face the facts. As I write this, our COVID-19 hospitalized population is growing again, very rapidly. Local and state governments will be shutting down more and more of our economy in order to slow the spread and keep us from running out of ICU beds and burning out our medical staffs. Our only defense against COVID-19 now is masking up, avoid gathering and enhanced hygiene. I think we’d all agree, these are temporary solutions at best (and overall, really suck!).

Whether or not to get vaccinated will ultimately be an Economic, and a Mental Health decision.

Economic because we cannot get back to our normal to-ing and fro-ing, shopping and working and gathering, and living our lives without putting COVID-19 to bed. Getting vaccinated makes you part of that solution.

Mental health because depression and suicides, especially among folks under 40, is skyrocketing while we are in the grips of COVID-19. The cognitive health of vulnerable seniors is deteriorating as they are denied human contact because of virus fears. As humans, we have a built-in NEED for other humans, to be able to gather, share and enjoy each other’s company. Think about what a lousy holiday season we’re going to have this year. As much as I’ve utilized Zoom, Teams, WebEx and the like over the last seven months, it’s just not the same. We as a nation are becoming more subject to depression and despair the longer this isolation goes on.

Straight Talk is, our only way out of this mess is mass vaccination. It’s the only way I can see to slow the spread of COVID-19 and stop closing things down and again let us gather and fest together, tailgate and hear “Calling Baton Rouge” on giant loudspeakers or the Human Jukebox IN PERSON. To “Stand Up and Get Crunk-ed!” together again. How nice would that be?

Get vaccinated. Remember my mom’s advice: “Everybody gets scared. Not everybody runs away.”