087: I Got the Moderna Vaccine

My ‘Reaction’ So Far

In This Episode: Two days before Christmas, I got a phone call: “Can you be here at 2:00?” asked Rebekah, our small county’s (only) Public Health nurse. Yes, I said, and by 2:30 Rebekah had injected my wife and me with the Moderna Covid-19 vaccine.

087: I Got the Moderna Vaccine

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Transcript

Welcome to Uncommon Sense, I’m Randy Cassingham.

Getting the Covid vaccine on Wednesday was quite a surprise. Public Health nurse Rebekah Stewart had given Ouray County Emergency Medical Services personnel a briefing on Zoom Tuesday evening. My wife and I are volunteer medics in our rural Colorado county. Our first Covid death was April 8, pretty early in the pandemic.

Rebekah didn’t even have an estimate of when their vaccine supply was arriving, but she wanted us to know the science behind the vaccine’s development. Pfizer’s and Moderna’s Covid vaccines are extremely similar, but as a small, rural county that didn’t have a freezer cold enough to keep Pfizer’s vaccine, we would be getting Moderna’s.

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Ouray County Public Health nurse Rebekah Stewart gives me the Moderna vaccine from the first vial opened (in the agency’s parking lot!) as full-time paramedic Ruth Stewart, no relation to Rebekah, looks on. (Photo: Kit Cassingham)

She also went over the expected side effects so, when it was offered to us, we’d have enough information to make an informed decision as to whether we would want it. I had decided long ago that I would take it as soon as it was offered to me.

So it was quite the surprise to get Rebekah’s call the next morning asking if we could be there at 2:00: our county’s initial supply had arrived by FedEx shortly after the Zoom call. FedEx was already working pretty late with the Christmas rush and Ouray, our county seat, is at the end of the route.

While the CDC provided suggested priority “phases” for vaccine rollout while production ramps up, states are allowed to adjust the priorities. The State of Colorado decided that “Phase 1A” would include the highest-risk healthcare workers — “People who have direct contact with Covid-19 patients for 15 minutes or more over a 24-hour period,” plus long-term care facility staff and residents; “Phase 1B” would include, among others, “EMS, firefighters, police, correctional workers, dispatchers … and other first responders.”

In our county, where EMS has transported multiple patients with confirmed Covid-19, well, we’re in direct contact with patients for a lot longer than 15 minutes. Here, there’s no 5-minute hospital rides: our transports are 20-60 minutes to get to the closest hospital, and that’s on top of any time we spend evaluating, treating, and loading them up before we can start moving. Our health department, then, decided to move EMS personnel into the first priority phase. Since we tend to be available at a moment’s notice, that’s how we — along with the longest-serving dentist in town and his assistant — ended up getting the first shots.

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Kit getting her shot. Note our festive seasonal masks! (Photo: Randy Cassingham)

When we arrived, our little Public Health department didn’t want anyone but their own employees inside the building, which helps keep it from getting contaminated, such as by people not knowing they have Covid. So we actually had to bare our arms, one by one, in the parking lot out front: it was lightly snowing, and 18 degrees (-8 centigrade), and then we had to stay there for 15 minutes to ensure none of us had any severe reactions. None of us did.

But let’s back up a little and talk about vaccine efficacy and effectiveness, which sound like they “should” be the same thing, but aren’t, and what they mean since I muddied the waters a little bit by not being clear and detailed enough in the previous episode.

First, back in June, the U.S. Food and Drug Administration announced that to win approval, any Covid-19 vaccine would have to prevent the disease — or decrease its severity — in at least 50 percent of the people who receive it. Also, they said, the group of test subjects should include a wide age range, and include minorities.

FDA Commissioner Stephen Hahn assured Congress the agency would follow established scientific principles, and “will not cut corners in our decision-making.”

That 50 percent figure, which refers to efficacy, was criticized for both being too low, and too high. 50 percent is “a realistic goal but not a very high bar,” said Dr. Peter Hotez, Professor of Pediatrics and Molecular Virology & Microbiology at Baylor College of Medicine in Houston, Texas. But even 50 percent wouldn’t be the end, he said, adding “Our first vaccine won’t be our best.”

“I would hope we could do better than 50 percent,” agreed Dr. Paul Offit, Professor of Vaccinology and Pediatrics at the Perelman School of Medicine at the University of Pennsylvania, as well as the director of the Vaccine Education Center at The Children’s Hospital of Philadelphia. The cutoff, though, is “generally reassuring because the FDA said it wouldn’t approve a vaccine unless it was effective.” Which, you may be starting to realize, is relative.

On the other hand, Dr. Stephen Ostroff, the FDA’s Chief Scientist and former acting commissioner, thought the 50 percent figure was too high a bar. “A vaccine that has efficacy of less than 50 percent may still be very beneficial for people at high risk of developing the disease,” he said. With the virus “rampaging through a lot of parts of the United States, I would certainly consider a vaccine with less than 50 percent efficacy.”

Pfizer recruited 43,661 volunteers to test the vaccine candidate, with about half randomly assigned to a placebo group, which means they were injected with saline, or sterile water with the same amount of salt as in our bodies, and the rest got the actual vaccine. To get to a statistically significant result, they then had to wait until 170 of those test subjects caught Covid.

Ironically, the surge in cases as colder weather rolled in “helped” (if I can use that word) get to 170 Covid cases among the test subjects.

No one in the test group knew if they got saline or the actual vaccine, and neither did the people who gave them the shots, which is called a “double blind” study — researchers want to ensure there is no psychological influence. Interestingly, the placebo group reported a significant level of side effects too, even though they didn’t actually get the vaccine: psychology really does play a large part in that.

But as the reports of Covid cases came in among the 43,661 volunteers, Pfizer’s computers knew who got the placebo, and who got the vaccine candidate. And of the 170, just 8 were from those who got the vaccine; 162 got the placebo. Do some simple math and find those 8 who got the vaccine among the 170 Covid cases is a hair over 4.7 percent, which leaves the efficacy at 95.3 percent, which Pfizer rounded down to 95 percent.

With the FDA expecting at least 50 percent efficacy, “Hearing that at the interim analysis we are over 90 percent effective — it was almost stunning to hear,” said Dr. Kathrin Jansen, Pfizer’s chief of vaccine research and development.

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EMS getting our shots (here, Chief Paramedic Kim Mitchell) was front page news. They go to print Wednesday afternoons, so they held page 1 open for the story and photo. (My photo of my copy of the paper.)

It was unprecedented.

Yet, that’s efficacy, not effectiveness. What’s the difference?

Efficacy is determined by testing in “best case scenario” conditions: a double-blind randomly controlled trial as just described. In addition, researchers have really tight controls on how the vaccine is stored, how it’s given to each test subject, and how those subjects are closely monitored. It’s one of the reasons vaccines are expensive: it’s a detailed process. And, it takes awhile.

What’s not a “best case scenario” is when those careful safeguards go out of the developers’ control: are the vials really kept at around −94 degrees Fahrenheit, in the case of the Pfizer vaccine? (Which is −71 degrees centigrade. That’s one cold freezer.) Moderna’s only needs to be kept at −4 degrees Fahrenheit (−20 degrees centigrade, which just about any freezer can do).

In the case of both the Pfizer and Moderna vaccines, once a vial is taken from the freezer and opened, the doses have to be used within six hours, or whatever is unused has to be thrown away because it degrades so quickly. You can bet that procedure was followed to the letter by the researchers. Do busy public health departments and hospitals follow the rules that closely? We hope so, but it’s hard to know for sure, and we can’t know for sure if every person who gets the vaccine will report back if they get sick later. They could, for instance, figure they caught a cold, not Covid. They might not get the second dose on time, or at all.

So if the “best case scenario” is a 95 percent efficacy, a number that will certainly change at least slightly as more of the volunteers get Covid (which is probably why Pfizer rounded down), then what’s the “real world” effectiveness going to be? Something different — something lower. And that’s the difference between efficacy and effectiveness: ideal conditions versus real world conditions.

But remember part of the definition that the FDA laid out in the first place: to win approval, that 50 percent efficacy requirement, was that the “vaccine would have to prevent the disease — or decrease its severity”. We know the vaccine won’t necessarily make you immune to Covid-19, but it’s still worth it for that reduction in severity if you do get it.

And remember, even when properly vaccinated under “best case” conditions, so far 8 of the volunteers still got Covid: none of the vaccinated population will really know if they’re “immune” from Covid. Any one of them can still get it, and be contagious, so that’s why we need to continue with the usual safeguards — wearing masks, social distancing, washing hands — even after getting the vaccine.

Interestingly, I found when researching this that while both Pfizer’s and Moderna’s vaccines are nearly identical — but not fully so, which is obvious when you consider their vastly different required storage temperatures — Pfizer’s contains 30 micrograms of vaccine, while Moderna’s has 100 micrograms. Yet Moderna’s efficacy is a little bit lower: 94.1 percent. That’s also subject to change as their studies continue, and maybe Moderna’s and Pfizer’s numbers will converge, but it goes to show that more isn’t always better.

More might — or might not — also create more side effects. After my first shot 2 days before Christmas, I felt fine. The next day, my arm was sore at a level I described to the CDC as mild. On Christmas, less sore. And a day later, I had to poke at the injection site on my arm to feel it at all. Sunday, as I’m recording this, I don’t even have pain if I hit my arm. I did sign up with the CDC’s vsafe program, discussed in the previous episode, and that’s how I reported all of that to them. But I never felt anything else, no other side effects, from my Moderna injection.

Some reports say that the second dose reactions can be more intense, but starting where I am, even if it’s 10 times worse, which seems unlikely, it would still be somewhere from mild to moderate, for a very short time. I’ll take that any day over getting Covid, since even symptom-free cases still develop long-term complications with lungs, heart, and other organs. No thanks!

I’m absolutely one of the lucky ones to get vaccinated so early, especially considering my little county can’t even handle the Pfizer vaccine, and had to wait for Moderna’s to be approved.

Pfizer expects to ship 50 million doses by December 31st — enough for 25 million people to get both doses, three weeks apart, and 1.3 billion more doses during 2021. Obviously, the U.S. doesn’t get all of those: other countries have also received their first shipments, with more to come soon.

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Employees at McKesson, a healthcare supply chain distributor, work in a freezer to pack up the first doses of the Moderna Covid-19 vaccine for shipment. (Photo: McKesson)

Moderna, meanwhile, which requires two doses 4 weeks apart, said they expect to ship 20 million doses by the end of the year, which is coming right up.

The Trump Administration’s Operation Warp Speed officials previously said they expect 20 million Americans to have their first shot of one vaccine or the other by the end of the year, and 100 million by the end of March, which could increase if we get another effective vaccine approved before then. But, so far, they’re behind that expected pace. That’s partly the difference between “best case scenario” and “real world conditions.”

The only question that remains to be answered is, how long will the vaccine last? Only time will tell, but the two companies have tens of thousands of volunteers who got the vaccine long before you will, so they’ll know that answer before you need any sort of booster.

My bottom line remains, when you get the chance, get the vaccine unless you have a condition your doctor says makes you a very high reaction risk, in which case you should definitely at least strongly encourage anyone near you to get theirs to help protect you.

One last thing: today I also finished creating a page with an assortment of my pandemic-related stories, meme-site cartoons, podcast episodes, Honorary Unsubscribes, and more from throughout the year. It helps provide the big-picture perspective that a single element just can’t provide by itself. I’ll link to it on the Show Page.

That Show Page for this episode is thisistrue.com/podcast87, which has links, and a photo of me getting my injection.

I’m Randy Cassingham … and I’ll talk at you later.

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23 Comments on “087: I Got the Moderna Vaccine

  1. I had Guillian Barre Syndrome way back when and am not supposed to get flu or pneumonia shots, even though I hadn’t gotten any vaccines or even had the flu itself, as far as I could tell. It’s now also been tied to COVID as a disease. At the 50% level, I was really not planning on getting it without more time to see if there were any correlations with the vaccine itself. At 90+% efficacy? Yep — I’ll be getting it ASAP. Age, diabetes, weight, type A blood … too many co-morbidities to ignore.

    You may have already found this, but: Epidemiological and cohort study finds no association between COVID-19 and Guillain-Barré syndrome (Brain: Journal of Neurology). Also, the vaccine appears safe for those with a history of GBS, says the leader of the team overseeing the Moderna COVID-19 vaccine trial in Colorado at UCHealth. -rc

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  2. YAY! You & Kit both got the vaccine! As a long-time avid reader, I was a bit worried that you & Kit would need the vaccine but wouldn’t qualify for phase 1. Glad your health department decided to move EMS personnel into the first priority phase.

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  3. I don’t foresee myself getting a dose anytime soon, only because I’m not an essential employee or a member of a high risk group. I’d take it even if I got side effects similar to the shingles vaccine (both of those doses knocked me for a few days, with soreness, pain, fatigue, and loss of appetite).

    Yeah, Shingrix caused me significant pain at the injection site that lasted a couple of MONTHS! I really wasn’t looking forward to the follow-up after that, but the second shot didn’t cause more reaction, it was much less. Either way, beats getting the shingles! -rc

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  4. The picture at the end of people packing the Moderna vaccine makes me say a little prayer for the poor bastards in the Pfizer shipping department who must be working in conditions akin to standing outside in Antarctica in the middle of winter.

    Ooh… that’s an excellent point. I hadn’t thought about that yet! -rc

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  5. I also was lucky enough to be in right place and time, I am a courier and am in and out of hospital labs and long term care centers, picking up and transporting specimens to the testing lab. My side effects were only the sore arm, I would compare the level of discomfort to a tetanus shot, and gone the 3rd day.

    For me, a tetanus shot feels like I was punched hard in the arm. The Moderna shot (again, for me!) wasn’t even that intense. -rc

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  6. As a First Responder, I agree with you and Kit getting the vaccine early! I am very healthy and watch what I do and where I go, so I am more than happy to wait for a while before getting the vaccine — there are millions of people who need it and should get it first!

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  7. This was helpful to my understanding, thanks. I’ve been wary of the two-shot factor after the shingles vaccine this fall (I had an off-book side effect that the pharmacist was familiar with but an advice nurse was not, that really trashed me for three months), but hope I can get, and better tolerate, this one.

    See comments above for my experience with Shingrix. -rc

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  8. Glad you, as an EMT, were able to be vaccinated early. Also glad you, as a person, chose to do so. Thanks for the science, too!

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  9. I hear there are some serious reactions. People are complaining about powerful erections and improved wi-fi.

    And for some reason I can eat whatever I want and yet I’m slimming down and getting more muscular. Dang these side effects! 😎 -rc

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  10. I got the Pfizer vaccination on 27/12/2020. So far, I’ve had no problems at all with it. Israel started vaccinations the Sunday before Christmas. They are at the point where they are trying to inoculate everyone over 60 and some other high risk individuals now. I fit the old fogey category. My second vaccination will be in 3 weeks.

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  11. I work in the field of disaster recovery — as such, many of my coworkers who go to disaster areas following a major event are slated to be in the 1B round of folks being vaccinated. My (federal) agency was very careful to keep the list intentional — only staff who have regular responsibilities at the office or staff who are in the field assisting disaster survivors are on “the list.” I know because I typed it up. My name is not on it. I am eligible to telework 100% and have not been into the office since March. I am glad that priority vaccinations are going to where they are needed. I am happy to wait my turn while living in my bubble at home.

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  12. I am among hoi polloi who need to wait my turn. I fortunately got very lucky to have only a mild case with no obvious long term consequences that I know of. But I will still be at the front of the line when my group is eligible.

    My understanding is they want recovered Covid cases to wait on the vaccine, because they presumably have antibodies for some time already, so it’s safer for them to wait than someone who is at risk and doesn’t already have the antibodies. -rc

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  13. Thanks for going over efficacy vs. effectiveness. Maybe in the next episode, you can go over ‘approval’ vs. ‘authorization’. My understanding is that neither vaccine is ‘approved’, they have been ‘authorized’ for emergency use. Approval is a much higher bar and will come (if it does) after much more testing and time has passed.

    You are correct, and the link you provided is a good summary. As it ought to be! -rc

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  14. Thank you for this, Randy — I am Posting this for everyone I know to read, cos it is relevant to all of us and so informative. One of the best things you’ve written.

    Thanks, Bob. Glad you found it useful. -rc

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  15. I wanted to give you a special thank you. Before Christmas I ended up in the hospital with double covid-19 pneumonia. My ambulance crew was great but they will never let me live down having to call them. My chief has not stopped texting me to report for duty. Lol

    Looks like I will be here for at least a month or more. No fun. Informed that this will leave me with asthma. Lots of IVs and respiratory issues.

    Today was the first day I had a chance to read the issue. Brought a smile to my face. I appreciate all you do. You and kit stay safe.

    Them razzing you just means they knew you weren’t gonna die. 🙂 (For others: Ken is a medic,

    Sorry to hear you got whacked, and hope it wasn’t from a patient! Glad to give you something to read while you heal. Get well soon. -rc

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  16. As a volunteer at our local hospital, I was able to get the Moderna vaccine the day after Christmas. My symptoms have been similar to yours. Our hospital was able to handle the cooling requirements of the Pfizer vaccine and many health care workers got that the prior week.

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  17. Thanks for the best article ever on this subject! I learnt more in 10 minutes of reading than I have in 10 months of lock down. Hope all goes well with the 2nd jab. Happier New Year!

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  18. Word problems are notoriously difficult, both to construct properly and to convert to and from math equations. 8 of ~20,000 that got the vaccine got Covid. 162 of ~20,000 that did not get the vaccine got Covid.

    “Something” caused the lower number of infections for those that got the vaccine. Had 85 of each group been infected, then the vaccine wouldn’t have worked at all. Part of the issue is that the resulting percentage from the division is the negative result. Those for which the vaccine was not effective. One needs to divide one side by the other, not one side vs the total. 85/85 equals 100%: had that been the result, we’d know that the vaccine is ineffective 100% of the time. With 8/162 we know that the vaccine was ineffective 4.9% of the time. (Since the number 8 is so small, using 170 as the denominator gives a reasonable, but incorrect, answer).

    Because 8/162 is so very close to 8/170, the mistake is easy to make and also has no material impact on the discussion (aside from trying to understand the math).

    Thanks for the correction, Tom. -rc

    Reply

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