There’s a right way to do things… and a wrong way… and if you think I’m about to talk about the removal of Donald Trump from office… I might. But not today… there’s time for that later, and, as I’m writing this, the people capable of doing exactly that are thinking about the right way to do it. By the time I get around to writing about it, he might be gone. Wouldn’t that be cool. At least he’s been permanently removed from Twitter. Four years too late. But the same thing could be said about the entire presidency.
So, on a completely different topic, what’s the right way to build IKEA furniture? What’s the right way to land a plane? In many cases, you can just wing it, though it’s highly advisable to listen to the people who designed it, built it, and presented it to you with specific instructions. That’s probably the best outcome. The bookcase might be fine (nobody will notice you had to remove a panel and flip it around because you did it backwards the first time) and you might land the plane with too much fuel on a runway that’s too slippery… and not slide off the runway… but going against the design specs is never recommended. As the famous acronym RTFM says… Read… The… Manual…
I’ve been a big supporter of the vaccine and have cheered on Pfizer and Moderna and all the rest of them… and a big reason why is because I understand the process that went into their creation. I understand how it was done so quickly and where the bureaucratic corners were cut to save time and where the relevant science was kept pristine, specifically the clinical trials and testing and follow-up. Out of all of that detailed science came the very detailed instructions.
Nobody was too sure what these vaccines would look like when they finally emerged; the super-cold requirement of the Pfizer vaccine was unexpected. The fact you’d need two jabs instead of one… that was expected, but the timing between them wasn’t clear. Weeks? Months?
Pfizer came out with their vaccine… and, first thing, the temperature requirements. Here’s the number. Transport it at that temperature. Thaw it like this, mix it like that. Can we transport it a little warmer? No. Can we dilute it a bit differently? No. Can we thaw it for longer? No.
These “no” answers aren’t Pfizer trying to be difficult; it’s quite simply the range of what’s tested and what’s expected for the outcomes they’ve projected. Which is why there’s appropriately a lot of head-scratching and pushback on Dr. Bonnie Henry’s strategy of spacing out jabs, well-past the recommended time frame. Pfizer says space them three to four weeks apart. Moderna says four weeks. Dr. Henry wants to push it to 35 days. Why? Here’s her argument…
A first jab provides significant protection. Pfizer has said 52% after just one dose, though England’s own studies argue it’s 89%. Moderna is purported to be 80% after one dose. If the intention is to protect as many people as you can, then you try to get the vaccine into as many arms as possible… and you give everyone first doses and then wait around for the next shipment.
Apparently, the timing works out in such a way that if you stretch the time between shots a bit, more people can get that first one. Dr. Henry stated their plan was to use everything they got initially as first doses. That’s fine, if you can stick to the script. But… this on-the-fly modification, contrary to the specs from Pfizer?
I’ll be honest, if I signed up to get the vaccine with the understanding that I’d be getting the follow-up shot within the specified time period… and was later told, no… we’re going to do it a bit differently… I’d be upset. I might have chosen to wait a bit, until I can be guaranteed the right period of time is being adhered to. There is already enough vaccine anxiety out there; a lot of people are skeptical and worried and, while not being anti-vaxx, want to make sure things go well before they take it themselves. To introduce a variable into this equation that can, at best, maintain the status quo but, at worst, derail things… seems like a bad idea. If a bunch of once-vaccinated people become ill, now we have to figure out why and when and how – did the vaccine fail? Were they infected between jabs… or did they not develop the proper immunity, thanks to the spacing of doses? This would do nothing to instill confidence. On the contrary.
I didn’t sign up to be a test subject, to test the boundaries of efficacy. Around here, nobody did. That doesn’t mean this will cause problems… certainly, it might be ok. In fact, other jurisdictions, under the same plan of “get the first one into as many people as possible”, are stretching that time even further. In Denmark, up to six weeks. In the U.K., up to 12(!) weeks.
But let’s be clear, when you introduce a variable, this is no longer an execution of a plan. This is now an experiment, and the BCCDC may as well be tracking the results of playing with these time frames, as should the U.K. and Denmark; collect the data… because if there are issues down the road, it will be useful to know. It’d be also be useful to know that 35 days (or 42 or 84) works just as well as 28.
I’m guessing their thinking is that “pretty good” for a lot of people is better than “really good” for far fewer people… especially when “pretty good” might actually turn out to be “really good” as well.
Except… that’s not what a lot of people signed up for; if something is worth doing, it’s worth doing right. The argument that this is “right” or “right enough” doesn’t hold a lot of water when the designer/manufacturer itself doesn’t agree. I think for a lot of people, myself included… we’ve waited this long, and we can probably wait a little longer… there’s just too much at stake.
Who was the great mind that came up with this quote… Plato? Socrates? Nietzsche? Oh yeah, no… it was Eminem: “You only get one shot to take your shot so don’t blow it.” Or something like that. See what happens when you veer off-script? Sometimes it doesn’t work so well.
20 Likes, 3 Shares
I checked with a friend who knows about these things and participated in the Pfizer vaccine trial. She says that it is probably better to give 60% immunity to more people than 90% immunity to fewer.
The issue about spacing between doses from the perspective of the company, is the 21-28 days spacing is the only one for which they have data. It’s absolutely not the case that 21-28 is optimum, it’s more likely to not be optimum. That particular dosing spacing was only used to complete the phase 3 trials quickly. The usual standard is 8 weeks. The experts extending the time between doses know what they’re doing, but totally understandable the company will recommend only using the timescales they used in their trials.
The HK Daily Report (3.5 min read)
I’ve got news for you, Horatio…. we will all be part of a massive experiment, like it or not.
I’m a physician and a researcher (retired) and I have reviewed all the data in the product monographs. Here’s my take on it.
(1) Immunity isn’t something that magically appears on Day 21 (or 28) and disappears a week later. The degree of immunity will increase and decrease gradually. In the trials, not all the patients got their second dose vaccine exactly on Day 21 or Day 28. There was a range. In fact, in the AstraZeneca trials, there was good evidence that people who had a gap of up to 42 days responded as well or better. So why did the drug companies choose 21 and 28 days? Because they have unassailable data for those intervals, and because they are doing CYA.
(2) In everyday clinical practice, it is impossible to guarantee that a service will be delivered exactly on a particular day for an individual patient. For example, an elective surgical operation can be delayed because the patient has a cold, or ate breakfast, or already had the surgery, or has decided against it, or because an emergency is tying up the OR, or too many nurses are off sick with Covid-19, etc, etc. All clinical services are delivered on a best efforts basis. Guaranteeing that the entire population will receive a second dose of vaccine exactly 21 or 28 days after the first is unattainable and a fool’s errand. It is more pragmatic and perfectly acceptable to aim for a reasonable time range during which there is clinical evidence that the second dose will be effective, based on the best scientific evidence. The WHO has just evaluated that evidence and has said that an interval of up to 42 days is perfectly acceptable. Welcome to the real world, people!
(3) The UK authorities (MHRA and JCVI) evaluated the same evidence and looked at the crisis they are in and recommended that the interval be up to 12 weeks. Based on my own review of the data, I think this is a big leap of faith not supported by data, because nobody had an interval that long.
My bottom line is that I support Dr. Henry’s plan to aim for 35 days. If I get my vaccine at intervals of 28 days or 35 days or even 42 days, I am confident that I will be protected. So should all of you.
There’s vaccine on his sweater already: mom’s spaghetti? #CloseEnough
I understand your trepidation, and feel the same way somewhat.
However there are lots of people way more knowledgeable who are making these calls, and others who have already commented here.
And I will go with what the experts say. And thank them for their contribution.
My only reference point that gives me comfort is that my father (an MD) used to say that pharmaceutical “expiry “ dates were based on when the drug had decreased to 95% effectiveness. Probably not relevant here, but…
Gee. I wanted to talk about the US today. Is that alright? I’d like to start by stating what might be obvious to most of you. The USA is overdue for a reckoning. COVID and Trump have really served to expose that fact. But their problems run a lot deeper. Between income inequality / homelessness, racism, healthcare insecurity, guns, ignorance, and more. It’s time they examined their core values and their constitution. I don’t think they even understand how far down the wrong road they have travelled. Unfortunately they (and us) are in line for a lot more trouble. Just the view from one ‘coastal elite’.
I am supporting the views of Doctor Cronin. Just makes sense . I think?????