Post #892: Moderna’s COVID-19 vaccine appears effective.

Today Moderna announced that its COVID-19 vaccine is 94.5 percent effective.  As with the Pfizer announcement earlier, it’s hard to tell exactly what that means.  But, based on the article cited just above, it appears to be 95% effective in preventing disease severe enough that the infected person sought medical treatment and was tested and found to have COVID-19.

This is based on a total of five COVID-19 cases diagnosed among persons vaccinated, versus 90 among the placebo (non-vaccinated) group in their clinical trial.

Up to now, no information suggested that the Moderna vaccine would be this effective.  And, certainly, their lack of track record (at ever having produced a successful vaccine) did not bode well for success.  Accordingly, I had assumed that Moderna’s COVID-19 vaccine would be just as (un) successful as all their prior attempts at making a vaccine.

I was wrong.

That said, I am still puzzling over an event that occurred two months ago. 

Two months ago, we got news that (some) vaccine sponsored by the US had just 70% immunogenicity.  See Post #815, dated September 16, 2020.  That is, just 70% of persons treated with the vaccine produced the appropriate antibodies against COVID-19.  That would have set an upper limit on effectiveness of no more than 70%, and set a likely effectiveness of (perhaps) 55%.

This was the episode in which the director of the CDC talked, on camera, about masks providing better protection against COVID-19 than a vaccine.  That was when he announced the 70% immunogenicity of (whatever) vaccine he was referring to.

The common assumption was that this was the Moderna vaccine.  I.e., both the Johnson and Johnson and Pfizer vaccines had published their immunogenicity data months earlier, per Post #827, and showed virtually 100% immunogenicity.)

Now that I look a little harder, I have no clue what the CDC director could possibly have been talking about.  By the date of that news conference, Moderna had also published its immungenicity data and showed high immunogenicity of its vaccine.

In any event, these results are not coming from the manufacturers, but from the Federal panel chosen to oversee the clinical trials.  So, absent some wacky conspiracy theory, we have to take them at face value.  Whatever-it-was that the CDC director was discussing two months ago is now just an odd and unexplained footnote.   As was the fairly common expectation among infectious disease professionals that the COVID-19 vaccines would be far less effective than the Pfizer and Moderna vaccines appear to be.

As a final footnote, you cannot compare the effectiveness of these vaccines, as stated, with the effectiveness of the seasonal flu vaccine.  The COVID-19 research is using a different measure than the flu vaccine research.  For flu, they count as failures all persons with any evidence of infection with flu at any point, based on antibodies found in their blood.  The “ineffective” flu cases include a significant fraction of individuals who were never sick with flu, and were only known after-the-fact to have been infected with flu, based on a blood test.  By contrast, the COVID-19 results appears to be based on counts of individuals who had symptoms severe enough to prompt them to seek medical treatment, and then to get tested for COVID-19.  Asymptomatic infections are never counted.  Because of that, the effectiveness measures for the COVID-19 vaccines will appear higher than the effectiveness numbers for the seasonal flu vaccine.

Post #827: Yeah, this really is the vaccine I want

Source: Safety and immunogenicity of the Ad26.COV2.S COVID-19 vaccine candidate: interim results of a phase 1/2a, double-blind, randomized, placebo-controlled trial.  Jerry Sadoff, Mathieu Le Gars, Georgi Shukarev, et al.,

Four days ago, in Post #824 , I stated that the Johnson and Johnson (J and J) COVID-19 vaccine is the one I want to get.  That was based on my reading of the initial research findings on monkeys, and some oblique hints dropped by US public health officials.

Friday’s news strongly reinforces that conclusion.  J and J tested the vaccine on hundreds of healthy people, and 98% of them developed “neutralizing antibodies” four weeks after vaccination. You can see popular press reporting of this at these links (The Independent, Reuters), and can read the original research at this link (medRxiv, hit “download pdf” to see full research paper.)
Continue reading Post #827: Yeah, this really is the vaccine I want

Post #824: This is the vaccine I want

Source:  Figure 5 from:  Mercado, N.B., Zahn, R., Wegmann, F. et al. Single-shot Ad26 vaccine protects against SARS-CoV-2 in rhesus macaques. Nature (2020). https://doi.org/10.1038/s41586-020-2607-z

I admit to being an unabashed fan of Johnson and Johnson (J and J).  That’s an informed opinion, having worked as a technical consultant to numerous Fortune 500 health care companies.  From what I could tell, in my limited perspective as a consultant, they were, with one possible exception, the best and the brightest of US health care manufacturers. 

And consummate business people.  I’m a fan, as I said.

And so, just to prep you for the conclusion here, if J and J thought that Moderna (the officially anointed US vaccine manufacturer) had some sort of amazingly effective and patented approach to producing vaccines, they’d have bought them already.  Or at least bid for them, up to what they believed the value the firm was worth.

To me, in this circumstance, the fact that J and J didn’t try to buy them speaks volumes.  It tells me that J and J thought they’d do better, relying only on expertise within the J and J family. Not that this is some point-of-pride thing, but merely adhering to a least-cost make-or-buy decision.  Just the way that is taught in business textbooks.

Understanding that I’m an economist, and not an expert on the science, let me try to read the tea leaves, on what’s now being reported on the J and J vaccine. Continue reading Post #824: This is the vaccine I want

Post #818: Well, turns out, this *is* as good as it gets.

Three days ago, the head of the US CDC said, more-or-less, that you’re going to get more protection from wearing a mask than you are from the forthcoming US vaccine.  He’s had to recant, publicly, since then.  But my guess is the he got it right the first time.

I summarized that in Post #815, What if this is as good as it gets?  With the title being my take on that testimony.  We’ve been expecting a vaccine to make a radical change in the situation.  But, taken at face value, the US CDC director basically just told us, that’s not going to happen.  Presumably, the implication of what he said is that it’ll do no more than mask wearing and social distancing have done.

Today I stumbled across a recent interview with Dr. Fauci where he said that if we adhere to all the current public health measures, and we get a “good” vaccine, we might be able to return to normalcy as early as the end of 2021.  Apparently, he’s been saying 2021 for some time.  This is the first time I’d seen it stated as the end of 2021.  And seen that conditional on having a “good” vaccine.

So, twice in the last couple of days, responsible public health leaders have told us that this is about as good as it gets, for the time being.  Vaccines really won’t alter the situation in any material way, for quite some time.  Even with a “good” vaccine, the situation we are in right now — with the shutdowns and social distancing and all of that — that’s as good as it gets, until at least the end of 2021.  And that’s only projected to end if we have a “good” vaccine, and everybody adheres to the other public health measures like social distancing and mask use.

At this point, I feel like I’ve been sleepwalking through this.  I need slap myself across the face, wake up, and start listening to the people who know what they’re talking about, and plan accordingly. 

The smartest people in the room are trying to tell us that we’re going to be in this semi-lockdown, socially-distanced, mask-wearing limbo for … a year or years to come.  Vaccine or no vaccine.

And now that I’m waking up, I realize just how many things I’d let slide because I unconsciously assumed that there was a chance that we could return to normalcy soon.  Particularly with numerous vaccines on the way.  No sense in doing things that incur a risk of COVID-19 infection if US society is likely to be COVID-free in the near future.

Should I list a few?  I’ve been slacking off on exercise, thinking, well, I’ll be able to get back to the gym soon enough.  Nope.  No I won’t.  So I’ve been putting on weight accordingly, but you know, that’ll come off when I can get back to the gym three days a week.  Nope, that’s not going happen any time soon.  I’ve put off seeing the doctor, figuring, it can wait until things are back to normal.  No sense being around a lot of sick people during a pandemic.  I’ve put off a major home repair because I don’t want workmen in the house, figuring things won’t have rotted out completely by the time we’re over this COVID thing.  Again, wrong, wrong, wrong.  And so on.

So I think I finally am getting my mind around this.  This really is as good as it gets.  For quite some time, anyway.  That’s what the smartest people in the business are telling us.  If you try to live your life in a reality-based fashion, plan accordingly.

 

Post #817: Vaccine and sins of omission.

I’ve had a series of posts arguing that Russia (and now the China) are doing the right thing by deploying their vaccines before they know their effectiveness.  That was stated most recently in Post #814.  Both countries are already providing those vaccines to high-risk populations such as health care workers, before they know how effective the vaccines are (or aren’t) in preventing (or lessening severity of) COVID-19 infection.

Today’s twist is that they are also winning allies and gaining international influence by supplying vaccines, now, to other countries that need them.  That’s written up in this Washington Post article.  So not only are they ahead in their own country, but they are gaining influence around the world by being first-to-market in a number of countries that need help right now.  (And, in an odd twist, they’ve decided to pool some efforts on their vaccines. )

In this post, I’m going to review the logic behind this one last time, and then do the grade-school arithmetic that validates that logic.  Something that, apparently, neither our elected officials nor our public health bureaucracy seems willing or able to do.  Or at least, to admit to doing, in public.

My best guess, using some quite conservative estimates, is that providing 10 million doses of vaccine now, instead of six months from now, would save just under 10,000 hospitalizations (worth about a quarter-billion dollars), and about 2800 lives.  This doesn’t even count other costs saved, such costs saved by avoidance permanent organ damage from COVID-19, or economic losses from work or school time not missed due to COVID-19 illness and quarantine.    Not only would the avoided hospital costs more than pay for the vaccine itself, these numbers are vastly higher than any plausible health or economic damage from any as-yet-undiscovered rare side effects of the vaccines.

Details follow.
Continue reading Post #817: Vaccine and sins of omission.

Post #815: What if this is as good as it gets?

Source:  Immunogenicity and protective efficacy of influenza vaccination
Claude Hannouna, Francoise Megas,  James Piercy,  Virus Research 103 (2004) 133–138.

The importance of this graph will be clear about five paragraphs down.

At this point, with the Phase III trials of coronavirus vaccines well underway, even if they don’t have enough “statistical power” to do the formal statistical test, our public health bureaucracy ought to have a fairly good indication of how things are shaping up.

I’ve been waiting for any US public health leader to start leaking information on the likely effectiveness of the coronavirus vaccines.   Informally tossing some numbers out there, to get us prepped for the eventual formal announcement.

We just got our first indication today.  And, although the CDC Director broke the news gently, and indirectly, and with spin, if you paid attention, the news was clearly not good. Continue reading Post #815: What if this is as good as it gets?

Post #814: COVID-19 vaccines. The Chinese get it, the Russians get it. We don’t get it.

In Post #777 (and earlier), I talked about why the Russian strategy of early use of their vaccine made good sense.  And now, it turns out that the Chinese are doing the same thing as the Russians.  They just didn’t brag about it, the way the Russians did.  I guess I am unsurprised that the Chinese are doing the rational thing here.

In both cases, they are taking vaccines that have passed safety trials, but have not yet completed trials showing whether or not they work, and they are using them right now, for high-risk populations such as health care workers.

This is so rational, and so logical.  And yet, apparently so beyond the grasp of our government.  Either our elected leaders or our professional bureaucracy. Continue reading Post #814: COVID-19 vaccines. The Chinese get it, the Russians get it. We don’t get it.

Post #812: Vaccine distribution: The National Academy of Medicine plan

 

Source: Discussion Draft of the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine, Committee on Equitable Allocation of Vaccine for the Novel Coronavirus, National Academies of Sciences, Engineering, and Medicine (September 1, 2020).

I almost missed this one, and thought I might bring it to your attention. Continue reading Post #812: Vaccine distribution: The National Academy of Medicine plan

Post #803: Hahaha. No, really? So make it 11/4/2020.

Cannot be rescinded. Not even questioned.

The whole COVID-19 vaccine thing just won’t quit.  We now have the officially-appointed spokesmodel saying that a November 1 deadline for having a vaccine in place is pure coincidence, and has nothing to do with election day.

If you’re just a civilian, you may not see this the way I see it.  But, if you’ve been in the game, you realize there’s a huge amount of slack in any deadline like that. 

They have no firm estimate of fill-in-the-blank here.  For example:  Of how effective the vaccine is.  Of how capable the manufacturers are of delivering large quantities by that date.  Of how capable state public health offices are of delivering it.  Of what temperature the vaccine must be kept at.  Of whether or not people are willing to get vaccinated with it.  Of who, exactly, will be eligible to receive the first doses.

And, plausibly, of which vaccine, exactly, they’re talking about.

And yet, November 1, 2020 is set in stone.  Cannot be rescinded, not even questioned.  When, to a fairly close approximation, you could avoid any question of the appearance of impropriety by postponing release to, say, a day or so after the election?

At some level, I just get tired of asking how dumb they think we are.  If you believe the party line on this, I feel sorry for you.  And I have a bridge in Brooklyn that I’d like to sell you.

Post #800: Vaccine by November 1. Who could possibly have guessed /s

Source:  Washington Post.

It’s not like the Administration hasn’t been signalling this for days now.  And, surprise, surprise, surprise, it’s scheduled for November 1.  Isn’t there some other important event that occurs in early November?  (Edit:  I forgot to mention that November 1 is a Sunday, almost as if nobody even bothered to look at the calendar before they announced the date.)

My best guess is that they’re going to offer this “emergency” authorized vaccine to health care workers only.  Nobody’s saying that, but that’s the only thing that makes good logical sense.  And that’s what the Russians did (e.g., Post #777).  The idea being that a) it’s known to be harmless, and b) even if it’s a dud (less than 50% effective, say, and so not meeting the standard that the FDA established) you can justify using it in a high-risk population if it reduces the odds of infection even a little bit.

And now some people will be offered the vaccine, and they have to come to some conclusion:  Is this real, or is it just political theater?

Let me walk though my analysis of it. Continue reading Post #800: Vaccine by November 1. Who could possibly have guessed /s