1/4/22
I wrote earlier today, reporting on the technical head of Operation Warp Speed, Dr. Moncef Slaoui, saying he or they are in talks with Moderna about giving people between the ages of 18 and 55 a half-dose of the COVID-19 vaccine. This was seemingly in response to the government’s pretty crappy roll-out of the vaccine distribution. I wrote, in part:
“What seems most puzzling about this approach isn’t whether it would be effective, but that actual vaccine production does not appear to be the reason why vaccinations are lagging. Slaoui indicated that 17.5 million does in the U.S. had been shipped as of yesterday, with 1.5 million people receiving the shots in the preceding 72 hours, which is about 500,000 per day. Although this appears to be an improvement over the first couple weeks, the bottleneck appears to be somewhere after the manufacturing process, not from the manufacturing process.”
I want to go back to this. I’m a medical writer and I have a degree in microbiology, but otherwise, I’m not an expert on vaccines or immunology. Still, my personal reaction to this is: WTF?
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID), seemingly in response to Slaoui’s comment on a Sunday morning talk show, at a different talk show, said, “We know what the science tells us. So my feeling … is let’s do it the way the clinical trials have instructed us to do it. But let’s get more efficient into getting it into people’s arms.”
Not to put words in Tony Fauci’s mouth, but I think “WTF?” might have been in the back of his mind.
If there’s evidence that the Moderna vaccine was going to be as effective with a half a dose, it really hasn’t been reported anywhere by Moderna. Same goes for Pfizer and BioNTech. And if it was, why not do it that way to begin with?
Of course, AstraZeneca and the University of Oxford, on the other hand, did report something along those lines, although one might reasonably say WTF? to that report. To reiterate for anyone who hasn’t been following this: in about 1800 patients in a clinical trial, they received a half-dose of the first shot of the Astra-Oxford vaccine by accident. Oops! But weirdly, that cohort had an efficacy rate of about 90% compared to about 62% in the full-dose-first-shot cohorts.
I haven’t heard of many vaccine experts or immunologists who are particularly excited about that data. Confused, yeah. Concerned, sure. And I heard of at least one biostatistician who wondered if it wasn’t just a statistical blip.
It makes one wonder if Warp Speed is trying to extrapolate from one clinical trial to another. It also makes one–okay, me!–wonder if Slaoui and/or Operation Warp Speed and/or Trump, are trying to divert attention away from the clusterf#$# that the initial rollout of this vaccine has been. After all, about the only person taking the blame is General Gustave Perna, who’s heading Warp Speed’s logistics operation. Give him credit for that.
And on a personal level, I’m not terribly surprised by the slow rollout. What they’re trying to do is completely unprecedented. And how it’s going so far rather closely resembles the Trump admin’s PPP efforts last March and April, and their COVID-19 testing efforts since, well, forever. I actually have quite a bit of faith in Slaoui and Perna, although more in Fauci, while I have little or none in the Trump admin. About the only thing they’ve done right is throw money at vaccine development. They probably should have thrown more money at the distribution problem at the state levels and done so earlier.
Personally, I’ll think it’ll scale up as states get on terms with Warp Speed and some very smart people at state and regional health systems finally stand up and say, “Y’know, let us handle it, we know what we’re doing.”
Meanwhile, my Spidey-Sense is tingling at Slaoui’s comment. I’d prefer the full dose, thanks.
BioPharmBiz 