Yesterday, the FDA gave the Janssen—did you know it’s pronounced yahn-sen? I didn’t—vaccine Emergency Use Authorization, allowing it to join the likes of Pfizer and Moderna in the exclusive club of vaccines that may now be distributed in the U.S. Welcome, Janssen. (As a total coincidence I’m wearing my shirt that just says “Vaccines!” on it as I write this.) But the addition of a new vaccine in circulation also brings data reporting questions with few easy answers.
I got to hear the VRBPAC (Vaccines and Related Biological Products Advisory Committee) hold music for the first time on Friday. As I am a full-time student, I couldn’t watch the entire meeting; thus, a lot of this coverage is aided by Helen Branswell and Matthew Herper’s liveblog on STAT News—thank you guys for saving me hours of video to sift through.
The gist of the meeting is that of course it passed the committee vote. I’m pretty sure no one expected it wouldn’t. Katelyn Jetelina, who runs the Your Local Epidemiologist newsletter, certainly didn’t, especially because we knew beforehand that it was 100% effective in preventing hospitalizations and deaths.
However, I did find it interesting that the vote was unanimous—which I wasn’t expecting, given the pattern established by Pfizer and Moderna beforehand. Pfizer passed with 17 pro and 4 against (and 1 abstention); they did not explain their votes in that meeting but authorization for kids aged 16-17 was a sticking point. Moderna passed with 20 pro and 1 abstention; the question—“Based on the totality of scientific evidence available, do the benefits of the Moderna Covid-19 vaccine outweigh its risks for use in individuals 18 years of age and older?”—was worded too broadly, and the abstainer would have preferred to target authorization to high risk populations).
So what changed? Herper noted in the liveblog that the unanimous vote doesn’t necessarily mean this is a better vaccine than Pfizer or Moderna. It was more about panelists’ increased faith in the EUA process. Pfizer and Moderna have been EUA’d for a while and, per Patrick Moore of the University of Pittsburgh, “things are looking good.” Agreed! Now if we could just get it into more deltoids…
But we’re not here for deltoids, we’re here for data. The J&J presentation basically reiterated what we knew with some key statistics: The big Phase 3 study enrolled more than 44,000 participants globally. Across the entire study, the protection efficacy against severe disease was 85%, and that’s including the U.S. and South Africa (important because of variant prevalence in the latter country). No one who got the vaccine was hospitalized or died due to COVID-19. The efficacy against moderate to severe disease was 72% in the US, and 66% across all countries studied. These numbers were similar across ages, comorbidity statuses, sexes, races, and ethnicities. In short: it works.
There is a lack of data in people aged 75 or older. Only 755 people (3.8% of all participants) in this age group received the vaccine in the ENSEMBLE trial, and the FDA noted that it’s hard to interpret such low numbers. As Branswell says in the STAT liveblog, the trial didn’t prove that the vaccine works in older individuals. However, the VRBPAC committee barely touched on this. Either way, it’s been approved for adults 18 and over, and there’s nothing in the recent communications that indicates adults 60 and over aren’t advised to get it.
There are data questions beyond the VRBPAC committee meeting, though. Most vaccination dashboards are set up for a two-dose vaccine; they document how many people have gotten both shots and how many people have gotten just the first. So we don’t really know what’s going to happen when the Janssen vaccine becomes available—will that number factor into “people who have only gotten one dose?” Personally, I think the dashboards are going to have to change to “people who have partially completed dosing regimen” and “people who have completed the dosing regimen,” but knowing the states, it’ll likely be more complicated than that. Drew Armstrong, who runs Bloomberg’s Vaccine Tracker, mentioned in our CDD workshop last week that his team is already calling public health departments in order to discern how their reporting will change.
The question of how the dashboards will change gets more complicated when one considers a sticking point that actually was brought up in the committee meeting: just how many doses Janssen will eventually recommend. This particular petition was for a single dose vaccine. But Janssen has also been testing a two-dose regimen. Dr. Paul Offit, a member of the committee and a vaccine researcher, brought this up and raised a very important question: what if the two-dose regimen works better? What happens then? How is that going to be communicated to the public? How is that going to show up in the dashboards?
It’s tricky. The response, for now, is that the two-dose trial is still double-blinded, and that right now we’re concerned with granting EUA to a single-dose vaccine. The possibility was raised that the two-dose regimen might be what Janssen presents for true-blue FDA authorization. But we’re not there yet.
However, to go back to our dashboard question, let’s entertain for a minute that Janssen sees that the two-dose regimen works demonstrably better than the single-dose regimen. I find it hard to believe that this will come before the single-dose vaccines have started to be administered—and documented in dashboards. What happens to the dashboards then? Even if we assume it’s changed by then to “completed vaccine regimen” vs “partially completed vaccine regimen,” does that mean everyone who got the Janssen vaccine before – and would be counted under “completed regimen”—would have to be moved to “partially completed regimen?”
The ending sentiment seemed to be that the two-dose questions are a bridge we should cross when we get to it. While I sort of agree, I do think it’s worth considering now when it comes to data ramifications. States should be thinking about how they’re going to document this so we’re not blindsided if Janssen and the FDA decide that you need two shots for maximum COVID protection. We have enough data problems as it is, why add more?
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