👀The FDA and CDC are calling for a pause in the use of J&J’s vaccine after a series of blood clots in six women.
Statement:
So far, about 6.86 million doses of J&J’s vaccine have been used in the U.S., so that’s a known rate of less than 1 in 1,000,000.
Many of the J&J doses have also been targeted, by the feds, at harder to reach populations. If there are vaccine-hesitant among those, this news may not help.
The J&J supply is a tiny fraction of what’s in the U.S. right now. But it’s expected to play a bigger and bigger role as the rollout goes on, in part because of the convenience a one-dose shot represents. Here’s what supply expectations look like:
☝️These events are rare, yes, but health regulators tend to take this stuff very seriously.
FDA is holding an advisory meeting tomorrow to discuss; we may see news after that.
This will likely also launch more investigation that could uncover more events or rule out some.
Useful context on the rate/denominator, which should be lower than 6M
It’s also worth noting that whether it’s 1 in 6M or 1 in 3M, that’s still better than your odds vs a Covid infection.
That ALSO said, it’s crucial to catch warning signs early, assess risk, figure out if some groups shouldn’t get a certain vaccine, or if it’s fine to continue.
All drugs and vaccines have risks. The FDA and health regulators elsewhere asses risk-benefit BALANCE. (With vaccines, weighing safety very very heavily.)
If the balance is okay, they’ll likely recommend resuming use.
Situations like this, or the concerns about AstraZeneca’s vaccine in the EU, are why countries doubled down and diversified vaccine R&D/purchasing and OVER-bought vaccines.
You don’t want you vaccine campaign to fall apart because one vaccine.
What's causing the blood clots? FDA's Peter Marks says this is just a theory, but that it could be an immune response that occurs very rarely after vaccination, causing activation of blood platelets.
Presser available live here:
Woodcock says FDA/CDC have done an extensive review of the reported events and looked at the background rate of these clots.
Marks says these types of clots have a background rate of 2-14 per million people. BUT says there's a pattern of events similar to Europe events.
We know there's been a lot of interest -- especially recently! -- in "how many shots are out there." Now you can see that, and see what's coming:
☝️This dataset is from the weekly CDC allocations, dated to the time of announcement (our best judgment on when doses are made "available" or "delivered" to the federal gov.). We've also recreated a history of non-CDC-allocated doses, which get announced by the WH.
This is a one-day record -- the second in a row. (The 4.5M day a big ago is an artifact of CDC's data reporting, which we'll correct if we can but.... it's a bit complicated.)
We're seeing surges in vaccines being shipped, lots more places to administer them, and an expansion of eligibility. No surprise the numbers are going up, here.
🧵2/ If past trends hold, we could be in for some very big numbers this weekend. (Saturdays and Sundays have been among our biggest days, typically.)
3/ There may also be some catch-up action going on here, so treat this number with a grain of salt. We know there were some states (texas) with some reporting delays earlier this week.
This is one frustration of having to rely entirely on CDC data after their methodology switch.
Our methodology blog post also has (from CDC) what the number today *would* have been with a normal pull time. You can find it here (it's still a lot):
⚠️This is a huge number that's 50% bigger than we've ever seen. it's possible there's some sort of data/methodological reason for this. We are investigating and will post a blog/more tweets if we find out something more.
In the meantime, <sportscenter voice> THAT'S A BIG ONE
There are some states here that are all having record days: Take a look at Cali, NY, Mississippi, North Carolina: