Thread by @cfishman

FDA & CDC ask states to *stop* administering the Johnson & Johnson covid vaccine.

The stop is temporary. It's also voluntary — the federal gov't is advising states there might be a safety issue with the J&J vaccine.

Feds will pause using J&J vaccine at their mass vaccine sites.

2/ How serious is this problem?

What triggered the stop — and is the vaccine safe or not?

NOTE: This is the vaccine I got (along with two other family members) last Friday.

I'm not worried. Here's why.

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3/ The J&J vaccine has been given to 6.8 million people in the US.

6 have developed a blood clotting problem after receiving the vaccine — between 6 & 13 days after.

That's 1 person out of 1.1 million doses with the syndrome.

All 6 are women, ages 18 to 48.

1 woman died.

4/ So the first thing to appreciate is how astonishingly rare this problem is.

Tennessee has 6.8 million people. If you gave the J&J vaccine to every person in Tennessee, 6 people in the state would have gotten the blood-clotting disease.

One would have died.

5/ FDA & CDC asked for the pause in vaccinations for several reasons.

First, they want to dramatically and quickly alert medical professionals across the US about the possibility of this condition.

It needs to be treated in a particular way. The pause gets dramatic attention.

6/ Second, the FDA and CDC are convening a meeting on Wednesday to review the data on the vaccine, the clotting problem, efficacy, who might be susceptible.

They'll make recommendations on whether it's safe to keep using the vaccine.

Two really important points from the data…

7/ If you get the J&J vaccine, at the moment, you have a 1 in 6.8 million chance of dying from this clotting condition (which may not be related to the vaccine).

If you get covid, you have a much greater chance of dying — 5 people die for every 300 who get covid.

8/ The vaccine may *not* cause the clotting syndrome. But whether it does or not, the vaccine is *much safer* than covid.

Let's imagine that of the 6.8 million people vaccinated with J&J, 5% would have gotten covid.

• 30,000 additional cases
• 500 additional deaths

9/ That's not to minimize what happened to these 6 women or their families, of course.

The clotting condition is called CVST—cerebral venous sinus thrombosis.

It's rare: 3–4 cases per 1 million Americans / year.

In 6.8 million people, you'd see 20-26 cases / year.

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10/ The J&J vaccine has been in use in the US about 5 weeks — 10% of the year.

So just based on the math, you'd expect 2 to 3 cases in 6.8 million people in 5 weeks.

No data — and no indication — of the clotting problem in people receiving Pfizer & Moderna, though.

11/ That's all why this is a complicated problem. It's not carelessness by Johnson & Johnson or the FDA — at least not based on what we know so far.

It could be a very rare side effect of the vaccine that some tiny number of people are vulnerable to.

12/ It could be a 'natural' occurrence of CVST, that is being highlighted by the overlay of people being vaccinated.

It could be something else.

But the data shows one thing very very vividly:

The vaccine is 99.999% safe — even if it causes CVST, which isn't clear.

13/ And you are much more likely to get covid, and be seriously ill or die, if you don't get the vaccine — than you are to get this syndrome.

The vaccine is much safer than the disease, much safer than *not* being vaccinated.

14/ People will jump to all kinds of conclusions.

But this 'pause' is a reminder that the US medical system is good & cautious. It's a sign that the vaccine system & the safety system are keyed up & not taking chances.

I got the J&J vaccine. Grateful. Not worried.

15/ And no: The US medical approval system is not perfect.

Are you perfect in your work?

How about 99.999% perfect?

Good moment to listen and absorb what people say — not immediately react to the headlines.