Thread by @ashishkjha

CDC's vaccine advisory committee ACIP met today to advise on J&J pause

After thoughtfully discussing what we know & don't know about rare clotting events, they punted

The advisory committee decided not to advise

This was a mistake. J&J should be un-paused soon

Thread

Initial pause by FDA on Tuesday was a close call

But I supported it

A few days to alert people, begin process of collecting more data, advise physicians -- all made sense

Now advisory panel wants to return in 7 - 10 days to discuss further

The risk-benefit here is all wrong

Nearly all the adverse events are in women 18-49 years old

Cerebral Venous Sinus Thrombosis (CVST), the clot seen with J&J, is known to be more common in young women

Suggests that young women probably the group at high risk

This actually gave ACIP a smart way forward

2/7

Given that most cases of vaccine-related CVST appears in women

ACIP should have recommended continuing pause for women 18-49 but resuming for everyone else

Keeping vaccine paused for everyone makes little sense

Risk-benefit keeping vaccine paused for everyone WAY off

3/7

But what about the fact that we have Moderna/Pfizer?

They are great. But not easy for everyone.

For many, J&J is a life-saver

Imagine 54 yo male migrant farm worker with diabetes who can't return for a 2nd shot?

Based on what we know today,

Would you give him J&J?

4/7

His risk of getting COVID may be as high as 1 in 1000 per day

His chances of dying of COVID may be 1 in 100

So each unvaccinated day, his risk of death is 1 in 100,000

His life-time risk of CVST from J&J?

WAY less than 1 in million

May be zero

No-brainer. Give him J&J

5/7

ACIP's decision to wait would be fine if there was no pandemic going on

But there is

And waiting 7-10 days won't do much. Not sure what data they will get in that time

But we'll have done real harm to a terrific vaccine particularly well-suited for vulnerable populations

6/7

Good news is that ACIP is just advisory

So FDA/CDC can still move forward and recommend resuming vaccinations for everyone except women 18-49

And for all groups, continue to vigorously, proactively collect data and make changes later if needed

7/8

We’re in a pandemic

Short pause to alert folks is reasonable

Waiting when its unlikely to change what we know is not

J&J highly-effective, safe vaccine with rare side-effects

I'd make it available soon, particularly for those for whom alternatives are not good choices

Fin