Thread by @VPrasadMDMPH

The CDC director, a political appointee, siding with the President, & his pre-ordained plan, against the advice of the ACIP advisors, with 0 RCTs measuring clinical outcomes & no idea of adverse events is not "doing one's job" it is politics > science, precisely what we feared 🧵

The process that led up to Pfizer booster is someday going to be seen as what many dreaded during the Trump administration.

The White House decided during the week of Sept 20, boosters will be made available, and all gears of drug regulation made it happen

Consider the 24 year old male health care aid living in Seattle who received 2 doses of Pfizer vax, and is now granted a path to take dose 3.

Can any medical expert answer 2 questions:
Do the benefits exceed the harms to this individual?
Is he a 'safer' employee?

The correct answer is that no one knows

That is kinda a huge error of medical regulation

A healthy 24 year old will receive a vaccine product, and we do not data to answer 2 simple qs.

How about another e.g.

A 25 year old, worried teacher, who had documented sars-cov-2 & recovered, 2 doses of Pfizer and works in LA

This teacher has a path to booster, but is it:
In their best interest (benefit/ harm)?
Benefit to others in their school?

The right ans = no one knows

And, It is entirely possible the third dose is a net detriment to them

Walid Gelad is right

https://twitter.com/walidgellad/status/1441391868252721156?s=20

One purpose of drug and vaccine regulation is to protect people-- avg. worried, concerned, nonchalant, indifferent, invested-- people from making choices that may worsen their health outcomes

this policy undermines that protection

If instead all you want is total autonomy to boost-- then why have the FDA at all.

Just live in a world where you can get all the boosters you want when you want.

That world would be brutish and short

As a general rule, the standards we use for very ill people (relapsed cancer) are more lax than very healthy people (very high)

In emergencies, the standard can fall

Having said all that, it is highly questionable to claim..

that a 25 year old who recovered from the virus and had 2 doses of pfizer faces an *emergency* such that the regulatory standard of *total speculation* is acceptable

Misusing expedited & lower evidence pathways to push products is a common failure at FDA

Politicians cannot drive these decisions.
Politicians want fewer cases -- end of story-- famously one asked that a Boat not dock at long beach to avoid the case count rising

Not testing sick people is another way to depress cases artificially
But also...

Boosting healthy people may reduce the rate some people test + on PCR, while not changing rates of severe illness, a tiny fraction may have serious AEs that offset any gains

A politician is not invested in the health of people, but the political implications

Finally, vaccine safety is a long game
Politicians have short term horizons, but any error here will destroy us..

Consider this...

https://twitter.com/apsmunro/status/1441291367892668425

If it is shown that healthy young (20 year old) health care workers getting booster results in a net health decrement to them (I'm not saying it does, IDK, but we can't exclude it), then what have you done to health care worker acceptance of vaccination...

You make any mistake here and you salt the earth.

As someone who has studied regulatory science for more than a decade, I would not have made this gamble

Politicians think differently.

Bad process.

Worse IMO is how many who would criticize this if trump did it, but when biden does

dark days for science ahead