Pre Vax 2020, FDA said π they would not accept vaccine efficacy less than 50% (minimum bar)
Ontario data now suggesting a 3rd dose (booster) has Vax effectiveness of 37% for Omicronπ
Yet FDA & CDC advising booster FOR omicron?
Few thoughts π§΅
medrxiv.org/content/10.110β¦
Ontario data now suggesting a 3rd dose (booster) has Vax effectiveness of 37% for Omicronπ
Yet FDA & CDC advising booster FOR omicron?
Few thoughts π§΅
medrxiv.org/content/10.110β¦
We are no longer conducting adequately powered RCTs in the vaccine space.
Boosters for 12 to 15 are based on no efficacy data at all, as of yesterdays EUA π
Non inferior Geometric mean Ab titers is not a clinical endpoint
It can't show benefits>harms
Boosters for 12 to 15 are based on no efficacy data at all, as of yesterdays EUA π
Non inferior Geometric mean Ab titers is not a clinical endpoint
It can't show benefits>harms
https://twitter.com/VPrasadMDMPH/status/1478022455625084936?s=20
There is a tension with an agency that explicitly said they would not approve a vaccine with a VE <50%, now advising a booster with a VE<50%, while simultaneously freeing the company of the obligation to test the booster in rigorous RCTs
I am concerned that panic in the WH is leading to bad decision making
Vaccination is great, but you want to maximize the benefit & minimize the harms
Simple actions have not been taken, for .e.g
Vaccination is great, but you want to maximize the benefit & minimize the harms
Simple actions have not been taken, for .e.g
The USA should ban Moderna in men < 40, as other nations had
We took way to long to fix J&J recommendations due to VITT
Boosting young men is a live issue
Observational data has scant events at these ages to show benefit of boosting
We took way to long to fix J&J recommendations due to VITT
Boosting young men is a live issue
Observational data has scant events at these ages to show benefit of boosting
Harms from D3 are not negligible for young men
Omicron has introduced substantial uncertainty into value of boosting
A VE of 37% would not have led to FDA EUA in fall of 2020-- for an older frail population where there was more to gain
Omicron has introduced substantial uncertainty into value of boosting
A VE of 37% would not have led to FDA EUA in fall of 2020-- for an older frail population where there was more to gain
Now it is used to make recommendations in Jan 2022, in a young healthy population
It is bizarre vaccine regulation, and would not have happened if Gruber and Krause had not resigned
It is bizarre vaccine regulation, and would not have happened if Gruber and Krause had not resigned
adding this here to make it clear:
https://twitter.com/VPrasadMDMPH/status/1478399342520139776?s=20
This also has direct implications for Booster mandates.
How can anyone mandate a booster that would not have cleared FDA's pre-vax 2020 bar?
How can anyone mandate a booster that would not have cleared FDA's pre-vax 2020 bar?
Some argue, we should accept lower VE now than in the fall of 2020; That is a bizarre claim to make.
In the depths of a pandemic with no approved vaccine, that's where you will be most permissive.
In the depths of a pandemic with no approved vaccine, that's where you will be most permissive.
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