More dishonest statements about boosters by the FDA's Marks and Califf
the NEJM correspondence is a new low
In response to Paul Offit’s NEJM editorial Peter Marks and Robert Califf from FDA have a reply that argues— falsely— that good evidence shows boosters benefit young people. I am going to dismantle their argument, sentence by sentence.
Let us go one at at time, starting paragraph 2 (para 1 is useless rhetoric, see above)
This study did find a small increase in neutralizing antibodies— but that is a surrogate endpoint and not something people care about. Moreover, the level of increase was so small it is unlikely to be meaningful— Offit makes the latter point in response, but not the former. I don’t care about transient antibody titer levels. Naturally the body doesn’t make all antibodies all the time, or our blood would be molasses.
This is not evidence for boosters now, but a summary of what happened in the past (using inaccurate data, no less). The forthcoming risk to young people 18-49 is lower than in the past. More people have had COVID now. The question is do 18-49 year olds benefit in the future? The fact the past had 7500 hospitalizations (PS you haven’t removed incidental hospitalizations) is not about the present, and a cheap emotional argument.
These studies are of low quality & all 3 are in MMWR (not a great journal — see past posts). None are randomized trials. All have biases, including unmeasured confounding.
One study is only >65 years old and up, which is not the topic of debate. One is a criminally stupid study that compares bivalent boosters to a group that includes people who got the original 2 doses but no 3rd dose. But bivalent boosters are nearly exclusively given to people who got 2 original doses AND a 3rd dose. Paul Offit concedes a transient reduction in symptomatic sars-cov-2, but argues this will wain with time, but I don’t concede that b/c the method cannot correct for bias. Only RCTs could show that.
But more to point, as Offit notes— if you focus on the outcomes we care about— severe disease or hospitalziation, “the protection against hospitalization that was afforded by bivalent boosters, which is the goal of this vaccine, was limited to people over 65 years of age4 and those with a median age of 76.5”
The last sentence is particularly problematic. Of course, myocarditis in boys aged 16-24, will be seen with bivalent boosters, and has been seen with monovalent boosting, and is not like influenza vaccines at all. Get out of here.
Robert Califf likes to say, “misinformation is the leading cause of death”. The irony of that statement is that he invented it, and has no data to support it. The same is true for bivalent boosters in people aged 18-49. Many European nations are not doing it. As seroprevalence rises, the harm/ benefit balance will shift towards harm. And at present, and when they gave EUA, they had no good evidence benefits outweigh harms.
This letter is emblematic of the FDA’s caliber of analysis— very poor quality analyses used to push conclusions for policy decision it has already reached.
Marion Gruber and Phil Krause were correct to resign.
I honestly wish you had broader exposure to what you write. You should go back to posting important stuff like this on Brownstone which has the biggest footprint by far. Withdrawing from there because they are not Bernie Sanders (or anyone else) supporters is bad for you and bad for getting the word out. You have much important to say -- not everyone will agree with everything you think. But the world needs you to have the most exposure you can get.
Gruber and Krause should be speaking out more, but they were probably forced to sign a non-disclosure. I think it is shameful that the NEJM has become the lap dog of the FDA but then VRBPAC member Eric Rubin is the editor.