CDC identities a potential safety signal with Bivalent vaccines
Randomized trials are needed PRIOR to using medical products
This administration's vaccine policy has been horrible, and always erred on the side of pushing doses. They initially denied the safety signal of myocarditis. They delayed pulling J&J in young women. They never banned Moderna in young men. And they rubber-stamped kids vaccines with inadequate efficacy data. All the while, they made no exemption for prior infection. They pushed vaccines in a reckless way, so much so that Marion Gruber and Phil Krause resigned from FDA’s vaccine division. The worst offenders have been: Walensky, Murthy, Jha, Califf, Fauci and Marks.
Most recently, long after the emergency phase of the pandemic ended, this administration granted EUA to the bivalent booster (down to 5 year olds!) based initially on mouse data, and, to this day, supported only by confounded observational studies. Arguably this is an illegal action as there is no emergency to justify boosting 20 year old men who had 3 doses.
Sensible doctors knew this was an error, as did the American people. Less than 20% signed up for the booster.
Pfizer had a 100 billion reason they should have performed and RCT, but this administration felt it better they save that money than run a study.
Now a reminder comes why this was bad policy. On Friday the 13th
We know very little, but it appears a safety signal of stroke may be identified. Of course, there is nothing magic about 65, so it may also occur at younger ages. What is the absolute risk? Where is the press conference? Sadly, no further info followed.
A sensible FDA commish would hold a press conference and state what was known. Instead of that, our FDA commish tweets a picture of himself in a grow house.
Who told him that the best way to handle the announcement of a novel vaccine safety signal was to immerse yourself in lettuce?
Bottom line is: when you approve products without RCTs that can prove a net clinical benefit, even modest safety signals can be devastating.
This administration is playing fast and loose with the agencies credibility. If this safety signal turns out to be salient. Their reputation will rightly be in tatter.
They may not care, but reputation matters.
Now, don’t exaggerate. It wasn’t “mouse” data. It was mice data. There were 8 of them! That’s basically a RCT right there.
The drop in uptake of other vaccines is not surprising. Trust in our public health agencies has been seriously eroded. There needs to be a committee formed to discuss how to begin to restore trust. That committee should include pro, anti and skeptical vaccine groups. There is a lot of lost ground to make up. Lettuce pray...