Robert Califf the FDA commissioner is making inappropriate and irresponsible claims about vaccines and boosters on twitter

The FDA would not allow Pfizer to make these claims based on this flimsy research.

Normally, FDA commissioners do not go on social media and make specific claims regarding specific drug products. This is the norm because it is NOT the job of the commissioner to engage in the advertisement or sale of medical products. This precedent has been violated by Robert Califf, which I talked about once before.

Bob Califf's tweets as commissioner of the US FDA are problematic

He is back at it.

The commissioner is again on twitter making claims which are not supported by randomized trials. Notably, the US FDA does not permit the manufacturer to make these claims. The commissioner is broadcasting claims that the US FDA has simply not vetted. The basis for these claims are observational studies, in some cases run by the company. These same studies WOULD NOT be accepted by the US FDA.

Even worse, at times the commish misinterprets data and spreads misinformation, denigrating the benefits of primary vaccination.

Here are the examples:

That is a bold claim, and based on this abstract. No paper has been published.

The abstract compares 67% of kids who got vaccinated to 33% who did not. It says 5% of kids had long covid sx, and vaccination was associated with less symptoms. Then it includes 3 figures that are misplaced— they have to do with paxlovid and different ages— not vaccination (attaching PDF here to see how bad this research is reported). Table 3 is not provided.

Long Covid Kids

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Obviously, this is bad research. Kids are not randomly assigned to vaccine, so there is likely residual confounding. But worse the reporting is so poor, Bob Califf could not possibly have read this study and thought about it, or he would ask… wait, why are the figures wrong.

This article was covered by Nature, and no one has mentioned the figures do not match the paper. Did the journalist not check?

Now, Califf is back with more nonsense.

This is a test neg case control paper from Kaiser. To be a case you had to have an acute respiratory infection billing code and a covid test 14 days before to 3 days after (in the Kaiser system). To be a case, same ARI code, but no + covid test.

The study did not examine if the hospitalization was actually due to covid or due to some other reason, and the person had a cold (aka covid) concurrently.

93% of people did not get a new covid booster, obv.

People who got the vaccine are very different.

4% of cases received prior boosters, and 7% of controls.

But the entire paper fails to prove the booster averted hospitalization, but may have just prevented PCR positivity (and hospitalization is incidental), and the paper assumes that boosted people seek medical care similarly to non boosted people and that is almost surely wrong. If boosted people are more likely to seek care for trivial (non covid colds, or even entirely nebulous ARI sx) then it could skew the entire analysis in the absence of a beneficial effect of boosting.

All you can truly conclude from this paper is no one wants the booster, and boosters do not stop COVID19.

Finally, the FDA would NEVER use these data to grant marketing authorization.

PS study authors include Pfizer.

Finally, Califf is totally wrong here. The unvax’d group has high natural immunity. The paper cannot show primary vaccination DOES NOT HELP. This is a childish error.

Bob Califf is debasing the office of FDA commissioner. He is promoting low quality evidence that the FDA has not vetted. He is acting like a Pfizer spokesperson and not a respected academic and scholar.

Its important to document this decline.