Monday, May 30, 2022

What is the FDA planning for more vaccine authorizations in June? Toby Rogers explains

FDA announces updated schedule for the June meetings regarding five pivotal vaccine decisions

Who needs data when you've got regulatory capture?

I. The June FDA meetings

This week the Washington Post copied and pasted from a Pfizer press release to announce yet another scientific miracle(TM) that will completely fail in practice. In the process WaPo also got some quotes from the FDA who have now nailed down the schedule for the 4 meetings in June in which they intend to assemble the final pieces for Pharma’s permanent dominance over the American people.

The new schedule is as follows:

June 7, Novavax 
June 14, Moderna in kids 6 to 17 years old
June 15, Moderna in kids 6 months to 5 years AND Pfizer in kids 6 months to 4 years
June 28, “Future Framework” (the plan to skip clinical trials in perpetuity)

There is a lot to parse in the WaPo’s brief article.

Contrary to the breathless headline, they still don’t have any data. 

Pfizer and BioNTech said the 80 percent efficacy finding was preliminary and based on 10 cases of Covid-19 in the study population as of the end of April. Once 21 cases have occurred, the companies will conduct a more formal analysis of efficacy... Pfizer and BioNTech said they plan to finish filing data with the FDA this week — and warned that the efficacy number was fluid because results are still arriving.

Let’s recap how we got here:

🚩 The Pfizer clinical trial in kids under 5 failed in December 2021.

🚩 So Pfizer added a third dose and that trial also apparently failed in February (which is why Pfizer was forced to withdraw its application on February 10).

🚩 Now Pfizer is describing a jerry-rigged trial of a third dose in 1,678 kids ages 6 months to four years old. Pfizer did not disclose how the kids were divided between the treatment and control group so it is impossible to run our own calculations on efficacy. Out of that sample, 10 developed Covid — although it is not clear how the 10 were distributed between the treatment and control group. (I suppose some quant on Twitter will figure out how to work backwards from Pfizer’s claims to calculate the numbers in each of these categories but needless to say, this is not the proper way to do science.) Of course Pfizer also failed to describe the contents of the “placebo.”

As always with “publication by press release” the announcement raised more questions than answers:

• “the efficacy finding was preliminary”; just 10 cases; “the companies will conduct a more formal analysis” next month; “the efficacy number was fluid because results are still arriving” — so you’re saying that these numbers are NOT statistically significant and in fact you have no valid “results” at all? Got it.

• How exactly will Pfizer double the number of Covid-19 cases in the clinical trial in the next month given that 74.2% of kids already had natural immunity in February which means that nearly 100% of children likely have natural immunity by now?

• Also, is the FDA seriously considering basing national policy, that impacts 18 million children, by relying on a study with only 10 cases? It appears that the FDA is not even pretending to care about science anymore.

What’s perhaps most troubling about this so-called clinical trial is that Pfizer is NOT looking at health outcomes in the real world (because there are none). Instead, all of their claims are based on antibodies in the blood. That’s strange because the members of the FDA’s Vaccines and Related Biological Products Advisory Committee unanimously acknowledged on April 6 that there are “no correlates of protection” in connection with Covid-19 shots (this means that there are no valid proxy measures, such as antibody counts, that can determine whether someone who has received this shot is immune to the virus or not.)

WaPo dutifully copied Pfizer’s disingenuous description:

While the adult trials recruited tens of thousands of volunteers and waited to see if vaccinated people were better protected, the children’s vaccine trials were primarily designed to measure immune responses using blood tests

No they were not “primarily designed to measure immune responses using blood tests.” The studies were intentionally undersized to hide harms from the shots in addition to other tricks that they use to skew the results (such as kicking you out of the trial if you call 911 or go to the emergency room). But when one shrinks the sample size, surprise! it becomes impossible to detect actual health benefits from the shots (the signal would have been tiny if at all, but when one uses a sample that small then any positive signal can also disappear into statistical insignificance.)...

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