The most recent Emergency Use Authorizations from the US FDA are a joke. Not that that’s a significant deviation from how they have been doing them for the past three years. But at least for the first ones they looked at some data and “supervised” trials.
Here are two doozies. First, the EUA for the fourth dose. You can read the original EUA here if you like. No need though. All it says is that based on waning efficacy of the first booster and experience in Israel suggsting a “potential survival benefit of a fourth (second booster) vaccine dose administered to individuals between 60 and 100 years of age“.
Drinking red wine has a potential survival benefit. So does eating smoked cheese. Imagine the government handing out free wine and cheese based on this nonsense. At least the take up rate would be higher.
And then this board of eminent scholars decided that, despite not doing any safety studies (and ignoring the numbers rolling in through VAERs), nor bothering to see if the booster works with other vaccines, it would take the weasel route and simply extrapolate their previous work:
… based upon the accumulated experience with primary series and first booster doses… it is also reasonable to extrapolate experience with a second booster dose in individuals ages 60 years and older (and more limited experience among individuals ages 18-59 years of age) to conclude a favorable benefit-risk balance for use of the Pfizer-BioNTech COVID-19 Vaccine as a second booster dose, regardless of the authorized or approved vaccine(s) used for primary vaccination and first booster doses, in adults ages 50-59 years (a group in which the risk of medical comorbidities is elevated compared to adults ages 18-49 years) and in individuals ages 12-49 years with certain kinds of immunocompromise (a group in which the risk of serious outcomes of COVID-19 is elevated compared to the general population).
Therefore, a recommendation is made for the authorization of a second booster dose
Source: FDA Review Memorandum
If I’d been able to get away this rubbish in university, I could have finished my engineering degree in six months. There would also be a lot fewer cars on the road.
The second one is actually worse. While the above EUA simply bypassed any trials or efficacy results, the most recent EUA (for infants up to 5 years) incorporates the data and then totally ignores it.
Here’s a fun chart:
Let me break this down for you:
After the second dose (you know, the original regime), 85/1002 vaccinated bubs got Covid, while 53/517 unvaxed bubs got covid in the same time frame. Normaliing this, you get 85 per thousand for vaxxed vs 103 per thousand unvaxxed.
So, potentially, the vaccine could have an efficacy (as defined by Pfizer) of 18/103 = 17.4%.
Given the small sample size, the 95% confidence interval goes negative, which means this study shows nothing. Most laughable is the implied 75.5% efficacy >7 days after Dose 3 based on 3 postive tests. That’s the statistical equivalent of using a different toothpaste for two days and noticing the stockmarket went up. It’s a ridiculous outcome that would’t pass the scientific rigor of kindergarten.
Therefore, the FDA granted emergency use authorization.
And while we do like to suggest the US FDA is deep in the pocket of Big Pharma, it’s hard not to notice that in Australia, Canada, and nearly every other country, the national drug safety and authorization boards simply rubber stamp whatever the FDA hands out. They are no better.
Except in India, where they told Pfizer they’ll have to do a local study to replicate the “results” of the US studies. Then they would be able to sell a billion vaccines. Pfizer turned down the offer. I wonder why?
Peter.
