Safe & Effective #4: How Pfizer Does "Science"
The "science" backing covid vaccines for kids under 5 is non-existent. Here is the breakdown of their own documents
I wrote this letter to friends and family of young kids, in light of the recent FDA and CDC decision to authorize these vaccines for kids under 5. Despite opportunities to editorialize more, I tried to keep it simply to the facts of the case.
Hi Friends, Family,
I wanted to write a quick (just kidding - you know I never write quick notes) note to friends and family with small children. As you may know, the CDC and FDA just approved the Covid vaccines for kids age 6 months to 5 years. I am writing to you to warn you about the lack of efficacy and the potential dangers that come with this.
Whatever your perspective, all I ask is that you take a look at what I'll share here. Obviously, the decision is yours and yours alone as to what you do. And call me old-fashioned, but I actually do believe that private medical decisions should be private. I don't really want to know if you end up getting your kid(s) the Covid vaccine because it is none of my business at the end of the day.
That said, I feel obligated to write to you because I care about you, and there is critical information that is being systemically attacked by the government, the public health establishment, the media, and large tech companies. This isn't a conspiracy so much as it is an emergent characteristic of a "hyper-internetized" world: politics is everywhere and politics desires a simplicity which must crowd out nuance aggressively for it to persist.
But my goal is to make you aware of that information. What you do with that, again, is up to you. But I do view it as my obligation as a friend/family member to share the evidence out there with you. I've tried to keep this as fact-based as possible in order to do this in a fair way. Almost everything covered here comes directly from Pfizer's own report to the FDA.
First - data sources - here is the risk benefit assessment from Pfizer itself submitted to the FDA: https://www.fda.gov/media/159195/download (66 pages). To the extent that you have time (you probably don't since you have young kids at home!) you should read through it yourself.
The best summary I've seen so far of this comes from Toby Rogers:
Like me, he is critical of these Covid vaccines more generally. But I've also looked at the original source and his summary is an accurate representation of the document, even if he does a bit more editorializing than I will do here. Make of that what you will, but his article assesses the raw data as filed by Pfizer to the FDA.
Again, I'd encourage you to take a look at both, but I'll try to give a quick summary:
The study was severely underpowered from the start to get at efficacy, because Covid is such a non-factor for kids. They focus on the fact that it creates S-antibodies, which is not necessary nor sufficient to prove efficacy. Even there, they limit the dataset down to ~5-10% of the total study participants for an unclear reason, and compare it to older populations from past clinical trials during outbreaks of different strands of the virus. This, bluntly, is scientific malpractice on a number of levels.
Pfizer's final efficacy number they report is 82% - but this is based just on 10 cases: 3 in the vaccine group and 7 in the placebo group that occurred after the third shot. However, this ignores negative efficacy between dose 1 and dose 2. If you include the full timeframe, it's ~30% effective, allegedly, against infection (data on page 39 of Pfizer's report).
The 95% confidence intervals on these estimates are incredibly wide. The 82% that Pfizer claims for 2-5 year-olds has an error bar from -8% to 98%, and for 6 mo. to 2 year-olds the 95% confidence interval goes from -370% to 99.6%. Put simply: these studies are too underpowered to make any substantive claims about efficacy.
Why don't they use severe covid, hospitalizations, or deaths? Perhaps it is due to this line on page 56 of Pfizer's report: "From Dose 1 through the data cutoff, 1 placebo recipient 6-23 months of age and 7 participants 2-4 years of age (6 BNT162b2 recipients and 1 placebo recipient) met the criteria for severe COVID-19, with only one hospitalization for severe COVID-19 disease in a BNT162b2 recipient 99 days post-Dose 2"
That's right: from the start of the trial to the end, there were 6 severe cases of Covid in the vaccinated group and only 2 in the placebo group. Now, the test group was ~twice as large as the placebo group, but this is still an adverse signal: 0.2% rate of severe covid in the vaccinated group, higher than the 0.13% rate in the placebo group.
As far as adverse events, the Pfizer data is suspicious in that it finds a higher adverse event rate in the placebo group as compared to the vaccinated group. These rates still seem quite high in both cases. This data is found on page 42 of Pfizer's report:
6 month to 2 years old: Vaccinated group: 1.4% serious adverse event (SAE) rate, Placebo group: 2.3%
2 years to 4 years old: Vaccinated group: 0.7% SAE rate, placebo group: 0.9%
If we just look at those who withdrew due to adverse events, it was 0.2% of vaccine participants (6 of ~3,000) vs. 0.07% of the placebo group (1 of ~1,500). Data again from page 42 of Pfizer's report.
Placing aside skepticism around a 1-2% serious adverse event rate from a placebo, it's still pretty clear that there is some non-zero risk of severe adverse events. If we use the withdrawal rate difference 0.2% vs. 0.07%, you are still adding a little over a 1-in-1,000 chance of a bad event (0.2%-0.07% = 1 in 770). That delta is larger than the risk of a severe case of covid, and as we noted above, there is no evidence here that the vaccine does reduce the chance of a severe case of covid.
If we take the 1 in 770 number, is your kid likely to be fine? Yes, most likely. But 1 in 770 also isn't a risk that any of us would take casually even if there was a big potential benefit, which there's not.
Lastly, let me just point out 3 main things that aren't explicitly following from the Pfizer data itself:
The vaccine is based on a now-extinct branch of the virus (Wuhan strand), it makes sense that it won't be effective with the newer, milder, strands (Omicron/BA.X strands) we have now and runs the risk of mis-training an immune system.
We should raise the question of how well did this study look at heart-related adverse events (like myocarditis and pericarditis) when dealing with kids who wouldn't even have a way to vocalize that their heart feels strange.
Lastly, though we're talking about Pfizer, it's probably still better than Moderna which many countries (e.g. Sweden, Germany, France, Denmark, and Norway) have suspended for those under 30 due to the heart-related risks and still comes in a more concentrated dose than Pfizer. If you do feel a need to get a Covid Vax, Pfizer is probably safer than Moderna.
I could go on, but I wanted to keep this fairly focused on what to do for young kids. I have been writing (and will write more) on the overall "safe and effective" topic on my Substack:
That said, I am also happy to answer any questions you want to send me as honestly as possible.
Wishing you all the best,
Ben
P.S. Please feel free to share with other parents, your doctor, or anyone else as well, as you feel comfortable. I've tried to keep this as factual as possible so that it can be hopefully separated from the emotional/political aspects of this topic.