Oct 5, 2022 • 9M

Approving Vaccines Under Pressure (Part 1)

The latest ACIP meeting had the CDC presenting an unflattering view of vaccines as they make the case that the bivalent booster is deeply needed

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Whenever there is a new vaccine approval, I try my best to watch the CDC’s ACIP meeting surrounding that approval. The latest presentation was on September 1st and concerned the approval of Moderna and Pfizer’s latest COVID vaccine. This latest vaccine is a bivalent vaccine, which means half the dose of the vaccine targets the mRNA sequences of the “ancestral virus” (the virus from March 2020) and half the dose incorporates the Omicron BA.4/BA.5 mRNA sequences.

Meeting Materials

ACIP Videos for Sept 1st meeting

Notes on the meeting (Google Doc)

In order to understand many of the presentations in this meeting, you have to start with the understanding that all the presentations were designed to steer the participants towards making the following recommendation, the wording of which was very precise:

A single booster dose of the bivalent Pfizer / Moderna COVID-19 vaccine is recommended for individuals ages 12 years and older for Pfizer (18 years and older for Moderna) and at least 2 months after receipt of a primary series or prior monovalent booster dose, under the EUA issued by the FDA.

The data presented was designed to drive the ACIP participants towards this recommendation but, in doing so, painted an incredibly unflattering picture of the efficacy of the existing vaccine options.

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Startling Results From Unpublished Data

I don’t think I’ve ever seen a CDC presentation work so hard to convince me of the poor efficacy of the existing vaccine regimen. In their efforts to argue for the necessity of the new vaccine booster, they presented chart after chart of preliminary unpublished data the CDC had collected, and it demonstrated an incredibly weak case for the existing vaccines.

For example, while presenting the argument for the importance of a second booster, they showed a chart demonstrating that there was no efficacy difference between a completed 2-dose vaccination and a vaccine + booster.

This startled me; I don’t think I’ve ever seen anyone from the CDC present evidence that the first booster dose wasn’t effective. They followed this up with a chart that shows that vaccine efficacy starts lower than we anticipated (85%-50% effective rather than 95%) and dwindles down to about 0% effective within 5 months.

This isn’t just about symptomatic infection, the efficacy rates for keeping kids out of the emergency room during the Omicron wave were simply atrocious, so bad that you could really only consider these vaccines effective in children within 2 months of their latest dose.

The data was slightly better for adults but even vaccinated + 2 boosters had barely 60% efficacy against hospitalizations.

Furthermore, while making the case in favor of updated and recent boosters, the CDC made the rather astonishing case that a previous COVID infection was, in fact, substantially more protective than the vaccine in the long term. In fact, when looking at individuals who had natural immunity through a previous infection, the primary series of both the Moderna and Pfizer COVID vaccine did not appear to make any long-term difference in the prevention of symptomatic COVID among those with a previous infection.

This presentation was meant to promote the importance of booster doses, but I just sat there with my jaw down. I knew that previous infection was protective, but I had not yet seen this data, presented with the blessing of the CDC, demonstrating that previous infection was actually far superior long-term protection than the vaccine alone.

Furthermore (as I mentioned when I first started reviewing this meeting), the rates of a serious adverse reaction (myocarditis in teenage boys and young men) are much higher than was previously reported. The main data that was shown was from US reporting but it was reinforced with data from Canada, which showed similarly high rates of vaccine-induced myocarditis in young men.

The intended takeaway from all this was meant to be that we need the ACIP group to recommend the latest vaccine because the existing vaccine regimen leaves individuals woefully unprotected. But the result was that they made a very strong case that, despite what we have previously seen and despite what we have previously been told, the existing vaccine leaves individuals woefully unprotected.

I don’t think the situation is actually as bad as what we see in these charts. Especially as so many people have had a COVID infection, we can hope that the more protective natural immunity will provide the long-term protection that we apparently do not get from the vaccines. But this flies so directly in the face of what we have been told and what I’ve said about the vaccines based on the data I’ve seen from the vaccine reports and from the CDC. I’m not sure we can so drastically alter the expectations around vaccine efficacy without calling into question the certainty with which they were promoted as the ultimate solution to the pandemic.

I originally intended this to be a single piece on the ACIP presentation, with the first part about the startling data that was presented and the second part about the manipulative and misleading tactics used by the FDA against the ACIP members. I’m realizing now that that second part is so important and so startling that it requires its own piece so as not to fatigue you, my dear readers.

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