Friday, September 17, 2021

The Independent Scientific Advisory Committee's Review and Recommendations to the FDA on Pfizer's Third-Shot Booster


Okay, so the independent scientific advisory board to the FDA (comprised of independent infectious-disease experts, pharmacists, and statisticians) voted "NO" (16-2) on recommending a third Pfizer shot for those 16 and older - HOWEVER - unanimously voted "YES" (18-0) to a subpopulation, those ages 65  and older (those most at risk/with lower immune systems).

Keep in mind, the FDA does not have to follow the independent advisory boards recommendations, but they typically do.

However again  - remember that recently, Aduhelm (adalimumab) was a prime example of a time that the FDA did not take the independent advisory panel's recommendations against the drug, and instead approved it - so it's anyone's guess.

Because today was an unusually long, full-day, intense debate, the FDA did not make it's decision, and thus the final vote will be next week. 

See?  Told you the scientific community was split on this one (see below post ;). 

In the end, it came down to whether the panel thought the small study that Pfizer provided proved any additional benefit from a third shot of the exact same formulation of the vaccine.

At the end of the day, it appeared the majority of the committee  wasn't fully convinced by the small study that a third shot provided additional benefit for everyone, except for those 65 or older,  who are most at risk and have the weakest immune systems.

But again, the FDA itself could disagree and still approve it anyway, like they did Aduhelm.

Now - what I'm not sure of is, if the FDA does agree with the independent advisory committee's recommendations, and it's not approved, either partially (for those 65+) or fully (ages 16 and up), whether Pfizer can reapply again, after new data, i.e. a larger population and longer-term studies for durability of response?

Typically not -  but the again, Aduhelm un-stereotypically (and inexplicably) got second and third chances, after producing more data (that still didn't prove much meaningful statistical significance) - so who knows?   

My hope is that Pfizer will perhaps instead focus on answering the question I posed below - which is whether mRNA vaccines will still need additional variant-strain genetic information added to the original formulation, like "live strain" vaccinations, or not - and if so - perhaps reapply after that has been done and studied in clinical trial for efficacy, safety, and durability of response?

Also, I know the Biden administration really wanted that third booster shot - but the evidence just isn't there yet.

The small study Pfizer provided neither proved nor disproved a third shot of the same formulation added any additional benefit - nor did it determine durability of response of the first two, one way or the other.

Now, I'm a die-hard Democrat, and I love Biden, but unlike Trumpers, I don't pretend he's the hand of God and that everything he says and does is a holy edict of God and that he's perfect - no one is.

If we Democrats claim to be the party that "follows the science," then we need to do that - wait for statistically significant evidence, instead of making biased assumptions, yes? 

Otherwise, we're no different than Trumpers - we can speculate and believe something all day, but that doesn't make it fact - we have to prove it ;)

Perhaps then if we just focus on getting the rest of the population vaccinated with the first two shots instead, because we DO have real-world proof of its efficacy against the original SARS-CoV-2 virus, and that it offers at least some protection against variants like the Delta variant, at least when it comes to severe disease.

Now, again - having said all of that - if the FDA goes against the IAC's recommendations and approves the third shot, and it's still offered for free, I would still get it - both because we had no ill effects from the first two, and because we have no proof either way, whether it provides any additional benefit or does nothing more - so why not? 

Interesting stuff, huh?

Well, maybe that's just to me :)

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