Tuesday, November 10, 2020

My Preliminary Thoughts/Questions on Pfizer's Vaccine ...


If you want to read about the new vaccine, read here at clinicaltrials.gov.

Note that the published results at the above site are phase 1 trial results only - and they are now in phase 2.

Thus, the researchers haven't formally published the "90%" number that everyone is talking about, because that is a phase 2/3 result that has just been independently reviewed and confirmed, but the results have not been finalized.  

(And by "everyone," I mean press releases by Pfizer and both medical and general press, after independent review panels confirmed 90% preliminary efficacy results from the phase 2 trial.)

The good news is, the confirmed phase 2 preliminary trial result of of  90% efficacy truly is a fantastic number.

HOWEVER - it's not just about the blanket-generalized term of  "efficacy" - we still have questions. 

Thus, here are my questions/concerns after reading the study, just off the top of my head - and I'm sure there will be more, when I have more time to think about it ...

Safety and tolerability are equally important - and we need to see that full data.  

How many severe adverse events,  and what kind?  

Are we talking anaphylactic shock or acute renal failure that can be treated or-?  

As for other less severe side effects; again, how many and what kind?   

The first primary outcome mentioned was injection-site reactions, which is typical for vaccines, nothing to worry about.

However, fevers were reported as the second primary outcome - so how high and how long?  

Lab and hematology abnormalities were listed as second, third, and fourth primary outcomes - what does that mean exactly, and how many?

And there are two shots - so did anyone at all have a degree of reaction, after the first injection, such that they declined the 2nd injection, and thus discontinued the series?  

If so, what happened when they didn't get that second injection?

Regardless, even if the safety profile is good - the truth is, we will not know the long-term safety effects for months, possibly even years - that is something we cannot possibly measure until time passes.

Also, note that the though the age ranges were broad, which is always a good thing - the list of exclusion criteria in phase 1 was fairly extensive, the list of people excluded from the study was super long - the title of the study even includes "in healthy adults."   

However again - the study does make a point to highlight the fact that this exclusion criteria is for phase 1 only, seeming to indicate that phase 2 and 3 did include some of these originally excluded patients?

Okay, well what previously excluded patients are now included, and which ones aren't?

So what does the new inclusion criteria for phase 2 include?

People with underlying conditions such as asthma, immunocompromised people, people with HIV, smokers, hypertension, cardiovascular disease, pulmonary disease, renal or hepatic disease, and did those things make an impact on efficacy?

Also, we need to know the range of COVID-19 that the vaccine is able to prevent - mild phenotype, severe phenotype?  

And for that 10% that did get COVID - was it mild, severe? 

And were there any common denominators in that 10%?  Any subpopulations in whom that made the difference? 

See that Trumpers?  That's called critical thinking - something you're apparently either incapable of or forgotten how to do - watch and learn lol.

Bottom line is, although the efficacy appears to be great - we still need to see the actual data from phase 2 and 3 - particularly safety and tolerability, the range of disease it was able to prevent,  and any common denominators found in that 10% that caught it, what subpopulations they were, if any parallels can be drawn.

As I've said from the beginning, a vaccine is our best hope - HOWEVER - I also said first doesn't always mean best or safest - particularly when there's a big-pharma corporate race for the cure, fueled by politics ;)

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