Questions for FDA

welcome to today's talk it's wednesday the 25th of august now i don't think i've had as many comments on a video as we did yesterday on the fda's full appro approval of the pfizer vaccine so i want to look into that a little more detail and do a bit of a critique and there are questions i would have for the fda let's just put it as simply as that there's a question i've got so um we'll look at it now now this is i started my thinking off on this looking at this article here from the british medical journal uh published on the 23rd of august so uh bmj opinion so it is opinion but um this is peter dosh i senior editor of the british medical journal now he says this the fda should demand adequate controlled studies with long-term follow-up and make data publicly available before granting full approval to covered 19 vaccines interesting now it seems he's concerned about uh adequate controlled studies long-term follow-up and data almost suggesting here that the data is not all publicly available so is this is is this true and we do find there are some justifications for his concern now i'm being really careful in this video only to say what is i've got evidence for so um just just bear with it there's a bit of a complicated one so this uh this here is the original uh pfizer press release so that that's this one fires a press release obviously all the references are there for you now this is from the first of april 2021 so this is the uh fisa press release on the original efficacy data of the uh their fighter bio end tech vaccine all there in its uh glorious detail if you if you want to read through that so the vaccine basically is highly effective with a 91.3 vaccine efficacy is the suggestion there and bear in mind this is the first of april uh before before delta times in virtually everywhere certainly before adult times in the united states but 91.3 vaccine efficacy against preventing uh infection but the data cut off for that was the 13th of march so this report here is clearly dealing with very early data um date data that uh was cut off on the 13th of march 2021 so pretty early stuff uh immunity measured uh measured seven days through up to six months after the second dose so here we're seeing that the longevity appears to be six months but remember that was published on the first of april and the data cut off was the 13th of march i know this is a bit complicated but stick with it now six monthly safety and efficacy uh vaccine data this is published on the 28th of july now that is this paper here available here in a pre-print form and again it's all there i've downloaded the pdf you can download the pdf there the full detail is actually there on that paper so again i think i'm only telling you what is in the uh in the literature here so that's that study that's the reference ongoing phase three covered 19 vaccine try now bear in mind the press release was the first of april uh there that's the first of april that was the press release and uh this is published on the uh this was published on the 28th of july so um april may june july so you'd expect six seven eight nine ten six seven eight nine ten ten you'd expect ten months follow-up data here wouldn't you which would make sense for this this large this paper ongoing phase 3 covered 19 uh ongoing phase 3 cover 19 vaccine trial good absolutely vaccine effectiveness against covered 19 was 91 so they're still quoting the same efficacy figures here on the 28th of published on the 28th of july as they were published on the first of april but bear in mind that first of april bit was cut off on the on the 13th of march um and then we take a direct quote from this is not from the abstract i've shown you this is from the paper itself the current report provides update efficacy analysis conducted on cases um occurred up to the 13th of march 2021 which of course is the same as the original press release and and strangely enough it's a 91.3 versus a 91 percent efficacy it's basically the same efficacy data so rather strange that that full follow-up paper published on the 28th of july still had a cut-off date way back in march the same as the first of april cut off but that same paper did acknowledge that the efficacy on average declines of uh around about six percent every two months even by that paper standards so you could argue that there's a lack of internal validity there that the uh it's almost contradicting itself but it does appear to become well in my mind it's certainly contradicting the previous press release of the first of april okay so move forward to the 23rd of um 23rd of was it the 23rd this was probably 23rd of august 23rd of august the fda's release now obviously this is a lot more time has passed now so obviously we'd expect um the data to be fully updated as the fda have done this massive full review of just about everything to give it full approval so let's see what the latest data is so that is from this here fda full approval that's the link based on results from clinical trials the vaccine was oh oh 91 effectiveness preventing covered 19 disease oh dear so we see that the data here apparently doesn't appear to have been updated from the 13th of march despite this full approval granted by the fda on the 23rd so i wonder i don't know i don't want to put words into um i don't want to put words into uh peter d'shai's mouth but maybe that's what he was concerned about that the should be uh adequate and uh data publicly available before granting full approval maybe this is part of his uh concern so uh that is interesting and again i'm just trying to go completely off what is actually said here in the literature i'm not giving you an opinion this is this is just what this report says this is the fda full approval here and that that's it and there we see it there we see it there based on the results of the clinical child the vaccine was a 91 effective at preventing disease and that sentence was published on the 23rd of august by the fda as their fda approval press release let me give you my opinion here sloppy at best fda sloppy at best so question to the fda here what's the latest figure what is the latest efficacy figure second question why wasn't the latest efficacy figure published on your press release granting uh giving the information about full approval on the 23rd of august now there's other other aspects of this we could have looked at but you know you can only look at one one we're just looking at one thing so we'd get it right let's get this detail correct so 91 efficiency we see from the press release from the paper and apparently reinforced by the fda on the 23rd of august come on come on fda simply in my view fda not good enough but let's go back to last week in the paper we reported on here by the cdc published 18th of august so that's what 18 19 20 21 22 23. five days before the fda published that uh questionable sentence we looked at this at the time in great detail of course um new york data from memory it was about 10 and a half million people in this study knew what new york data protection against infection 25th of july 25th of july in the united states in the new york area 97.8 97.8 but we look at the uh august the 23rd press release from the uh fda and we see their sentence says 91 efficacy so to me 91 efficacy there and uh 79.8 percent efficiency then in fact that there it is let me just show you the whole thing so you know i'm not making this up there's the whole thing there that is that uh paper of the 18th of august yeah here we see it in this paper here um the the overall age adjusted vaccine effectiveness and against new covered 19 cases for all adults to climb from 91.7 to 79.8 during this time period so uh read the full thing for yourself now we have to balance this um because we're talking about protection against infection here now this same study this um uh that one from the cdc that did point out this um so age-adjusted effectiveness against hospitalization was maintained so that that they said that range from 91.9 to 95.3 so this is not talking about protection against hospitalization it's talking about protection against infection direct quotes during may the 3rd to july the 25th 2021 the overall age-adjusted vaccine effectiveness against new covenant 19 cases for all adults declined from 91 to 79.8 so that's clear but during the same period the overall age effectiveness against hospitalizations was relatively stable 91 to 95.3 so direct quotes in case i've misinterpreted something so um that is pretty clear really i think now moving on to more up-to-date data provided by israel um so israeli data here now this is a reuters report vaccine effectiveness in preventing both infections and symptomatic disease fell to 64 since the 6th of june and of course in israel they are now starting to give a lot of third doses so israeli data 64 there and if we just remind ourselves of what the uh the fda approval report said published on the 23rd of august um yep 91 effectiveness okay i mean that this really is it really is a bit sloppy isn't it i mean israel says fires are covered 19 vaccine is just 39 effective as delta spreads but it still prevents severe illness so still preventing severe illness we need we need vaccination but uh it'd be good to have accurate data and that data is from the 20th of june to the 17th of july so um interesting statement from uh peter d'shai there we need a bit more data and we need full public transparency and to be quite honest i expect fda press releases to be up to date i would expect that now the reason people are concerned about this is justified because let me just give you some information as i understand it now i got this i started off again from the british medical journal here uh and uh did check the references now this paper here is published by fierce farmer um you can read it for yourself i've put the link there i've no reason to assume it's uh inaccurate but i can't actually validate its validity um either but the reason that we're a lot of people are concerned is is this that the data from here that's from the so the bmj is quoting this source and that is the that is the source here the uh fierce farmer is the source of this information um the company now predicts 2021 sales of 33.5 billion dollars i mean we're dealing with money that's off the scale here pfizer and bioentech now expect to deliver 2.1 billion doses of uh co i haven't learned to say this word yet commonality that's the new pfizer biointent vaccine how it's being marketed worldwide this year and manufacture three billion wow and we believe according to this article this article actually tells us that the average price is uh about 15 or this or another article in that series um now i i have no way of authenticating this i don't know but that's what that source says uh 2022 production capacity at 4 billion so to sell 4 billion doses you don't need me to tell you that's like over 60 billion dollars so um you can see why some people might be a little bit uh cynical about about this now um what do i think well i'd like to ask the fda those questions why was the press release out of date um it seems clear though that the the data is saying that the vaccine protects us against good levels of protection against hospitalization and death but it also seems clear now that infection protection against infection alone is waning and that press release from the fda doesn't really seem to communicate that clearly to my mind now different people in different parts of the world are looking at this of course i'm only one guy looking at one aspect that's all we can do but um those questions for the fda remain why was your information apparently out of date on your press release of the 23rd of august what is the new uh what is the new um the new figures and when will we be able to see these new figures thank you i'm toast thank you thank you very much for watching

Channel: Dr. John Campbell

Views: 382,618

Keywords: physiology, nursing, NCLEX, health, disease, biology, medicine, nurse education, medical education, pathophysiology, campbell, human biology, human body

Id: WOtvpk9rZLs

Length: 15min 18sec (918 seconds)

Published: Wed Aug 25 2021