Saturday, December 19, 2020

About These mRNA Vaccines: You See, What Happened Wuz.....,

nakedcapitalism |  Earlier this week, we posted An Internal Medicine Doctor and His Peers Read the Pfizer Vaccine Study and See Red Flags [Updated]. Most readers responded very positively to the write-up by IM Doc, which included the reactions of the eight other members of his Journal Club who reviewed the article and its editorial, as they have done regularly with important medical journal articles. We have embedded the Pfizer article from the New England Journal of Medicine (NEJM) below; the link to the editorial is here.

However, some took issue with IM Doc noting that two nurses in the UK had suffered anaphylaxis, a severe, potentially life threatening allergic reaction, after getting the Pfizer shot. IM Doc criticized the paper and editorial for not including or adding a discussion of any exclusion criteria, particularly since Pfizer’s proxies admitted that severe allergies were an exclusion criterion. From MedicalXpress:

Moncef Slaoui, who is the chief advisor to the US program for COVID vaccine and treatment development, told reporters, “Looking into the data, patients or subjects with severe allergic reaction history have been excluded from the clinical trial.

“I assume—because the FDA will make those decisions—that tomorrow this will be part of the consideration, and as in the UK, the expectation would be that subjects with known severe reactions, (will be asked) to not take the vaccine, until we understand exactly what happened here.”

Slaoui is the co-head of Operation Warp Speed and previously head of GlaxoSmithKline’s vaccine department. Other media outlets and professional medical writers (see here and here for examples) picked up his statement that subjects with severe allergic reactions were excluded.

If you look at the article below, you will see that it is not searchable. That indicates an expectation that it would be read as a print out only. You will find it make no mention of “exclusion criteria”. Neither does the the separate editorial by NEJM editors. The article does does mention “protocols” in the text, twice, but does not have a link to where to find them, does not have a written URL, nor does it provide a name or location to assist in finding them.

Some critics argued that the protocol (which you need to search through to find the selection process for candidates, including the exclusion criteria, for the Phase III trials) could “easily” be found in the Supplemental Materials and further asserted that any regular reader of medical papers would be able to find then. The fact that IM Doc, who has been reading medical papers for 30 years, and his eight colleagues did not locate them is already significant counter-evidence, particularly since the NEJM’s media kit lists the publication’s audience solely as physicians. No doubt scientists read it too, but the eyeballs advertisers really want to reach are doctors, academics or scientists in the employ of competitors.