Pfizer Process 2: Vax in trials vs vax in public vials
Podcast show notes w references from our discussion w/Retsef Levi & Joshua Guetzkow
It was such an honor to showcase the findings and intelligence of Drs. Retsef Levi and Joshua Guetzkow on Christine’s and my show, Sensibly Curious about Vaccines.
Now that the YouTube views are at 107k view (or as I like to say 0.107 mill!) it’s time for some serious show notes. (I finally got cred from my 12 year old for this many views… of course all thanks to the guests, Christine & the topic; it was my 1st time being the official host and there’s lots of room for improvement)
Shownotes
Intros
Retsef Levi, PhD is from Israel and studies mathematics at Tel Aviv University, spent 12 years in the Israeli Defense Forces, went to Cornell for a PhD in Research Operations, is full Professor and runs a lab at MIT in the School of Management. Tracy & Retsef met at the Academy for Science & Academic Freedom conference in D.C in 2022.
Josh Guetzkow is from California, went to Berkeley and studied Sociology and obtained his PhD in Sociology from Princeton. He then went to Harvard for post-doc worked with Nikolas Christakis. He is currently an Associate Professor at Hebrew University in Tel Aviv. Tracy & Josh connected over X. It’s a wonderful platform for research collaboration!
Retsef and Josh’s letter to BMJ about Process 2 vs process 1. “Evidence from existing research and trial documents highlights the importance of publicly disclosing the analysis comparing reactogenicity and safety of process 1 and 2 batches as specified in the trial protocol, and more generally patient-level batch and lot data from the trial.”
mRNA cardiac side adverse events
Retsef’s team’s publication in Scientific Reports finding a 25% increase cardiac & cardiac arrest emergency calls in Israel following the Pfizer vaccine rollout.
Korean myocarditis and sudden cardiac death study with autopsies; 21 total deaths, 8 SCS with autopsy proven myocarditis post-vaccination. UK self-controlled case series study.
My team’s pre-print publication (now published in EJCI) from August of 2021 on post-vaccination myocarditis in adolescents released while the CDC provided vast underestimates of how common it was and insisted both doses had benefits that outweighed the risks in all circumstances. We found the harms of dose 2 to outweigh the potential benefits over 120 days in non high risk adolescent males when adjusting for incidental hospitalizations and this was pre-omicron and assuming no natural immunity.
Process 1 vs 2
Pfizer original clinical trial publication in NEJM. Around 22,000 participants got the vaccine. 252 received process 2.
Outline of who received process 2 vs process 1.
Adverse events in process 1 vs process 2 from the original trial
Process 3 Pfizer was with Tris buffer, which Moderna had used all along. Moderna also used process 2 all along, but were able to remove more of the DNA plasmids and had no SV40 promoter in the DNA according to Kevin McKernan.
If anyone knows for sure what the 150 and 568 in the center of the circles represents please let me know. A friend suggested it may be total # of AEs with some participants reporting multiple.
Josh’s X thread on the process switch.
Josh's substack on CDC’s VAERS safety monitoring of the mRNA Covid vaccines.
The Ontario Preprint by Speicher et al showing plasmid DNA with SV40 promoter-enhancer ori in Pfizer mRNA vaccines. Moderna did not have SV40 promoter. Reporting higher AEs with batch number that had higher DNA plasmid concentrations.
History
Simian Virus (SV)40 was initially in polio vaccine.
Pandemrix vaccine safety & what we knew when by Peter Doshi. The whole article is brilliant, including the part about reassurance from Fauci)
Cutter incident (polio vaccine in Berkeley CA contained live infectious virus). Of note, being a PM&R doc in California, I have personally treated a patient with post-polio syndrome from this vaccine.
Turtles All the Way Down by anonymous, mentioned by Josh.
Postmarketing surveillance
Pfizer’s initial 4,000 person study of their vaccine’s safety in pregnant women only recruited
The study of only 683 women is complete but results haven’t been reported to the public.
Two studies required by FDA upon vaccine approval on subclinical myocarditis where the results have not been reported to the public.
Pfizer
and Moderna.
Pfizer deletes SV40 promoter info from plasmid map given to the EMA. EMA does not double check DNA sequence. Health Canada just did and verify SV40 promoter is in the Pfizer vaccine.
Kevin McKernan explains how he knows Pfizer deleted the SV40 information
Dr. Guetzkow's paper on censorship and suppression of scientists and doctors who raise safety concerns about vaccines.
What did I miss? I will try to add what people note I am missing. I did not go back and listen again so this was just from what I remembered.
Also, let us know who you would like us to invite as our next guest/s. We can cover any topic about any vaccine.
Otherwise
Where do you like to run this time of year? Here is a nice trail up to the Tahoe Rim Trail in Tahoe Vista
& Here’s a great Swedish song “Ett fel närmare rätt” (one mistake closer to correct) by Den Svenska Björnstammen (The Swedish bear clan)
