The powers-that-be do not want for there to ever be an objective threshold of safety applied to vaccine safety monitoring. If such a threshold existed and was communicated to all parties, then people could get in an uproar upon finding a dangerous vaccine that sits beyond the objective threshold of safety.
For this reason, talk of what it is that constitutes a “safe vaccine” has always been opaque. But there is an unspoken-of threshold of safety, and it involves the deliberate move away from DTP vaccines (with whole-cell pertussis in them) to DTaP vaccines with acellular pertussis — and with a lower rate of serious adverse event reports (AERs).
While regulators never say it out loud, their actions speak louder than words:
48 serious adverse events per million is unacceptably high
At the bottom of the second column in from the right-most column is the reporting rate for serious adverse events from DTP vaccine: 4.8 per 100,000 doses (48 per million). But you can watch the progression of reduction in annual reports, along with the not-so-coincidental rise in DTAP reports (as everyone switched their children over).
But if 48 serious AERs per million doses is unacceptably high, then what about Moderna Lot # 030 A 21 A?
The number of serious AERs for this lot was 525, but the lot size was 1.0703 million doses in total (top row):
If every shot made it into someone’s arm, then the reporting rate for serious AERs would be:
But 490.5 per million is over 10x higher than a value (48 per million) found to be unacceptably high. Evidence suggests that this lot was over 10 times worse than an “already-bad” vaccine that had been getting replaced in the 1990s — i.e., because of how unacceptably bad it was.
Reference
[48 serious AERs per million doses is “too much” harm] — Zhou W, Pool V, Iskander JK, English-Bullard R, Ball R, Wise RP, Haber P, Pless RP, Mootrey G, Ellenberg SS, Braun MM, Chen RT. Surveillance for safety after immunization: Vaccine Adverse Event Reporting System (VAERS)--United States, 1991-2001. MMWR Surveill Summ. 2003 Jan 24;52(1):1-24. Erratum in: MMWR Morb Mortal Wkly Rep. 2003 Feb 14;52(06):113. PMID: 12825543. https://www.cdc.gov/mmwr/preview/mmwrhtml/ss5201a1.htm
[VAERS search page showing serious AERs by specific lot numbers of Moderna] — https://medalerts.org/vaersdb/findfield.php?TABLE=ON&GROUP1=VMANLOT&TSORT=down&VAX[]=COVID19&VAX[]=COVID19-2&VAXTYPES=COVID-19&VAXMAN=MODERNA&SERIOUS=ON
[ICAN page with a link to the 17Mb PDF file showing lot sizes] — https://icandecide.org/article/exclusive-moderna-lot-and-dose-data-release/
The risk is offset by the profit potential.
Great article, Deep Dive! What are the overall rates for Pfizer and Moderna in severe adverse events per million?