COVID-19 Vaccines by Lot Number: Product Consistency and Safety Standards

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Explore the importance of product consistency in COVID-19 vaccines by lot number, the FDA's Good Manufacturing Practices, and VAERS data on adverse events. Learn why excessive lot-to-lot variability is concerning and how regulations ensure quality and safety in vaccine production.

  • COVID-19 vaccines
  • Product consistency
  • FDA regulations
  • Vaccine safety
  • Lot numbers

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  1. COVID 19 Vaccines by Lot Number Do all lots contain the same product? Excessive lot-to-lot variability is highly unusual and must be investigated. 1

  2. About the Authors Team Enigma We are a group of independent researchers with experience in: Pharmaceutical R&D and manufacturing Clinical trials Pharma industry regulations Data analyses and modeling Statistics Located worldwide, conducting independent analyses of the same data Financially and politically independent We are not afraid to think for ourselves and speak up 2

  3. Why does this matter? All drugs are poisons, it is a matter of dosing, application and risk/benefit: Warfarin (blood thinner) its other application is rat poison Chemotherapy agents for cancer are highly toxic Mass produced food, beverages, vitamins, supplements, homeopathic products, etc: If you drank a can of beer from your favorite brand and the result was 300% different from previous time, would you drink that beer again? That s why product consistency matters! 3

  4. FDA Good Manufacturing Practices (GMP): 21CFR210.1 High quality, consistency and purity standards for drugs/vaccines: Expectation that every new lot/batch is almost the same as all previous lots Expectation that vaccines from different manufacturers for a disease indication are the same or interchangeable product Current FDA GMP regulations were developed after several adulterated or poorly tested products poisoned and killed 100s of people (early 1900 s to 1960 s) The failure to comply shall render such drug to be adulterated shall be subject to regulatory action . 4

  5. VAERS Data: Covid 19 mRNA Vaccines vs Seasonal Flu Vaccines Seasonal Flu Vaccines Covid 19 mRNA Vaccines 9 injectable products 3 injectable products 10+ manufacturers 3 manufacturers (Pfizer, Moderna, Janssen) 10+ years of data <12 months of data 22,334 manufacturing lots* 24,945 manufacturing lots* 9,429 Serious Adverse Events** 47,239 Serious Adverse Events** 906 deaths** 7,335 deaths** *Unvalidated i.e. lots that are present in VAERS database, not complete list, contains typos. This does not matter when comparing two datasets that have the same error-prone data. **Numbers of events reported to VAERS in each category 5

  6. Flu Vaccines: Consistent product across many manufacturers, lots, years, only 2 outliers Serious Adverse Event per Lot* Sorted Alphabetically 40 35 Range= 1-37 reports per lot 30 25 20 15 10 5 0 T58906 U0594AA U1075AA U214AB U2445AA U2765AA U3203AA U3599AA U1431AC U4906AC No Idea QFAA1703 11175P1 U1765FA 111 9BK4X 0127P 1341P 3B544 881292P J97D2 UT7330MA 79897 145404 195235 279794 765412 985890 1412401 4018038 4928230 4958091 4988216 49281039365 07049211A 599BA 70461-0320-03 U4481B UH907ZA AFLLA178AA AFLLA726AB 47G53 AFLUA715BA E59240GA UT2786GA UT4176AA u5595ca UH439AA UH716AC uj005af E06741LA UT5897LA XT59706 2497AA UI422AB UI544AA UI826AB UJ290AB UJ747AB AFLUA451AA 6 *Includes lots with non-zero SAE Reports only, N= 5,797 Lot Numbers

  7. Covid Vaccines: Does this look like the same consistent product by manufacturer and by lot? SAE Reports per Lot* Number Sorted Alphabetically 700 Pfizer Lots 600 Range= 1-622 reports per lot 500 400 Moderna Lots Janssen Lots 300 Flu vax outliers below this line (37) 200 100 0 010M20QA 030L020A 043L20A E40580 fc3182 EI9266 EM9801 El9267 WAGLY539 002B21B 019B12A 0292Lzoa 051EZIA N/A - was not a O24CZIA 10 8735 105020 939903 1821286 47192119 025J20 026m20A D42B21A Ewo217 FF3389 J4J PFIZEREN6208 006 M20A 012220A 016720A 032020A 042421A 06C21A 2021421A EN201 EN6201 EN8731 PD8448 651-483-5461 013L20A & 031M2 038CZ1A 211D21A 310M20A EL1284 (1st on EL5269 ev0151 FR8732 c039b21a 007N20A 022N20A 036A20A 03ZM20A 0472A1A EP6957 #EN6203 ER2370 EW0156 EW0196 EW6205 ER8731, EW0167 TT lot FC3182. 110-20-026L20A EK9231 and EL 9 Lot#013M20A, Lo *Includes lots with non-zero SAE Reports only, N= 4,122 Lot Numbers 7

  8. The unusual pattern persists even after removing typos in lot numbers Severe Adverse Event Reports per Lot Number* Sorted Alphabetically 6000 Range= 1-5130 reports per lot Moderna Lots 5000 Pfizer Lots 4000 3000 Janssen Lots Flu vax outliers below this line (37) 2000 1000 0 E18962 FM9309 029L2CA EK0142 EM0150 ENS208 01ZLZ0A 025LZ0A 04ZAZ1A EZ3247 061E21A 001B21A 040B214 33026BD 20215 316204 1802068 1821287 031620A 038KWA 042620A 04421A FF2590 009C21B 036C21A PZIFER 006M204 012M20A 016M21A 027D21A 101M20A ERE733 GW0196 023M0A EL0410 EL3302 EL9226 EN0208 EN6148 EN7539 A03468 003B2VA EE0181 ER0150 ER8233 EW0151 EW0196 EW2613 VW0107 CW01E6 011A4N 014F12A 032F214 0472A1A 085A21A 204A2A 22A21A FC3281 *Includes lots with non-zero SAE Reports, after cleaning typos N= 2,244 8

  9. and for Death Reports DEATH Reports per Lot* Number Sorted Alphabetically 160 Pfizer Lots 140 Range= 0 -142 reports per lot 120 Moderna Lots 100 80 Janssen Lots 60 40 20 0 039L20A 302L20A CV0224 E13247 FD8444 031L0A 211AZ1A EC9266 EJ3616 EM0150 011J20A 020R21A 201B21A ZR8733 20215 390096 1802072 1822811 007821A 013620A 017BZ1A 025220A 030020A EN0217 EN6193 EN8201 FF8841 026C21A 049C1A 054C21A 072C21A 001CZ1A 00M2017 014M30A LL3302 EL0142 EL3294 EL92106 ES1686 F197485 FW0153 043A210 0N120A 7A7485 EP10955 SC3182 028BQ1A ER0727 ER8713 EW0162 EW0250 EW6207 003F21A 033F21A 037F21A 041AZIA 045AZIA *Includes lots with zero Death Reports, after cleaning typos N= 2,244 9

  10. Moderna: Does this look like the same consistent product lot-to-lot? Moderna: SEVERE AE per LOT NUMBER, Sorted Alphabetically 6000 Range= 1-5130 reports per lot 5000 4000 3000 Flu vax outliers below this line 2000 1000 0 027L208 034L204 012L10A 01ZAZIA 028L26A 029L24A 041L2A 042L2A 0ISM20A 026AZ1A 032LZ0A 011LZCA 013LZUA 058EZ1A G38A21A 006B21A 007B12A 018B2A 20215 296205 1222334 011821A 01721A 023121A 025021A 027620A 039H21A 041120A 044921A 04DC21A 401321A 91301A D08B21A 03/620A 046C21A 072C21A 010M204 031BZIA 014M2A 025D21A 030M21A 036CZ1A 038CZ1A 03M20A 088D1A 212M20A 002B2LA 003A214 009DZ1A 031MZ0 048A218 103MZ0A 004F21A 007S21A 013A12A 016A21A 021A21A 037F21A 045A21A 051F21A 064F21A 001AZIA *Includes lots with non-zero SAE Reports, after cleaning typos N= 2,244 10

  11. 5-12 Times Higher Variability in C19 Vaccines Lot-to-Lot vs Control Dataset Coefficient of Variation for Each Dataset Product Type SAE Reports Deaths ALL COVID19 VACCINES 1019% 1195% MODERNA ONLY 1005% 1159% ALL FLU VACCINES 224% 99% 11

  12. Variability in Adverse Events of C19 Vaccines Lot-to-Lot is Excessive and Unusual Excessive variability is a highly unusual pattern and must be investigated: C19 Vaccines DO NOT show same consistency lot-to-lot as do flu vaccines when measured by the outcomes data 5-12 times higher lot-to-lot variability Manufacturers make assurances of product consistency and GMP compliance when applying for EUA/FDA approval, in SEC filings, to public, Medicare/Medicaid and to private health insurers: Are these assurances fraudulent? If manufacturers are exempt from GMP for covid vaccines do patients and providers know this? Do investors and insurers know this? If manufacturers do not have liability the vaccinators and mandate pushers certainly do! 12

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