Counting the dead

I’ve been looking at all the different covid trials after a long time of being solely focused on Pfizer-BioNTech, and there is a lot to unpack. I could spend ages more on this article and still be nowhere near finished, so I only double-checked the numbers, added sources, and hit send.

Pfizer-BioNTech

The Pfizer-BioNTech stuff from EMA CDP is one big zip file and this folder. I’ll fix it up at some point.

• BNT162-01 n=512 23.4.2020 - 23.10.2020 no deaths, 1 death listed in the EU CTR results

Data window April-October 2020

• C4591001 n=46k 1:1 placebo 4.5.2020-14.12.2020 placebo controlled window, data window -March 2021

21-17 vax placebo

EU CTR results (28.09.2023 last update)
60/21 (blinded placebo-controlled follow-up Phase 2/3)

Open Label Crossover Follow-up Period (placebo/BNT162b2)

+38

Protocol amendment 18 (boosters)

+46 (+1 12-15)

• C4591031 Substudy A 01.07.2021-08.02.2022 n=10k from C4591001 2-dose participants randomized 1:1 to receive a booster or placebo, 22.9.2021 booster EUA’d by FDA (LOOOOL) so they vaxed the placebo arm too. pfizer literally says this was just before their first planned interim analysis at two months (what a coincidence!)

9 deaths 2 in “placebo” 3 in vax arm and 4 in “placebo” crossover page99 1031-p-csr-body. not adding the deaths to the tally until i’m certain they’re not included in the C4591001 count, but with Pfizer’s incredible report compartmentalization strategy, that’s next to impossible to be sure of.

145/21

Moderna (all files)

• p205 mRNA-1273.211 booster study m5351-205-p-csr-interim-body

  1 death

• p205 Part F+G m5351-205-p-app1612-csr-body-part-g

  3deaths

• P301 n=30k 1:1 placebo

4 vax 4 placebo dead in the “overall stage” i.e. data extraction date 11.11.2020, m5351-mrna1273p301-p-safety-tables-figures-row

4 vax 6 placebo DED 25.11.2020 m5351-mrna1273p301-p-unblinded-safety-tables-batch-1

6 vax 7 placebo DED 03.12.2020 m5351-mrna1273p301-p-exec-summ-safety-tables

17 vax 16 placebo DED 04.05.2021 p2959 m5351-301-p-csr-body-part1

24 vax 19 placebo DED +Part b open-label m5351-301-p-csr-body-add1

HART Group’s substack counts 24/19 in their reading of the files and I’m inclined to defer.

28/19

AstraZeneca (all files)

• December 17 Safety narratives

2/4

These deaths are not part of the large D8110 trial, I had this wrong. They were accrued in the four studies listed on Page 6 of the clinical package 1. Importantly, only 1.5 of four trials had saline as placebo, the first two trials and dose 1 of the third trial’s placebo arm used MenACWY, a “meningococcal Group A, C, W-135 and Y conjugate vaccine”. (re-reading this, it’s pretty nonsensical, any vaccine + placebo is still not placebo of course, but i’ll count them as placebo).

• D8110C00001 n=30k, 2:1 placebo Start date 28.8.2020

7/7 during blind

8/7 after unblind cutoff page192

17/9 final count cutoff 30.07.2021 m5351-d8110c00001-p-sec143-tables-figures-dco3 p5913 +p11294

• D7220C00001 booster study 27.6.2021-17.11.2021 n=1300 700:600 double-dose AZ or mRNA

1 AZD arm death p1393

20/13

Janssen (all files)

• m5353-pooled-safety-analysis-p-report p1991 44/74 + 8 open-label/1placebo n=38538vax/37809placebo

51/74

• cov1001 n=~1k 500 2dose: 300 1dose: 200 placebo 16.7.2020-21.7.2021

  1 death

• cov2001 n=582 25 placebo patients 31.8.2020-8.3.2022

  1 vax arm death

• 3009 n=31k 1:1 placebo data window 16.11.2020 - 25.6.2021

11/15 m5351-cov3009-p-fa-db-csr p334

• 3001 n=40k 1:1 placebo 21.9.2020-9.7.2021

3/16 cutoff 22.1.2021 m5351-cov3001-p-interim-csr-prim-analysis

28/55 9.7.2021 double blind p467

40/63 9.7.2021 open label p477 m5351-cov3001-s-fa-db-csr-vol-a

52/79

Novavax (all files)

• 2019nCoV-301 n=30k 2:1 placebo Data extraction 27.12.2020-01.6.2021 Page 1460 m5351-2019ncov301-p-csr-body-interim

  9/5

• 2019nCoV-501 n=4.4k 1:1 placebo addendum m5351-2019ncov-501-p-csr-with-app page 460 data window 17.8.2020-15.09.2021

  6/2 (2/2 pre-crossover, then 4 deaths in the placebo→ vaccine arm)

• 2019nCoV-302 n=15k data window 28.9.2020-23.02.2021

  2/1

17/8

*****old result, new totals under construction***** 263 vax / 134 placebo or 397 total.

I’m definitely going to be comparing placebo groups and criteria, the discrepancies are crazy. Maybe make a timeline for better visualisation? And to better compare death counts at different trial stages.

This listing is guaranteed to not be complete, either. there are dozens of substudies that have one death here and there, but I’ve been reading a lot of material and it kind of blurs together, so this is to be considered a work in progress.

For all EMA CDP files I’ve rehosted thus far, see here: