Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine

• p. 8 Table S1, Figure 1 row

  All enrolled population N=37,706

• p. 10 Table S3 title/caption

  (All Enrolled Participants)

• p. 8 Adverse Events

  all en-rolled 43,252 participants

Only the authors can say what is right here.

Judge's note: Supp-02 p8 Table S1 Figure 1 row: "All enrolled population N=37,706 'main safety subset'". Supp-02 p10 Table S3 caption defines 'all enrolled' as all participants who received at least 1 dose. Table S1 also lists N=43,252 for Table S3, and main p8 says "all enrolled 43,252 participants". The explanation column of the same Table S1 row makes clear that 37,706 is the main safety subset, so the problem is the label, and only the authors can say which wording they intend.

Second check: another model agreed

• p. 9 Results, Efficacy paragraph

  efficacy, 94.6%; 95% CI, 68.7 to 99.9; case split: BNT162b2, 2 cases; placebo, 44 cases

Only the authors can say what is right here.

Judge's note: With equal surveillance time, 2 vs 44 gives VE 95.5%. Reaching 94.6% needs a placebo:vaccine time ratio of about 1.19. With the Clopper–Pearson exact method for 2 of 46, upper p≈0.147, so the VE lower bound is ≈82.8% at ratio 1; a lower bound of 68.7% would need a ratio of ≈1.8, and an upper bound of 99.9% would need a ratio of ≈0.2. No single ratio fits all three numbers. Every other subgroup in Table 3 has a ratio near 1. Surveillance time for the hypertension subgroup is not reported, so query the authors on which case split, analysis population and method produced each number.

Second check: another model agreed

• p. 10 Discussion, right column

  This rate of severe fatigue is also lower than that

• p. 10 Discussion, preceding sentence

  which is higher than that observed in recipients of some vaccines recommended for older adults.

Only the authors can say what is right here.

Judge's note: Crop C010-a confirms the wording. Both statements can be true because they concern different comparator vaccines, but the connective 'also' makes the passage read as contradictory. The files cannot show whether 'higher' is itself in error, as one reviewer claimed. Treated as a wording ambiguity.

Second check: another model agreed

• p. 11 Table S4, age group and at risk rows vs At risk / Overall rows

  16–64 and not at risk

Only the authors can say what is right here.

Judge's note: Checked on the page image of supp-02 p11. At risk Yes + No = 17411, which matches Overall, but the age-by-risk subgroups add up to 14 fewer (vaccine) and 13 fewer (placebo). The age-by-obesity subgroups also fall short (8811+4734+2582+1265=17392). Surveillance times add up (0.962+0.744+0.227+0.281=2.214). The footnotes do not mention missing age or BMI data. Probably missing data, but only the authors can confirm.

Second check: another model agreed

• p. 6 List of Investigators, Zerbini

  Sao Paolo, Brazil

Judge's note: Crop C015-a shows 'Sao Paolo'. The main article appendix (crop C013-a) gives the same institution (Centro Paulista de Investigação Clinica) in 'São Paulo'.

Second check: none (judge only)

• p. 7 SARS-CoV-2 Testing Information

  was conducting using the Roche Elecsys

• p. 7 SARS-CoV-2 Testing Information

  Testing for SARS-CoV-2 antibodies was conducting using the Roche Elecsys

• p. 7

  Testing for SARS-CoV-2 antibodies was conducting using the Roche Elecsys®

Judge's note: The page image shows "was conducting using". The sentence just before it correctly says "was conducted using". Cosmetic verb-form error.

Second check: none (judge only)

• p. 9 Results, Efficacy, first paragraph

  prior SARS CoV-2 infection

Judge's note: Crop C006-a shows 'SARS CoV-2' mid-line. The same page also prints 'SARS-CoV-2' elsewhere.

Second check: none (judge only)

• p. 9 Table 2 title

  Vaccine Efficacy against Covid-19 at Least 7 days after the Second Dose

Judge's note: Crop C004-h shows lowercase 'days'. The Table 3 title uses 'Days' ('before 7 Days after Dose 2').

Second check: none (judge only)

• p. 10 Table 3, Sex, Male, placebo

  1.108 (8762)

Judge's note: Crop C011-a shows '8762' without a comma, while the neighbouring cells use commas.

Second check: none (judge only)

• p. 13 Reference 13

  Shringrix (zoster vaccine recombinant,

• p. 13 References, entry 13

  Shringrix (zoster vaccine recombinant, adjuvanted) product information

• p. 13

  Shringrix (zoster vaccine recombinant, adjuvanted)

Judge's note: Crop C012-a shows 'Shringrix' printed. The URL in the same reference spells it 'shingrix'.

Second check: none (judge only)

• p. 13 Appendix, affiliations

  Mainz (ÖT., U.Ş.)

Judge's note: Crop C013-a shows 'ÖT.'. All other initials in the appendix carry a period after each letter.

Second check: none (judge only)

• p. 21

  The first 5 participants in in each sentinel group will be observed

Judge's note: The page image shows "in in" on a single line of footnote c.

Second check: none (judge only)

• p. 32

  and Stage 3; a final candidate/dose large-scale stage

Judge's note: Confirmed on the crop image. Punctuation only.

Second check: none (judge only)

• p. 43

  (BNT 162 RNA-

Judge's note: Confirmed on the full page image. Cosmetic.

Second check: none (judge only)

• p. 51

  positive nonvaccine antigen SARS-CoV-2 antibody result in a participant with a prior

Judge's note: Confirmed on the crop image. The sentence is grammatical only if it reads 'whose prior' (or 'with a prior ... result that was negative'). Cosmetic wording.

Second check: none (judge only)