Correspondence
COVID-19 vaccines:
effectiveness and
number needed to treat
In a Lancet Microbe Comment,
Piero Olliaro and colleagues1 suggest
that reporting relative risk reduction
(RRR) for vaccination does not reflect
entirely its therapeutic performance
and consider the solw use of RRR
a reporting bias. In addition, they
propose that absolute risk reduction
(ARR) should be reported as a measure
of the vaccine’s effectiveness. The
authors end up comparing the
numbers needed to vaccinate to
prevent one case of COVID-19 among
the vaccines, which derives from the
absolute reductions.
However, this suggestion might
have a paradoxical effect in misleading
perception of treatment performance.
This approach disregards three epi­
demiological facts.
First, number needed to treat
(NNT) is not an intrinsic property of
a treatment, it is rather a property
of the population that receives a
treatment: for a constant relative risk
reduction, populations of different
baseline risks will have different
absolute reductions. Therefore, NNT
www.thelancet.com/microbe Vol 2 July 2021 e281
comparison of different treatments
across studies should be avoided,
because sample populations will
always have baseline risk variations.
Indeed, this approach is the actual
reporting bias.
Second, the authors raise a concern
that different levels of background
risk might change relative risk
reduction of studies. This statement
disregards the constant property of
relative risk repeatedly demonstrated
by subgroup analysis of clinical trials
and meta-scientific evaluations
of a treatment across studies of
different baseline risks.2 For example,
statins,3,4 anti-hypertensive therapy,5
and aspirin6 have the same relative
risk reduction across the baseline
risks of primary or secondary
prevention.
Finally, effectiveness—a real-world
property—is about clinical decision
making, and not to be derived
from efficacy studies (randomised
controlled studies). As a clinician
or an epidemiologist, one should
multiply the RRR (intrinsic property
of a treatment) by the baseline risk
of a given population or patient,
individualising the ARR and NNT. They
are not scientific concepts, they are
circumstantial information.
We declare no competing interests.
Copyright © 2021 The Author(s). Published by
Elsevier Ltd. This is an Open Access article under the Published Online
CC BY-NC-ND 4.0 license. May 14, 2021
https://doi.org/10.1016/
*Luis C L Correia, Denise Matias S2666-5247(21)00119-1
luis.correia@bahiana.edu.br
Center for Evidence-Based Medicina, Medical and
Public Health School of Bahia, Salvador 40290-000,
Brazil (LCLC, DM)
1 Olliaro P, Torreele E, Vaillant M. COVID-19
vaccine efficacy and effectiveness—the
elephant (not) in the room. Lancet Microbe
2021; published online April 20. https://doi.
org/10.1016/ S2666-5247(21)00069-0.
2 Furukawa TA, Guyatt GH, Griffith LE.
Can we individualize the ‘number needed to
treat’? An empirical study of summary effect
measures in meta-analyses. Int J Epidemiol
2002; 31: 72–76.
3 Heart Protection Study Collaborative Group.
MRC/BHF Heart Protection Study of
cholesterol lowering with simvastatin in
20,536 high-risk individuals: a randomised
placebo-controlled trial. Lancet 2002;
360: 7–22.
4 Yusuf S, Bosch J, Dagenais G, et al. Cholesterol
lowering in intermediate-risk persons without
cardiovascular disease. N Engl J Med 2016;
374: 2021–31.
5 Phillips RA, Xu J, Peterson LE, Arnold RM,
Diamond JA, Schussheim AE. Impact of
cardiovascular risk on the relative benefit and
harm of intensive treatment of hypertension.
J Am Coll Cardiol 2018; 71: 1601–10.
6 Baigent C, Blackwell L, Collins R, et al.
Aspirin in the primary and secondary
prevention of vascular disease: collaborative
meta-analysis of individual participant data
from randomised trials. Lancet 2009;
373: 1849–60.