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Approximately 96 COVID-19 vaccines are at various stages of clinical development.
At present, we have the interim results of four studies published in
scientific journals (on the Pfizer–BioNTech BNT162b2 mRNA vaccine, the Moderna–US National Institutes of Health [NIH] mRNA-1273 vaccine, the AstraZeneca–Oxford ChAdOx1 nCov-19 vaccine, and the Gamaleya GamCovidVac [Sputnik V] vaccine) and three studies through the US Food and Drug Administration (FDA) briefing documents (on the Pfizer–BioNTech, Moderna–NIH, and Johnson & Johnson [J&J] Ad26.COV2.S vaccines).
Furthermore, excerpts of these results have been widely communicated
and debated through press releases and media, sometimes in misleading
ways.
Although attention has focused on vaccine efficacy and comparing the
reduction of the number of symptomatic cases, fully understanding the
efficacy and effectiveness of vaccines is less straightforward than it
might seem. Depending on how the effect size is expressed, a quite
different picture might emerge (figure; appendix).
FigureRRR and NNV with 95% CI ranked by attack rate in the unvaccinated (placebo) group for five COVID-19 vaccines
Vaccine
efficacy is generally reported as a relative risk reduction (RRR). It
uses the relative risk (RR)—ie, the ratio of attack rates with and
without a vaccine—which is expressed as 1–RR. Ranking by reported
efficacy gives relative risk reductions of 95% for the Pfizer–BioNTech,
94% for the Moderna–NIH, 90% for the Gamaleya, 67% for the J&J, and
67% for the AstraZeneca–Oxford vaccines. However, RRR should be seen
against the background risk of being infected and becoming ill with
COVID-19, which varies between populations and over time. Although the
RRR considers only participants who could benefit from the vaccine, the
absolute risk reduction (ARR), which is the difference between attack
rates with and without a vaccine, considers the whole population. ARRs
tend to be ignored because they give a much less impressive effect size
than RRRs: 1·3% for the AstraZeneca–Oxford, 1·2% for the Moderna–NIH,
1·2% for the J&J, 0·93% for the Gamaleya, and 0·84% for the
Pfizer–BioNTech vaccines.
ARR
is also used to derive an estimate of vaccine effectiveness, which is
the number needed to vaccinate (NNV) to prevent one more case of
COVID-19 as 1/ARR. NNVs bring a different perspective: 76 for the
Moderna–NIH, 78 for the AstraZeneca–Oxford, 80 for the Gamaleya, 84 for
the J&J, and 117 for the Pfizer–BioNTech vaccines. The explanation
lies in the combination of vaccine efficacy and different background
risks of COVID-19 across studies: 0·9% for the Pfizer–BioNTech, 1% for
the Gamaleya, 1·4% for the Moderna–NIH, 1·8% for the J&J, and 1·9%
for the AstraZeneca–Oxford vaccines.
ARR
(and NNV) are sensitive to background risk—the higher the risk, the
higher the effectiveness—as exemplified by the analyses of the J&J's
vaccine on centrally confirmed cases compared with all cases:
both the numerator and denominator change, RRR does not change
(66–67%), but the one-third increase in attack rates in the unvaccinated
group (from 1·8% to 2·4%) translates in a one-fourth decrease in NNV
(from 84 to 64).
There are many
lessons to learn from the way studies are conducted and results are
presented. With the use of only RRRs, and omitting ARRs, reporting bias
is introduced, which affects the interpretation of vaccine efficacy.
When communicating about vaccine efficacy, especially for public health
decisions such as choosing the type of vaccines to purchase and deploy,
having a full picture of what the data actually show is important, and
ensuring comparisons are based on the combined evidence that puts
vaccine trial results in context and not just looking at one summary
measure, is also important. Such decisions should be properly informed
by detailed understanding of study results, requiring access to full
datasets and independent scrutiny and analyses.
Unfortunately,
comparing vaccines on the basis of currently available trial (interim)
data is made even more difficult by disparate study protocols, including
primary endpoints (such as what is considered a COVID-19 case, and when
is this assessed), types of placebo, study populations, background
risks of COVID-19 during the study, duration of exposure, and different
definitions of populations for analyses both within and between studies,
as well as definitions of endpoints and statistical methods for
efficacy. Importantly, we are left with the unanswered question as to
whether a vaccine with a given efficacy in the study population will
have the same efficacy in another population with different levels of
background risk of COVID-19. This is not a trivial question because
transmission intensity varies between countries, affected by factors
such as public health interventions and virus variants. The only
reported indication of vaccine effectiveness is the Israeli mass
vaccination campaign using the Pfizer–BioNTech product. Although the
design and methodology are radically different from the randomised
trial, Dagan and colleagues
report an RRR of 94%, which is essentially the same as the RRR of the
phase 3 trial (95%) but with an ARR of 0·46%, which translates into an
NNV of 217 (when the ARR was 0·84% and the NNV was 119 in the phase 3
trial). This means in a real-life setting, 1·8 times more subjects might
need to be vaccinated to prevent one more case of COVID-19 than
predicted in the corresponding clinical trial.
Uncoordinated
phase 3 trials do not satisfy public health requirements; platform
trials designed to address public health relevant questions with a
common protocol will allow decisions to be made, informed by common
criteria and uniform assessment. These considerations on efficacy and
effectiveness are based on studies measuring prevention of mild to
moderate COVID-19 infection; they were not designed to conclude on
prevention of hospitalisation, severe disease, or death, or on
prevention of infection and transmission potential. Assessing the
suitability of vaccines must consider all indicators, and involve
safety, deployability, availability, and costs.
We declare no competing interests.
Supplementary Material
- Supplementary appendix
References
- 1.Covid-19 Vaccine Tracker.https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.htmlDate accessed: March 10, 2021
- 2.Safety and efficacy of the BNT162b2 mRNA COVID-19 Vaccine.N Engl J Med. 2020; 383: 2603-2615
- 3.Efficacy and safety of the mRNA-1273 SARS-CoV-2 Vaccine.N Engl J Med. 2021; 384: 403-416
- 4.Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK.Lancet. 2021; 397: 99-111
- 5.Safety and efficacy of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine: an interim analysis of a randomised controlled phase 3 trial in Russia.Lancet. 2021; 397: 671-681
- 6.Vaccines and Related Biological Products Advisory Committee meeting: FDA briefing document.https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-december-10-2020-meeting-announcementDate: Dec 10, 2020Date accessed: March 10, 2021
- 7.Vaccines and Related Biological Products Advisory Committee meeting: FDA briefing document.https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-december-17-2020-meeting-announcementDate: Dec 17, 2020Date accessed: March 10, 2021
- 8.Vaccines and Related Biological Products Advisory Committee meeting: FDA briefing document.https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-february-26-2021-meeting-announcementDate: Feb 26, 2021Date accessed: March 10, 2021
- 9.What does 95% COVID-19 vaccine efficacy really mean?.Lancet Infect Dis. 2021; (published online Feb 17.)
- 10.Outcome reporting bias in COVID-19 mRNA vaccine clinical trials.Medicina (Kaunas). 2021; 57: 199
- 11.BNT162b2 mRNA COVID-19 vaccine in a nationwide mass vaccination setting.N Engl J Med. 2021; (published online Feb 24.)
Article Info
Publication History
Published: April 20, 2021
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