Evaluating the Long-term Efficacy of Coronavirus Disease 2019 (COVID-19) Vaccines.
Clin Infect Dis
; 73(10): 1927-1939, 2021 11 16.
Article
in English
| MEDLINE | ID: covidwho-1522145
ABSTRACT
Large-scale deployment of safe and durably effective vaccines can curtail the coronavirus disease-2019 (COVID-19) pandemic. However, the high vaccine efficacy (VE) reported by ongoing phase 3 placebo-controlled clinical trials is based on a median follow-up time of only about 2 months, and thus does not pertain to long-term efficacy. To evaluate the duration of protection while allowing trial participants timely access to efficacious vaccine, investigators can sequentially cross participants over from the placebo arm to the vaccine arm. Here, we show how to estimate potentially time-varying placebo-controlled VE in this type of staggered vaccination of participants. In addition, we compare the performance of blinded and unblinded crossover designs in estimating long-term VE.
Keywords
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Vaccines
/
COVID-19
Type of study:
Cohort study
/
Experimental Studies
/
Prognostic study
/
Randomized controlled trials
Topics:
Long Covid
/
Vaccines
Limits:
Humans
Language:
English
Journal:
Clin Infect Dis
Journal subject:
Communicable Diseases
Year:
2021
Document Type:
Article
Affiliation country:
Cid
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