Early Vaccine Authorization Raises Ethical and Logistical Challenges for Trial Sponsors
Applied Clinical Trials
; 29(11):4, 2020.
Article
in English
| ProQuest Central | ID: covidwho-20244560
ABSTRACT
The much-anticipated meeting of FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) last month addressed a number of critical issues related to testing and approval of vaccines to prevent COVID-19 infection, including policies and data requirements for determining that a pandemic vaccine can be considered safe and effective, particularly when based on more limited, early clinical trial data. While studies sponsored by AstraZeneca and Johnson & Johnson's Janssen unit resumed soon after the meeting, the study pauses were described by researchers as a sign that clinical trial safety systems were working as intended, as the analysts determined the adverse events were unrelated to the test vaccine candidates. The aim is to gain further information on vaccine efficacy and side effects, including rare adverse events and fuller comparisons among patient groups with differences in age, sex, comorbidities, and ethnic characteristics.
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Collection:
Databases of international organizations
Database:
ProQuest Central
Type of study:
Experimental Studies
/
Prognostic study
/
Randomized controlled trials
Topics:
Vaccines
Language:
English
Journal:
Applied Clinical Trials
Year:
2020
Document Type:
Article
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