Independent US board expresses concern over AstraZeneca's announcements about findings
Mar 23, 2021
Washington [US], March 23 : An independent board that reviews data from multiple Covid-19 vaccine candidates in the United States has expressed concern over AstraZeneca's announcements about its latest findings, according to a statement posted Tuesday by the National Institute of Allergy and Infectious Diseases.
"Late Monday, the Data and Safety Monitoring Board (DSMB) notified NIAID, BARDA, and AstraZeneca that it was concerned by information released by AstraZeneca on initial data from its COVID-19 vaccine clinical trial. The DSMB expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data," the statement from the NIAID read.
"We urge the company to work with the DSMB to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible," it added.
The statement stated further that the authorisation and guidelines for use of the vaccine in the United States will be determined by the Food and Drug Administration and Centers for Disease Control and Prevention after a review of the data by independent advisory committees.
On Monday, AstraZeneca issued a news release saying its Covid-19 vaccine showed 79% efficacy against symptomatic disease and 100% efficacy against severe disease and hospitalization, citing long-awaited US trial data.
The latter figure was based on five total cases of severe disease or hospitalization in people who received the placebo, and zero similar cases among those who received the vaccine, NIAID director Dr. Anthony Fauci said during a coronavirus briefing Monday, as reported by CNN.
The DSMB is an independent expert group which sees trial data before the pharmaceutical companies, the doctors running the trials, or even the US Food and Drug Administration.
"It has the power to advise a company of positive interim findings, or to halt a trial over safety concerns. That's what happened to the AstraZeneca trial in September after a study participant developed neurological symptoms, for example," CNN reported.
The US's medical research agency, the National Institutes of Health, appointed a common DSMB to monitor Covid-19 vaccine clinical trials funded by the federal government -- including AstraZeneca, Moderna and Johnson & Johnson.
This DSMB has 10 to 15 members with specialties including vaccine development, statistics and ethics.
