The Data and Safety Monitoring Board (DSMB) has notified the National Institute of Allergy and Infectious Diseases (NIAID), Biomedical Advanced Research and Development Authority (BARDA), and AstraZeneca that it is “concerned by information released by AstraZeneca on initial data from its COVID-19 vaccine clinical trial”.
Trial volunteers received two standard doses of the Oxford-AstraZeneca vaccine or a placebo vaccine, at a four-week interval, and AstraZeneca recently announced that the data showed the vaccine was 79% effective against symptomatic COVID-19, and 100% effective against severe, or critical symptomatic COVID-19.
Andrew Pollard, Professor of Paediatric Infection and Immunity, and Lead Investigator of the Oxford University trial of the vaccine, initially said: “These results are great news as they show the remarkable efficacy of the vaccine in a new population and are consistent with the results from Oxford-led trials.”
The DSMB expressed concern that AstraZeneca may have included outdated information from this trial, which may have provided an incomplete view of the efficacy data. A statement from the NIAID said: “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”.
Authorisation and guidelines for use of the vaccine in the United States will be determined by the Food and Drug Administration and Centres for Disease Control and Prevention after thorough review of the data by independent advisory committees.