Independent Review Board Shares Concerns Over Outdated Data in AstraZeneca COVID-19 Clinical Trial

March 23, 2021

AstraZeneca responded to the concerns by promising to release the most up-to-date data within 48 hours.

The Data and Safety Monitoring Board (DSMB) has shared concerns about data from AstraZeneca’s COVID-19 vaccine clinical trial, notifying the National Institute of Health’s (NIH) National Institutes of Allergy and Infectious Diseases (NIAID), the Biomedical Advanced Research and Development Authority (BARDA), and the pharmaceutical company.1

According to DSMB, “AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data,” the statement said.

On Monday, AstraZeneca shared interim data from its ongoing phase 3 clinical trial of AZD1222, reporting an efficacy rate of 79% against symptomatic cases of COVID-19.

“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,” NIH stated.

The announcement follows news of several European and Asian countries suspending the use of the AstraZeneca COVID-19 vaccine due to reports of patients having severe blood clots, though the data are inconclusive as to whether the shots have been causing these adverse events (AEs). AstraZeneca reported on Monday that DSMB found no increased thrombosis-related risks in its independent safety review of the vaccine. 

Related: European Countries Suspend Use of AstraZeneca’s COVID-19 Vaccine

AstraZeneca responded on Tuesday by clarifying that the recently published data were “based on a pre-specified interim analysis with a data cut-off of February 17,” in a news release. The pharmaceutical company additionally affirmed its willingness to work with DSMB and provide the most up to date efficacy data within 48 hours.2

References

  1. NIAID Statement on AstraZeneca Vaccine. News Release. NIH; March 23, 2021. Accessed March 23, 2021. https://www.nih.gov/news-events/news-releases/niaid-statement-astrazeneca-vaccine.
  2. Update following statement by NIAID on AZD1222 US Phase III trial data. News Release. March 23, 2021. Accessed March 23, 2021. https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2021/update-following-statement-by-niaid-on-azd1222-us-phase-iii-trial-data.html.