A board of independent experts tasked with monitoring data and safety from the AstraZeneca COVID-19 vaccine trial raised a red flag over the company’s press release on Monday, which claimed the vaccine was 79 percent effective in prevention. of symptomatic COVID-19.
In the early hours of Tuesday, the National Institute of Allergy and Infectious Diseases released an unusual statement indicating that the study’s Data and Security Monitoring Council (DSMB) had contacted the federal agency and also the company. The statement said:
The DSMB expressed concern that AstraZeneca may have included outdated information from that study, which may have provided an incomplete view of the efficacy data. We urge the company to work with the DSMB to review effectiveness data and ensure that the most accurate and up-to-date effectiveness data is made public as soon as possible.
In an interview with Good Morning America on Tuesday morning, NIAID director and infectious disease specialist Anthony Fauci tried to add more context to the situation. He noted that the DSMB, which has access to all AstraZeneca test data, was surprised by what the company said in its press release.
“When [the DSMB] they saw that press release, they were concerned and wrote a very rough note for them and a copy for me, ”said Fauci. “They felt that the data in the press release was somewhat out of date and could, in fact, be misleading.”
The unusual dispute is just the latest stumbling block for AstraZeneca’s COVID-19 vaccine, which has been plagued by doubts and disappointing results. Last week, more than a dozen countries in Europe and elsewhere temporarily halted the vaccine’s launch due to concerns that it was causing life-threatening blood clots in a very small number of people.
Health experts, including the World Health Organization, urged countries to resume using the vaccine, noting that the benefits of protection against COVID-19 far outweigh the risk of rare blood clots. Many countries followed the advice and restarted vaccination, but there are still doubts about the vaccine. The new dispute over US press release data is likely to only raise doubts.
“It is really unfortunate that this has happened,” said Fauci this morning at GMA, calling the disaster of the press release an “unforced error” that would raise further doubts and may contribute to the vaccine’s hesitation. “The fact is, this is most likely a very good vaccine,” added Fauci. “If you look at the data, it really is very good, but when they put it in the press release, it was not entirely correct.”
In a press release on Tuesday, AstraZeneca addressed the controversy, apparently maintaining its effectiveness data for the time being:
The figures published yesterday were based on a pre-specified interim analysis with a data cut on February 17.
We reviewed the preliminary assessment of the primary analysis and the results were consistent with the intermediate analysis. We are now completing the validation of the statistical analysis.
We will immediately contact the independent data security monitoring board (DSMB) to share our primary analysis with the most up-to-date effectiveness data. We intend to issue the results of the primary analysis within 48 hours.