A panel of independent experts tasked with overseeing the data and security of AstraZeneca's COVID-19 vaccine study raised a red flag over the company's press release on Monday, which indicated that the vaccine was 79 percent is effective against symptomatic COVID-19.
In the early hours of Tuesday morning, the National Institute for Allergies and Infectious Diseases released an unusual statement indicating that the study's Data and Safety Monitoring Board (DSMB) had been in contact with both the federal agency and the company. The statement read:
The DSMB expressed concern that AstraZeneca may have included out of date information from this study, which may have provided an incomplete view of the efficacy data. We urge the company to work with the DSMB to review efficacy data and ensure that the most accurate and up-to-date efficacy data is released as soon as possible.
In an interview with Good Morning America Tuesday morning, NIAID director and top infectious disease expert Anthony Fauci tried to add more context to the situation. He noted that the DSMB, which has access to all of the data from the AstraZeneca study, was surprised by what the company said in its press release.
"When (the DSMB) saw this press release, they got concerned and wrote them a pretty hard note and copied it for me," Fauci said. "They felt that the data in the press release was a little out of date and could indeed be misleading."
The unusual dispute is just the latest stumble upon 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 suspended rollouts of the vaccine because they feared it could cause life-threatening blood clots in a very small number of people.
Health experts, including the World Health Organization, urged countries to resume use of the vaccine – and many have noted – that the benefits of protection against COVID-19 far outweigh the risk of infrequent blood clots. Many countries have followed the advice and resumed vaccination, but doubts remain about the vaccine. The new dispute over the data in the US press releases is likely to only add to the doubts.
"It's really unfortunate that this happened," Fauci said on GMA this morning, describing the press release debacle as an "easy mistake" that could raise further doubts and potentially contribute to a vaccine delay. "The fact is, this is very likely to be a very good vaccine," added Fauci. "If you look at the data, it's actually pretty good, but when it was put on the press release, it wasn't entirely accurate."
In a press release early Tuesday, AstraZeneca addressed the controversy and apparently stood by its effectiveness data for the time being:
The numbers released yesterday are based on a pre-determined interim analysis with a February 17th data cut-off date.
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 be in touch with the independent DSMB (Data Safety Monitoring Board) immediately to share our primary analysis with the most up-to-date effectiveness data. We intend to publish the results of the primary analysis within 48 hours.