In an unusual statement released early Tuesday, the National Institute of Allergy and Infectious Diseases said the independent board that reviews data from multiple Covid-19 vaccine candidates has raised concerns about AstraZeneca’s announcement of efficacy data from its vaccine 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“The DSMB expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data,” said the NIAID statement released early Tuesday.
“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.”
On Monday, AstraZeneca had issued a press 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, NIAID Director Dr. Anthony Fauci said during a coronavirus briefing Monday.
In a statement Tuesday, AstraZeneca said the numbers shared Monday were based on a pre-specified interim analysis with a data cutoff of February 17.
It said it has reviewed an early assessment of its primary analysis, and those results were consistent with the interim analysis.
“We will immediately engage with the independent data safety monitoring board (DSMB) to share our primary analysis with the most up to date efficacy data,” the statement said.
“We intend to issue results of the primary analysis within 48 hours.”
The DSMB is an independent expert group that sees trial data before the pharmaceutical companies, the doctors running the trials, or even the US Food and Drug Administration.
It has the power 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.
Last year, the National Institutes of Health appointed a common DSMB to monitor Covid-19 vaccine clinical trials that were being 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.
Fauci said on Good Morning America on Tuesday that when the DSMB saw AstraZeneca’s press release, “they got concerned and wrote a rather harsh note to them — and with a copy to me — saying that in fact they felt that the data that was in the press release were somewhat outdated and might in fact be misleading a bit, and wanted them to straighten it out.”
Read more: https://edition.cnn.com/2021/03/23/health/astrazeneca-vaccine-dsmb-statement/index.html