AstraZeneca could have used “outdated information” when it released data from a late-stage study of its 19-month COVID vaccine, federal officials say. The Data and Safety Monitoring Committee (DSMB) said later in the day that it was “concerned” by the information the British drug manufacturer had made public about the large-scale US study of the vaccine it had developed. together with Oxford University.
The National Institute of Allergy and Infectious Diseases (NIAID) stated that “DSMB expressed concern that AstraZeneca could have included outdated information from this study, which could have provided an incomplete picture of efficacy data. We urge the company to work with DSMB to review the effectiveness data and ensure that the most accurate, up-to-date efficacy data is made public as soon as possible. “
AstraZeneca reported Monday that its COVID-19 vaccine provided strong protection among adults of all ages in a long-awaited study in the United States, a finding that could have helped rebuild public confidence in the world of shooting and its proximity. one step closer to US clearance
AstraZeneca said in a statement on Wednesday that the data published on Monday “was based on a pre-specified interim analysis with a February 17 data limit. We revised the preliminary assessment of the primary analysis and the results were consistent with the interim analysis. “
The drug manufacturer said that it “completes the validation of the statistical analysis” and “will immediately interact with the independent data safety monitoring board (DSMB) to share our primary analysis with the most up-to-date efficacy data.” We aim to publish the results of the primary analysis within 48 hours. “
Dr. Anthony Fauci, director of the US National Institute of Allergy and Infectious Diseases and President Biden’s chief medical adviser, said Wednesday that the AstraZeneca vaccine itself was “good”, but that the pharmaceutical company had issued a “somewhat outdated” press release. “Monday,” which is somewhat misleading. “
He told ABC News that NIH had told AstraZeneca “we want the press release to be updated” and called the information issued by the company “quite unhappy because it is a good vaccine”.
In the study of 30,000 people, AstraZeneca said the vaccine was 79% effective in preventing symptomatic cases of COVID-19 – including in older adults. There were no serious illnesses or hospitalizations among vaccinated volunteers, compared to five such cases in participants who received placebo vaccines – a small number, but consistent with findings in the UK and other countries that the vaccine protects against the most serious diseases. .
AstraZeneca also said that the study’s independent safety monitors found no serious side effects, including no increased risk of rare blood clots like those identified in Europe, a scare that has led many countries to briefly suspend vaccinations last week.
The company plans to file an application with the Food and Drug Administration in the coming weeks. It was not known whether this request would be delayed due to DSMB concerns.
The government’s external advisers will publicly debate the evidence before the agency makes a decision. Authorization and guidelines for the use of the vaccine in the United States will be established by the Food and Drug Administration and the Centers for Disease Control and Prevention, after thorough examination of the data by independent advisory committees.