AstraZeneca may have used “outdated information” when it released data from a final-stage trial of its COVID-19 vaccine on Monday, federal officials said. The Data and Security Monitoring Council (DSMB) said at the end of the day that it “was concerned” about the information that the British drugmaker made public about the large-scale US trial of the vaccine it developed with the University of Oxford.
The National Institute of Allergy and Infectious Diseases (NIAID) said “The DSMB expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data. 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. “
AstraZeneca reported on Monday that its COVID-19 vaccine provided strong protection among adults of all ages in a long-awaited American study, a finding that could have helped rebuild public confidence in the injection worldwide and lead to her a step closer to the release in the we
AstraZeneca said in a statement on Wednesday that the data released on Monday “was 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 provisional analysis. “
The drug manufacturer said it was “completing the validation of the statistical analysis” and that “it would immediately engage with the independent data security monitoring board (DSMB) to share our primary analysis with the most up-to-date efficacy data. We intend to issue the results of the primary analysis in 48 hours. “
Dr. Anthony Fauci, director of the United States National Institute of Allergy and Infectious Diseases and chief medical adviser to President Biden, said on Wednesday that the AstraZeneca vaccine itself was “good”, but that the pharmaceutical company disclosed a “somewhat outdated press release” on Monday, “which is somewhat misleading.”
He told ABC News that the NIH had told AstraZeneca “that we wanted the press release to be updated”, and called the information issued by the company “somewhat unfortunate, 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 the vaccinated volunteers, compared with five of these cases in participants who received placebo injections – a small number, but consistent with the findings in Britain and other countries that the vaccine protects against the worst. of the disease.
AstraZeneca also said that the study’s independent security monitors found no serious side effects, including none increased risk of rare blood clots such as those identified in Europe, a scare that prompted several countries to halt vaccination briefly last week.
The company planned to file an order with the Food and Drug Administration in the coming weeks. There was no word on whether that request would be delayed due to DSMB concerns.
External government consultants 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 determined by the Food and Drug Administration and the Centers for Disease Control and Prevention, after a complete review of the data by independent advisory committees.