AstraZeneca may have used “outdated information” when it released data from a final-phase trial of the COVID-19 vaccine early Monday, federal officials say. The Data Control and Safety Board (DSMB) said at the end of the day that it was “concerned” by the information the British drug manufacturer made public about the major US vaccine trial it developed along with the Oxford University.
The National Institute of Allergy and Infectious Diseases (NIAID) said that “the DSMB expressed concern that AstraZeneca might include obsolete information from this trial, 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 performance 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 an expected study in the United States, a finding that could have helped rebuild public confidence in the shooting worldwide and bring it closer. -a further step in the liquidation WE
AstraZeneca said in a statement on Wednesday that the data released Monday “was based on a pre-specified interim analysis with a February 17 data cut. We reviewed the preliminary assessment of the primary analysis and the results were consistent with the analysis provisional “.
The drug manufacturer said it was “completing the validation of the statistical analysis” and would “immediately collaborate with the Independent Data Security Control Board (DSMB) to share our core analysis with the most effective data. We intend to publish results of the main analysis in 48 hours. “
Dr. Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases and chief medical adviser to President Biden, said Wednesday that the AstraZeneca vaccine itself was “good,” but that the pharmaceutical company had posted a “slightly outdated” information press release “Monday, which is a bit misleading.”
He told ABC News that the NIH had told AstraZeneca “that we wanted the press release to be updated” and described the information issued by the company as “quite unfortunate, because it is a good vaccine”.
In the 30,000-person study, AstraZeneca said the vaccine was 79% effective in preventing symptomatic cases of COVID-19, including older adults. There were no serious illnesses or hospitalizations among vaccinated volunteers, compared with five such cases in participants who received placebo vaccines, a small number but consistent with findings from Britain and other countries that the vaccine protects against the worst of the disease.
AstraZeneca also said the study’s independent safety monitors found no serious side effects, including not increased risk of rare blood clots like those identified in Europe, a scare that led many countries to briefly suspend vaccinations last week.
The company intended to file an application with the Food and Drug Administration in the coming weeks. It was not known if this application would be delayed due to DSMB concerns.
External government advisers will publicly discuss the evidence before the agency makes a decision. Authorization and guidelines for vaccine use in the United States will be determined by the Food and Drug Administration and the Centers for Disease Control and Prevention following a thorough review of the data by independent advisory committees.