AstraZeneca may have used “outdated information” when it released the data of a late-stage trial of its COVID-19 vaccine early Monday, federal officials said. The Data and Safety Monitoring Board (DSMB) said late in the day that it was “concerned” about the information the British drugmaker had released about the large-scale US trial of the vaccine it was developing with the University of Oxford.
The National Institute of Allergy and Infectious Diseases (NIAID) said: “The DSMB has expressed concern that AstraZeneca may have included outdated information from the trial, which may have given an incomplete overview of the efficacy data. We request the company to contact the DSMB. work together to review efficiency data and ensure that the most accurate, up-to-date efficiency data is released as soon as possible. ‘
AstraZeneca reported Monday that its COVID-19 vaccine provides strong protection among adults of all ages in a long-awaited U.S. study, a finding that could help rebuild public confidence in the shot around the world and make it a step closer to clearance in the US
AstraZeneca said in a statement on Wednesday that the data released on Monday was based on a predetermined interim analysis with a February 17 data cut-off. We reviewed the preliminary assessment of the primary analysis and the results are consistent with the interim analysis. “
The drugmaker said it was ‘completing the validation of the statistical analysis’ and that it would immediately have a discussion with the Independent Data Security Board (DSMB) to share our primary analysis with the most recent efficacy data. We plan to get the results of the primary analysis within 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 on Wednesday that the AstraZeneca vaccine itself was “good” but that the pharmaceutical company had published a “somewhat outdated” . press release ‘on Monday’, which is somewhat misleading. ‘
He told ABC News that the NIH told AstraZeneca “we want the press release to be updated”, and called the information released by the company rather unfortunate because it is a good vaccine.
In the study of 30,000 people, AstraZeneca said that 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 with five such cases in participants who received placebo shots – a small number, but in line with the findings of Britain and other countries that the vaccine protects against the worst disease word.
AstraZeneca also said the study’s independent safety monitors found no serious side effects, including no. increased risk of rare blood clots such as those identified in Europe, a scare that led many countries to suspend vaccinations briefly last week.
The company planned to submit an application to the Food and Drug Administration in the coming weeks. There was no word on whether the application would be delayed due to the concerns of the DSMB.
The outside government advisers will discuss the evidence in public 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 Centers for Disease Control and Prevention after thorough review of the data by independent advisory committees.