AstraZeneca may have used “outdated information” when it released data from a late-stage trial of its COVID-19 vaccine early Monday, federal officials say. The Data and Safety Monitoring Board (DSMB) late in the day said it was “concerned” about the information released by the British drug company about the large-scale US trial of the vaccine it had co-developed with Oxford University.
The National Institute of Allergy and Infectious Diseases (NIAID) said: “The DSMB expressed concern that AstraZeneca may have included outdated information from that study, which may have provided an incomplete picture of the efficacy data. We urge the company recommends working with the DSMB. Review efficacy data and ensure that the most accurate, up-to-date efficacy 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 highly anticipated US study, a finding that could have helped restore public confidence in the shot around the world and take it one step further. closer to adoption in the world. U.S
AstraZeneca said in a statement Wednesday that the data released on Monday was “based on a pre-specified interim analysis with a cut-off of Feb. 17. We reviewed the preliminary assessment of the primary analysis and the results were consistent with the interim analysis. analysis. “
The drug company said it “completed validation of the statistical analysis” and “would immediately contact the independent Data Safety Monitoring Board (DSMB) to share our primary analysis with the most current efficacy data. primary analysis within 48 hours. “
Dr. Anthony Fauci, director of the US 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Biden, said on Wednesday that the AstraZeneca vaccine itself was “good,” but the drug company issued a “somewhat outdated” press release on Monday. , which is somewhat misleading. “
He told ABC News that the NIH had told AstraZeneca “we wanted the press release to be updated,” calling the company’s information “a shame because it’s 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 injections – 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 no increased risk of rare blood clots as identified in Europe, a shock that led many countries to short-term vaccinations last week.
The company planned to file an application with the Food and Drug Administration in the coming weeks. There was no word as to whether that application would be delayed because of the concerns of the DSMB.
The government’s outside advisers will publicly debate the evidence before the agency makes a decision. Authorization and guidelines for use of the vaccine in the United States will be established by the Food and Drug Administration and Centers for Disease Control and Prevention after in-depth review of the data by independent advisory committees.