WASHINGTON (AP) – US test results for AstraZeneca COVID-19 vaccine may contain “outdated information”, which could mean the company has provided an incomplete view of efficacy data, US federal health officials said on Tuesday.
A spokesman for the pharmaceutical company said on Tuesday it was “studying”.
AstraZeneca said Monday that its COVID-19 vaccine has provided strong protection in a long-awaited U.S. study of adults of all ages, which some experts believe will help restore public confidence in the worldwide shot. cleaning. In the United States
In a study of more than 30,000 people, the company reported that the vaccine was found to be 79% effective in preventing symptomatic COVID-19, including in older adults. There were no serious illnesses or hospitalizations among the vaccinated volunteers, compared with five such cases in participants who received a small number of fake shots, but in line with the findings in the UK and other countries that the vaccine protects against disease exacerbation.
AstraZeneca also said that independent safety observers in the study found no serious side effects, including the risk of a rare blood clot found in Europe, which prompted many countries to stop short-term vaccinations last week.
But just hours after the announcement of those encouraging results, the US National Institute of Allergy and Infectious Diseases issued an unusual statement.
The agency noted that the Data Security Monitoring Board was “concerned that AstraZeneca may contain outdated information from the trial that could provide incomplete insights into performance data.”
“We urge the company to work with DSMB to review performance data to ensure more accurate, up-to-date publicity for up-to-date data,” the statement added.
The company intends to apply to the Food and Drug Administration in the coming weeks, and then the government’s external advisers will publicly discuss the evidence.
Vaccine authorization և guidelines in the United States are determined by the FDA իվանդ Centers for Disease Control և Prevention after a thorough review of the data by independent advisory committees.