The data was supposed to pave the way for approval of the shooting in the United States, but officials say it may include “ outdated ” information.
Results of a new american test AstraZeneca’s COVID vaccine may have used “outdated information,” US federal health officials have said, in a shock to the company that has faced scrutiny over safety concerns.
In a statement on Tuesday, the National Institute of Allergy and Infectious Diseases (NIAID) said it had been informed by the Data and Safety Oversight Board (DSMB) of fears that AstraZeneca “may have provided an incomplete view 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 efficacy data is made public as quickly as possible,” said NIAID.
The post comes hours after AstraZeneca announced on Monday that its COVID vaccine offered strong protection in adults of all ages in a long overdue U.S. study. It was expected that the discovery restore public confidence in shooting around the world and bring it closer to approval in the United States.
In the study of 30,000 people, the vaccine was 79% effective in preventing symptomatic cases of COVID-19, including in the elderly. Previous studies had raised questions about the effectiveness of the inoculant in the elderly.
There were no serious illnesses or hospitalizations among the vaccinated volunteers, compared to five such cases in participants who received dummy 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 that the study’s independent safety monitors found no serious side effects, including any increased risk of rare blood clots, concerns on which many countries, mainly in Europe, briefly suspended the drug. vaccine use last week.
The company intends to file an application with the U.S. Food and Drug Administration (FDA) in the coming weeks, and outside government 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 determined by the Food and Drug Administration and the Centers for Disease Control and Prevention after a thorough review of the data by independent advisory committees.
The NIAID statement did not provide further details of its concerns, but comes as Washington faced increased pressure to share Astrazeneca vaccines produced in the country ahead of approval.
Last week, the White House said the United States has seven million “releasable doses” of the vaccine as part of its 300 million-dose order. This too announced plans “Lend” three million doses to Mexico and Canada.