The National Institute of Allergy and Infectious Diseases of the United States (NIAID) raised doubts about the efficacy data of the Oxford / AstraZeneca vaccine against covid-19 being tested in the country. In a note released on Tuesday (23), the entity said the study may contain “outdated information”.
This Monday (22), the pharmacist announced that the clinical trial conducted in the American territory, with more than 32 thousand volunteers, resulted in an efficiency of 79% in the prevention of symptomatic cases of the disease and 100% in relation to severe conditions and hospitalizations.
With that, the company hoped to request authorization for emergency use of the Oxford vaccine in the United States. However, NIAID said it had received an alert from the Data Security and Monitoring Council (DSMB), an independent group of experts who review the study’s data, about the possibility of outdated data in it.
If the information is really out of date, the pharmaceutical company may have provided an “incomplete view of the efficacy data”, according to the institute, which asked the company for a new review, “as soon as possible”, done in conjunction with the DSMB.
Reply from AstraZeneca
In response to NIAID, the British laboratory said the released result was based on data collected until February 17. “We reviewed the preliminary assessment of the primary analysis and the results were consistent with the intermediate analysis,” commented the company.
The company also revealed that it is completing the evaluation of the most recent data from the clinical trial and will share it with the Council, issuing a new opinion within 48 hours, providing a more complete view on the vaccine’s effectiveness.
Thereafter, the study data will still need to be reviewed by independent advisory committees, so that the Federal Food and Drug Administration (FDA) and the Disease Control Center (CDC) then decide on authorization for use in the USA.
The Oxford vaccine has been involved in a number of problems in recent months. One of the most recent was the suspicion of clots in the blood of people who received doses of the formula, leading to discontinuation of use in some countries in Europe, who later re-applied it.
For the immunologist and director of NIAID Anthony Fauci, the wrong disclosure of the study data can lead to an unnecessary hesitation around the immunizer. “This is really what you call an unforced error, because the fact is that most likely this is a very good vaccine,” commented the expert.