The AstraZeneca laboratory committed this Tuesday to providing recent data within 48 hours to the American regulator overseeing clinical trials of its Covid-19 vaccine.
In a statement, the group explained that it had used data dating back to before February 17 for the results, published on Monday, of clinical trials in the United States.
He assured that he wanted to get in touch "immediately" to provide the Data and Safety Monitoring Board (DSMB, trial monitoring committee) "with an analysis with the most up-to-date efficacy data possible", with the intention of “Provide primary analysis results within 48 hours”.
Used in many countries including the European Union, the vaccine developed by AstraZeneca and the University of Oxford has not yet been approved in the United States, where the authorities had requested more data on phase III trials conducted on American territory.
Called to order by the regulator
After the publication of the results of these trials on Monday, the National Institute of Infectious Diseases and Allergies (NIAID), which oversees clinical trials of vaccines in the United States, had expressed its "concern" that the Swedish laboratory British company was able to "use obsolete information" in the course of its tests.
This could lead to "an incomplete estimate of the effectiveness" of the vaccine.
The Institute therefore urged the laboratory to work with the Data and Safety Monitoring Board “to assess the effectiveness of the data and ensure that the most precise, recent and most effective data possible are made public as soon as possible. ".
News: NIAID Statement on AstraZeneca Vaccine https://t.co/gcHWPIX9QQ
- NIH (@NIH) March 23, 2021
According to the results, published Monday, of these trials conducted with more than 32,000 participants, the vaccine is 80% effective against Covid-19 in the elderly and does not increase the risk of blood clots.
The vaccine is 79% effective in preventing symptomatic Covid-19 in the general population and 100% in preventing severe forms of the disease and hospitalization, the laboratory added.
This month, several countries suspended its use for fear that it could cause blood clots, sometimes fatal.
Thursday, the European Medicines Agency (EMA) yet deemed it "safe and effective" and the use of the vaccine has resumed in some countries.
