A surveillance group expressed “concern that AstraZeneca may have used outdated information in this trial” in the United States, “which may have resulted in an incomplete estimate of the effectiveness” of the vaccine, said reported the National Institute of Infectious Diseases and Allergies (NIAID), which oversees clinical trials of vaccines.
“We urge the company to work with the Data and Safety Monitoring Board (DSMB), to assess the effectiveness of the data and ensure that the most accurate, recent and the most effective possible be made public as soon as possible, “he added in a statement.
The AstraZeneca laboratory defended its vaccine on Monday, rejected by a large part of Europeans, claiming that it was 80% effective against Covid in the elderly and did not increase the risk of clots, after phase III clinical trials conducted in the United States, with 32,449 participants.
The Swedish-British AstraZeneca 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 after these clinical trials.
This month, several countries have suspended its use over fears 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.
AstraZeneca to provide recent data to US regulator within 48 hours
The AstraZeneca laboratory pledged on Tuesday to provide recent data within 48 hours to the US regulator overseeing clinical trials, which criticized potentially “obsolete” data on its anti-Covid vaccine. In a statement, the group explained that it had used data dating back to before February 17 for the results published Monday of clinical trials in the United States, and want to get in touch “immediately” to provide the Data and Safety Monitoring Board (DSMB, trial monitoring committee, Editor’s note), “an analysis with the most up-to-date efficacy data possible”.