Will AstraZeneca finally be authorized in the United States?
The British laboratory's Covid-19 vaccine is finally 76% effective against symptomatic cases, the group announced, after an update of its data from a clinical trial in the United States, Peru, and Chile.
The results of "the primary analysis of phase III trials (of the vaccine) in the United States confirmed that (its) efficacy was consistent" with data announced on Monday, AstraZeneca said in a statement.
The laboratory also announced that the effectiveness of its vaccine was 100% in preventing severe cases of Covid-19, a figure similar to that previously announced.
AstraZeneca pledged 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, then announced 79% effective in preventing symptomatic cases.
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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, according to NIAID, result in "an incomplete estimate of the effectiveness" of the vaccine.
An order of 300,000 million doses already placed
As part of Operation Warp Speed launched in the spring of 2020 by the Trump administration to support the development of a vaccine against Covid-19, an order for 300 million doses had been placed with AstraZeneca - much more than the number initially ordered from Pfizer / BioNTech, Moderna or Johnson & Johnson (100 million each), the three vaccines currently authorized in the United States.
New contracts have since been signed, so that the United States will have been delivered with enough doses of these three vaccines to be able to vaccinate all American adults by the end of May, the Biden government promised.
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This month, several countries suspended use of AstraZeneca's vaccine over fears it could cause blood clots, sometimes fatal.
Last Thursday, the European Medicines Agency (EMA) yet deemed it "safe and effective" and the use of the vaccine resumed in some countries.
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.
