AstraZeneca expects US vaccine data ‘soon’ — with 50M doses ready by the end of April
AstraZeneca said it’s readying the release of data from its US-based Phase III trial, which has more than 32,000 participants, for its upcoming emergency use authorization application.
“We expect data from our US Phase III trial to be available soon, in the coming weeks, and we plan to file for emergency use authorization shortly thereafter,” a company spokesperson said via email.
A snap decision on the vaccine would put the US months behind the EU in authorizing it, but recent concerns about blood clots pushed Norway, Denmark and Iceland to halt the vaccine’s use. The European Medicines Agency, however, noted, “As of 9 March 2021, 22 cases of thromboembolic events had been reported among the 3 million people vaccinated with COVID-19 Vaccine AstraZeneca in the European Economic Area.”
Estonia, Lithuania, Luxembourg, Latvia have suspended one particular batch (1 million doses) of the vaccine, which was delivered to 17 EU countries. Still, other countries are seeking doses of the vaccine.
In Friday’s Covid-19 press briefing with the Biden administration, a Reuters reporter asked about the unwillingness of the US to share some of its supplies of the AstraZeneca vaccine (the New York Times also reported Friday on its front page that the US is hoarding about 30 million of doses of the AstraZeneca vaccine). And AstraZeneca’s spokesperson confirmed that it was aware of other governments that may have reached out to the US government about donating doses, “and we’ve asked the US government to give thoughtful consideration to these requests. If those donation actions were to proceed, we would seek guidance from the US Government on replacement of doses for use in the US.”
As far as how many doses are to be expected in the coming months in the US, should the vaccine win an authorization, the AstraZeneca spokesperson said: “We believe we will have roughly 30 million doses available to the US government by the end of March, and another 20 million, for a total of up to 50 million, by the end of April.”
And the Biden administration is making clear that it has no intention of giving those doses up right now.
Jeff Zients, Biden’s coronavirus czar, told reporters on Friday:
As to AstraZeneca, we’re following the exact same process that we did with the other three now-approved vaccines — Moderna, Pfizer, and J&J. And just as we did with those vaccines, as we awaited for the completion of the clinical trial — and right now, my understanding is that AstraZeneca is in the middle of its phase three trial — and then an FDA determination of when they submit the data from the clinical trial, we have a small inventory of AstraZeneca so that, if approved, we can get that inventory out to the American people as quickly as possible, as we just did with J&J. So, AstraZeneca, we’re awaiting the clinical trial and then the decision by the FDA and CDC.
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