Vaccine maker AstraZeneca has completed enrollment in its Phase 3 clinical trial in the US, according to slides posted to US Centers for Disease Control and Prevention website Wednesday ahead of a presentation by a company representative.
The slides clarify the ongoing trial, which includes more than 32,000 participants, will serve as “the primary basis” for the company’s application to the US Food and Drug Administration for emergency use authorization, “with supporting data” from trials abroad.
Of the 32,459 participants enrolled, 26,327 received their second dose by Jan. 21, the slides say. About two-thirds of participants in the US trial receive the vaccine, and the remaining third receive placebo.
Some background: On Sept. 6, AstraZeneca’s US trial was put on pause in the US after a trial volunteer in the UK developed neurological symptoms. The trial resumed in the US on Oct. 28, after a review by the US Food and Drug Administration concluded it was safe to do so.
AstraZeneca’s vaccine has not been authorized for emergency use in the United States, but it has in other countries, such as the UK and India.
Earlier this month, Operation Warp Speed’s Moncef Slaoui projected AstraZeneca’s vaccine could be authorized in the US by the end of March. The US has contracted to purchase 300 million doses of the company’s vaccine.