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AstraZeneca says following successful trials it will apply for emergency use authorization in the United States

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Posted: Monday, March 22, 2021. 2:50 pm CST.

By Rubén Morales Iglesias: Following the Oxford/AstraZeneca US trials which proved the vaccine to be 79% effective, AstraZeneca said in April it will apply for emergency use authorization in the United States.

AstraZeneca said its vaccine trials in the US proved “79% efficacy at preventing symptomatic COVID-19 and 100% efficacy against severe or critical disease and hospitalization.”

“We are preparing to submit these findings to the US Food and Drug Administration and for the rollout of millions of doses across America should the vaccine be granted US Emergency Use Authorization,” Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D said.

“These results add to the growing body of evidence that shows this vaccine is well tolerated and highly effective against all severities of COVID-19 and across all age groups,” Pangalos said in the AstraZeneca report. “We are confident this vaccine can play an important role in protecting millions of people worldwide against this lethal virus.

AstraZeneca said it applied its vaccines to 32,449 volunteers and that the “vaccine efficacy was consistent across ethnicity and age. Notably, in participants aged 65 years and over, vaccine efficacy was 80%.”

The company said “79% were white/Caucasian, 8% black/African American, 4% Native American and 4% Asian, and 22% of participants were Hispanic.”

The AstraZeneca report said: “The vaccine was well tolerated, and the independent data safety monitoring board (DSMB) identified no safety concerns related to the vaccine” and “found no increased risk of thrombosis or events characterized by thrombosis among the 21,583 participants receiving at least one dose of the vaccine.”

The company executives reportedly said it can supply the U.S. with 50 million vaccine doses in the first month after authorization.

In a briefing today, Anthony Fauci, the US top infectious diseases adviser said US trial results are an “important contribution to global health in general” adding the FDA will review the data in detail before authorizing the use of the AztraZeneca vaccine.

There has been heightened concern after the Oxford-AstraZeneca vaccine roll-out was temporarily suspended in Europe in countries including Norway, France and Denmark because of reports of blood clotting. However, the European Medicines Agency (EMA) said last Thursday after an investigation that the vaccine is safe and effective in preventing coronavirus and that it is not associated with an increase of thromboembolic events or blood clots.

“These findings reconfirm previous results observed in AZD1222 trials across all adult populations but it’s exciting to see similar efficacy results in people over 65 for the first time,” Ann Falsey, Professor of Medicine, University of Rochester School of Medicine, US, and co-lead Principal Investigator for the trial said in the AstraZeneca report. “This analysis validates the AstraZeneca COVID-19 vaccine as a much-needed additional vaccination option, offering confidence that adults of all ages can benefit from protection against the virus.”

AstraZeneca said that it will continue to analyze the data and prepare for the primary analysis to be submitted to the US Food and Drug Administration for Emergency Use Authorization in the coming weeks.

More than 70 countries have already approved the Oxford-AstraZeneca vaccine. The company said it plans to manufacture up to 3 billion doses this year.

 

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