Why is AstraZeneca not approved in the US?

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Why is AstraZeneca not approved in the US?

However, officials from the monitoring board overseeing the vaccine trial expressed concern the data released by AstraZeneca may have “provided an

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However, officials from the monitoring board overseeing the vaccine trial expressed concern the data released by AstraZeneca may have “provided an incomplete view of the efficacy data”, according to the National Institute for Allergy and Infectious Diseases.

The National Institute for Allergy and Infectious Diseases then urged AstraZeneca “to work with the DSMB to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible.”

On March 24, AstraZeneca announced its vaccine was 76 percent effective at preventing symptomatic disease.

The findings were based on a Phase III trial including more than 32,000 participants.

Last month Mene Pangalos, AstraZeneca’s executive vice-president, said the latest analysis “confirms that our Covid-19 vaccine is highly effective in adults, including those aged 65 years and over”.

Mr Pangalos added: “We look forward to filing our regulatory submission for emergency use authorisation in the US and preparing for the rollout of millions of doses across America.”

The FDA is now tasked with scrutinising the AstraZeneca vaccine’s data, to see whether it will receive approval in the US.



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