AstraZeneca may have provided outdated COVID-19 trial data, according to NIAID

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AstraZeneca may have provided outdated COVID-19 trial data, according to NIAID


AstraZeneca may have provided an incomplete view of efficacy data related to its clinical trial of the COVID-19 vaccine, according to the National Institute of Allergy and Infectious Diseases (NIAID) on Tuesday.

The British pharmaceutical company said in a statement Monday morning that the phase III trial of its COVID-19 vaccine – which was conducted in the United States – showed 79% effectiveness in preventing symptomatic infections and effective of 100% “in the prevention of serious diseases. and hospitalization. ”

Later Monday, the Data and Security Oversight Committee [DSMB] notifié AstraZeneca, NIAID et la Biomedical Advanced Research and Development Authority [BARDA] that he was concerned about information released by the company on initial data from its COVID-19 vaccine clinical trial, NIAID wrote in a statement.

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A policeman receives an injection of AstraZeneca’s COVID-19 vaccine in Munich, Germany on March 2, 2021 (Sven Hoppe / dpa via AP, file)

“The DSMB expressed concern that AstraZeneca may have included outdated information from this trial, which may have provided an incomplete view of efficacy data,” the statement said. “We urge the company to work with the DSMB to review efficacy data and ensure that the most accurate and up-to-date efficacy data is released to the public as quickly as possible.

AstraZeneca did not immediately respond to a request for comment late at night from Fox News.

The request to review the efficacy data comes as the company plans to apply for a U.S. emergency use authorization for the vaccine in the coming weeks.

Authorization and directions for use of the vaccine in the United States will be determined by the Food and Drug Administration. [FDA] et Centers for Disease Control and Prevention [CDC] after a “thorough review of the data by independent advisory committees,” the statement said.

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This week, AstraZeneca US President Ruud Dobber said the company will be able to deliver 30 million doses to Americans once the vaccine is cleared for emergency use.

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Dobber recently sought to assure the American public that the company’s COVID-19 vaccine was safe, despite concerns about links to potential blood clots raised in Europe.

Brittany De Lea ‘Edmund DeMarche and Fox Business’ of Fox News contributed to this report

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