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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 – has shown 79% effectiveness in preventing symptomatic infections and efficacy of 100% “in the prevention of serious illness. and hospitalization.”
Later Monday, the Data and Monitoring Committee [DSMB] notified AstraZeneca, NIAID and the 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“The DSMB expressed concern that AstraZeneca may have included outdated information from this trial, which may have provided an incomplete view of efficacy data,” the statement said.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 the efficacy data and ensure that the most accurate and up-to-date efficacy data is made 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 emergency use authorization in the United States 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] and 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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