FDA widens U.S. safety inquiry into AstraZeneca coronavirus vaccine
WASHINGTON - The U.S. Food and Drug Administration has broadened its investigation of a serious illness in AstraZeneca Plc's COVID-19 vaccine study and will look at data from earlier trials of similar vaccines developed by the same scientists, three sources familiar with the details told Reuters.
Effective vaccines are seen as essential to help end a pandemic that has killed more than one million people worldwide. The FDA, however, wants to determine whether similar side effects emerged in trials of other vaccines designed by AstraZeneca's coronavirus vaccine partner, researchers at Oxford University, the sources said. That does not mean the agency believes there were safety issues associated with any of these vaccines, they added.Further complicating the situation is that the data requested by FDA is in a different format than what the U.S. regulator requires, two of the sources said.
Reuters reviewed six research papers that detailed safety data of vaccines using the engineered chimpanzee adenovirus called ChAdOx1 for diseases including tuberculosis, prostate cancer and influenza. The U.S. government's effort to speed development of a COVID-19 vaccine - and promises by Trump that one could be available prior to the Nov. 3 presidential election - has led to concerns of political interference in the regulatory process at the expense of safety. The FDA has denied this.
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