FDA Expands Critical Illness Investigation into AstraZeneca Coronavirus Vaccine Study: Report


The Food and Drug Administration (FDA) has reportedly broadened its investigation into a serious illness suffered by a patient participating in AstraZeneca’s COVID-19 vaccine testing trials.Reuters reported on Thursday that FDA officials would seek data from the University of Oxford, AstraZeneca’s testing partner, regarding vaccine trials for other diseases unrelated to COVID-19 in hopes to determine if patients in these trials developed similar side effects.

The move comes after the AstraZeneca / Oxford project was suspended in early September due to a UK trial participant who fell ill with what was believed to be rare transverse myelitis of the spine.

“It just shows that the FDA is thorough,” a source close to the investigation told Reuters.

The expanded scope of the investigation would not indicate an FDA opinion that AstraZeneca’s trials are not safe or that other vaccines used in the trials by Oxford were either safe, according to the sources, who have noted that some delays have occurred due to data from Oxford. presented in a different format than what the FDA requested.

The FDA declined to comment on Reuters, while AstraZeneca has pledged to continue working with the agency to provide a COVID-19 vaccine.

“We continue to work with the FDA to facilitate the review of the information necessary to make a decision on whether to resume the US trial,” said a spokesperson for the company.

A number of private companies are pursuing COVID-19 vaccines in various stages of clinical trials, including drug makers Pfizer and Moderna; AstraZeneca is also conducting clinical trials in countries other than the United States, including the United Kingdom and India.


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