FDA widens US security investigation into AstraZeneca coronavirus vaccine

WASHINGTON – The US Food and Drug Administration has broadened its investigation of a serious disease 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 said. Told Reuters.

AstraZeneca’s large, late-stage US trials have been in place since the moratorium on sept 6, after a study participant in the UK fell ill following what was believed to be a rare spinal inflammatory disorder called Is called transverse myelitis.

The broad scope of FDA investigations increases the possibility of additional delays for one of the most advanced COVID-19 vaccine candidates in development. Sources said the requested data was expected to reach this week, after which the FDA would need time to analyze it.

Effective vaccines are considered essential to help end an epidemic that has killed more than a million people worldwide.

President Donald Trump’s administration has pledged $ 1.2 billion to support the development of the AstraZeneca vaccine and secure 300 million doses for the United States. Other leading companies in the American vaccine race include Pfizer Inc., Modern Inc. and Johnson & Johnson.

Regulators in the UK, Brazil, India and South Africa have allowed AstraZeneca to resume its clinical trials.

The FDA, however, wants to determine whether similar side effects have been revealed in trials of other vaccines designed by researchers at the University of Oxford, Austronesca’s coronavirus vaccine partner. This does not mean the agency believes there were safety issues associated with any of these vaccines, he said.

“It just shows that the FDA as a whole is happening,” one of the sources said.

The further situation is that the data requested by the FDA is in a different format than that of the US regulator, two sources said.

The FDA declined to comment on discussions related to an experimental product. Oxford did not respond to requests for comment. “We are continuing to work with the FDA to facilitate the review of the information required to make a decision about resuming the US trial,” AstraZeneca said in a statement.


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