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The FDA could authorize by emergency rules, despite fears of authorities waiving for security reasons
The Trump administration is considering circumventing normal US regulatory standards to speed up approval of a UK experimental coronavirus vaccine for use in the U.S. before the presidential election, according to three people informed about the plan.
An option being evaluated to speed up the availability of a vaccine would involve the Food and Drug Agency (FDA) granting “emergency use authorization” (USA) in October for a vaccine being developed in partnership between the pharmaceutical company AstraZeneca and the University of Oxford, based on the results of a relatively small study carried out in the United Kingdom, if it is successful, the sources said.
Read more at Folha de S.Paulo.
