President Donald Trump, who seems intent on announcing a Covid-19 vaccine before Election Day, could legally authorize a vaccine over the objections of experts, officials at the Food and Drug Administration and even vaccine manufacturers, who have pledged not to release any vaccine unless it’s proved safe and effective.

In podcasts, public forums, social media and medical journals, a growing number of prominent health leaders say they fear that Trump — who has repeatedly signaled his desire for the swift approval of a vaccine and his displeasure with perceived delays at the FDA — will take matters into his own hands, running roughshod over the usual regulatory process. The worries intensified over the weekend, after Alex Azar, the administration’s secretary of Health and Human Services, asserted his agency’s rule-making authority over the FDA. The fear is that Trump's pressure on the HHS could influence the speed of an authorization. HHS spokesperson Caitlin Oakley said Azar’s decision had no bearing on the vaccine approval process.

An intervention in the process would signal another injection of politics into a sensitive public health decision by the norm-breaking Trump administration. Trump has repeatedly contradicted the advice of senior scientists on Covid-19 while pushing controversial treatments for the disease.

Overruling the FDA’s scientific judgment could lead to the rushed release of a vaccine of limited efficacy and, worse, unknown side effects.

Vaccines are typically approved by the FDA. But Azar — who reports directly to Trump — can issue an emergency use authorization, even before any vaccines have been shown to be safe and effective in late-stage clinical trials.







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