The U.S. Food and Drug Administration has issued a set of strict new guidelines for emergency authorization of a COVID-19 vaccine in defiance of strong objections from the Trump administration.
The guidance released Tuesday by the FDA requires pharmaceutical companies to observe participants in late-stage clinical trials for at least two months after they receive a second and final dose of an experimental vaccine.
The new rules were included in a document prepared for a meeting later this month with the FDA’s vaccine advisory board, which will discuss requirements for either emergency use authorization or the full licensing of a potential vaccine.
The publication of the rules comes a day after several U.S. news outlets reported that the White House had rejected the proposals. The strict guidelines mean a possible COVID-19 vaccine will not be ready before the November 3 presidential election, undercutting predictions made by President Donald Trump.
The FDA and other federal scientific and regulatory agencies have seen their credibility diminished by constant administration efforts to revise their reports and guidelines to maintain Trump’s more optimistic views about the nature of the pandemic.
“Being open and clear about the circumstances under which the issuance of an emergency use authorization for a COVID-19 vaccine would be appropriate and is critical to building public confidence and ensuring the use of COVID-19 vaccines once available,” Dr. Peter Marks, director of the FDA division responsible for approving vaccines, said in a statement.
President Trump, who is recovering from a COVID-19 infection that led to a three-day stay at Walter Reed Military Medical Center until Monday, lashed out at the new guidelines late Tuesday night on Twitter. “New FDA Rules make it more difficult for them to speed up vaccines for approval before Election Day. Just another political hit job!” the president wrote, tagging FDA Commissioner Stephen Hahn.
The U.S. leads the world with 7.5 million total COVID-19 cases, including nearly 211,000 deaths. Several states are experiencing a sharp rise in new coronavirus cases after weeks of steady declines.
The director of the World Health Organization’s Europe division says that region is falling prey to coronavirus “fatigue” just as many countries are battling a sudden resurgence of the disease.
Dr. Hans Kluge said Tuesday the level of fatigue was as high as 60% in some countries, acknowledging that such high levels are to be expected after citizens have made “huge sacrifices.”
Dr. Kluge said leaders across the continent must look beyond biomedical science to “reinvigorate and revive efforts” among the public “to tackle the evolving COVID-19 challenges that we face.” He urged them to interact with citizens to understand their needs and behaviors, and develop innovative strategies to keep them involved in the fight against the pandemic.
