Senior White House officials have raised objections to the U.S. Food and Drug Administration’s proposed standards for deciding whether a Covid-19 vaccine should be given widely and don’t appear likely to sign off on the agency’s guidelines, people familiar with the matter said.
In talks with the FDA in recent days, White House officials expressed a number of concerns about the draft guidelines, including a proposal that would require researchers to monitor study subjects for side effects for two months after getting a shot, the people said.
The disagreement could put the administration on a collision course with the FDA over whether and when to authorize use of a Covid-19 vaccine, once the late-stage trials that are testing the shots start providing data—perhaps in as little as a few weeks—on how the injections are performing.
The White House could drop its objections and permit the FDA to publish its guidelines, the people said. Yet so far in talks, administration officials haven’t indicated they would approve the FDA’s proposal or seek to resolve concerns.
A White House spokesperson declined to comment.
The White House doesn’t need to approve the guidelines, because they simply indicate the FDA’s thinking, rather than carrying the force of, say, a regulation. Yet the agency often seeks an administration’s stamp of approval so companies and the public will know what goals medicines need to meet in order to be cleared for use.
The FDA wanted the administration’s blessing in this case to reassure Americans that any vaccines they might be offered would meet high standards, one person familiar with the matter said.
The refusal so far to sign off could reignite concerns that the Trump administration might interfere in science-based decision making at the FDA and pressure the agency to rush out a vaccine for political reasons.
It could also make it harder to persuade many Americans—who polls show are concerned about the safety of the shots—to get one once use is permitted. Health officials say administering safe and effective vaccines widely will be critical to halting the pandemic in the U.S., where nearly 7.3 million have been infected and more than 208,000 people have died from Covid-19.
Companies developing the leading vaccines, seeking to ease public concerns about the shots’ safety, have indicated support for the requirements, saying they wouldn’t seek a shot’s authorization unless it met the kinds of targets that the FDA has laid out. Plans for each of the leading vaccine candidates require they prove at least 50% more effective than placebo during studies, as the agency recommended.
“I’m concerned by the level of micro-management by political forces here. The FDA’s attempt to inform manufacturers and the public should be coming from the scientists at the agency,” said Aaron S. Kesselheim, a Harvard Medical School professor whose research often focuses on the FDA.
At issue in the White House’s dispute with the FDA are the guidelines the agency wants to follow for assessing whether a coronavirus vaccine works safely enough to be widely used.
The FDA typically follows a lengthy approval process for vaccines. But due to the urgent need, the agency sought to establish guidelines that would allow for a much faster review while still ensuring a shot worked safely. Despite that accelerated timetable, the FDA has proposed holding Covid-19 shots to the same rigorous standards it would have used if it conducted a lengthier review, The Wall Street Journal has reported.
The leading vaccine candidates are in the last stage of testing. The trials for shots developed by Moderna Inc. and Pfizer Inc. could start providing some key results by the end of this month or next month, executives at the companies have said.
The administration officials also objected to issuing the guidelines now, since the late-stage trials evaluating whether experimental vaccines work safely could start providing key results in as soon as a few weeks, one of the people said.
Among the White House officials raising concerns were chief of staff Mark Meadows and some high-ranking aides in the Office of Management and Budget, the person said.
Even without the administration’s signoff, the FDA plans to follow its guidelines, the people said. The agency recently sent a letter to major vaccine manufacturers laying out the standards and saying vaccines must meet them in trials to secure authorization, according to the people.
Many of the FDA’s guidelines stuck closely to the requirements the agency planned to follow for a normal review, people familiar with the matter said. For instance, the guidelines call for an experimental vaccine to reduce the rate of infections among people exposed to the coronavirus during a late-stage trial by a statistically significant 50% compared with people getting a placebo, people familiar with the matter said.
The FDA sought to monitor study subjects for side effects for a median of two months following injection because safety issues typically emerge within about six weeks, one of the people familiar with the matter said.
If a vaccine met the standards, the FDA would clear the shot for use during the pandemic through emergency-use authorization, a tool the agency often uses during public-health crises. After the pandemic ended, a vaccine would require a normal approval for continued use.
The agency has followed the emergency authorization process to clear a few Covid-19 therapies, including the antiviral remdesivir. Yet FDA’s the proposed requirements for emergency authorization of a vaccine would make that difficult to issue before Election Day, according to people familiar with the matter.
President Trump has said he would like a vaccine to be available before the election on Nov. 3. He said last month that a shot could be available this fall, hours after the Centers for Disease Control and Prevention Director Robert Redfield said a vaccine might not be widely available until next year.
After details emerged about the FDA’s draft plan for authorizing a vaccine, Mr. Trump said he “may or may not” go along, and said the rigorous standards seemed like “a political move more than anything else.”
He tweeted Sept. 23 about the vaccine process: “@FDA must move quickly.”
In Tuesday’s presidential debate Mr. Trump doubled down on his previous remarks, saying drugmakers had told him vaccines could be widely available before the summer timetable federal health officials had been giving.
“They can go faster than that by a lot,” the president said. He also said he was told by the head of the federal coronavirus-response program that “it’s a possibility that we’ll have the answer before Nov. 1st.”
Until recently, the FDA had appeared to sidestep White House pressure. That changed when Mr. Trump began urging people to take malaria drugs hydroxychloroquine and closely related chloroquine to treat Covid-19.
In March, the FDA authorized emergency use of the antimalarials. The agency reversed the decision in June, as evidence pointed away from the drugs’ usefulness for Covid-19 and toward cardiac and other risks.
The FDA also suffered a public-relations black eye after it authorized the use of convalescent plasma, the antibody-rich blood component from recovered Covid-19 patients, to treat current cases.
Agency officials had decided by the weekend of Aug. 22 to authorize convalescent plasma after testing showed its benefits outweighed the risks, a person familiar with that matter has said. That same day, however, the president accused the FDA of being dominated by “deep state” officials seeking to slow down approvals to hurt his re-election effort. And when the FDA authorized the plasma the next day, Mr. Trump took credit, saying his administration had taken steps to end the delay.
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