WASHINGTON – Top White House officials are blocking strict new federal guidelines for the emergency release of the ronavirus vaccine, objecting to a provision that would almost certainly guarantee that the vaccine would not be given before the Nov. 3 election, according to sources familiar with the approval process.
Facing the White House blockade, the Food and Drug Administration is exploring other ways to ensure the vaccine meets the guidelines. That includes sharing the standards with an outside advisory committee of experts – perhaps earlier this week – that is expected to meet in public before a vaccine is authorized for emergency use. It is hoped the committee will implement the guidelines regardless of the White House’s response.
The conflict over the guidelines is part of a month-long war between the White House and federal agencies on the front lines of the epidemic response. Interventions have often been made by White House officials to shape decisions and public announcements that paint the administration’s response to the epidemic in a positive light.
That pattern has led to an increase in the number of career officers and political appointees involved in the administration’s fight that has claimed the lives of more than 209,000 people in the United States.
Vaccine guidelines are of particular importance: By refusing to allow the Food and Drug Administration to release them, the White House is undermining the government’s efforts to reassure the public that any vaccine will be safe and effective, health experts fear.
President Trump’s health secretary, Alex M., on Thursday called on the biotech industry trade association. In a letter to Azar II, he urged that “if we want to end the epidemic, we must have full confidence in the scientific process and the rigor of the FDA’s regulatory oversight.” , Asking to publish guidelines.
The Food and Drug Administration submitted guidelines to the Fiscal Management and Budget for approval more than two weeks ago, but they were stuck in the White House Staff of Mark Meadows. Their approval is now seen as very unlikely.
The chief executive has recommended that the vaccine be administered to volunteers who have participated in clinical trials for about two months after the final dose before any authorization is given, said a senior administration official and others familiar with the situation. People said. Anonymity condition. Given where the clinical trials are, it would exclude a two-month follow-up period, the approval of any emergency before election day.
The conflict began almost immediately after the Food and Drug Administration submitted guidelines to the White House budget office fees on Monday, September 21. The next day, the FDA commissioner, Dr. Step. Stephen M. Hahn briefed Mr. Azar on the matter.
That Wednesday, Mr Meadows raised a series of concerns, a senior executive official said. He questioned the need for two months of follow-up data, saying the stricter recommendations would change the rules between clinical trials and suggested that Dr Hahn was more influenced by his agency’s career than scientists. The White House did not respond to a request for comment Monday.
Speaking to reporters on September 23, Mr. Trump publicly expressed doubts about whether the guidance would be approved. “Whether we recognize it or not, we will not allow it,” he said, suggesting that regulatory action was “more of a political move than anything else.”
FDA officials later gave the White House additional justice, explaining that a two-month follow-up was needed to identify possible side effects and ensure that vaccine protection against corovirus disease, Covid-19, was not short-lived. . But they could not break the deadlock.
The White House reserves the right to intervene in such non-binding guideline documents – one step below applicable regulations – at least in part due to an October 2019 executive order that tightened restrictions on the issuance of such documents. The order emphasizes that “agencies sometimes misuse this right in their efforts to regulate people,” and White House officials have forced it to force the Food and Drug Administration and other agencies to submit epidemic-related guidelines to the White House Budget Office. Review before public release.
According to former and current federal officials, staff members of the budget office examine documents for statements that could snatch the president’s public message that the administration is either controlling the epidemic or soon, according to former and current federal officials.
Vaccine testing and release is an issue that has attracted widespread national attention. Mr. Trump has repeatedly misrepresented how quickly the vaccine could become available to most Americans, guaranteeing great success in vaccine development as early as this month. Although no clinical trial in the United States has yet progressed enough that any vaccine is safe and effective, a vaccine developer Pfizer expects interim results soon after its trial.
The Food and Drug Administration’s new guidelines were aimed at reassuring companies developing vaccines that they are being kept to a normal standard and can reassure the public. Polls suggest Americans are increasingly wary of taking the coronavirus vaccine: A survey published last month by the Pew Research Center found that 1 percent of Americans would probably or would definitely take one, down from 5 percent in May.
Dr. Peter Marks, the FDA’s top regulator for vaccinations, said at an event hosted by Friends Cancel Cancer Research last week that the government needs to be transparent about the standards being used to evaluate experimental vaccines to boost government confidence. He and other health officials insisted that vaccine companies were already fully aware of the agency’s expectations for products seeking authorization for emergency use.
Mr Azar, in a confrontation with the White House on Friday, told the House panel that people concerned about his involvement in the guidelines were building a “mountain from Molehill”.
Mr Azar said the commissioner is proposing to put the vaccine in a public emergency authorization guideline on a vaccine that would be consistent with letters sent to manufacturers. “The FDA has already told manufacturers what they are looking for.”
Several vaccine manufacturers, including Johnson and Johnson, have publicly indicated that they will follow the agency’s recommendations, regardless of White House action.
In a recent meeting with members of the FDA staff, Dr. Marks said the agency could “hear more voices in the press” about the difficulty with guidance, but added that “the goal is not to fight the fight,” according to his acquaintances in the comments. “Not everyone is excited,” he said at the Friends Cancel Cancer Research event because “we will convene a transparent advisory committee to authorize each emergency use.”
Privately, Dr. Mar. Marcus told colleagues that an angry tweet attacking Mr. Trump on FDA scientists over the guidelines could damage people’s confidence in the coronavirus vaccine.
The guidelines set out more specific criteria for clinical trial data and were recommended for review by an advisory committee of independent experts. It is expected to be included in the briefing papers of the next meeting of the committee to be held on October 22.
Food and Drug Administration officials hope the committee will consider these standards before approving any emergency use for the vaccine. The most likely recipients of any vaccine that wins is the high-risk population, such as health care workers.
In addition to the two-month follow-up period, the guidelines state that there should be at least five cases in the placebo group, as evidence that the vaccine is effective in preventing more than just mild to moderate illness. About 10 percent of Covid-19 cases are considered serious.
The agency also expects vaccine manufacturers to continue to evaluate the long-term safety and efficacy of the drug if emergency use is allowed.
Katie Thomas contributed a report from Chicago. Kitty Bennett contributed to the research.
