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WASHINGTON – Senior White House officials are blocking tough new federal guidelines on the emergency clearance of a coronavirus vaccine and opposed a provision that would almost certainly guarantee that no vaccine can be approved before the Nov. 3 election process.
With a blockade at the White House, the Food and Drug Administration is looking at other ways to ensure vaccines are compliant. This includes sharing the standards – possibly as early as this week – with an external advisory committee of experts to meet publicly before an emergency vaccine is approved. The hope is that the committee will enforce the guidelines regardless of the White House's reaction.
The battle over guidelines is part of a month-long tug-of-war between the White House and federal agencies on the front lines of the pandemic. White House officials have intervened repeatedly to craft decisions and public announcements that would cast a positive light on the government's response to the pandemic.
This pattern has dismayed a growing number of career officials and political figures involved in the government's battle against a virus that has killed more than 209,000 people in the United States.
The vaccination guidelines have a special meaning: by refusing to allow the Food and Drug Administration, the White House is undermining government efforts to reassure the public that any vaccine will be safe and effective, health experts fear.
"The public must have full confidence in the scientific process and the strict supervision of the FDA if we want to end the pandemic," pleaded the trade association of the biotech industry on Thursday in a letter to President Trump's Minister of Health, Alex M. Azar II Requests the publication of the guidelines.
The Food and Drug Administration submitted the guidelines to the Bureau of Administration and Budget for approval more than two weeks ago, but they stalled in the office of Mark Meadows, the White House chief of staff. Your approval is now considered highly unlikely.
A key sticking point was the recommendation that volunteers who participated in vaccine clinical trials should be followed for a median of two months after the final dose before approval is given, according to a senior administrative officer and other people familiar with the situation who spoke on condition of anonymity. Given the status of the clinical studies, this two-month follow-up period would virtually rule out an emergency release before election day.
The conflict started almost as soon as the Food and Drug Administration presented the guidelines to the White House Budget Office on Monday, September 21. The next day, Dr. Stephen M. Hahn, the F.D.A. Commissioner, briefed Mr Azar on the matter.
This Wednesday, Mr Meadows raised a number of concerns, a senior administration official said. He questioned the need for two-month follow-up data, said stricter recommendations would change the rules during clinical trials, and suggested that Dr. Hahn was overly influenced by his agency's career scholars. The White House did not respond to a request for comment on Monday.
Speaking to reporters on Sept. 23, Mr Trump publicly doubted whether the guidelines would be approved. "We may or may not approve it," he said, suggesting that the regulatory move "was a political move more than anything."
F.D.A. Officials later gave additional reasons for the White House, stating that the two-month follow-up was necessary to identify possible side effects and ensure that a vaccine’s protection against Covid-19, the disease caused by the coronavirus, is not short-lived. But they couldn't break the stalemate.
The White House has the power to intervene in such non-binding guidance documents – a step below enforceable regulations – at least in part due to an October 2019 ordinance tightening restrictions on the issuance of such documents. The order alleged that "agencies have sometimes inappropriately used this authority to regulate the public". White House officials have cited it to force the Food and Drug Administration and other agencies to submit guidelines on the pandemic to the White House Budget Office for pre-release review.
Budget officials are reviewing the documents for statements that could undermine the president's public message that the administration either has the pandemic under control or will soon, according to former and current federal officials.
The testing and approval of a vaccine is a topic that has received a lot of national attention. Mr Trump has repeatedly misrepresented how quickly a vaccine could be available to most Americans and promised a major breakthrough in vaccine development earlier this month. No clinical trial in the US is advanced enough to prove a vaccine is safe and effective, although Pfizer, a vaccine developer, is hoping for interim results from its study soon.
The Food and Drug Administration's new guidelines should reassure companies developing vaccines that they are under a common standard and reassure the public. Surveys show Americans are increasingly concerned about taking a coronavirus vaccine: A poll published by the Pew Research Center last month found that 51 percent of Americans would likely or definitely take one, up from 72 percent in May.
Dr. Peter Marks, the top vaccine regulator at F.D.A., told an event hosted by Friends of Cancer Research last week that the government needs to be transparent about the standards it uses to evaluate experimental vaccines in order to build public confidence. He and other health officials have stressed that the companies that develop vaccines are already fully aware of the agency's expectations for products that require approval for use in an emergency.
Mr Azar on Friday downplayed the conflict with the White House, telling a panel in the House that those concerned about his involvement in the guidelines were "making a mountain out of a molehill."
"What the Commissioner is proposing is guidance on how to authorize emergency public use for a vaccine, in line with the letters already sent to manufacturers," said Azar. "The F.D.A. has already told manufacturers what they are looking for."
Some vaccine manufacturers, including Johnson & Johnson, have publicly stated that they will follow the agency's recommendations regardless of White House actions.
At a recent meeting with F.D.A. Staff, Dr. Marks said the agency "may hear more press noise" about problems with the guidance but added that the "goal is not to get into fights," according to people familiar with his comments. He said at the Friends of Cancer Research event that there was no need to "get excited" because "we will have a transparent advisory committee meeting for any continuous approval for emergency use."
In private, Dr. Mark's colleague says an angry tweet from Mr. Trump, the F.D.A. Scientists over the guidelines could damage public confidence in a coronavirus vaccine.
The guidelines set more specific criteria for clinical trial data and recommended that they be reviewed by the advisory committee of independent experts. It is expected to be included in the briefing papers for the next meeting of the committee, which is scheduled for October 22nd.
Food and Drug Administration officials hope the committee will review these standards before granting emergency approval for a vaccine. The most likely recipients of a vaccine to receive this approval are at risk populations such as health care workers.
In addition to the two-month follow-up period, the guidelines stipulated that there should be at least five cases of severe infections in the placebo group to demonstrate that a vaccine is effective in preventing more than just mild to moderate illness. Around 10 percent of Covid 19 cases are considered serious.
The guidelines also set out the Agency's expectation that vaccine manufacturers would continue to assess the long-term safety and efficacy of the medicine if given emergency approval.
Katie Thomas contributed to coverage from Chicago. Kitty Bennett contributed to the research.