Comment Trump officials have repeatedly blocked the Food and Drug Administration’s plan to extend safety studies of coronavirus vaccines into fall 2020, as President Donald Trump pushed the agency for a faster timeline so vaccines could be approved before the day of the election, according to emails, text messages and interviews. conducted by a congressional committee investigating the response to the pandemic. White House officials like trade adviser Peter Navarro and outside allies like TV host and doctor Mehmet Oz also pushed federal officials in 2020 to approve the antimalarial drug hydroxychloroquine as a treatment for the coronavirus, with Navarro and a deputy to work behind the scenes to have a hospital. submit a request to the FDA for broad access to the debunked treatment touted by Trump, the select House subcommittee on the coronavirus crisis concluded in a report released Wednesday. The report offers new details in contemporary reports about the Trump White House’s efforts to influence the FDA in the first year of the pandemic, a pressure campaign that has spooked agency officials and threatened to undermine confidence in vaccines and other medical treatments, the former commissioner Stephen Hahn; he told the panel. “I felt very strongly that our scientists had created it [vaccine] Directive. I fully supported the science and clinical data behind it and objected to any proposal to change it,” Hahn said in a January 2022 interview that the commission recently released. “I also felt that any changes would be obviously reported and further reduce confidence in the vaccine.” Public health officials and experts also said Trump’s attacks on the FDA left lingering scars on the agency and contributed to eroding trust in health officials responding to the pandemic across the government. “These attacks on our nation’s public health institutions have undermined the nation’s response to the coronavirus — and are precisely why we must never again settle for leaders who prioritize politics over keeping Americans safe,” said Representative James E. Clyburn (DS.C.), Committee Member. chair, states a statement. How Trump’s Offended ‘Deep State’ Scientists Helped Him Achieve an Unprecedented Achievement Republicans blasted the Democratic-led panel’s work as politically motivated and vowed to launch their own investigations into Anthony S. Fauci, the administration’s top infectious disease expert, and the Biden administration’s response to the coronavirus if regain one or both houses of Congress. fall. “For over two years, Congressional Democrats have refused to hold a single hearing on the origins of COVID or our government’s possible financial involvement in the for-profit investigation. That will change when House Republicans take over the majority next year,” Rep. Steve Scalise (La.), the top Republican on the committee, wrote in a statement Monday after Fauci announced he was leaving in December. Gain-of-function research involves using laboratory techniques to amplify a virus, which some argue without evidence led to the pandemic. The House report issued Wednesday focuses on several FDA decisions in 2020, including officials’ discussions about how best to speed up vaccines while ensuring they are safe and effective. Trump has publicly and privately campaigned for the FDA to move faster, accusing it of deliberately delaying decisions until after the Nov. 3 election to undermine his re-election prospects. “The deep state, or anyone else, at the FDA makes it very difficult for drug companies to get people to test vaccines and therapeutics,” Trump tweeted on Aug. 22, tagging then-Commissioner Hahn. “Apparently, they hope to delay the response until after November 3rd. We need to focus on speed and save lives!” A spokesman for Trump did not immediately respond to a request for comment. Behind the scenes, senior FDA officials concluded by September that they wanted to review two months of safety data after clinical trial participants had received the second shot of the Pfizer-BioNTech or Moderna vaccines — a decision that would delay vaccine approval decisions of the organization until after the elections. “We weren’t going to cut corners in our evaluation,” Hahn told the panel in his interview, adding that the agency had already streamlined a vaccine approval process that typically took much longer and feared it would affect vaccine confidence. “I was worried about the whole environment: a presidential election, sharp divisions in the country and in Congress. And for me, it was a pretty significant combination of factors that led to a decline in … trust in science and medicine,” Hahn said. But after the FDA submitted its planned timeline for approval in September 2020, Trump officials delayed the agency’s request, pressing for its justifications, causing FDA officials to worry about the impact. “The ambiguity here actually creates more problems than a decision one way or the other” about finalizing guidance to vaccine makers, Peter Marks, the FDA’s top vaccine official, wrote in a Sept. 29 email to Hahn and to the then head of the organization. of staff, Keagan Lenihan; The FDA finally overruled the White House on Oct. 6, publishing its vaccine guidelines in briefing papers for the organization’s external consultants. The White House later that day formally approved the guidance — but Trump mocked the decision on social media. “The FDA’s new rules make it harder for them to fast-track vaccines for approval before Election Day. Another political success!”. Trump wrote on Twitter, tagging Khan again in his tweet. In his panel interview, Hahn acknowledged that the FDA has faced pushback from the White House and senior health officials, including former Health and Human Services Secretary Alex Azar. But Hahn said he was confident the agency had prioritized safety. “This ended up being the most appropriate and realistic way to evaluate vaccines,” Hahn said. “Balancing speed with making sure we made the right decision.” Through a spokesman on Wednesday, Khan declined to comment on the report. Hazard did not immediately respond to a request for comment. The panel’s report also details the months-long battle over hydroxychloroquine, the long-running anti-malaria drug that Trump and some others have used as a treatment for the coronavirus despite scant evidence. Beginning in March 2020, Hahn and other health officials were inundated with messages from pro-hydroxychloroquine commentators, including emails from Fox News host Laura Ingraham and Oz, who urged patients to start receiving the treatment immediately . “We have a potential pandemic solution on our hands,” Oz wrote on March 23 to Jared Kushner, then a senior White House adviser and Trump’s son-in-law. The TV presenter cited evidence from a French scientist that “after 6 days of treatment, 100 percent of patients in the trial were virus-free” and said a US study of the drug should be a “national priority”. Oz is now a Republican candidate for the Senate in Pennsylvania. Through a campaign spokeswoman, Oz defended his work on hydroxychloroquine, saying that at the beginning of the pandemic, he “talked to health experts around the world who saw hydroxychloroquine and azithromycin as viable treatment options for desperate patients with Covid and [Oz] offered to fund a clinical trial at Columbia University.” The FDA initially approved hydroxychloroquine on March 29, despite skepticism from career scientists who were concerned about the scant evidence that it was effective. However, the agency revoked permission for the treatment in June amid mounting evidence that it did not work to fight the coronavirus. “The scientific data is really pretty clear now about the lack of effectiveness,” Fauci told CNN on May 27, warning of potentially harmful side effects for the heart. The reversal frustrated Navarro, a top trade adviser to Trump, and Stephen Hatfill, a deputy and virologist, who plotted how to overturn the FDA’s decision, using allies such as Sen. Ron Johnson (R-Wis.), according to with in emails received from the panel. In one case, Navarro and Hatfill partnered with a Michigan-based hospital group, Henry Ford Health, to lobby. For example, Hatfill drafted a request letter that the health system could submit to the FDA, though he instructed the agency to “NEVER mention the White House along with my name” in a May 2020 email to a physician who leads of system work for hydroxychloroquine. Regardless, the FDA in August rejected the hospital system’s request, having repeatedly warned of safety concerns related to the drug. “The FDA has decided not to renew it [emergency authorization] for hydroxy,” Hatfill wrote in an August 2020 email to himself obtained by the committee. “That’s fine because it was already arranged that Hahn be dragged before Senator Johnson’s committee to answer some questions. The senator is pissed and I wrote the questions – so it should be a good show—. Through a spokesman, Hatfill acknowledged his work with Henry Ford Health and said his actions to encourage hydroxychloroquine were appropriate. “We have never unfairly pressured anyone. We simply followed the science and overwhelming evidence as detailed in various studies available at the time,” Hatfill wrote in a statement. In a statement, Navarro also defended his advocacy of hydroxychloroquine, citing excerpts from his memoir, “In Trump Time,” which describes his clashes with Fauci, Hahn and other officials over the drug. “The House Select Subcommittee’s bipartisan report ‘badly’ perpetuates one of the deadliest lies of the pandemic, namely that the safe and potent therapeutic for treating COVID, hydroxychloroquine, was somehow dangerous,” Navarro wrote. The FDA did not respond to specific questions about the report. “Throughout the…
