president Donald Trump A video released on Wednesday stated that “no president has ever pressured the Food and Drug Administration,” as he fears the government is pressuring the agency to quickly approve a vaccine against the coronavirus.
The FDA released on Tuesday new guidelines for vaccine manufacturers This means they must provide at least two months of safety data after vaccinating study participants in order to apply for an emergency permit. Therefore, approval of a vaccine before the November 3rd presidential election is highly unlikely.
“We’re going to have a great vaccine very, very soon. I think we should have it before the elections, but honestly, politics is involved and that’s fine. They want to play their games,” Trump said in a video that was published on Twitter. “The FDA has acted faster than ever before in history … No president has ever pushed them like I pushed them to be honest.”
He added that “The FDA approves things in a matter of weeks that previously took a few years.”
After the FDA released its new guidelines on emergency approvals for vaccine manufacturers, Trump tweeted that this was “another political hit!”
The FDA has significantly accelerated the trial and approval process for treatments and vaccines against the coronavirus by, for example Prioritize promising treatments and streamline clinical trial design. The agency has taken such steps to respond quickly to the pandemic, which, according to Johns Hopkins University, has already infected more than 7.5 million people in the United States and killed at least 211,500 people.
Trump Administration’s Operation Warp Speed - the Covid-19 vaccine development program – has also helped accelerate the manufacturing process by working with and investing in companies with promising vaccine candidates. While the companies’ potential vaccines go through clinical trials, the companies have ramped up production of cans with US funding so that they can be shipped quickly to Americans once approved.
In addition to discussing vaccines, Trump also campaigned for experimental monoclonal antibody treatments from biotech companies Regeneron and pharmaceutical companies Eli Lilly. Trump received a dose of 8 grams of Regeneron’s antibody cocktail at the beginning of his Covid-19 infection.
“They call it therapeutic, but it wasn’t therapeutic for me, it just made me better. I call that a cure,” he said in the video released on Wednesday. “I have an emergency permit and we need to get it signed now.”
Ultimately, companies must decide to apply for emergency clearance, and it is the responsibility of the FDA to approve or not, depending on whether the potential benefits outweigh the risks. But Trump insisted that “we authorized it. I authorized them.” The White House does not have the authority to approve new drugs, which is the FDA’s responsibility.
Regeneron’s shares rose nearly 3% hours after Trump’s comments.
Eli Lilly announced on Wednesday that they have requested approval for its antibody treatment, but Regeneron has not yet announced that it has filed an application.
The pace at which the FDA approves treatments and vaccines, as well as the apparent pressure from Trump, has raised concerns among some former health officials, public health professionals, politicians and the public.
Trump has FDA Commissioner Dr. Stephen Hahn and other agency officials have been publicly pressured in the past. At the beginning of the pandemic, Trump called for urgent approval of the use of the malaria drug hydroxychloroquine. Recipes for the 60 year old Medicines increased by 2,000% in March, but later studies found it actually accelerated death in some patients, and those The FDA received its emergency clearance in June.
More recently, the President publicly criticized Hahn, urging him to quickly approve convalescent plasma for the treatment of Covid-19. Some scientists said that while the treatment seemed safe, the country would have been better served if the treatment hadn’t been approved and instead studied more closely in large clinical trials.
Earlier this week a The House Supervision Subcommittee opened an investigation whether White House officials have put undue pressure on the FDA and the Centers for Disease Control and Prevention.
“The public wants a COVID-19 vaccine they can trust. The FDA and its experts certainly want that too,” wrote subcommittee chair Raja Krishnamoorthi, D-Ill. In a letter to Hahn. “Unfortunately, President Trump has promised to bring a vaccine to market, undermining public confidence in the FDA’s ability to provide a safe and effective vaccine.”