Trump Says He Might Reject Tougher FDA Vaccine Standards
President Donald Trump said Wednesday that the White House might not approve tougher FDA standards for authorizing the emergency use of any COVID-19 vaccines.
"That has to be approved by the White House," Trump said. "We may or may not approve it."
Trump said the FDA's decision to revise the vaccine standards was "a political move," Politico reported.
His comments came as the FDA considers having new COVID-19 vaccine standards that will likely push an authorization beyond election day. Trump has vowed that a vaccine will be ready before November 3. But scientists have said it's highly unlikely to happen.
The FDA declined to comment on Trump's claims. But an FDA official told CNN that their guidelines go through the White House Office of Management and Budget review process.
Regulators and drugmakers have also made vows to adhere to the science of making vaccines, noted Bloomberg. They decided to put aside politics until a vaccine is ready to reach the market.
What are the Vaccine Standards?
If a vaccine shows signs in the initial stages of the study that it is safe and effective, it can be allowed to reach the marked on an emergency basis. The release can be done even before full results from a clinical trial are made available.
Some companies are already in late-stage clinical trials. These are Pfizer Inc., Moderna Inc., AstraZeneca Plc and Johnson & Johnson. Some firms are likely to produce data on the vaccines' efficacy to their candidates as soon as October.
FDA officials said they would hold the COVID-19 vaccine to a higher standard than other medications. They wanted to make sure they weren't treating the virus, just like other ordinary diseases wherein they give emergency waivers.
Trump's Coronavirus Handling
Trump is behind Democratic presidential nominee Joe Biden in polls asking about the handling of the virus crisis. Amid all this, Trump chose to focus on other topics, claiming that his administration is doing a good job handling the COVID-19 crisis.
His supporters also questioned whether government employees are trying to sabotage his efforts in fighting off the virus.
This isn't the first time Trump claimed the FDA was being "political." In August, he also attacked the agency for harboring "deep state" staff slowing vaccine work. But there's no evidence of his claim.
Politics and a Virus
Trump's comments about FDA could fuel doubt and unease in the vaccine process. This is dangerous, considering the process is already gaining doubt from Americans in polls.
On top of that, the FDA is also gaining doubt from Americans for being easily influenced by politics.
Public health experts believe the lack of trust in the vaccine is a "nightmare scenario." People lacking confidence in the top health agency could shred the hope of ending the pandemic.
Last Wednesday, FDA commissioner Dr. Stephen Hahn said the FDA "will not authorize or approve a vaccine that we would not feel comfortable giving to our families."
He promised that any COVID-19 will have to meet the agency's "rigorous expectations for safety and effectiveness" before being authorized or approved.
"FDA will not permit any pressure from anyone to change that," he noted.
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