Watchdog Group to Congress: Act Now to Restore COVID Vaccine Confidence

“I write to you on behalf of the millions of Americans who are desperate for this pandemic to end, who are hopeful that a safe and effective vaccine will be developed quickly, and who have lost faith in the government’s vaccine development process to urge you to take immediate action to restore public trust…”

“We are deeply alarmed by President Trump’s recent comments regarding his government’s vaccine approval process, specifically his… [attacks on] new guidance from the FDA intended to ‘boost transparency and public trust’…” 

“Congress must move quickly to pass legislation that would protect the integrity of the FDA review and approval process and restore public confidence in any announced vaccine.”

“First and foremost, especially given President Trump’s comments on Wednesday, authority over FDA vaccine approval guidance must be removed from the White House and the Office of Management and Budget as long as we are in this pandemic…Second, Congress must bolster transparency and independent oversight of any vaccine approvals.”

“… the Trump Administration undermined trust in his government vaccine approval process with the wildly inappropriate rhetoric and actions taken by President Trump and his senior advisors to apply pressure to government scientists and regulators and to openly politicize the vaccine development process.”

“The best way for the confidence of the American people to be restored is if Congress takes action immediately to ensure that any vaccine approved in advance of the election is transparently and independently verified to be safe, effective, and up to the best scientific and public health standards.”

The full text of the letter is below (see the signed version here):

Dear Majority Leader McConnell, Speaker Pelosi, Minority Leader Schumer, and Minority Leader McCarthy:

I write to you on behalf of the millions of Americans who are desperate for this pandemic to end, who are hopeful that a safe and effective vaccine will be developed quickly, and who have lost faith in the government’s vaccine development process to urge you to take immediate action to restore public trust by quickly passing new legislation to remove the White House and the Office of Management and Budget’s (OMB) ability to weaken or block vaccine-related guidance from the Food and Drug Administration (FDA) and by mandating transparency and independent oversight of any vaccine approvals, including and especially pre-Election Emergency Use Authorizations.

We are deeply alarmed by President Trump’s recent comments regarding his government’s vaccine approval process, specifically, his comments on Wednesday, September 23, in which he attacked new guidance from the FDA intended to “boost transparency and public trust,” calling the plan from government scientists “extremely political,” and threatening to block it. This comes as Trump continues to promise that a vaccine would be coming “very, very shortly” and as polls show that fewer than 1 in 10 Americans have a great deal of confidence in Trump to confirm vaccine effectiveness.” The Washington Post reported that “public health experts are increasingly worried that President Trump’s repeated predictions of a coronavirus vaccine by Nov. 3, coupled with the administration’s interference in federal science agencies, may prompt Americans to reject any vaccine as rushed and potentially tainted.”

Congress must move quickly to pass legislation that would protect the integrity of the FDA review and approval process and restore public confidence in any announced vaccine. 

First and foremost, especially given President Trump’s comments on Wednesday, authority over FDA vaccine approval guidance must be removed from the White House and the Office of Management and Budget as long as we are in this pandemic. This will require new legislation and should be moved on as quickly as possible.

Second, Congress must bolster transparency and independent oversight of any vaccine approvals. One good way to do this would be to quickly pass the recently-introduced Science and Transparency Over Politics (STOP) Act. According to the bill’s sponsors, the STOP Act “would create a task force of the Pandemic Response and Accountability Committee charged with conducting a thorough investigation into any political interference with decisions made by scientific agencies of the Department of Health and Human Services in connection with the pandemic response. These reports would be released to committees of jurisdiction and could be made public so Americans and independent experts can see with full transparency whether scientists were unimpeded in their work or a product was pushed for political reasons. Additionally, the task force would have full discretion to release any information that it deems is in the public interest and may be important to public safety.”

It is absolutely critical that the public have confidence that any vaccine approval, especially any coming before Election Day, doesn’t call on them to simply trust the Trump Administration – and these two steps would be strong steps in the right direction. 

Right from the start, the Trump Administration undermined trust in his government vaccine approval process with the wildly inappropriate rhetoric and actions taken by President Trump and his senior advisors to apply pressure to government scientists and regulators and to openly politicize the vaccine development process.

This was especially notable in the case of hydroxychloroquine, when Stephen Hahn, the Commissioner of the FDA, caved to President Trump’s pressure by issuing an emergency use authorization for the unproven treatment after President Trump called it a “game-changer” and explicitly called for it to be approved, which then had to be retracted in the face of continued evidence of the drug’s dangers. It later came out that a top health official was removed from his position by Trump appointees after he had pressed for more rigorous scrutiny of hydroxychloroquine against the wishes of President Trump.

We saw this form of pressure applied once again when President Trump and Commissioner Hahn held a press conference to hype blood plasma treatments, which was roundly criticized as a “major breach,” “bullying…at the Highest Level,” an “alarming development,” and based on “nonsensical, inflated claims.” Hahn subsequently apologized, but the damage was done.

President Trump has also personally attacked and bullied government scientists, calling them members of the “deep state” and explicitly saying that they may delay a vaccine until November 4th in order to hurt him politically. A partial timeline of President Trump’s pressure and intimidation campaign is in Appendix A below.

This level of pressure, bullying, and politicization by President Trump of what should be a process dictated by science and public health is unprecedented, deeply damaging, and it needs to end. 

It has been encouraging to hear career scientists within the Administration, including Dr. Anthony Fauci and top scientists within the FDA, speak up and do as much as they can to reassure the public that they won’t cave to pressure when it comes to a vaccine approval, including with their release of this recent guidance. But given what we’ve seen and continue to hear from President Trump and his political appointees, this is simply not good enough.

The best way for the confidence of the American people to be restored is if Congress takes action immediately to ensure that any vaccine approved in advance of the election is transparently and independently verified to be safe, effective, and up to the best scientific and public health standards. 

Thank you for the consideration. 

Sincerely,

Kyle Herrig
President, Accountable.US

Appendix: Partial timeline of political pressure on health officials