FDA and Vaccine Safety

Political Influence

The testing and release of a vaccine is an issue that has gained wide national attention. Media outlets have reported that White House political officials are blocking new safety guidelines for the emergency release of the coronavirus vaccines. Trump believes he needs the vaccine prior to the election to win re-election. Trump publicly cast doubt on whether the guidance would be approved.

“We may or may not approve it,” he said, admitting that his regulatory action “was a political move more than anything else.”

White House political officials and campaign staffers have repeatedly interfered to influence decisions forcing public announcements in ways that imply Trump’s response was adequate. The political influence makes people doubt the safety of the vaccine. The inappropriate pressure has concerned career officials and consumer advocates.

The vaccine safety guidelines are significant. The Food and Drug Administration submitted the guidelines to the Office of Management and Budget for approval weeks ago. By blocking the release, the White House is undercutting the effort to reassure the public that any vaccine will be safe and effective.  A survey published last month by the Pew Research Center found that 51 percent of Americans would either probably or definitely take one, down from 72 percent in May.

“The public must have full faith in the scientific process and the rigor of F.D.A.’s regulatory oversight if we are to end the pandemic,” the biotech industry’s trade association pleaded in a letter asking for release of the guidelines to health secretary, Alex M. Azar II.

Safety Guidelines

Trump repeatedly misrepresents how quickly a safe vaccine will be available. He keeps promising a major breakthrough in vaccine development before the election. However, no clinical trial has advanced enough to prove that any vaccine is safe and effective.

Health experts and scientists at the Food and Drug Administration want the vaccine to meet basic safety guidelines. The FDA’s new guidelines will reassure the public and create common standards for vaccine developers.

The guidance laid out more specific criteria for clinical trial data and recommended that it be reviewed by the advisory committee of independent experts. An outside advisory committee of experts should meet publicly before any vaccine is authorized for emergency use. The hope is that the safety committee can  enforce the guidelines regardless of Trump’s threats and political influence.

Another safety recommendation is to follow participants in vaccine clinical trials for two months before authorization is granted. Trump’s problem is that would preclude any emergency clearance before Election Day. F.D.A. safety experts explained that the two-month follow-up was necessary to identify possible side effects. The monitoring ensures that a vaccine’s protection against Covid-19 is not temporary. Trump didn’t care.

The guidelines also laid out the agency’s expectation that vaccine makers would continue to assess the long-term safety and efficacy of the drug, if granted emergency use authorization. The most likely recipients of any vaccine that wins that authorization will be high-risk populations such as health care workers. Wear a mask until then!