On Sept. 7, President Trump told reporters, “We could have a vaccine soon, maybe even before a very special day. You know what day I’m talking about.” The remarks came amid growing concerns that a fast-paced vaccine-development and approval schedule may compromise safety and effectiveness — and dissuade people from obtaining the vaccine should it become available.
In the early days of the coronavirus pandemic, the administration launched Operation Warp Speed with an initial goal to have a vaccine ready in October, though this was later updated to January 2021. The initiative funneled billions of dollars into promising vaccine candidates, supporting the research, manufacturing, and eventual distribution of these vaccines, with full payment contingent on companies meeting specific timing milestones.
In May, Trump announced Dr. Moncef Slaoui would be the initiative’s chief adviser, despite his glaring financial conflicts of interest. After Sen. Elizabeth Warren called him out for holding more than $12 million in stock options for biotechnology company Moderna, Slaoui sold his stake and resigned from the company’s board. But he still has millions of dollars of shares in his former company, GlaxoSmithKline, which is a contender in the vaccine race and is supported by more than $2 billion in taxpayer money. And an investigation by the House found that he also has undisclosed holdings in Lonza Group, a biotechnology company that has a contract with Moderna to manufacture its coronavirus vaccine.
In August, as multiple vaccine candidates began to enter phase three trials, the Centers for Disease Control and Prevention notified state officials to prepare to distribute a coronavirus vaccine as early as late October, and Director Robert Redfield asked governors to prepare vaccine distribution sites by Nov. 1. A month later, the administration released a vaccine distribution plan that promised a free vaccine and called for states to submit distribution plans to the CDC by Oct. 16. Officials are also rushing a new and untested system to track vaccines.
While the groundwork is laid, leaders of science agencies are cautioning against expecting a vaccine so soon. Dr. Anthony Fauci, director of the National Institutes of Allergy and Infectious Diseases, said it’s unlikely a vaccine will be approved before the election, and Redfield has repeatedly stated that it’s impossible to determine when exactly a vaccine will be available. Both have made it clear that any vaccine available at the end of this year would be of limited supply and prioritized for specific groups, such as health-care workers, and Redfield has said that a vaccine likely won’t be widely available until months into 2021.
In response, Trump has attacked Redfield publicly for tempering expectations. He’s also dismissed and threatened to deny White House approval to Food and Drug Administration plans for stricter guidelines of vaccine authorization, which includes more rigorous criteria for clinical trials and a recommendation that a committee of independent experts review the data. Previously, Trump claimed that the “deep state” at the FDA was attempting to delay the vaccine process until after the election.
American Oversight is investigating the Trump administration’s interference with the vaccine process and has filed multiple requests for agency and White House communications about coronavirus vaccines. We’ve also filed requests seeking contracts and communications with leading vaccine developers, including Pfizer, Moderna, and AstraZeneca. And as the administration moves into distribution plans, we’ve filed requests with state officials seeking communications with federal officials about coronavirus vaccine plans.