The Trump administration is doubling down on distributing a COVID-19 vaccine before Election Day, aligning the timeline for a crucial public health measure with the President’s political fortunes.
The director of the Centers for Disease Control sent a letter last week to state governors asking that they prepare to have vaccine distribution facilities be “fully operational” by Nov. 1, and that the states waive requirements that would purportedly prevent a private vendor from meeting that deadline.
The CDC followed the letter with additional materials telling states to be ready to distribute the vaccine by late October.
McClatchy first reported the letter on Wednesday morning.
The move is the latest and perhaps starkest example of President Trump leveraging the fight against COVID-19 for his re-election.
Instead of emphasizing safety and prudence, the President has been making extravagant promises and raising expectations that a vaccine will be ready in time for the November elections. His public conduct has ignited fears among vaccine experts, including members of the FDA advisory panel, that politics rather than good science will drive the production of a new vaccine, creating its own public health risk.
Officials with Operation Warp Speed, the administration’s effort to accelerate a COVID-19 vaccine, have already said that they plan to “overwhelm” the airwaves with vaccine messaging in October, while Trump himself has said that he wants a vaccine “right around” Election Day.
In so doing, experts say, Trump is taking a sledgehammer to trust two institutions critical to public health: vaccines and the Food and Drug Administration, responsible for ensuring safety in drugs and other treatments.
The Aug. 27 CDC letter sent by Dr. Robert Redfield does not condition the vaccine on whether the FDA has approved one for use.
Rather, the letter “urgently” asks that state waive safety regulations for vaccine distribution “that would prevent these facilities from becoming fully operational by November 1, 2020.”
“I think that the key to do with timing is really the FDA approval,” Claire Hannan, executive director of the association of immunization managers, told TPM. “And the timing of that is just unknown, and we don’t want to race to a certain date because we want that approval to be done thoroughly and correctly.”
There is nothing to suggest that the phase III trials currently testing the efficacy and safety of three vaccines are compromised in any way. The statement does come amid broad concerns, however, about whether the FDA may give into ongoing political pressure to approve a vaccine before enough data has come in to assess it.
“Everybody is nervous out there because, as we say, we live in very unconventional times,” Dr. William Schaffner, professor of preventive medicine at Vanderbilt University, told TPM. “The last thing you’d want is a vaccine announcement and have the public health community and doctors all over the country saying it’s too early, we’re going to wait for more data.”
The CDC documents came as part of Operation Warp Speed, a joint effort between the Defense Department and Health and Human Services. The effort relies on a strategy in which the government pays for massive amounts of vaccine to be produced as those same vaccine candidates are tested. If approved by the FDA, that would allow the government to immediately begin large-scale vaccinations, drastically shortening the time it normally takes to develop, test, and distribute a vaccine.
To some, Redfield’s letter simply reflects that policy. Dr. Kelly Moore of the Immunization Action Coalition told TPM that the letter has to do with the CDC ensuring that state are prepared for the COVID-19 vaccine program.
“The letter relates to CDC’s preparations for a COVID-19 vaccine distribution program. Obviously, the goal is to have all of the vaccine distribution infrastructure prepared before the earliest moment a vaccine might be approved in order to prevent any delays in distribution of an approved product,” she wrote. “I do not infer from it that a vaccine should be expected to be approved by that date.”
But others expressed concern about the letter’s apparent certainty that a vaccine would be ready for distribution by Nov. 1 – two days before the 2020 election.
Schaffner told TPM that the Nov. 1 date struck him as unnecessary and unusual.
“I wish they hadn’t put that date in there. That was a bad idea,” Schaffner said.
To Gary Slutkin, a former WHO epidemiologist who fought disease in Africa, it was difficult to assess because “nobody knows two things – what the vaccine trials are really showing in terms of efficacy, and what kind of politics are surrounding this.”
The two vaccine candidates that are the farthest along their phase III trials have each enrolled a little over half of the 30,000 people that need to be inoculated before the trial is full, the manufacturers say. Both vaccines require two shots, weeks apart, and started in late July, meaning that only a few of the participants have actually received the full course of the vaccine.
“We basically don’t know the most important thing about this, which is what the trials are actually showing,” said Gary Slutkin, a former WHO epidemiologist who fought disease in Africa.
Schaffer added that the key would be to see whether the FDA’s vaccine advisory committee recommends that a vaccine be approved. The committee being sidestepped, he said, would be a final nail in the coffin of politicization.
“Talk about chaos,” he said.
Read the letter here: