President Trump wants there to be a COVID-19 vaccine in time for the November presidential election, he told Geraldo Rivera Thursday morning.
Experts have said that approving a vaccine by early November is unrealistic, in part because the mass clinical trials that began last week won’t collect their full roster of 30,000 participants until late September, at the earliest.
In a radio appearance, Trump told Rivera that a vaccine would be ready “sooner than the end of the year, could be much sooner.”
River then asked whether a vaccine would be approved “sooner than November 3.”
“I think in some cases, yes, possible before, but right around that time,” Trump replied.
The President’s statements come as administration officials plan to “overwhelm the airwaves” with vaccine information in a six-week campaign.
“You may not hear a lot about promoting vaccines over the airwaves in August and September, but you’ll be overwhelmed by it come November,” an official from Operation Warp Speed — the Trump administration’s effort to accelerate vaccine development — told reporters last week.
Experts have expressed caution in conversations with TPM about the November timeframe for a potential vaccine.
Two vaccine candidates entered so-called phase three trials last week, with 30,000 people participating in each trial. In the trials, researchers give half the group the vaccine candidate, and the other half a placebo.
The test subjects, frequently chosen for their proximity to COVID-19 hotspots, are then left to go about their daily lives. Once a statistically significant number of people in the test pool are infected, the data between the two groups is compared to see if those who were vaccinated have gained a meaningful level of immunity.
At the same time, researchers monitor the tests for potential adverse effects, trying to ensure that a potential vaccine is both safe and effective.
Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital Philadelphia and a member of the FDA’s vaccine advisory committee, told TPM earlier this week that he expected the trials to generate enough data to discern safety and effectiveness by early 2021.
Both the vaccines require two doses. Moderna, the company developing one of the two candidates, has said that it won’t complete enrollment of the trial until the end of September.
The Moderna vaccine requires two doses, each one month apart.
“So now, you’re already in the middle of October,” Offit said. “And then, you’re looking to see if you have enough people in the placebo group who have been infected.”
“It would still take a few months to get the numbers,” he added.
Dr. Susan Hassig, an epidemiologist at Tulane, made a similar point in an interview with TPM last week.
“The reality is, they just started enrolling people,” Hassig said.
Operation Warp Speed officials have said that they intend to use an emergency use authorization — a process by which the FDA can issue early approval for a promising treatment before studies are complete – for the COVID-19 vaccine. An EUA was issued for an Ebola vaccine candidate.
Offit has expressed concern that the Trump administration will issue emergency approval for one of the COVID-19 vaccines for political reasons.