With investigators recruiting participants for late-stage COVID-19 vaccine trials, officials are working behind the scenes at the federal, state and local levels to deliver the first doses by Nov. 1, McClatchy reports. That timeline appears to be ahead of when the shots can definitively prove safety and efficacy.
Last week, Centers for Disease Control and Prevention Director Robert Redfield, M.D., sent an “urgent” request to states asking their “assistance in expediting applications” for COVID-19 vaccine distribution facilities, according to the publication. If necessary, he said, states should “consider waiving requirements that would prevent these facilities from becoming fully operational by November 1, 2020.”
As of now, three COVID-19 vaccine programs are in phase 3 trials in the U.S., including the AstraZeneca shot that just entered late-stage testing in the U.S. this week. It’s not clear whether those vaccines can show efficacy in a matter of months or whether the FDA would issue an emergency use authorization before the Nov. 1 delivery goal.
Larry Corey, M.D., an expert who is co-leading the studies, doesn’t think it's likely. The studies are designed “to get an answer about seven months from the time that the trial starts," he told McClatchy. Pfizer and Moderna started late-stage studies in July, and AstraZeneca just entered its U.S. phase 3 study this week.
But if the data are overwhelmingly positive, an independent data monitoring board could decide to end a trial early, National Institute of Allergy and Infectious Diseases Director Anthony Fauci, M.D., told Kaiser Health News this week. The researchers would have a “moral obligation” to do so if the data warrant it, he said.
Redfield’s letter sought to assure state officials that the “requirements you may be asked to waive in order to expedite vaccine distribution will not compromise the safety or integrity of the products being distributed.”
The letter was a part of an aggressive effort to start U.S. COVID-19 vaccinations on Nov. 1, according to the report. The CDC has been working with states over the last month, McClatchy reports, and the efforts are set to intensify.
But the team faces challenges thanks to the extremely cold temperatures required for storing the leading candidates. Rural areas with limited resources face additional hurdles, and officials still need to make complicated logistical decisions.
Even if U.S. officials seek to make a vaccine available as soon as possible, the vaccine developer would need to feel comfortable enough to submit data to the FDA and eventually release doses. Eli Lilly CEO David Ricks recently said Americans can trust the pharmaceutical industry to serve as a backstop against political pressure on the agency's decision-making.
Despite reassurances, there's evidence Americans aren’t ready to accept vaccines that move quickly through the development and approval process. In a recent survey conducted by Stat and Harris Poll, more than 80% of people responded that they’d worry about safety for a hastily approved vaccine. Nearly 80% see politics driving the approval process rather than science.