Enlarge /. WASHINGTON, DC – JULY 2, 2020: Dr. Robert Redfield, director of the Centers for Disease Control and Prevention (CDC), removes his protective mask before speaking.
The U.S. Centers for Disease Control and Prevention is calling on states to be ready to begin distributing a COVID-19 vaccine by November 1 – a hugely ambitious plan that comes just days before the presidential election falls conspicuously.
Although public health experts say federal and state officials should definitely plan a vaccination rollout – and the daunting task of eventually gradually, fairly, and orderly vaccinating more than 300 million Americans against COVID-19 – the deadline should be for the area code for work increases the fear of political interference in the effort.
In recent weeks, critics and experts have been alarmed by political changes and decisions by the CDC and the Food and Drug Administration that appear politically motivated. For example, the CDC, which will help coordinate vaccine distribution, recently reversed evidence-based testing guidelines. The move alarmed and outraged experts so much that two high-profile scientists and former officials encouraged states to completely ignore the agency and set their own evidence-based public health guidelines.
And the Food and Drug Administration, which has to give approval or emergency clearance for every vaccine that is distributed, isn't in a much better position. Just last week, critics accused the agency of defying political pressure to allow the use of a convalescent plasma to treat COVID-19 patients, despite experts pointing out clinical data do not yet support the use of plasma, and the National Institutes of Health is publicly against it.
In this regard, experts and the public have repeatedly raised concerns that the FDA may face political pressure to approve a vaccine before the necessary safety and efficacy data is collected, particularly ahead of the November elections that will benefit the Trump administration could. In a recent survey conducted by Stat News and the Harris Poll, 78 percent of Americans said they were concerned that FDA approval of a COVID-19 vaccine is driven more by politics than science.
The CDC's new, urgent push to prepare vaccine distribution before the elections is unlikely to lower these numbers.
In a letter to all 50 states dated Aug. 27, CDC Director Robert Redfield urged governors to expedite vaccine distributor approvals and licenses, according to McClatchy.
"CDC urges your assistance in expediting applications for these distribution facilities," wrote Redfield, "and requests that you waive any requirements that would prevent these facilities from becoming fully operational by November 1, 2020, if necessary."
Similarly, the New York Times reported that on the same day that Redfield sent his letter, the CDC sent three vaccination planning documents to public health officials in all 50 states and some major cities. The documents include planning guidelines, a readiness checklist, and various scenarios of how vaccine distribution might work with different vaccines that have different handling considerations (storage temperatures, pre-administration mixing requirements, etc.). The documents suggest that millions of vaccine doses could be ready by late October or early November.
"This first deployment schedule in late October is extremely worrying in terms of public health politicization and potential safety implications," Saskia Popescu, an Arizona-based infection prevention epidemiologist, told The Times. "It's hard not to see this as a push for a pre-election vaccine."
Although experts say it is possible that a vaccine could prove effective and safe by the end of the year, or even fall, it seems too optimistic to have a vaccine ready and manufactured by November.
Dr. Larry Corey, co-director of coronavirus vaccine clinical trials for the National Institutes of Health's COVID-19 prevention network, told McClatchy this week that the vaccines were extremely unlikely to be ready by November. And he stressed that the science needs to be clear before putting a distribution plan on a schedule. "Knowing what vaccine works and how well it works is incredibly important for our country and the world," said Corey. "They look like they're doing great and we have to let science take over because without that we have no public order."