Don’t be surprised if there’s no COVID-19 vaccine candidate approved before Election Day.
The first phase of vaccines shipped out to states is not likely to be until November or December, depending largely on both drug manufacturers’ clinical trials and the Food and Drug Administration’s review of each candidate submitted for emergency use authorization.
This week, the FDA released updated guidance for what each vaccine manufacturer must show in order to receive emergency use authorization for a vaccine for COVID-19.
Helen Branswell, with Stat News, equated the new guidelines to “tapping the breaks” on the part of the FDA, after an initial push largely by the Trump administration to have a viable vaccine candidate by Election Day.
The FDA also announced an additional advisory committee will review each vaccine candidate application. That committee is scheduled to meet Oct. 22, although it will schedule further meetings as needed to evaluate each vaccine candidate.
“Being open and clear about the circumstances under which the issuance of an emergency use authorization for a COVID-19 vaccine would be appropriate is critical to building public confidence and ensuring the use of COVID-19 vaccines once available,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. “The FDA’s new guidance on emergency use authorization of COVID-19 vaccines underscores that commitment by further outlining the process and recommended scientific data and information that would support an emergency use authorization decision.”
At a symposium hosted by the University of Washington and Johns Hopkins University this week, state and local health officials heard from federal officials, including Dr. Anthony Fauci, in discussions about the distribution of a vaccine. State Health Officer Dr. Kathy Lofy, who listened in on the webinar, said the presenters discussed four vaccine candidates. Lofy said they expect to see clinical trial results for the two vaccine candidates that use the RNA platform in November or December.
In the meantime, states have a lot of preparation to do. Michele Roberts, assistant secretary at the Department of Health, told reporters the department plans to begin reaching out to health care providers statewide next week to enroll them in the COVID-19 vaccination system. The process will likely last through the month of October and into November, largely due to logistics.
“We are working on an electronic way to do that enrollment,” Roberts said. “What we got from the federal government was a paper form, and we want to make sure we can collect that information electronically, and that’s what we’re working towards.”
The state also has to submit its COVID vaccination plan to the federal government next week.
The state health department is working on how it will prioritize vaccinations to specific groups chosen to receive the first doses. The National Academies of Science, Engineering and Medicine released its framework for equitable allocation of COVID-19 vaccines in phases last week.
The first round of vaccines would go to high-risk health care workers in hospitals and long-term care settings, as well as first-responders. U.S. residents with two co-morbidities or underlying health conditions would eventually be included in that first round, as well as adults living in long-term care settings.
Roberts said the state will look to the FDA advisory committee’s recommendations on equitable distribution of the vaccine, but she said the Academy’s guidelines help the department begin to think about who would be selected.
“We’re going to use this report to influence how we prioritize vaccines,” Roberts said.
While the state might receive a small amount of vaccine before the end of 2020, the vast majority of vaccine candidates will not be distributed until spring or summer 2021, Spokane County Health Officer Dr. Bob Lutz said on Wednesday.
Lutz listened in on the UW-Johns Hopkins webinar this week.
“(It was) encouraging to hear that you may have tens of millions of doses of vaccine available by late November, early December, but far and away a more realistic timeline is spring and summer of 2021,” Lutz said. “You’re looking at six months minimum for Phase 3 trials to proceed without hiccups along the way.”
COVID-19 cases continue to increase statewide, as well as locally.
The Spokane Regional Health District confirmed 94 cases of COVID-19 on Wednesday. There are 33 county residents in the hospital with the virus.
The Panhandle Health District confirmed 67 cases Wednesday, and four more residents in the five-county region died.
Lofy mentioned the uptick in cases in Spokane County. Both the reproductive rate of the virus and the number of people testing positive is increasing statewide, Lofy said.
“Clearly this is going in the wrong direction,” she said.
Arielle Dreher's reporting for The Spokesman-Review is funded in part by Report for America and by members of the Spokane community. This story can be republished by other organizations for free under a Creative Commons license. For more information on this, please contact our newspaper’s managing editor.
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