About 3.5 million Floridians, mostly healthcare providers, medically vulnerable and first responders, could be given priority status when the first doses of the long-awaiting coronavirus vaccine arrive in the state, according to a draft report from the Florida Department of Health.
Will the state even get that many doses and if not who decides where the first ones go? Those are some of the many unanswered questions as the state prepares for the first vaccine delivery as early as December.
Optimism over a vaccine to provide protection against the deadly COVID-19 virus grew Monday when Pfizer announced it will pursue expedited approval from the Food and Drug Administration after preliminary and incomplete results showed its coronavirus vaccine was 90 percent effective.
The next big job will be to navigate the logistical hurdles of getting the vaccine first to the people who need it most, and then to overcome public distrust and skepticism of a process that had become politicized during the presidential election.
According to the Florida Department of Health’s draft vaccine distribution report, submitted to the Centers for Disease Control and Prevention on Oct. 16, the state will roll out the vaccine in three parts as it becomes available.
The first round will go to the “health care personnel likely to be exposed to or treat people with COVID-19; those at higher risk for severe illness from COVID-19, including those with underlying medical conditions; and other essential workers,” the report said. There are an estimated 497,000 licensed healthcare professionals in the state.
The next allocation will go to 223,000 staff and 145,000 residents of nursing homes and other long-term care facilities. Also covered in the second round would be people with vulnerable medical conditions, and that could include 2.7 million people with disabilities. The final distribution, Phase 3, will involve the rest of the public. Only after more vaccine becomes available does the state plan to launch mass vaccination clinics.
"It’s going to take a few months or longer to get this done,'' said Gail Matillo, president of the Florida Senior Living Association whose members include assisted living and memory care facilities. It is one of several healthcare organizations included in a vaccine distribution work group organized by the Florida Department of Health.
Although Pfizer has said the first batch will cover 15 million Americans, it is not known how many doses Florida will receive so the state must devise a rationing system, the criteria of which have not been announced.
“A clear plan around prioritization is going to be important,” said Steve Bahmer, president of LeadingAge Florida, an association of long-term care communities and also a member of the work group. “The end goal is for sufficient doses to be available for everyone, and until we get there, there needs to be a clear plan for how the doses that are available will be distributed.”
The first recipients will be “focused on the critical populations identified in draft guidance documents as well as locations that can accommodate the time and dosing requirements.” the draft said.
The Pfizer vaccine comes with some unique conditions: requiring every person vaccinated to get two shots weeks apart and have the product be retained in super cold storage, -80 degrees Celsius, about four times colder than the average residential freezer.
"There remains a lot of questions about when a vaccine will be available, and the work group’s goal is to put the infrastructure in place so that when it’s ready our members are ready to deliver it,'' Bahmer said. “I don’t know how many doses will be available in Florida so obviously that remains a question.”
The Centers for Disease Control and Prevention has the final say as to who is first in line and "prioritization of vaccine recipients is not yet determined by the (Centers for Disease Control and Prevention),'' the report states.
The Florida Department of Health says it is in the process of surveying hospitals to know which of them can handle the super-cold conditions needed, and it is asking hospitals to enroll in its existing vaccination programs, called Florida SHOTS.
Currently, 274 out of the 314 hospitals in Florida are enrolled in Florida SHOTS, the draft report said.
"The initial facilities that have been identified as meeting both requirements are hospitals, as most have a large staff and some level of capacity for ultra-cold storage,'' the report stated. “Once additional federal guidance is received, further prioritization decisions will be made.”
Monica Corbett, spokesperson for the Florida Hospital Association (FHA) said the federal government has contracted with McKesson, a medical supplier, to coordinate delivery of all COVID-19 vaccines, but Pfizer has elected to handle the distribution and shipping on its own.
"Pfizer has developed packaging to keep the vaccine at temperature for up to 10 days with pelletized dry ice,'' Corbett said. “(The Florida Hospital Association) is coordinating with (the Department of Health) on the safe delivery and storage of vaccine when it is available.”
Hospitals are working to identify which of their essential workers will get the vaccine first, Corbett said. And the (the Florida Hospital Association) also has plans to work with state health officials “to publicly communicate information about the vaccine’s safety and efficacy.”
The federal government also has contracted with Walgreens and CVS to provide on-site vaccine clinics at nursing homes, assisted living facilities and congregate care communities across the country. Florida facilities are being asked to sign up with a pharmacy partner.
Several healthcare providers said at this point the vaccine is expected to be voluntary for long-term care residents and hospital patients, but regulators could mandate that all healthcare personnel be vaccinated as part of their licensing requirement.
Some nursing homes and other senior centers could also require that vaccination be a condition of future admissions, much as schools require vaccination for students.
Will vaccine be required?
Many providers are wary about the preliminary news that the vaccine is effective and reliable, said Jason Hand, vice president of public affairs for the Florida Senior Living Association.
"There’s been a lot of questions from the community, and their response has been: ‘We have to wait until the trials are done and see more data’, " he said.
The state is considering having state-managed vaccination sites run by county health departments “to supplement vaccination efforts and to increase capacity in community-based settings,” the report said.
Community health clinics will also be deployed to provide vaccination services, and, “Since COVID-19 has had a disproportional impact on minority groups, minority populations will also be a focus of these efforts.”
The report says that “GIS mapping of provider locations is being used to identify areas where there is a need to enroll additional providers” particularly among the at-home elderly and other vulnerable populations.
Among the lowest priority for the vaccine may be young children who will get it as part of their routine vaccination schedule. “This type of administration will be contingent upon smaller dosed vials that allow clinics to vaccinate in routine patient care settings,” the Florida report says.
Full scale months away
Florida has been ramping up for this moment for a while, although during the political campaign officials promised the vaccine by the end of October. In September, Florida officials announced they were preparing for distribution of 5 million vaccine doses by the end of October and had purchased 5 million syringes and 5 million alcohol swabs to be prepared.
Only one other company, Moderna, is producing a vaccine candidate has reached active Phase III clinical trials and its product also requires extremely cold shipment and storage conditions.
It could be months before the vaccine is widely available and demand for the vaccine stabilizes. When that happens “the state will transition to providing the vaccine through routine healthcare delivery systems, including commercial pharmacies,” the report states.
Many healthcare providers interviewed this week that progress on the vaccine was a hopeful sign in a challenging time.
"We are excited about the prospect of soon having a safe and effective vaccine available to protect our population from COVID-19 if they desire to receive it.,'' said Veronica Catoe of the Florida Assisted Living Association, also a member of the work group. “Combined with social distancing and wearing masks, it will be a major step toward controlling the widespread impact that has ravished our communities and economy related to the pandemic.”
Until then, many healthcare providers said they have no plan to let up on mitigation efforts that attempt to keep coronavirus at bay.
"We are all still waiting on vaccine and widely avail therapeutics,'' said Bahmer of LeadingAge. “In the meantime, our members have continued to talk about screening and and testing and [personal protective equipment] usage and all the protocols for preventive procedures.”
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