How will Florida distribute first wave of COVID vaccines?

Miami Herald (Sunday) - - FRONT PAGE - BY MARY ELLEN KLAS meklas@miamiheral­d.com Herald/Times Tallahasse­e Bureau

• About 3.5 mil­lion Florid­i­ans — health­care providers, the med­i­cally vul­ner­a­ble and first re­spon­ders — are el­i­gi­ble for the ini­tial vac­cines, but who will get pri­or­ity?

TAL­LA­HAS­SEE

About 3.5 mil­lion Florid­i­ans, mostly health­care providers, med­i­cally vul­ner­a­ble peo­ple and first re­spon­ders, could be given pri­or­ity sta­tus when the first doses of the long-awaited 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 in­creased 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%

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 longterm 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 having 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 CDC has the final say as to who is first in line, and “prioritiza­tion of vaccine recipients is not yet determined by the CDC,” 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 of 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, 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. “FHA is coordinati­ng with DOH 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 FHA 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.

Many providers are wary of 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 communityb­ased settings,” the report said.

Community health clinics will also be deployed to provide vaccinatio­n services, the report said 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.

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, that 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 said 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 the coronaviru­s at bay.

“We are all still waiting on vaccine and widely available 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.”

IT COULD BE MONTHS BEFORE THE VACCINE IS WIDELY AVAILABLE AND DEMAND FOR IT STABILIZES.

First pa­tient vac­ci­nated in Pfizer’s trial at Univer­sity of Mary­land School of Medicine in Bal­ti­more.

DAVID MORRISON AP

Eli Lilly researcher­s prepare cells to produce possible COVID-19 antibodies for testing in a laboratory in Indianapol­is.

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