| Capital Bureau
Pfizer says vaccine 95% effective, will seek FDA’s okay “within days”
Pfizer says its potential COVID-19 vaccine was 95% effective in final results. It will submit the candidate for approval from the FDA within days.
As Florida breaks the 900,000 milestone for COVID-19 cases since the pandemic began, a plan to distribute a COVID-19 vaccine in the state is all but imminent.
“We’ve got a solid plan,” Jared Moskowitz, director of emergency management for Florida, told the USA TODAY NETWORK-FLORIDA on Wednesday. His agency will be in charge of distribution of a vaccine once one is approved by the U.S. Food and Drug Administration.
Moskowitz has bought millions of syringes, alcohol swabs, gauze — even freezers for the Pfizer vaccine, which has to be stored at minus 80-100 degrees — in anticipation of the day there would be a vaccine to distribute.
“We’re ready to deploy the vaccine when it comes,” Moskowitz said.
The first doses will go to the hospitals, he said. The big unknown is how many doses Florida will get and who will get them first.
“Who is going to be able to receive the vaccine is conjecture,” Moskowitz said. “We won’t know until the emergency use authorization comes out.”
Pfizer and its partner, BioNTech, announced its vaccine was safe and 95% effective and will next seek emergency authorization from the FDA to distribute the vaccine to those who need it the most.
The U.S. government placed an initial order of 100 million doses for $1.95 billion and can acquire up to 500 million additional doses, Pfizer said in a news release.
Another pharmaceutical company, Moderna, said this week that its vaccine is 94.5% effective.
Meantime, Gov. Ron DeSantis left the Legislature’s organization session Tuesday to fly to Washington to meet with top health officials about who’d be among the first recipients to get a vaccine.
Among those he met with were Health and Human Services Secretary Alex Azar, Operation Warp Speed director Paul Ostrowitz, Centers for Disease Control and Prevention Director Dr. Robert Redfield and CDC Director of Public Health Preparedness and Response Dr. Stephen Redd.
By Wednesday morning, DeSantis talked to CEOs of four of the major urban hospitals in the state who have partnered with the state on fighting the pandemic: Jackson Memorial in Miami, Memorial of Hollywood, Tampa General and Advent Health in Orlando.
All four hospitals and a fifth in Jacksonville will be among the first to receive a vaccine once it’s approved, the South Florida Sun-Sentinel reported Wednesday.
The only public comment by DeSantis about his meetings with federal public health officials was a tweet after 5 p.m. Wednesday:
“As we draw near to the release of a COVID-19 vaccine, I met w/@SecAzar to discuss strategy & next steps for its distribution in Florida once available. We also discussed the availability of the new monoclonal antibody treatment & the promising prospects of this new therapeutic.”
Meanwhile, the state has set new records for coronavirus cases, adding 7,925 to bring the total to 905,248 with a death toll among state residents of 17,731 since the pandemic began. The daily positivity rate is around 9.7% for new cases.
Florida is part of a federal five-jurisdiction pilot program along with California, Minnesota, North Dakota and Philadelphia, to come up with a plan to safely deliver a COVID-19 vaccine to Americans and could serve as models for others.
Using their existing plans, each jurisdiction has to come up with a “microplan” identifying vaccination sites and the logistics in disbursing vaccines, according to an 11-page report by the Department of Health and Human Services.
“The microplans will need to be flexible to allow adaptation as more information about the specific characteristics of the vaccines becomes available,” the report said.
In mid-October, Florida submitted a 51-page preliminary provisional plan for distribution of the vaccine when it becomes available.
As explained in Florida’s draft report said, “Prioritization of vaccine recipients is not yet determined by the CDC. Priority groups may vary based on the vaccine that is ultimately approved, vaccine availability and the groups it is authorized for.”
Florida’s provisional plan, which is subject to change based on CDC recommendations and guidelines, was developed on a planning structure based on lessons learned during the H1N1 pandemic, seasonal influenza outbreaks, and the Hepatitis A vaccination program.
Under the plan the first groups most likely to get the vaccine would be health care and other “essential” workers, persons with medical conditions that place them at high-risk for COVID-19 complications, and adults 65 and older.
According to state records, Florida has over 1.34 million licensed health professionals, including 82,000 medical doctors, 364,000 registered nurses and 194,000 certified nursing assistants.
The state also has over 145,000 residents in long-term care facilities, which employ over 225,00 employees. Census data shows about 4.34 million Floridians 65 and older.
The Department of Health said it would “communicate directly with physicians, nurse practitioners and physician extenders regarding information and resources to vaccinate patients with underlying medical conditions for COVID-19.”
Initially, while supplies are limited, vaccines will be distributed by selection hospitals, according to the draft plan.
Next in line would come long-term care staff and residents, based on guidance includes nursing homes, assisted living facilities and intermediate care facilities for the developmentally disabled, the plan said.
Third would come first responder and critical infrastructure personnel, according to the draft plan. Emergency medical services personnel would vaccinate first responders, law enforcement officers and essential employees.
As vaccine becomes more available, the state would move to Phase 2 where traditional providers of vaccines, including pediatricians, primary care providers and pharmacies, would receive doses.
“It is likely that in this phase, the (county health departments) will open Public Mass Vaccination Clinics, and the Department and/or Florida’s Division of Emergency Management might open such clinics to ensure there is equitable distribution of the vaccine, in the same way COVID-19 testing was made available,” the report said.
Pfizer also announced this week that it was starting a COVID-19 immunization pilot program with four states to help refine its plan for delivery and deployment of its vaccine.
The states are New Mexico, Rhode Island, Tennessee and Texas and were chosen “because of their differences in overall size, diversity of populations, and immunization infrastructure, as well as the states’ need to reach individuals in varied urban and rural settings,” the company said in a press release.
The four states won’t receive vaccine doses earlier than other states based on their participation, nor will they receive any differential consideration, the company said.
Contact Jeff Schweers at email@example.com and follow him on Twitter @jeffschweers.
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