TALLAHASSEE — Following the federal government’s direction, Florida officials say they are preparing for distribution of 5 million vaccine doses by the end of October, but in the unprecedented frenzy to produce a vaccine before the November election, there remain doubts — about safety, distribution, trust and whether the timeline is even realistic.
In anticipation of a vaccine, the state purchased 5 million syringes and 5 million alcohol swabs, said Division of Emergency Management Director Jared Moskowitz. He said Florida bought the supplies two months ago in an attempt to get ahead of the demand instead of being forced to compete with other states as it had during the rush to secure personal protective equipment in March.
“We’re ahead of the game,” Moskowitz said. “I have that stuff sitting in a warehouse ready to go.”
But to distribute a vaccine in time for the November election, the Food and Drug Administration would have to approve the emergency use of one or more of the vaccines being developed and race through the third and final phase of the gold-standard trial traditionally relied upon before widespread use of a therapeutic vaccine is authorized.
Even once a vaccine is administered, it will take two doses three to four weeks apart, so even a rushed process wouldn’t be completed for many to get vaccinated by Election Day, Nov. 3.
The Centers for Disease Control and Prevention indicated last week it wants states to be ready to go in October. Last week, it sent out a letter asking governors to fast-track permits and licenses for new distribution sites, and requested states submit proposals by Oct. 1.
Florida is one of five jurisdictions — California, North Dakota, Minnesota and the city of Philadelphia are the others — selected by a Centers for Disease Control and Prevention working group to create pilot distribution programs intended to serve as models across the country.
The group, which began meeting weekly in August, discussed allocation strategies, weighed how to prioritize who gets a vaccine first, and reviewed data from the initial clinical trial phases of the leading vaccine candidates.
But while the state may be preparing for a vaccine, the White House’s chief vaccine adviser on Thursday cast doubt about the prospect that the vaccine could be ready by the end of October.
“There is a very, very low chance that the trials that are running as we speak could read before the end of October, extremely unlikely but not impossible,’' said Moncef Slaoui, the chief scientific adviser of the Trump administration’s coronavirus vaccine and treatment initiative in an interview with National Public Radio.
He said that if a vaccine emerges, “the right thing to do” is to be prepared.
If and when a vaccine is ready for distribution in Florida, hurdles remain, not the least of which is whether the public will trust a vaccine whose fast-pace development, named Operation Warp Speed by the president, is strategically being timed to coincide with the election and targeting Florida.
“I want to hope that our state is not putting people’s lives in danger as it prepares to be that model state and that this is happening because they believe people will be helped and lives will be saved,’' said state Rep. Shevrin Jones, a Broward County Democrat and one of four legislators who has been diagnosed with COVID-19.
Florida is a logical choice to be on the front end of vaccine distribution “because it’s [the president’s] home state and the governor is working with the president trying to do what’s best for Florida,’' said Sen. Joe Gruters, a Sarasota Republican who is chairman of the Republican Party of Florida.
Gruters denied Florida was selected because it is a pivotal swing state deemed essential for President Trump to win re-election and the vaccine plan “is not a Nov. 1 surprise.”
“This pandemic transcends politics,’' he said. “I don’t know if it will have massive political implications because people already know it’s coming.”
He hopes Trump “will get the credit he deserves for pushing Operation Warp Speed as fast as humanly possible” and predicted that the vaccine will ultimately “have a bigger impact on the economy than it does on politics.”
But uncertainty over the timing of a potential COVID-19 vaccine on Thursday had investors squeamish, as the Dow dropped 807 points as stocks posted their worst day since June.
Fauci discusses Operation Warp Speed coronavirus vaccine development program
At a news conference in Daytona Beach on Wednesday, Gov. Ron DeSantis tamped down expectations about a vaccine, and laid the responsibility for its distribution on the federal government.
“I wouldn’t want people to think that in two more months, you know, everything is going to be gone,’' the governor said, suggesting that the flu vaccine is only 50 percent effective among the senior population compared to other populations, “so just people should have tempered expectations.”
(The governor did not cite research related to the flu vaccine, but recent data from the National Institutes of Health refutes that claim.)
DeSantis added that he doesn’t know how many vaccines “will end up being produced,” but he signaled that the burden of producing a successful vaccine now falls on the drug companies.
“I know they basically paid all these companies already so that they could just go ahead and roll with it as the trials are going,’' he said.
How the federal government manages the messaging about a vaccine is going to be crucial to managing public expectations, public health experts said.
Peter Pitts, president of the Center for Medicine in the Public Interest and a former FDA associate commissioner for external relations, said one of the biggest challenges states will face when distributing a new vaccine is public skepticism.
“Having a vaccine that nobody uses is a public health failure,” he said, adding that time is running out for public health officials to get out a persuasive message.
Americans already are skeptical. A poll released Monday by Harris and STAT found that 78 percent of Americans believe that the COVID-19 vaccine process is being driven more by politics than science.
But when it comes to trust in the president, the public breaks down along partisan lines. Although only 46 percent of the public trusts the president or the White House to provide accurate information about the development of a COVID-19 vaccine, 71 percent of Republicans believe Trump compared to only 28 percent of Democrats.
There is more trust in the FDA than the president: 68 percent say they are confident that the Food and Drug Administration will only endorse a vaccine that is safe.
Gruters, who is one of the president’s most vocal cheerleaders in Florida, said he expects most of the public will trust a vaccine.
“There is a lot of distrust in government overall, but the (Food and Drug Administration) and its policies and science transcends politics,’' he said. “If they say it’s ready and if they are getting results in these trials, then I’m confident.”
In a presidential election year, Pitts said, the pandemic and the government’s response has become “hyper-politicized.”
“If you don’t believe the messenger, you’re not going to believe the message.”
The president and the Food and Drug Administration didn’t help engender trust when the head of the Food and Drug Administration grossly misstated claims about the lifesaving power of a plasma therapy for COVID-19 authorized by his agency on the eve of the Republican National Convention, then quietly tried to correct it and demoted the official in charge of the botched roll out.
Barry Bloom, an immunologist and research professor with Harvard T.H. Chan School of Public Health, said the Food and Drug Administration’s track record of questionable emergency use approvals during the pandemic is worrisome.
He noted that in addition to the the Food and Drug Administration’s emergency approval of convalescent plasma, it also gave emergency approval for hydroxychloroquine as a COVID-19 therapy in April, only to revoke the authorization in June. The agency also allowed dozens of coronavirus antibody tests on the market without review, only to later find that many of the tests were not accurate.
“That is worrisome because in the case of vaccines, the pressure will be far greater,’' Bloom said during a conference call with reporters on Aug. 25.
“I would hope the leadership of the (Food and Drug Administration) would stand firm on the scientific basis. Otherwise, the trust in the whole scientific enterprise becomes compromised. And there are a lot of people in the anti-vaccine world that are looking forward to precisely that.”
The government also has to manage the logistics of distributing a vaccine on a mass scale.
Only two of six vaccine candidates that have the backing of the federal government — those being produced by Moderna and Pfizer — are in active Phase III clinical trials, and require extremely cold shipment and storage conditions.
Sen. Gayle Harrell, chair of the state Senate Health Policy Committee, invited representatives from pharmaceutical companies a month ago to conduct a briefing session for fellow Republican lawmakers about the status of vaccines. She said that because of the need for super-cold condition there are a limited number of facilities in Florida that can store it.
She said that once a vaccine is thawed, it must be used within a day or two. That leaves research hospitals and research labs as the most likely locations to handle the product.
“You have to really think this thing through to set up a mass distribution,’' Harrell said.
“The healthcare logistics aren’t being discussed, which is a huge issue, not the least of which is cold storage,” Pitts said. “It’s not as though a big box of pills arrives and you put them on a shelf. Vaccines require special care. They have to be shipped in different ways and have to be stored in different ways. The question is: Is our healthcare infrastructure prepared for that?”
Who gets vaccinated first?
After logistics, the state must decide who will be eligible for the first round of limited supplies of a vaccine.
The governor said this week that “if there is a safe and effective vaccine, I think that the most vulnerable population should have priority.” He described that as people who are 65 and older and those with underlying health conditions that increases their risk.
Operation Warp Speed officials have suggested that the state should expect the elderly — including those homebound, in nursing homes and in senior living facilities — as well as healthcare workers, frontline essential workers, national security workers and communities of color, to be among the priority groups for the first vaccine doses.
Bloom, the Harvard immunologist, said the limited availability of vaccines in the beginning stages will create pressure “for every group, every pressure group, every organized group and lots of influential individuals to try to get access to that vaccine.”
But Harrell, the state senator, said “not everyone will want to get vaccinated,’' especially in the early months of the vaccine.
Critical to the public messaging is that everyone should be allowed to evaluate their own risk, she said. Unlike using experimental therapy for treatment of COVID-19, a vaccine involves giving a dose of the virus to healthy people, she said. “It has to be a voluntary thing, and if you don’t want to do it you can’t be forced to do it.”
Jones, the Broward legislator, said that many in the Black community are going to be reluctant to get vaccinated given the state’s historical failure to provide healthcare access to it.
“Is the state coming to us because they want everyone to be safe or are they coming to the Black community because they want them to be your lab rats?’' he said. “That’s the message that is out there on social media. They need to educate the community first.”
He said he doesn’t see any effort to educate the public now, however, and that could lead to increase distrust.
“If the governor’s office knows this is coming in October, the smart thing would be to launch a campaign to show this is about to happen,’' Jones said. “In Florida, we get a lot of things wrong and we are the laughingstock on a lot of things. We need to get this right.”