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Will rollout of vaccine proceed smoothly here?

STORY BY MICHELLE GENZ (Week of December 10, 2020)

As plans for distributing the COVID-19 vaccine begin to come together, thousands of Indian River County healthcare workers and long-term care residents are thinking hard about their part in the rollout.

Sunday, the chief scientist from Operation Warp Speed said everyone in those groups could have the first dose of a vaccine by mid-January. Critics called that a best-case scenario, but with only weeks until needles are in arms, the example set by these earliest inoculations may affect the general public’s willingness to take the vaccine.

Last week, a CDC advisory committee voted to give those groups priority for the first vaccine doses, made jointly by Pfizer and BioNTech. That vaccine was slated to be reviewed by the FDA for emergency use authorization this Thursday, Dec. 10. A second vaccine, by Moderna, will be reviewed a week later.

Both vaccines show 95 percent efficacy and no serious safety concerns based on interim analysis of phase 3 trials, according to the companies.

Both products require two doses three to four weeks apart, with the second dose said to cause worse side effects than the first – fever, headache and body ache that typically resolve within hours.

Neither vaccine has undergone trials specifically in the long-term care population, and that was enough of a concern for one member of the advisory panel to vote no. That lone dissent came from Helen Keipp Talbott, a researcher who studies vaccines in older people. She said there was no evidence yet the vaccine even worked in that population, potentially sicker than the older adults healthy enough to take part in the trial.

She also worried that underlying conditions might appear as adverse events and unfairly taint the rollout.

Talbott, an associate professor of infectious diseases at Vanderbilt University, told the health news site Stat, “I fear a loss of confidence in the vaccine – that the vaccine will actually truly be safe, but there will be temporally associated events and people will be scared to use the vaccine.” Temporally associated events refers to health issues happening around the same time the vaccination is received but not necessarily caused by it.

Don Wright, owner of three long-term care facilities including Rosewood Manor, said all three have signed up for a provider to come in and do vaccinations, though no date has been determined.

“As I understand it, residents will be first, then caregivers at some point thereafter,” he said. “We cannot force anyone to participate, and at this stage in the process we do not know the percentage of folks that will participate.”

Polls bear out the reluctance of older people to go first with the vaccine.

A survey of older people conducted by the University of Michigan found that 63 percent of those between the ages of 65 and 80 were likely to get a COVID-19 vaccination. But only a quarter said they wanted to get the vaccine as soon as possible.

Nearly half said they preferred to wait. Of adults 50 to 80, 46 percent strongly agreed they have concerns about the vaccine having been developed quickly.

Vaccine hesitancy among healthcare workers is another problem faced by the vaccine roll-out, despite the tragic effect of the disease on their heroic ranks. As of Dec. 1, 245,000 healthcare workers had contracted COVID-19 in the U.S. and 858 had died since the start of the pandemic.

“Early protection of healthcare personnel is critical to preserve capacity to care for patients with COVID-19 or other illnesses,” said an Oct. 30 report by the CDC’s Advisory Committee on Immunization Practices, or ACIP. 

Healthcare workers’ view of the vaccines could have a ripple effect as doctors and nurses are asked their advice by co-workers and neighbors. “Concerns among healthcare providers is a risk for overall vaccine confidence,” the CDC report said.

Jennifer Pippin, a registered nurse who works in the operating room at Cleveland Clinic Indian River Hospital, said half of the people she knows will refuse to take the vaccine.

“I, for one, will not be getting it,” she said. Pippin said many health workers she knows will forgo the vaccine because of how quickly it was developed and uncertainty about “the short-term and long-term effects.

“Like masking, it’s a 50-50 split for pro-vaccine/anti-vaccine for the coronavirus,” said Pippin, who is an outspoken opponent of mask requirements in public schools.

The split on the COVID-19 vaccine was in fact 50-50 in September but rose to 58 percent willing to be vaccinated by late October, according to a nationwide Gallup poll released last week.

The poll pointed to another hurdle in vaccine acceptance in Indian River County – political affiliation. It found 69 percent of Democrats are willing to be vaccinated, up from 53 percent in September. But Republicans and Independents remained at only 49 percent willing to take the vaccine.

Democrats make up only 28 percent of Indian River County registered voters.

Still, demographics in Vero – an older, more vulnerable population – may compensate for political differences surrounding vaccine support.

“I know many people who cannot wait for the vaccine to come out in the hospital – mostly older workers with preexisting conditions,” said Pippin. “They are so scared of the virus that they will be taking the vaccine.”

Until now, anti-vaccine sentiment in the U.S. has been largely centered on children. Not this time.

“A new pandemic, and a new adult-focused platform means shifting tactics,” the CDC report said, Concerns are “understandable, and need to be addressed with empathy and transparency.”

Operation Warp Speed scientist Moncef Slaoui, who spoke on a Sunday morning news show last weekend, was later called overly optimistic by experts who feel his mid-January inoculation prediction didn’t take into account all the possible tripwires in the distribution process.

Just last week, the Wall Street Journal publicized what others had already noted, that the projected number of Pfizer doses ready in December had been cut in half some weeks ago, to 50 million. Scaling up the raw material supply chain on top of a delay in the clinical trial outcome was blamed for the drop from 100 million doses, according to a Pfizer spokeswoman.

The company said production is fully scaled up now and it expects to manufacture the full 1.3 billion doses it has promised.

Moderna has said it expects to produce between 100 million and 125 million doses for global distribution in the first three months of next year.

With each passing day and every rise in cases, it seems hospitals will have a harder time making space in the chaos to deliver vaccines to their workers, especially since the shots will likely need to come in shifts so as to stagger staff days off due to side effects.

Cleveland Clinic Florida hospitals including Indian River still had adequate bed capacity on Monday, but in all but one of its Ohio hospitals, Cleveland Clinic suspended all non-essential inpatient surgeries requiring a hospital bed or ICU care until Jan. 4.

“We are currently experiencing the highest volume of patients with COVID-19 since the start of the pandemic,” the system stated in a news release about the Ohio decisions. “With these steps, we are proactively making more beds available to accommodate what we anticipate will be a continued increase in COVID-19 patients needing hospitalization.”

The move came as Cuyahoga County, where Cleveland is located, ordered more refrigeration units, in anticipation not of the vaccine, which needs to be kept cold, but of an increase in bodies.

While prioritizing the elderly reflects a humanitarian belief, inoculating long-term care residents will also have the effect of keeping them out of the hospital, freeing up beds and workers for others with the disease.

In nursing homes alone – not counting assisted living – there have been 500,000 cases of COVID-19 and 70,000 deaths.

As of press time Monday, it was not known how many doses from Pfizer’s first batch of the vaccine, should it be authorized this week, are destined for Indian River County. An ultra-cold freezer, bought with county CARES Act funding, won’t arrive at the health department until mid-January.

In the meantime, vaccines will be stored at five major Florida hospitals designated as distribution hubs, including AdventHealth in Orlando, the closest to Vero. The other hospitals are Tampa General, UFHealth Jacksonville, Jackson Memorial in Miami and Memorial Regional Hospital in Hollywood.

In Ohio, Cleveland Clinic is one of 10 distribution hubs in the state.

In the Florida system, Dr. Greg Rosencrance, president of Cleveland Clinic Indian River, said plans have been underway “for several weeks” to determine how to distribute the vaccine. “That includes ensuring we have freezers at our Weston, Martin Health and Indian River locations that can accommodate requirements for vaccines that require cold storage,” he said.

“Cleveland Clinic is closely monitoring the progression of potential COVID-19 vaccines,” he said. “We are working with federal, state and local authorities, as well as area hospitals on distribution plans, including how the FDA-approved vaccines will be received and distributed and the order in which people may receive the vaccines.

”As part of its planning process, Cleveland Clinic also is developing policies related to the vaccine and caregivers,” Rosencrance added.