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By Anne Blythe
Promising COVID-19 vaccines that could be on the way in the coming days have been heralded often as the light at the end of the tunnel.
Figuring out how to distribute them equitably across North Carolina, with many unknowns still, might seem a bit like standing at a railroad switchyard, knowing train cars could soon be barreling out of a dark tunnel with precious cargo but unable to give precise estimated times of arrival.
On Thursday, Mandy Cohen, secretary of the state Department of Health and Human Services, and Amanda Fuller Moore, pharmacist for the state Division of Public Health, shared what logistics they could about how North Carolina will crank up its COVID-19 vaccine distribution plan once those initial doses arrive.
“There’s still more pieces of this puzzle that we need to learn about before we turn on this vaccination effort,” Cohen said. “But we’re right on the precipice of this incredible tool that we’ve been waiting for, for so long, but just know we are going to learn as we go here.”
They are fairly certain about what North Carolina will get in its first weekly shipment if the federal Food and Drug Administration and the Centers for Disease Control and Prevention give the necessary approvals and guidance.
An independent panel of experts advising the FDA, the Vaccines and Related Biological Products Advisory Committee, met on Thursday to go over the data provided by Pfizer and BioNTech, the first partnership to seek emergency use authorization for a COVID-19 vaccine that has shown great success in clinical trials. The panel voted late in the afternoon to recommend emergency use approval.
The CDC advisory board, which will determine which age groups and people with risk factors should or should not get the vaccine, meets over the weekend. That committee could vote on its decision as soon as Sunday.
“Our job right now is to make sure we can get the vaccines that come to us from the federal government to folks that are high priority as quickly as possible,” Cohen said. “But again …we are learning as we go.”
In North Carolina, 11 sites have been selected for the initial 85,800 doses of the Pfizer vaccine. They include 10 hospitals and one storage site that are spread out across the state.
Those doses are to go to health care workers in COVID-19 wards and emergency rooms, where those caring for the sick are most likely to come into contact with the extremely contagious virus.
“Hospitals need to make sure they are staggering the way they administer the vaccine so that the folks who may have some of the temporary side effects of feeling crummy for 24 hours,” Cohen said. “We don’t want everyone to feel crummy all at the same time and have to call out and then have staffing challenges.”
Temporary side effects
Trial participants and people who have been vaccinated over the past few days in Great Britain report that like with many vaccines they experienced mild side effects.
“Some people may have temporary reactions after the vaccine is injected, such as swelling from the injection at the injection site or tiredness or feeling off for a day or two,” Cohen said.
That often happens with flu shots and other vaccinations as a person’s immune system swings into action in response to the foreign element. Cohen has stressed that vaccines do not contain COVID-19.
The Vaccines and Related Biological Products Advisory Committee discussed reports from the United Kingdom, where people have been getting inoculations of the Pfizer vaccine, that two people had severe allergic reactions. That could lead people with severe allergies to have vaccine hesitancy.
The FDA added language to its emergency use authorization before the reports from the United Kingdom to caution that people with allergies to any components of the vaccine should not get it. The language also states that equipment for dealing with severe allergic reactions should be available, STAT reported.
The early COVID-19 vaccine candidates were built quickly on the foundation of years of research developed for other vaccines, one created by Pfizer, and another one created by Moderna, a pharmaceutical company also seeking FDA emergency use authorization. Many adults are used to vaccinations that require only one dose, but like many childhood vaccines, two doses are needed to provide adequate protection.
North Carolina built a massive tech system to track the vaccine distribution, as well as the dosing to make sure people get back to their providers for the second shot. Since the Pfizer and the Moderna vaccines are not interchangeable, health care providers need to be sure a patient is getting the correct second dose.
To do so, Cohen and Fuller Moore said, will necessitate people giving personal information such as phone numbers and addresses to the health care providers or pharmacy companies that do the inoculating.
That has caused concern among advocates for North Carolina’s Latinx population, many of whom avoid or worry about going to health care systems that require mounds of paperwork for fear that it could be shared with immigration officials. The issue came up Wednesday during a Zoom call with Latin-19, an advocacy group born at Duke Health.
“I want to address privacy concerns overall,” Cohen said. “We take that incredibly seriously. This is the bread and butter work of public health to make sure that we can handle this kind of sensitive information. We have been making sure to ensure that our systems are secure and safe, as well as thinking about any sharing of data in a very proactive way to make sure that we are protecting personal information.”
Privacy concerns for Latinx residents and others
“That is across the board for everyone,” Cohen added. “I would say particularly to our Hispanic and Latino communities who I know have more concerns about giving information, we do not want that to stop folks from getting this potentially life-saving vaccine.
“This is not information that is going to be shared beyond health care providers.”
The data-use agreement is very specific, Cohen said, that such information is only to be shared with health care providers.
“I just want to echo that we are really serious about the use of the data and the control of the data,” Fuller Moore said. “We share the privacy concerns.
“We have to have the individual information so that we connect the person’s first dose to the person and the correct vaccine in the second dose.”
Some people might go to one site for the first dose and go somewhere else for the second dose 21 days after receiving a Pfizer vaccine or 28 days after getting inoculated with Moderna, if they both win FDA emergency use approval.
“We truly are only using the information so we have it for our health care personnel so that they know if you go to one place for the first dose, they have access to be able to see,” Fuller Moore said. “Because health care providers are the ones with access to the system, they can see what was the second dose.”
The vaccines will be packaged with ancillary supplies, such as the needles and other things that go with that vaccine. One item will be a vaccine record card, which the health care providers are not only encouraged to fill out at first inoculation, they’re being told to encourage the vaccine taker to snap a picture of it on their phone in case the card gets lost.
The database builders anticipate that happening.
“It’s a backup mechanism if the card gets lost, if the picture gets deleted,” Fuller Moore said. “We really need to be sure that we match the first and second dose and we can get people back in for the second dose.”
Gaining public trust
The vaccines were developed during an election year when much of the political rhetoric downplayed the severity of the pandemic, misrepresented the timelines and contradicted those coming from the scientists at Operation Warp Speed and other federal agencies. So, public health officials are planning public relations campaigns to win trust in a tool that could lead the country out of the coronavirus pandemic.
“We have been working very hard here in North Carolina to do a lot of research, focus-group testing, to understand folks and where they are related to the vaccine,” Cohen said. “What they understand, what they may not, where that weariness comes from.
“Understandably there is some. So what we are working on is a very robust communications campaign.”
Cohen said she thought there also needs to be more federal support in the coming months, both in dollars and in more consistent messaging from the top on how the entire country talks about the disease and vaccines to stop it.
“There’s a lot of details here,” Cohen said. “I think it’s going to be really important that we’re all singing off the same sheet of music, if you will. So I think that coordination between the federal government and the state government, and all of our partners that we are all giving good, high quality, consistent and simple information about vaccines. …There are tons of common themes that I think we can share across this country.”
How long before widespread immunity?
Despite all the public relations campaigns, health care leaders expect some people to forgo vaccines, just as many do when it comes time for a flu shot.
There will be some people who try to jump the line and get a COVID vaccine before it’s their turn, while there might be others who won’t step forward.
Will there come a time when North Carolina could see herd immunity and emerge from the mask-wearing, social distancing and curbs on what used to be everyday life, Cohen was asked. Is there a percentage of the population that public health officials think must be inoculated before 2021 might start to look more like 2019?
“We want as many people in North Carolina to get vaccinated as possible,” Cohen said. “But we know that it’s going to take some time.”
Supplies will be limited at first simply because of the inability of the drug manufacturers to crank out a large enough supply to inoculate the world.
“We don’t really know yet what the time sequence is going to be in terms of us having vaccine that is more widely available for the general public,” Cohen said in response to questions from NC Policy Watch. “It is not going to be in the early part of 2021, let me just say that. I think it’s going to be closer to the springtime before vaccine is widely available across our state for everyone.”
Additionally, public health officials don’t yet know how long the vaccines will protect people, whether it’s months, years or more.
Cohen, also known as “the three Ws lady,” reminded everyone at that point of the importance of continuing to wear masks, waiting six feet apart from each other and washing hands frequently, even as vaccines begin to be distributed.
Hospital staffing challenges
North Carolina reported 5,556 new lab-confirmed cases of COVID-19 on Thursday morning. There were 2,444 people hospitalized on Thursday morning with severe illness related to COVID-19. The number of people who have died during the pandemic in this state is 5,714.
“I am very worried about our recent trends,” Cohen said, repeating words she used on Tuesday, when the governor imposed a statewide curfew between 10 p.m. and 5 a.m. that takes effect Friday and lasts until Jan. 8.
“We continue setting records on new daily cases that are reported, the percent of tests that are positive and most concerning, the number of people hospitalized, and those in the intensive care unit. Our hospitals are feeling the strain and this is really worrisome.”
While there are beds available for more sick people in the state’s health care systems, many hospitals are struggling with staffing shortages due to COVID-19 infections on nursing teams and others caring for the sick.
In May, North Carolina prepped Sandhills Regional Medical Center, a shuttered hospital in the Richmond County town of Hamlet, to serve as a field hospital if health care systems became overwhelmed with patients sickened from COVID-19.
Cohen said Thursday, that while health care systems are groaning from the weight of caring for so many patients, plans are not in the works yet to open the Sandhills hospital.
“Obviously we are concerned about capacity, but more concerned about staffing as we talked about in our last press conference, more worried about doctors and nurses rather than physical space,” Cohen said. “That is the commodity, our resource, that is really precious here is our people, and it is one of the reasons why, when we think about our vaccination effort, they are certainly the ones that we want to make sure we vaccinate first.”
Cohen said what’s happening in North Carolina is because there is more community spread, more health care providers either have the virus or have been exposed to it and need to stay home.
Vaccine hesitancy among health care workers?
Plans already are in the works to make sure health care workers and long-term care workers trust the vaccines enough to overcome any hesitancy about being among the first to get them and make a difference on the frontlines.
Long-term care facilities, nursing homes and their staff are close to the front of the line for vaccines that will be distributed by CVS and Walgreens through federal government plans.
“We’ve actually worked with our hospitals since they are the ones that are first going to be getting this vaccine,” Cohen said. “I just met with all our hospital CEOs yesterday and they’re being incredibly thoughtful about how do they talk to their own team about this.”
North Carolina has been home to many clinical trials and had many North Carolinians participate in those, which Cohen called an advantage.
“Some of our biggest hospitals have had two or three hundred participants already in these trials,” Cohen said. “So we’re actually trying to use their stories and their experiences to help others understand what’s coming.”
Another plan is to make sure the leadership, whether it’s the head of clinical units or others, are first in line, getting the vaccine and showing they are safe.
Cohen has recorded her story to share with long-term care workers, as well as the families who have loved ones in those settings.
Focus groups have shown that people want to know the stories of their friends, their bosses, other families, the real-life stories that can help to diminish any hesitancy.
“I think this is about sharing individual stories and making sure they see their other peers getting these vaccines as well,” Cohen said. “We’re going to be trying to lift up those stories. We’re working in coordination with the hospital association here in North Carolina, as well as the individual hospitals to make sure we’re aligned on that.”
Coronavirus by the numbers
According to NCDHHS data, as of Thursday afternoon:
- 5,714 people total in North Carolina have died of coronavirus.
- 416,083 have been diagnosed with the disease. Of those, 2,444 are in the hospital. The hospitalization figure is a snapshot of people hospitalized with COVID-19 infections on a given day and does not represent all of the North Carolinians who may have been in the hospital throughout the course of the epidemic.
- 341,041 people who had COVID-19 are presumed to have recovered. This weekly estimate does not denote how many of the diagnosed cases in the state are still infectious. Nor does it reflect the number of so-called “long-haul” survivors of COVID who continue to feel the effects of the disease beyond the defined “recovery” period.
- To date, 5,778,458 tests have been completed in North Carolina. As of July 7, all labs in the state are required to report both their positive and negative test results to the lab, so that figure includes all of the COVID-19 tests performed in the state.
- People ages 25-49 make up the largest group of cases (40 percent). While 15 percent of the positive diagnoses were in people ages 65 and older, seniors make up 82 percent of coronavirus deaths in the state.
- 493 outbreaks are ongoing in group facilities across the state, including nursing homes and correctional and residential care facilities.
- There are 3,545 ventilators in hospitals across the state and 1,041 ventilators in use, not just for coronavirus cases but also for patients with other reasons for being in the hospital. As of Tuesday, 573 COVID-19 patients were in intensive care units across the state.