By Anne Blythe and Thomas Goldsmith

North Carolina could get its first shipment of COVID-19 vaccines by late next week or soon after if the federal Food and Drug Administration grants Pfizer an emergency use authorization, the state’s top public health official said on Tuesday.

Gov. Roy Cooper and Mandy Cohen, secretary of the state Department of Health and Human Services, outlined details of the state’s early distribution plan once a vaccine gets the eagerly awaited good-to-go nod from the FDA.

“COVID-19 vaccines will help us defeat this virus and get back to the people and places we love,” Cohen told reporters at a Tuesday briefing. “Vaccines imitate an infection so that our bodies think a germ like a virus is attacking and we make antibodies that we need to fight the real germs if they come and attack.”

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Health care workers on the hospital front lines and custodial staff in those facilities would be the first to roll their sleeves up for a shot in the arm that could be a huge boost to a state, and a country, struggling with high caseloads and hospitalizations.

Residents in nursing homes, long-term care facilities and the staff that take care of them also would be near the top of the list.

It could be sometime in January when people with two chronic diseases such as obesity, diabetes, heart disease or cancer could get the vaccine, Cohen said, while stressing the many variables in the timeline.

“The first folks that are going to see the vaccine are going to be our hospitals in order for them to vaccinate their health care workers that are high-risk for exposure, those that are caring for or cleaning the areas of folks with COVID-19,” Cohen said. “As we get more vaccine, we’ll be able to share that with even more hospitals, again focusing on our front-line health care workers who are at high risk for exposure.”

An independent advisory committee is set to review safety data from the first three phases of the Pfizer and BioNTech vaccine trial on Dec. 10.

The FDA’s Center for Biologics Evaluation and Research then would consider the committee’s recommendation and decide if emergency use authorization should be granted.

Moderna, another pharmaceutical company developing a COVID-19 vaccine, sought emergency use authorization this week from the FDA, making it possible that later this month or early next year more than one vaccine could be available in this country.

“Between those two vaccines, more than 70,000 people have participated in clinical trials to see if these vaccines are safe, and if they can effectively prevent someone from getting COVID-19,” Cohen explained. “The preliminary data looks very strong. We look forward to reviewing the complete data when it’s made publicly available in the next few days.”

States will receive limited supplies initially of any vaccines authorized by the FDA.

The Pfizer vaccine requires ultra-cold storage, making its distribution more likely to health care facilities already equipped with the necessary freezers. Cooper noted that much of North Carolina is rural and the distribution of vaccines needing ultra-cold storage could be challenging, but the state will work to overcome those obstacles.

North Carolina would get 85,000 vaccines in the first of what are expected to be weekly shipments, Cohen said. Without a national distribution plan, the states are responsible for getting the vaccines to their people.

Free vaccines

North Carolina’s distribution plan has been in the works for several months, largely put together by a COVID-19 Vaccine Advisory Committee convened by the North Carolina Institute of Medicine.

The state sent the Centers for Disease Control and Prevention its proposed plan in mid-October. It also incorporates the National Academy of Medicine’s equitable distribution guidance.

“The key takeaways are that vaccines will initially be available in limited settings, primarily focused on our hospitals across the state and then our long-term care residents and staff,” Cohen said.

The vaccines will be free to everyone, according to Cohen and Cooper, and any fees associated with the administration of it are to be paid by insurance companies or the government.

“We’ve been hard at work preparing for this moment,” Cohen said. “Our vaccine plan outlines the critical steps needed to administer a vaccine program of this scale.”

The plan takes into account:

  • How to enroll providers to give the vaccines;
  • Ensuring equitable distribution and proper storage;
  • Development of an IT system to manage vaccine supplies, as well as to ensure people get the necessary two doses of the vaccine; and
  • Training providers to use the system and show how to monitor it for any adverse reactions that might occur.

To carry out such a wide-scale distribution program, states will need the ongoing support of the federal government as well as federal funds.

“Having a safe vaccine within reach is an extraordinary achievement,” Cohen said. “But at the same time, it is not a quick fix. It will take several months to have enough supplies so that anyone can readily get a vaccine.”

Until then, Cohen and Cooper pleaded, North Carolinians should double-down on wearing masks when with anyone outside their immediate household, as well as maintain a safe distance from others, and wash or sanitize their hands rigorously.

‘Don’t give up now’

“With hope so close on the horizon, we have to keep using the tools we know slow the spread of this virus to help save lives during the next few months,” Cooper said. “Don’t give up now when help is on the way.”

North Carolina’s trends and metrics have been producing the kinds of COVID-19 records in recent weeks that give public health officials great cause for concern.

On Tuesday, Cooper reported a “record high” of 2,033 people in the hospital with illness related to the novel coronavirus and a total death toll of 5,284 people.

“We’re seeing cases and hospitalizations rise steadily, as are many states across the country,” Cooper said, noting that many options are under review for how to tamp down the spread if those trends continue.

Cooper and his team have studied the possibility of a statewide curfew, looking to other states where such measures have been employed.

After tightening mask requirements last week to include wearing them when with anybody outside your immediate household, Cooper and Cohen have tried to work with cities and counties with viral hotspots to do more enforcement.

Greensboro Mayor Nancy Vaughan put an emergency order in place recently that allows for civil penalties for businesses not complying with statewide orders.

Winston-Salem, Asheville and Buncombe County have also stepped up enforcement efforts, Cooper said.

“This enforcement, along with more local governments getting on board can bring our numbers down and keep us from having to go backward,” Cooper said. “Don’t give up now. We need to work together to stay vigilant. If we do, I know we’ll get through this.”

Heat assistance for older North Carolinians and people with disabilities

As the pandemic continues, the state plans to help older North Carolinians and those with disabilities stay warm this winter by automatically selecting people who already get specific benefits from the Department of Health and Human Services and adding in assistance for heating bills, officials said Monday.

People who previously received heat assistance from the Low-Income Energy Assistance Program, or LEAP, should get help beginning Dec. 1. Those receiving Food and Nutrition Services also should see automatic payments.

This method, DHHS said, allows the state to get help to the recipients while also practicing safe, socially distanced precautions.

DHHS notified the previous recipients in November that they’d be signed up for LIEAP. Other people who might qualify can apply at their local departments of social services next month.

“More of our neighbors may be facing financial hardships because of COVID-19, and this funding can help eligible households with their heating expenses this winter,” state DHHS Secretary Mandy Cohen said in a statement. “We want to ensure seniors and people with disabilities are healthy and safe during a difficult time of the year.”

To be eligible for the LIEAP program, a household must:

  • Contain at least one U.S. citizen or another non-citizen who meets the other criteria for eligibility;
  • Have an income level that’s the same amount or less than 130 percent of of the federal poverty limit;
  • Have $2,250 or less in cash, savings of less than $2,250; and
  • Include the person who keeps track of whether the light bill gets paid.

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Coronavirus by the numbers

According to NCDHHS data, as of Tuesday afternoon:

  • 5,284 people total in North Carolina have died of coronavirus.
  • 367,395 have been diagnosed with the disease. Of those, 2,033 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.
  • 315,979 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, 5,322,584 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.
  • 432 outbreaks are ongoing in group facilities across the state, including nursing homes and correctional and residential care facilities.
  • There are 3,532 ventilators in hospitals across the state and 1,009 ventilators in use, not just for coronavirus cases but also for patients with other reasons for being in the hospital. As of Tuesday, 241 suspected COVID-19 patients were in intensive care units across the state.

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Anne Blythe, a reporter in North Carolina for more than three decades, writes about oral health care, children's health and other topics for North Carolina Health News.