‘Learning as we go’: NC health leaders offer clarity on vaccine distribution plans

RALEIGH — The North Carolina Department of Health and Human Services says safe and effective COVID-19 vaccines will be available soon to help us defeat the coronavirus and get back to living our normal lives, and on Thursday, health leaders provided a deeper look at distribution plans for the state.

In a news conference, NCDHHS Secretary Dr. Mandy Cohen and state pharmacist Amanda Fuller Moore explained in more detail how the state’s first allocations of the Pfizer vaccine will be distributed, should it receive emergency use authorization.

(Watch below as NCDHHS Sec. Mandy Cohen, M.D., and Division of Public Health Pharmacist Dr. Amanda Fuller Moore, PharmD, share an update regarding COVID-19 vaccines and the distribution of vaccines in North Carolina.)

Cohen said 53 North Carolina hospitals -- decided based on number of beds, number of health care workers in direct contact with COVID-19 patients, and county population -- will receive the first shipment of 85,800 vaccines. That includes 11 hospitals identified as having enough ultra-cold storage to keep the Pfizer vaccine for a number of weeks, should the authorization process be delayed.

“These are going to be shipped in batches of at least 975 doses in a unit,” Cohen said. “So each location must be able to store this amount of vaccine in ultra-cold storage or keep the shipping container for up to 30 days and use those doses within 10-15 days without having to reuse the dry ice.”

Cohen and Moore said that while the state knows how many doses it will receive in the first week, it’s unclear at this time how many doses the federal government will allocate to North Carolina in the second and third weeks, when health officials hope to get doses to additional hospitals and long-term care facilities.

--------------------

Highlights from Thursday’s update:

• 11 hospitals will get the Pfizer vaccine first after the FDA emergency use authorization.
• 42 hospitals will get the Pfizer vaccine after the initial 11 hospitals. Those hospitals will get doses after the CDC votes on its recommendations (they’re meeting through the weekend). These hospitals were chosen based on bed capacity, health care workers and county population.
• North Carolina will receive 85,800 doses of the Pfizer vaccine in the initial round.
• Long-term care facilities are expected to get the vaccine once Moderna receives FDA emergency use authorization.
• They will begin sharing data about who is getting vaccinations on Dec. 22.

--------------------

”We’re right on the precipice of this incredible tool that we’ve been waiting for for so long, but we’re learning as we go,” Cohen said.

Cohen said that FDA approval isn’t the final step in getting the vaccine to the public. It needs CDC approval, too, which could come as early as Sunday. While she said she couldn’t provide specifics about timing, she did say that people outside of health care workers and those living or working in congregate living settings shouldn’t expect to be vaccinated before spring 2021.

“We want as many people in North Carolina to get the vaccine as possible, but we know that’s going to take a while,” Cohen said.

>> We brought in a panel of local experts to talk about the historic COVID-19 vaccine. Hear their answers to your questions here.

Everything you need to know about North Carolina’s COVID-19 vaccine plan

“There is no COVID-19 virus in the vaccine,” the NCDHHS said in a release. “The vaccine imitates the infection so that our bodies think a germ, like the virus, is attacking. This creates the antibody defenses we need to fight off COVID-19 if and when the real germ attacks. Some people may have temporary reactions after being vaccinated, such as swelling from the injection, tiredness or feeling off for a day or two. A tested, safe and effective vaccine will be available to all who want it, but supplies will be limited at first. Independent state and federal public health advisory groups have determined that the best way to fight COVID-19 is to start first with vaccinations for those most at risk, then reach more people as the vaccine supply increases throughout 2021.”

>> CLICK HERE for the full vaccination plan

North Carolina’s COVID-19 vaccination plan lays out who will get the vaccine first and when it will be distributed.

These are the phases of distribution:

Phase 1A (Est. population: 140K-161K people):

• Every health care worker at high risk for exposure to COVID-19 -- doctors, nurses, and all who interact and care for patients with COVID-19, including those who clean areas used by patients, and those giving vaccines to these workers.
• Long-Term Care staff and residents -- people in skilled nursing facilities and in adult, family and group homes.

Phase 1B (Est. population: 587K-790K people):

• Adults with two or more chronic conditions that put them at risk of severe illness as defined by the CDC, including conditions like cancer, COPD, serious heart conditions, sickle cell disease and Type 2 diabetes, among others.
• Adults at high risk of exposure including essential frontline workers (police, food processing, teachers), health care workers, and those living in prisons, homeless shelters, migrant and fishery housing with 2+ chronic conditions.
• Those working in prisons, jails and homeless shelters (no chronic conditions requirement).

Phase 2 (Est. population: 1.18M-1.57M people):

• Essential frontline workers, health care workers, and those living in prisons, homeless shelters or migrant and fishery housing.
• Adults 65+
• Adults under 65 with one chronic condition that puts them at risk of severe illness as defined by the CDC.

Phase 3 (Est. population: 574K-767K people):

• College and university students.
• K-12 students when there is an approved vaccine for children.
• Those employed in jobs that are critical to society and at lower risk of exposure.

Phase 4 (Est. population: 3.6M-4M people):

• Everyone who wants a safe and effective COVID-19 vaccination.

Frequently Asked Questions about the vaccines (provided by NCDHHS)

Are there vaccines that might be safe and work in preventing COVID-19?

Yes. As of November 30, 2020, there are two vaccines that are at the end of the last phase of testing in clinical trials with promising results. One is from Pfizer and one from Moderna. Reports so far indicate the Pfizer vaccine is 95% effective and the Moderna vaccine is 94.5% effective in preventing COVID-19 with no safety concerns.

Who verifies that the vaccines are safe and can prevent COVID-19?

The U.S. Food and Drug Administration (FDA) is responsible for making sure the vaccines are safe and effective. While the COVID-19 vaccines must go through and pass clinical trials like other drugs and vaccines, the FDA can get them to the public faster through an Emergency Use Authorization, as long as the vaccines are found to be safe and effective -- and then verified by an independent committee.

What is an Emergency Use Authorization (EUA)?

An Emergency Use Authorization (EUA) is issued by the FDA during a public health emergency to allow for the use of new medical products, such as a vaccine, more quickly -- but only if research data proves that a vaccine is safe and that it can prevent disease. An independent advisory committee reviews the vaccine testing data before issuing an EUA for a COVID-19 vaccine. The advisory group has no ties to any company, political administration or individual, and its meetings and findings are open to the public. Information about upcoming meetings is posted by the FDA. Pfizer applied for an EUA on November 20, 2020 and the advisory committee will meet on December 10, 2020. Moderna applied for an EUA on November 30, 2020 and the advisory committee will meet on December 17, 2020.

What happens after an EUA is issued?

The Center for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices will review the data and recommend who should be vaccinated based on clinical trial results. This ensures that the vaccine is safe and effective for those who get it.

How much vaccine will the state receive?

Once a vaccine is authorized for use by the FDA, states will receive very limited supplies, at first. The federal government will determine the number of COVID-19 vaccines each state will receive. The amount of vaccine sent to states will be based on the size of the state’s population.

Who will be vaccinated first?

Independent state and federal public health advisory groups have determined that the best way to fight COVID-19 is to first start with vaccinations for those most at risk, then reach more people as the vaccine supply increases from January 2021 to June 2021.

The initial supply of vaccines will go to a small number of hospitals to vaccinate health care workers at high risk of exposure to COVID-19 -- those who are caring for or cleaning areas used by patients with COVID-19. Because of the limited initial vaccine supply, not all hospitals will initially receive vaccines. As more vaccine becomes available, it will be distributed to more of the state’s hospitals and to our local health departments to focus on vaccinating high-risk health care workers.

Long-term care staff and residents are also one of the first groups who will receive a vaccine. Giving vaccinations at nursing homes and most adult care homes and other long-term care settings are being managed by the federal government. However, the vaccines used in long-term care will come from North Carolina’s supply.

We hope that by early 2021, health departments and community health centers will start vaccinating other adults who are high risk for complications—meaning they have two or more chronic conditions identified by the CDC that make them higher risk for exposure.

As more vaccine becomes available, vaccinations will be offered in a variety of settings to everyone who wants one, including in clinics and pharmacies, as well as at vaccination events in prioritized settings and in the community.

While clinical trials have shown safety and effectiveness for adults, children will not receive vaccines until clinical trials with children are completed to ensure safety and effectiveness.

How will the vaccine be shipped?

The federal government is coordinating the shipment of the vaccines and vaccination supply kits to states. Vaccines will be shipped to states as soon as they receive FDA authorization so that states have supplies ready once the CDC Advisory Committee on Immunization Practices recommends who should receive the vaccine.

How will the vaccine be stored?

We have a plan to store the vaccines safely, so they can be effective. North Carolina is prepared to receive vaccines that require ultra-cold storage or frozen storage as soon as they become available from the federal government. Eleven hospital sites across the state have been identified that have the greatest capacity for ultra-cold storage for the anticipated Pfizer vaccine. Vaccines that require ultra-cold storage will come with packaging and cooling material to meet the storage requirements for sites that do not have permanent ultra-cold storage. The Moderna vaccine does not require ultra-cold storage. The state and CDC will deliver training on COVID-19 vaccine storage, handling and administration based on federal recommendations and product information from vaccine manufacturers.

How will staff and residents in long-term care facilities be vaccinated?

The federal government is managing vaccinations for most staff and residents of long-term care facilities, however, those doses will come from the state’s allotment. Long-term care facilities include skilled nursing facilities, adult care homes, family care homes, group homes and intermediate care facilities for individuals with intellectual disabilities. The federal government, in coordination with the CDC, has created the Pharmacy Partnership for Long-Term Care Program with CVS and Walgreens to vaccinate people in these settings. These pharmacies will work directly with long-term care facilities to provide vaccines separate from the vaccination efforts being coordinated by the state.

Are there side effects from the vaccines?

So far, no serious side effects have been reported. However, people have reported temporary reactions like sore arms, swelling at the injection site, fevers and tiredness 24-48 hours after receiving the vaccine. As a result, vaccinations in prioritized settings, such as hospitals and long-term care facilities, may be staggered. We will have more information on the side effects from the Pfizer and Moderna vaccines when the findings from the clinical trials become available.

If two shots are necessary, how will people know when to get their second shot?

The Pfizer, Moderna and AstraZeneca vaccines require two doses, given a set number of days apart. It is important to know when a person received the first dose of vaccine, and which vaccine, to ensure they receive the second dose of the same vaccine at the right time. The shot you take, and when you need the second dose, is health information that is carefully managed to protect your privacy. North Carolina will use a secure data system called the COVID-19 Vaccine Management System (CVMS) to manage vaccinations. When a person gets a first dose, they will be given information on when to come back for a second dose and asked to make a second appointment. They will also be given a card with information about which vaccine they got for their first dose and the date of that dose.

How much will the vaccines cost?

The COVID-19 vaccine will be available to everyone for free, whether or not you have health insurance. The federal government will be purchasing the vaccines.

Do people who have had COVID-19 still need to be vaccinated?

Until we have a vaccine available, the FDA releases information as part of the EUA, and the Advisory Committee on Immunization Practices makes recommendations on how to best use COVID-19 vaccines, the CDC cannot comment on whether people who had COVID-19 should get a vaccine. We don’t know enough to say if having had COVID-19 creates natural immunity or how long that may last. Early data suggests that natural immunity from COVID-19 may not last very long, but more studies are needed to better understand.

Will people who have been vaccinated still need to wear a mask and avoid close contact with others?

Yes. While experts learn more about the protection that COVID-19 vaccines provide under real-life conditions, it will be important for everyone to continue using all the tools available to us to help stop this pandemic, like the 3 Ws - wearing a mask, waiting 6 feet apart, washing your hands, and limiting gatherings. Receiving the COVID-19 vaccination and following the 3 Ws will offer the best protection from getting and spreading COVID-19.

Will people who have been vaccinated still need to be quarantined?

Experts need to understand more about the protection that COVID-19 vaccines provide before deciding to change recommendations on whether people who are vaccinated still need to be quarantined if they have been in close contact with someone who has COVID-19.

These 11 hospitals will be the first to get the vaccines

North Carolina Department of Health and Human Services Secretary Dr. Mandy Cohen said Sunday on CNN that the first 85,000 doses of the COVID-19 vaccine will go to about 50 to 60 hospitals in North Carolina.

The hospitals that receive the vaccine will then decide which workers will be prioritized to get it.

Cohen said the second shipment will go to hospitals and long-term care facilities.

Vaccines in long-term care facilities will be handled through the federal government’s partnership with CVS and Walgreens, which means the state’s focus will primarily be on vaccinating medical workers first.

The plan includes four phases -- the timeline on who will get the vaccine depends on age, occupation and risk.

Cohen said the state created its own COVID database so that it can keep track of when people get the vaccines and which vaccine they get.

>> Have questions about the coronavirus pandemic and its impact on the Carolinas? We have an entire section dedicated to coverage of the pandemic -- CLICK HERE FOR MORE.

On Monday, the NCDHHS said these 11 facilities will get the early ship shipments:

• Bladen Healthcare LLC (Bladen County Hospital)
• Caldwell Memorial Hospital
• CarolinaEast Medical Center
• Catawba Valley Medical Center
• Cumberland County Hospital System Inc (Cape Fear Valley Health System)
• Duke University Health System
• Henderson County Hospital Corporation (Margaret R. Pardee Memorial Hospital)
• Hoke Healthcare LLC (Hoke Hospital)
• The Charlotte-Mecklenburg Hospital Authority (CMC Enterprise)
• University of North Carolina Shared Services Agreement
• Wake Forest Baptist Health

“More hospitals will also get vaccine shipments during Phase 1a,” the NCDHHS said in an email. “Once a vaccine is authorized for use, supplies will be very limited at first. Independent federal and state groups of experts determined that the best way to fight COVID-19 is to start first with vaccinations for those most at risk. Therefore, the initial supply of vaccines will all go to a limited number of hospitals to vaccinate health care workers at high risk of exposure to COVID-19 -- those who are caring for or cleaning areas used by patients with COVID-19.

“Because of the limited initial vaccine supply, not all hospitals will receive the vaccine initially. As more vaccine becomes available, it will be distributed to more of the state’s hospitals and to our local health departments to focus on vaccinating high-risk health care workers. Long-term care staff and residents (for example, nursing homes) will also be in the first group to receive the vaccine. The majority of long term care facilities will be vaccinated with state allocated vaccine by the federal pharmacy partnership for LTC with CVS and Walgreens. Following these groups will be adults with two more chronic conditions that the CDC has defined as putting them at high risk for serious illness.

“If the FDA grants Emergency Use Authorization, a CDC committee will review the data and recommendations based on which populations should receive the vaccine.”

Atrium Health will be among the very first hospitals in the country to give those shots, and Channel 9′s Tina Terry spoke to officials at Atrium Monday about their plan.

>>Watch the video below to hear what Atrium told us about COVID-19 vaccine distribution in the Charlotte area

Channel 9 talks to Atrium about COVID-19 vaccine

They said they will start distributing those shots as soon as they receive the shipment, possibly before Christmas.

Atrium will be the only hospital in Charlotte, and one of only 11 in the state, to receive an advanced shipment of the vaccine.

Hospital officials said that, at this point, they do not know exactly how many doses they’ll receive early on, but have heard numbers possibly in the low thousands.

Notably, Novant Health is not on the list of 11. A spokesperson for Novant sent Channel 9 the following statement on Monday:

Novant Health is an approved vaccination administration site and we will receive our allocation 24 to 48 hours after the Advisory Committee on Immunization Practices (ACIP) issues its recommendations. While we will not receive early shipment of vaccinations prior to official authorization, it’s important to note that no sites can administer doses until after the FDA approves and these ACIP recommendations are issued. As a member of the North Carolina Vaccine Advisory Team, we continue to work closely with federal, state and county officials on distribution plans, which include a vaccine prioritization framework that reflects our commitment to diversity, inclusion and health equity.

Our teams have been working diligently to ensure we can immediately begin vaccine procurement and distribution, including the purchasing of specialized refrigeration units with the capacity to store 500,000 vaccines. We are prepared to meet the needs of our team members and communities.

The NCDHHS later clarified that all sites receiving week-one allocations are hospitals, and the 11 facilities receiving advance/early shipments are just a portion of the sites included in the week-one distribution.

“There are several dozen other sites in addition to the advance/early ship sites,” officials said Monday. “The key difference is that these 11 facilities have sufficient ultra-cold-storage space to get and hold vaccine pending final authorization. No site will be able to administer the vaccine until after final FDA authorization and recommendations from the CDC on who the vaccine is appropriate for approval. And for any reason, should the CDC recommendations be delayed, these 11 facilities will have to continue to hold the vaccine.

“After the CDC makes its recommendations, within 24 hours, the remaining week-one sites will receive an allocation of the vaccine shipped from the manufacturer or distributor. All these doses of vaccine will be to vaccinate healthcare workers at high risk of exposure to COVID-19 -- those who are caring for or cleaning areas used by patients with COVID-19.”

When could children get COVID-19 vaccine?

Staff at nursing homes will be among first to get COVID-19 vaccine

COVID-19 has done the most damage in nursing homes and long-term care facilities, which accounts for nearly half of the deaths related to the virus in North Carolina.

Workers at these facilities will be some of the first to receive the vaccine. However, not all employees are onboard.

“It just doesn’t sit very well with me,” an employee who did not want to be identified told Channel 9. “This thing is new. Nobody knows what type of effect it’s going to have on people.”

Dr. Kevin O’Neil, chief medical officer for nine senior living facilities in the Charlotte area, said they have mandated flu vaccines for staff. They plan to do the same when COVID-19 vaccines are released.

“Traditionally, that’s the most common reason how it gets introduced into senior living communities,” O’Neil said.

Attorney Josh Van Kampen, who specializes in employment law, said it is not entirely clear if the facilities can require employees to get the vaccine, but he has a hunch.

“I would be very confident in saying, in a health care setting, a COVID-19 vaccination could be required,” Van Kampen said.

Vaccine side effects

FDA provides rigorous approval process for vaccine

The Pfizer vaccine still needs to be approved in the U.S., but it was approved in the United Kingdom.

“I don’t think (the U.K.) cut corners, but their process is different,” said Dr. Gavin Yamey, with the Duke University Global Health Institute.

The Food and Drug Administration goes much deeper into data from the vaccine trials than the U.K.

FDA officials get documents and records from the source then comb through that data themselves.

The approval process in the U.K. relies more on what researchers provided.

“They use rolling data all the way through the year,” Yamey said. “That’s a difference. And they work more with company data and don’t do the kinds of absolutely unbelievable checks and balances the FDA do, which is really the gold standard for the world.”

The FDA is having a meeting on Dec. 10 with an independent panel of experts to review the Pfizer vaccine.

Pfizer officials said it will cut the number of vaccines it originally planned to ship this year in half, the Wall Street Journal reported Thursday.

The company said its run into supply chain issues.

Pfizer hoped to roll out 100 million vaccines around the world by the end of the year, but now only says it can send out 50 million.

FDA provides rigorous approval process for vaccine

CDC wants people to wear buttons, stickers after getting COVID-19 vaccine

The Centers for Disease Control and Prevention wants to see people wear buttons or stickers to show they’ve gotten the COVID-19 vaccine. The CDC is planning to distribute vaccination buttons and stickers to healthcare providers as part of a toolkit to promote awareness for COVID-19 vaccinations.

A CDC representative told ABC News about the plans.

Earlier this week, we learned the Department of Defense has plans to send out COVID-19 vaccine cards to everyone getting the vaccine. On Thursday, President-elect Joe Biden said he’ll ask Americans to wear a face-covering for 100 days for one of his first acts as president in an effort to curb the spread of the virus.

Biden also said he asked Dr. Anthony Fauci to stay on in his administration as a “chief medical advisor.”

Vaccination cards will be issued to everyone getting COVID-19 vaccine, health officials say

Images from the Department of Defense show what COVID-19 vaccination record card and vaccination kits will look like.

Vaccination cards will be used as the “simplest” way to keep track of Covid-19 shots, said Dr. Kelly Moore, associate director of the Immunization Action Coalition, which is supporting frontline workers who will administer Covid-19 vaccinations.

”Everyone will be issued a written card that they can put in their wallet that will tell them what they had and when their next dose is due,” Moore said. “Let’s do the simple, easy thing first. Everyone’s going to get that.”

Vaccination clinics will also be reporting to their state immunization registries what vaccine was given, so that, for example, an entity could run a query if it didn’t know where a patient got a first dose.

Moore said many places are planning to ask patients to voluntarily provide a cell phone number, so they can get a text message telling them when and where their next dose is scheduled to be administered.

Every dose administered will be reported to the US Centers for Disease Control and Prevention, said Claire Hannan, executive director of the Association of Immunization Managers.

As far as vaccine kits, the DoD image shows the kits include a card, a needle and syringe, alcohol wipes and a mask. Operation Warp Speed has 100 million vaccine kits ready to go if and when distribution of a coronavirus vaccine starts, Gen. Gustave Perna, Warp Speed’s chief operating officer, said last month.

The images come as two companies -- Pfizer and Moderna -- await emergency use authorizations (EUA) in the United States. A panel with the US Food and Drug Administration is expected to discuss whether to authorize the EUAs on December 10 and 17.

Should Pfizer and Moderna get the authorization, the vaccines’ first shipments could happen December 15 and 22, respectively, according to a document from the federal government’s Operation Warp Speed.

Cox Media Group