By Anne Blythe
With the prospect of COVID-19 vaccine shipments coming to North Carolina in mid-December, Mandy Cohen, secretary of the state Department of Health and Human Services, and other public health officials are stepping up the campaign to get public buy-in for the newest tool that could help guide the state toward an end of the coronavirus pandemic.
Gov. Roy Cooper and Cohen shared details earlier this week about the early stages of North Carolina’s vaccine distribution plan as two pharmaceutical companies, Pfizer and Moderna, await decisions from the federal Food and Drug Administration about whether their COVID-19 vaccines will win approval for emergency use.
Cohen discussed the FDA review process during a briefing with reporters on Thursday, sending several strong messages to anybody who might be reluctant to be vaccinated.
“It is important for people to understand, there is no COVID-19 virus in the vaccine itself,” Cohen said. “The vaccine imitates the infection so that our bodies think a germ, like the virus, is attacking, and this creates the antibody defenses we need to fight off COVID if and when the real germ attacks.”
Because the vaccines were developed during a presidential election year when political rhetoric often failed to accurately reflect decades of scientific progress and research used to develop the new products, public health officials find themselves having to assure people that it will be OK to roll up their sleeves for inoculation.
“Although vaccines were developed quickly over the course of this year, corners were not cut,” Cohen said. “The vaccines were built upon years of work in developing vaccines for similar viruses, such as SARS.”
SARS, or severe acute respiratory syndrome, also was caused by a coronavirus that first was reported in Asia in February 2003 and spread to countries in Europe, North America and South America before it was contained. Since then, according to the Centers for Disease Control and Prevention, no new cases have been reported.
For the vaccine candidates awaiting emergency use authorization from the FDA and other trials underway billions of dollars were invested so clinical trials could proceed without delay and also allow manufacturing of the products as researchers studied their effects on trial participants.
More than 70,000 people participated in the Pfizer and Moderna vaccine trials in which some received the vaccine and others got a placebo to weigh the safety and effectiveness.
“Both companies worked to recruit people from historically marginalized populations,” Cohen said.
Latinx and Black vaccine trial participants
COVID-19 hit those communities disproportionately hard, in part because of long-standing health care disparities, but also because many Black and Latinx North Carolina residents work in nursing homes, grocery stores, construction and agricultural jobs that put them at higher risk of contracting the virus.
For the Pfizer trial, Cohen said, 41 percent of the participants were not white. Twenty-six percent of the participants were Hispanic or Latinx, Cohen said, and 10 percent were Black.
For the Moderna vaccine, 37 percent of the participants were not white with 29 percent who were Hispanic or Latinx and 10 percent who were Black.
The process used by the FDA to decide whether emergency use should be granted includes review by an independent advisory panel that does not have ties to the company awaiting decisions. Career scientists in the FDA who are not political appointees also do their own, separate, review.
Once a vaccine wins authorization from the FDA for emergency use, supplies will be limited in the coming months.
The federal government will decide how many vaccine doses are allotted to each state in the early phases of distribution. North Carolina expects about 85,000 in its first shipment if the FDA gives Pfizer its good-to-go nod.
The Moderna review schedule is about a week behind Pfizer’s, so it is possible that later this month, North Carolina could see its weekly shipment of vaccines increase.
Looking toward Dec. 15
As Cohen and Cooper said earlier this week, North Carolina’s first shipment will go to the larger hospitals for inoculation of health care workers and others working in COVID-19 wards and emergency rooms where exposure could occur.
The hospitals will decide who in their facilities is first in line to get a jab.
“We’re asking them to really be thoughtful about prioritizing people who work on COVID units, cleaning COVID units, maybe part of the environmental staff, folks who are in the emergency room maybe taking care of people who they don’t know if they have COVID or not, but have a high risk of exposure,” Cohen said.
Cohen and her team are looking at Dec. 15 as the date when vaccines could start coming to North Carolina.
“It could be a few days earlier, a few days later,” she said.
Hospital workers in COVID-19 wards up first
The Pfizer vaccine requires ultra-cold storage. Larger health care systems have the freezers to store them at such a low temperature, though Cohen said Pfizer also has made plans to send shipments with dry ice so the doses can be kept at the appropriate temperature and distributed more widely.
Nearly 1,000 vaccines will be in each package, Cohen said. Instead of breaking them up to send to smaller hospitals in the initial distribution phase, the state plans to keep its focus on larger health care systems.
“We certainly don’t want to be wasting any vaccine in our early days here,” Cohen said. “We want to be really efficient with how we get our vaccine out. So it will be to a limited number of hospitals. It will be based on hospital size as well as figuring out the population.”
Children have not yet been participants in any vaccine trials, though protocols are being developed for such trials after more is known about the effectiveness and safety of COVID-19 vaccines.
More grim COVID-19 milestones
The news about the vaccine comes at a time when North Carolina, like many other states across the country, is seeing a jump in caseloads, hospitalizations and deaths.
On Thursday, a week after many North Carolinians ignored public health pleas and gathered with others outside their immediate households for Thanksgiving, North Carolina reported a record 5,637 new cases.
There were 2,201 people in the hospital suffering from serious illness related to COVID-19 by Thursday afternoon. In North Carolina, 5,410 people have died from the virus, and 410 of those deaths have occurred in the less than two weeks since the state passed the grim milestone of 5,000 deaths.
On Wednesday, the state hit a positivity rate of 11.4 percent, the highest yet including in the spring when the governor issued a statewide stay-at-home order.
“I am very worried,” Cohen said. “I know this is a particularly hard time of year to stay home and away from family and friends yet it is the best way we can take personal responsibility and show our care for them as we fight this global pandemic.”
Cohen, who often urges North Carolinians to “get behind the mask,” did so again Thursday.
2021 will be ‘a transition year’
Earlier in the day, a panel of Duke professors discussed the promise of vaccines and the opportunities and pitfalls for how they will be distributed at home and abroad.
Thomas Denny, chief operating officer of the Duke Human Vaccine Institute, cautioned against thinking that the introduction of vaccines will mean an immediate return to the days when social distancing and masking were not part of everyday life.
“I see 2021 as a transition year,” Denny said. “As we begin to get more people vaccinated — and I think it’ll take us at least into the second quarter, end of second quarter to see large numbers there — slowly we’ll come out of the social distancing, and less masking.
“I do think the majority of 2021 we’ll still be behaving like we’re behaving now,” Denny added. “We’ll get people vaccinated and then truly understand the long-term efficacy.”
Until vaccine trial participants have been followed for longer than six months and others inoculated with COVID-19 vaccines authorized for emergency use have been monitored for safety and efficacy, it is difficult to say how long the vaccination will protect people from the virus.
“There will be studies that will continue,” Denny said. “What we call the long-haulers type of approach where you continue to follow people and look for long-term protection. But until we get more markers of protection, antibody levels … and understand that, we’re not going to know if you’re going to have to be boosted once a year, or be boosted every five years.”
“This could end up being a cocktail piggy-backed with the annual flu vaccine,” he added.
As public health officials work on plans to get public buy-in and try to chart equitable distribution of vaccines in North Carolina and elsewhere across the country, Gavin Yamey, a professor at the Duke Global Health Institute, and David McAdams, a professor at the Duke Fuqua School of Business, cautioned against a hoarding of vaccines by wealthier countries so others without as much economic power are left with limited supplies.
“An adage in global health and public health … is that an outbreak anywhere can become an outbreak everywhere,” Yamey said. “We’re really not going to really bring this pandemic under control until we control viral transmission everywhere. It cannot just be in the rich world.
“Based on previous pandemics, we were concerned the vaccine would not be distributed fairly, globally, equitably,” he added.
In 2009 during the H1N1 pandemic, a vaccine was developed and wealthier countries made direct deals with the manufacturers, leaving poor countries with fewer doses and slower distribution, Yamey said.
“I’m very sad to say that behavior has repeated itself,” he added. “Rich countries are hoarding the vaccine. Over 80 percent of the (Pfizer and Moderna) vaccines have already been purchased by rich nations. Poor nations left behind. That is an enormous concern.”
The World Health Organization, the Coalition for Epidemic Preparedness Innovations and Gavi, an international vaccine alliance, have joined together to lead COVAX, which is designed to prevent such inequitable distribution.
“This race to develop vaccines around the world has the potential to take on the flavor of what we call a zero-sum game, where something we do here to benefit us in the United States may harm others by limiting its access,” McAdams said. “But it doesn’t have to be that way. Things rich countries do to benefit themselves could also benefit poor parts of the world.”
McAdams suggested that wealthier countries and pharmaceutical companies work with poorer nations to perhaps use facilities that are churning out doses of vaccines now that could fail so they can shift to the production of those found to be safe and effective.
“If we can lay the groundwork for that kind of tech transfer, we can stand up those facilities faster and get more doses out to the world faster and that will benefit poor people everywhere,” McAdams said.
Coronavirus by the numbers
According to NCDHHS data, as of Thursday afternoon:
- 5,410 people total in North Carolina have died of coronavirus.
- 377,231 have been diagnosed with the disease. Of those, 2,101 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, 5,409,434 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 3,527 ventilators in hospitals across the state and 1,027 ventilators in use, not just for coronavirus cases but also for patients with other reasons for being in the hospital. As of Tuesday, 369 suspected COVID-19 patients were in intensive care units across the state.