After months of anticipation, the first doses of the coronavirus vaccine — granted emergency use authorization by the U.S. Food and Drug Administration last Friday — were administered across the country and state Monday to healthcare workers.
North Carolina expects to receive 85,800 doses of the Pfizer-BioNTech vaccine, which has an efficacy rate of 95%, divided up among more than 50 hospitals across the state this week. The first shipments Monday went to Duke Health in Durham, Atrium Health in Charlotte and Wake Forest Baptist Health in Winston-Salem, where they were given to employees who work with and around COVID-19 patients. In two weeks, the same N.C. hospitals will receive doses of the vaccine, said N.C. Department of Health and Human Services Secretary Mandy Cohen at a Tuesday news conference, as a vaccination must include two dosages two weeks apart in order to be effective.
“The first doses of COVID-19 vaccine have arrived in North Carolina,” Gov. Roy Cooper tweeted shortly before 10 a.m. Monday. “It’s a limited supply for now, but this is a remarkable achievement for science and health. We all need to keep wearing a mask and acting responsibly while we get as many people vaccinated as fast as we can.”
The New York Times reported Tuesday morning that the FDA is also expected to approve Moderna’s coronavirus vaccine on Friday. That vaccine has a 94% efficacy rate, and if approved, distribution could begin next week. At the governor’s news conference on Tuesday, Cohen said N.C. expects to receive 175,000 dosages of the Moderna vaccine next week.
Chatham Hospital administered it's first COVID-19 vaccine Wednesday afternoon, two days after the first N.C. vaccinations were given and more than nine months into combatting the pandemic. On Tuesday, before Chatham Hospital had begun vaccine distribution, the Chatham County Public Health Department announced a county vaccination plan in a news release. The plan, which it said has been in development for months, is the result of meetings since late summer between representatives from the CCPHD, Chatham County Emergency Management, Chatham Hospital, Piedmont Health Services and other local, regional and state partners, according to the release.
“Following national and state guidance, the vaccine will be given first to individuals who work in healthcare settings at higher risk of COVID-19 exposure, those who will lead vaccination efforts in Chatham County and residents and staff of long-term care facilities,” the release said.
Health care workers with high risk for COVID-19 exposure and long-term care staff and residents will make up the first phase of distribution, Phase 1A, while Phase 1B will include adults with two or more chronic conditions that put them at the highest risk of severe illness, adults with high risk of exposure and those working in prisons, jails and homeless shelters.
Next, Phase 2 will include adults at “high risk for exposure” and increased risk of severe illness, such as essential and health care workers and adults aged 65 and older. Students and critical industry workers will make up Phase 3, with Phase 4 including anyone in the general public who wants a vaccination.
“Prioritization is set by the CDC and NCDHHS, which we follow,” CCPHD Director Mike Zelek told the News + Record. “It may be several weeks or even a few months before it is available to all of the general public.”
The vaccine has been authorized for two doses, 21 days apart to individuals 16 years of age and older. It is not yet clear when a vaccination for children will become available.
Safety of vaccine
While the Pfizer vaccine was granted authorization by the FDA, this is technically different from receiving approval. Under section 564 of the Federal Food, Drug, and Cosmetic Act, the FDA Commissioner may allow unapproved medical products to be used in an emergency “to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by (chemical, biological, radiological and nuclear) threat agents when there are no adequate, approved, and available alternatives.”
Still, Zelek emphasized that the vaccine is safe.
“... This does not mean that the vaccine has not been tested,” Zelek said. “Thousands of Americans, in addition to studies taking place in other countries, have already received the Pfizer and Moderna vaccines through clinical trials. In granting EUA for the Pfizer vaccine, the FDA, with guidance from the advisory committee, made clear that the benefits of the vaccine outweigh any risks. This is a strong indication that the vaccine is considered both safe and effective, and is an important turning point in the fight against COVID-19.”
Chatham County resident Catherine Kehl was one such clinical trial participant, volunteering in July to receive the then-in-testing Pfizer vaccine. Kehl, who is a bio-roboticist, has been able to do most of her work from home since the pandemic started.
“I’d been frustrated by how little I could do to help directly,” she said. “So, when this came up, I figured it was something I could do.”
While participants are not told whether they receive the vaccine or a placebo saline injection until later, Kehl said she’d be surprised if she didn’t receive it based on side effects she experienced. Similarly to other vaccines, people can experience temporary reactions to the coronavirus vaccine, including swelling at the injection site, fatigue and headache — a sign that your body is developing an immune response to protect against COVID-19.
“Having spent a good chunk of my life in research, but never being involved in a drug trial before, seeing the process was interesting,” Kehl said. “I was impressed by how hard they worked to be clear and organized, and to explain some fairly complex biological concepts to an audience who mostly weren’t scientists. I felt like they were doing their very best to be as transparent and as careful with their data as they could.”
Zelek acknowledged that historical injustices — such as the 1932-1972 Tuskegee Syphilis Study, in which African Americans were told they were receiving treatment for syphilis but did not — have created mistrust among certain communities.
On Monday, several Black journalists emphasized on Twitter the differences between the withholding of treatment in the Tuskegee study and the administering of a vaccine, saying improving access to the vaccine is important — particularly when the coronavirus is disproportionately impacting Black and Latino communities.
In the Triangle, retired nurse Faye Williams, a Black woman who volunteered to return to Duke Hospital at the start of the pandemic, was the first person to receive the vaccination yesterday, the city of Durham tweeted. In New York City — considered the U.S. epicenter in the early months of the pandemic — Northwell Health nurse Sandra Lindsay, a Black woman, was the first New Yorker to get the vaccine. She told the New York Times that because of lingering skepticism about the vaccine, she wanted to lead by example, particularly understanding the history of unequal and racist medical treatment in the U.S.
“That was the goal today,” Lindsay told the New York Times. “Not to be the first one to take the vaccine, but to inspire people who look like me, who are skeptical in general about taking vaccines.”
Chatham’s Zelek emphasized that striving for equity in creating and communicating about vaccines has been important at the state and local level.
“This trust is key,” he said, “and we must work to build it by acknowledging these legitimate concerns, providing services that are culturally and linguistically appropriate, and engaging diverse communities throughout this process.”
Remaining vigilant
Though the distribution of the vaccine is a positive sign, providing much-needed hope as COVID-19 cases surge throughout the country and in North Carolina, public health officials have emphasized that there is still a long road ahead in getting cases under control.
Just Monday, the nation hit another grave milestone: more than 300,000 people have died since March from COVID-19. In North Carolina, weeks of record daily case counts and hospitalizations led to Gov. Cooper tightening mask mandates and imposing a statewide “curfew” last week.
In Chatham, there have been 2,623 COVID-19 cases, with 309 cases reported in the last two weeks, and 65 deaths. Zelek urged residents to continue taking the coronavirus seriously and following health protocols like wearing a mask and socially distancing. Until a significant percentage of the public is vaccinated, he said, the community cannot let its guard down. And while the clinical trial results show the vaccine is effective in preventing vaccinated people from getting sick from COVID-19, it’s not yet clear if the vaccine prevents a vaccinated person from spreading the virus.
“The pandemic is hitting us, like communities around the country, as hard as ever, and we need to remain steadfast in our response,” he said. “What this means is that we should celebrate the good news, get vaccinated when it becomes available to us, and continue to practice the 3 Ws, including wearing a face covering when around others. We’ve got a lot of work to do ... Let’s all continue to do our part to slow the spread of the virus, throughout this holiday season and beyond.”
More information on the COVID-19 vaccine can be found at www.chathamnc.org/coronavirusvaccine.
Reporter Hannah McClellan can be reached at hannah@chathamnr.com.