RALEIGH — Federal officials on Tuesday called for a pause on using the Johnson & Johnson COVID-19 vaccine after six women developed rare blood clots days after receiving the single-dose shots.
The U.S. Food and Drug Administration said it's joining the Centers for Disease Control and Prevention in urging a halt on administering the single-shot vaccines.
One of the women died and another is currently in critical condition, Dr. Peter Marks, director of the Center for Biologics Evaluation and Research at the Food and Drug Administration, said during a news conference Tuesday morning.
The CDC said its Advisory Committee on Immunization Practices is meeting Wednesday to "review these cases and assess their potential significance." The FDA also will investigate and recommends halting the use of the vaccine until the work is finished.
Nationwide, more than 6.8 million doses of the Johnson & Johnson vaccine had been administered as of Monday, officials said.
Six people who received the shot developed "a rare and severe type of blood clot," the FDA and CDC said in a joint news release Tuesday morning.
The reported blood clots, called cerebral venous sinus thrombosis, were all among women ages 18 and 48, the agencies said. They developed the symptoms six to 13 days after they received the vaccine.
In addition to the blood clots, the six women also experienced low blood platelet levels. The cases required treatment different than what's typically given, officials said.
"These adverse events appear to be extremely rare," the agencies said. "COVID-19 vaccine safety is a top priority for the federal government, and we take all reports of health problems following COVID-19 vaccination very seriously."
Dr. Carlos del Rio, the executive associate dean at Emory University School of Medicine, told CNN on Tuesday that people who received the Johnson & Johnson vaccine should not "freak out," because they have "a much higher chance of getting run over by a car" than developing blood clots after the shot.
"I think the first takeaway is that it's a very rare event. I mean, you're talking about one per million. And when you give millions of doses of vaccines, you will see events like this that you won't see in the clinical trials just because you didn't have millions of people involved," del Rio told the outlet.
Still, he said, the CDC and FDA did the right thing by calling for a pause.
"Vaccine safety has always been a priority, and I think this is exactly the right move until we understand what's going on and what's the way forward," he said.
Federal officials encourage people to call their doctors if they experience serious "headache, abdominal pain, leg pain, or shortness of breath" within three weeks of receiving a Johnson & Johnson vaccine.
The pause comes after "adverse reactions" to the Johnson & Johnson vaccine recently were reported at vaccination sites in at least four states.
In North Carolina, two providers temporarily said they stopped administering the vaccines last week after some people receiving the shots experienced reactions including fainting and dizziness. The sites later resumed the use of the vaccines after the CDC said there were no safety issues.
In Georgia, a vaccination site paused use of Johnson & Johnson vaccines last week after administering 425 doses on Wednesday. Officials said eight people who received them had "adverse reactions" that were "consistent with common reactions in adults being vaccinated with any vaccine," McClatchy News reported.
Dr. Ashish Jha, dean of the Brown University School of Public Health, also said it's "the right step" to halt the Johnson & Johnson vaccine.
"Central to vaccination success is ensuring people have confidence they are safe," he wrote on Twitter.
Del Rio of Emory University said the vector, or method of delivery, of the Johnson & Johnson COVID-19 vaccine may be behind the blood clots, but he cautions there isn't enough evidence yet to make such a conclusion.
The shot, just like the AstraZeneca COVID-19 vaccine which has been linked to blood clots in Europeans, is a viral vector vaccine. It works by delivering a harmless DNA virus called an adenovirus that has been genetically modified so it cannot make copies of itself in humans or cause disease. This modified virus carries specific instructions into the body's cells that teach them how to make the spike protein the novel coronavirus uses to infect people.
Cells then display the spike proteins on their surfaces like a trophy on a pedestal, which the immune system doesn't recognize. This triggers the production of coronavirus-fighting antibodies and primes the body to protect itself against the pathogen if it comes into contact with it.
However, del Rio told CNN that evidence from Europe shows this process may be sparking the production of antibodies against platelet factor 4, a protein that is known to cause blood clots. Still, much remains unknown about the relationship between the Johnson & Johnson vaccine and the recent cases of blood clotting.
This method is different from how the Pfizer and Moderna shots work. Instead of DNA, they insert mRNA — a molecule already found in the body — which stores directions that teach our cells to make copies of the coronavirus spike protein, sparking the creation of antibodies without the assistance of a separate harmless virus.
GREENSBORO — Andrew Prine has a well-stocked workshop at home, so he had a chance to start practicing his carpentry class skills during remote learning.
But for fellow Weaver Academy junior Kyndall Miller, hands-on learning this school year didn’t start until early March, when he and Prine and other high school upperclassmen resumed in-person instruction a couple of days a week.
Before then, he watched the instructor’s videos, same as Prine, but was left itching to try it out for himself.
“Once I got into the shop and actually used some of the tools, learning became easier,” Miller said.
The COVID-19 pandemic radically altered education for students. During school board meetings, district leaders have frequently discussed the likelihood that many students would fall behind in subjects like English, math and science as a result of months of remote learning and that they would need help to get back on track.
But there’s a group of students for whom classroom learning has been even harder to replicate over the internet: those enrolled in hands-on, tech-heavy courses with school-based equipment. That’s the case for many students taking career-tech classes at Weaver Academy for Performing and Visual Arts and Advanced Technology in downtown Greensboro.
Weaver offers tech classes and equipment not present at every high school in subjects like construction, HVAC, culinary arts and video production. Many students in the tech classes are bused in from their high schools during the school day to take advantage of the opportunities.
Across the district, there are about 25,000 middle and high school students enrolled in one or more career-tech classes. These students make up over a third of the district’s entire K-12 enrollment.
After months of remote learning, students in these classes who chose to return to in-person learning are trying to make the most of the last weeks of school to practice as much as they can.
Students who spoke for this story said they were able to learn some things from their teachers during remote learning. They tried to learn what they could from watching videos that many teachers posted of themselves demonstrating techniques. And there’s also some book learning, like memorizing vocabulary, that’s the same as in other subjects.
But they also agreed that there’s no real substitute for practice in these classes. They see that practice as relevant to their main career goals, back up career plans, or life skills they were expecting to acquire.
“I feel like there’s definitely some stuff I could have learned if we were in person the whole time,” said John Richmond, a junior taking automobile fundamentals at Weaver. “But I feel like even after everything that has happened this year, and with how Mr. Dove is such a good teacher, I can learn what I really need to know just for life.”
Richmond said he learned about safety and the names of automobile parts during remote learning, but without the in-person lessons he is getting now, he doesn’t think he would be getting the skills he wanted out of the class.
“Without this, it would have been kind of a waste of time, because I wanted to learn how to change the oil or change the tires on a car because it’s a useful skill,” he said.
He said thus far, it’s coming easily — and it’s all a lot less labor-intensive than how he’d seen mechanic work depicted on TV.
Dove said it’s been a challenging year teaching his classes.
When students were all on remote learning, he posted his own videos and also found others on YouTube. Now he’s trying to jam pack the days students are in class with hands-on practice and keep any book work to remote learning days. And some students have chosen to stick with remote learning through the end of the year.
Instead of maybe 16 or so students in class together in a typical year, Dove’s in-person group for the automobile fundamentals class on Thursdays and Fridays is just a few students.
With the two other in-person students absent on Friday, Richmond had the vehicles in the shop to himself.
That’s more hands-on access than he would have seen in a more typically sized class during a normal school year.
“There’s not 18 cars you can bring in,” Dove said.
Still, Dove said, he’s looking forward to when many of his students will come back to school full time. Middle and high school students who are learning in-person two days a week now are set to return full time on Monday.
“I’m not going to miss the A-day, B-day,” Dove said, referring to how students were split into two groups that came to school on different days to allow for social distancing. “I’m ready to get back to normal.”
Every day, he said, he faces the worry that students aren’t learning what they need.
“It’s very difficult,” he said.
Eboni Chillis, the district’s interim chief innovation officer, said the district tried to help these students get the most that they could out of the online learning period. One strategy was to set up some students to use “Splashtop” software, which allowed them to remotely access desktop computers at the schools that had specialized software used in their classes.
Another strategy, she said, was to bring in a production company to help some career tech teachers, including some at Weaver, make videos of themselves demonstrating their equipment to the students.
And one particular group of students, seniors enrolled in the semester-long nursing fundamentals with practicum course, were given the opportunity to return in the fall, before other high school students. They needed to meet the required 40 clinical practicum hours to be eligible for the state health department’s certified nursing assistant exam in 2021, hours that were not possible to get online.
Chillis and other district leaders also have been concerned with making sure students across all other career tech subjects are at least able to take the skills tests they would need to receive industry certifications.
Last spring, when the pandemic hit, tests were canceled, she said.
Now the district has a plan to get students tested for their classes this semester, and to offer students opportunities to take tests they may have missed last year or last semester.
They are planning one big push of testing between Saturday and April 23, plus more toward the end of the year.
“We are going for the gusto,” Chillis said.
RALEIGH — After North Carolina’s agricultural workforce was hit hard by the pandemic last year, health leaders have been working for months to prepare for the daunting task of vaccinating tens of thousands in an effort to battle potential outbreaks this season.
That includes those who live here and thousands of seasonal immigrant workers with H-2A work visas coming from Mexico to work on the state’s key crops. Many live in congregate housing and work in close quarters with others living at home with their families.
“Access to vaccines is at the top of the list of everybody’s efforts right now because we want to vaccinate the workers as quickly as possible,” said Elizabeth Freeman, the director of the North Carolina Farmworker Health Program.
Since vaccines are scarce throughout Mexico and most of Latin America, coming to the United States will be the only chance many workers have to get inoculated.
The N.C. Department of Health and Human Services has helped establish vaccine teams in all 100 counties to connect with and educate farmworkers and farmers about the vaccine and how to get it. As of late last week, at least half of the teams told the state they have connected with growers to plan vaccinations for workers.
So far, 3,784 total doses have been administered to farmworkers, according to state health officials. Many are the first people from their towns or cities to receive a COVID-19 vaccine.
“It feels good to be able to come here to work and get the vaccine here, honestly,” said Leo Jasso, a farmworker from a rural town in the Mexican state of Jalisco.
Jasso, 23, signed up to get a shot just a day after arriving from Mexico to his Johnston County labor camp. Outreach staff from the North Carolina Farmworkers’ Project, a nonprofit, were visiting the camp to educate workers about the vaccine and to help make appointments. He will join about 20 other workers he lives with for a vaccination event organized by the Farmworkers’ Project.
“My mom and dad back home have been trying to look for the vaccine,” Jasso said.
Crowded housing conditions in labor camps have left farmworkers vulnerable to a virus that thrives when people are close together for long periods of time. Thousands of farmworkers have contracted the respiratory disease, with conditions worsened by a lack of preparation and regulation from the state health, labor and agricultural departments.
As of April 9, there have been 4,336 COVID-19 cases and 18 related deaths attributed to certain congregate-living facilities.
But the exact number of affected workers is unknown.
Freeman said the department began working on plans to get farmworkers vaccinated around December.
The state estimates that there will be about 72,000 farmworkers in North Carolina this year, including about 33,000 migrant seasonal workers; 22,500 migrant workers with work visas; and about 16,000 who live in the state year-round, who will work the peak season in the summer and fall.
Once workers become eligible, they are receiving the vaccine in different ways. Some are visiting federally qualified or rural health clinics, while others are attending events set up exclusively for farmworkers.
Farmworkers don’t all arrive in the state at one time, though, which Freeman said could complicate the vaccination effort. For example, a grower might have four farmworkers at the beginning of the year, expect 15 more later on and then a few additional workers even later in the season.
Advocates, growers and outreach workers need to ensure that all workers know how to find a shot, no matter when they arrive.
“It’s not just that outreach is done that one time to a farm,” Freeman said. “There’s got to be a follow-up plan.”
The North Carolina Growers Association, the largest user of seasonal farmworkers in the state, will play a role in helping growers to vaccinate their workforce this agricultural season.
“I’ve been on dozens of conference calls with different stakeholders and government people,” said Lee Wicker, deputy director of the association. “Everybody is working together in a cooperative manner to try to come up with the very best, most efficient way to make vaccines available.”
Wicker says growers are eager about these plans as they seek to avoid additional economic strain from last season’s COVID-19 outbreaks.
“The scarcity of the vaccine in Mexico is making workers open to receiving the vaccine while they are here,” Wicker said.
Groups are moving to disseminate as much information as possible about the vaccine to workers and growers alike.
The North Carolina Farmworkers’ Project has spent the past month making appointments for H-2A farmworkers as they arrive.
Janeth Tapia, the outreach director of the North Carolina Farmworkers’ Project, says “the dynamic has changed a lot” in terms of growers being eager to cooperate with them, in contrast to them being reluctant to get workers tested or quarantined for COVID-19 in the past.
“Growers have called me asking about the vaccine for their workers, and I sense a better reception and openness about workers getting vaccinated,” Tapia said in Spanish. “I think many reluctant workers will get with the program because it rests on educating them about what the vaccine is and how it protects them. They rely a lot on influence, and if they see leaders on the job getting the shot, they will follow.”