The Johnson & Johnson single-dose vaccine has been a shot that many people have been drawn to because it offers one-and-done protection from COVID-19 as the global coronavirus pandemic continues into a second year.
Then, in yet another of the endless twists and turns delivered by the coronavirus pandemic, the Centers for Disease Control and Prevention and the Food and Drug Administration suggested on Tuesday that vaccine providers temporarily suspend administration of the vaccine, which was developed by Belgian vaccine-maker Janssen, a subsidiary of pharmaceutical giant Johnson & Johnson.
North Carolina public health officials learned of the federal government’s recommendation to pause at 7:30 a.m. Tuesday and immediately got the word out to vaccine administrators.
“Today’s actions are the results of a vaccine safety system that is working,” Mandy Cohen, secretary of the state Department of Health and Human Services, told reporters during a briefing later in the day.
What led to the pause were reports of a rare kind of blood clot found in six women ranging in age from 18 to 48 who had received the vaccine six to 13 days before detection of the cerebral venous sinus thrombosis, or CVST, as the uncommon clots are called.
Those clots were discovered in combination with low platelet counts in the women, further complicating treatment.
Though the incidents represent only six cases from the 6.8 million doses of Johnson & Johnson/Janssen vaccine administered across the United States, one woman died and another was in critical condition on Tuesday morning, according to Peter Marks, director of the FDA Center for Biologics Evaluation and Research.
“What we are talking about today is an incredibly rare event, literally one in a million,” Cohen said.
Nonetheless, the CDC has asked the Advisory Committee on Immunization Practices, ACIP, to meet on Wednesday and delve deeper into the cases and the significance of the adverse effects. The FDA will review the committee’s analysis and look into the incidents on its own.
“Right now, I’d like to stress, these events seem to be extremely rare,” Janet Woodcock, the acting FDA Commissioner, said in a joint media call with Marks and Anne Schuchat, a CDC principal deputy director.
What to look for
People who received the Johnson & Johnson vaccine more than three weeks ago should have no cause for concern at this point, Cohen said.
“If you have recently had the Johnson & Johnson vaccine and you are feeling well, you don’t need to do anything right now and you should not be concerned,” Cohen said. “If you are someone who has had Johnson & Johnson within the last three weeks, and after day three of the vaccine, you develop a severe headache, severe abdominal pain, difficulty breathing, leg pain, then you should be calling your doctor or other health care provider and let them know you are having those symptoms and to let them know you had the Johnson & Johnson vaccine.”
Cohen, who received the Johnson & Johnson vaccine on March 5, said her arm was sore afterward and she experienced fatigue and felt achy overall.
Such side effects are typical with the Johnson & Johnson vaccine, as well as the two-dose Moderna and Pfizer vaccines.
Part of the reason to take a break in administering the Johnson & Johnson, Cohen and other public health leaders say, is to get the word out to health care workers that such anticoagulants and blood thinners typically used on other, more common types of clots, could be dangerous for people with cerebral venous sinus thrombosis.
“This is a way that we want to make sure that our providers have a high degree of suspicion if they are seeing someone with a clot and with low platelets that they should be asking about vaccine history and making sure to put these pieces together to say, ‘Hey, this blood clot is not like a typical blood clot and probably needs to be treated differently,’” Cohen said. “In this case, this is a kind of clot that is associated with low platelets and you don’t want to be using an anticoagulant called heparin in this case. You need to be using other treatments, so that is something we’re making sure to communicate to providers.”
The announcement comes as North Carolina is seeing supplies of COVID-19 vaccines beginning to be greater than the demand for shots in some counties.
North Carolina has administered 242,000 doses of the Johnson & Johnson vaccine. By shortly before midnight on April 12, nearly 31 percent of the state population 18 and older had been fully vaccinated.
When North Carolina hit the pause button, there were 85,000 first doses of Pfizer and Moderna shots held over from the previous week that will be distributed quickly to providers, according to Amanda Fuller Moore, the pharmacist for the DHHS Division of Public Health.
Those will be sent to vaccine administrators in the coming week, as will new shipments from the federal government of Moderna and Pfizer doses expected in the next few days.
Vaccine providers who had been planning to administer Johnson & Johnson doses have been asked by the state to reach out to those who had appointments. Some have Moderna and Pfizer doses that they can provide instead. Others will have to reschedule appointments for some who might have wanted the one-shot vaccine because they have a fear of needles.
Shaping the message
David Wohl, an infectious disease specialist at the UNC Chapel Hill medical school, and Cameron Wolfe, an infectious disease specialist at Duke University, spoke with reporters over Zoom on Tuesday about their takes on the CDC and FDA decisions.
As Cohen did, they described the news as evidence of the vaccine safety system working and continued to tout the importance of getting people vaccinated as expeditiously as possible.
“The events of the last day really reflect the vigilance that we have in our systems,” Wohl said. “We have a safety net for reasons. There’s scrutiny and monitoring for adverse events and the system is working for us.”
Health care providers are encouraged to report any adverse event that occurs after the administration of a vaccine even if it is not clear that it is tied to the inoculation to the Vaccine Adverse Event Reporting System.
“It’s actually reassuring that such a rare signal can filter through the noise of vaccinating so many people and be detected,” Wolfe said. “One of the things I think it is worth us remembering up front is that all of these vaccines, because of the nature of the pandemic, are all under emergency use authorization. And yet true to each medication or vaccine that will be ultimately approved, there’s always going to be the chance for random adverse side effects to appear outside of clinical trials and we need robust systems in place to be able to find those.
“Here you’ve, in fact, got a signal that we need to know more about quite frankly, and probably will in the next couple of days about a rare incident of a clotting problem.”
Similarities to AstraZeneca
The Johnson & Johnson vaccine is an adenovirus vector vaccine, which means it uses a modified version of a different virus to transmit instructions to cells to produce a spike protein. When the cell displays the spike protein, that triggers an immune system response that protects against future infection of COVID-19.
Unlike older-style vaccines which included weakened viruses, this vaccine does not contain any form or part of the coronavirus itself.
The AstraZeneca COVID-19 vaccine also uses a modified adenovirus to deliver genetic material coding to the cells so a spike protein can be created.
The United States has not approved AstraZeneca’s vaccine for emergency use in this country, but shots have been administered in Europe.
Blood clots have been reported as adverse events after administration of the AstraZeneca shot as well, leading some countries to restrict who is eligible for the vaccine.
That will be further researched, Wohl and Wolfe said, while also acknowledging the importance of keeping the adverse event in context and tamping down those reluctant to trust the safety of COVID-19 vaccines.
“Maybe the greatest side effect of what we’ll see from this is maybe more hesitancy or more skepticism,” Wohl said. “I do think we have to try to control that. There very well may be people saying, ‘See, I told you so, there’s problems.’ But really put this in context.”
‘We don’t throw away penicillin’
What has been shown, Wohl says, is that all three vaccines work, that they prevent people from dying and getting seriously ill from COVID-19.
Furthermore, Wohl said, people experience adverse effects from other vaccines and medications that don’t necessarily put them on the shelf forever.
“We have people who react seriously to penicillin,” Wohl said. “We don’t throw away penicillin. Penicillin is very, very useful as an antibody. It saves lives even though some people can get a reaction to penicillin. So we have tools. We have to understand how to use them. Sometimes they’re a little double-edged, but the vast benefits of these vaccines so far really, really outweigh any risk there is.”
In a statement released on April 13, Johnson & Johnson stated that the safety and well-being of people who use the company’s products is of utmost importance.
In addition to awaiting the findings from CDC and FDA, the company has been reviewing its cases with European health authorities and decided to delay the rollout of the J&J/Janssen COVID-19 vaccine in Europe.
“We have been working closely with medical experts and health authorities, and we strongly support the open communication of this information to healthcare professionals and the public,” according to the statement posted on the company’s website.
Johnson & Johnson has seen a spate of publicity recently that has caused some concern among those trying to combat vaccine hesitancy.
In late March, the company announced that a quality control process done at Emergent Biosolutions, a Baltimore site where the vaccines will be manufactured, detected a batch of drug substance that did not meet standards. The review process found the problem before any doses had been distributed, resulting in another refrain from public health leaders that the safety network was working.
Then last week, North Carolina briefly paused administration of the Johnson & Johnson vaccine at a mass clinic in Wake County and a couple of others in Orange County after several incidents of fainting were reported.
Colorado reported similar events.
Wohl speculated at the time, and said again on Tuesday, that he thought those adverse reactions were tied to people who have needle anxiety. Now, Wohl, Wolfe and others offer people with a fear of needles an opportunity to get their shot in a reclining chair.
The CDC reviewed the incidents and declared last week that it was safe to resume administration of the single-shot vaccine. If such a declaration is made after the investigation into the clotting events so soon after the fainting episodes, it could be challenging to get buy-in from some.
“Does the optics of that happening within the space of a week make it challenging?” Wolfe said. “Yeah. That’s why we want to make sure that messaging is as accurate as you can [make it].”
According to NCDHHS data, as of Tuesday afternoon:
- 12,173 people total in North Carolina have died of coronavirus.
- 936,425 have been diagnosed with the disease. Of those, 1,032 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.
- 887,724 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, 11,749,277 tests have been completed in North Carolina. As of July 7, 2020, 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 (39 percent). While 15 percent of the positive diagnoses were in people ages 65 and older, seniors make up 83 percent of coronavirus deaths in the state.
- 289 outbreaks are ongoing in group facilities across the state, including nursing homes and correctional and residential care facilities.
- As of Tuesday, 257 COVID-19 patients were in intensive care units across the state.
- As of April 12, 5,965,026 North Carolinians have received at least one dose of the coronavirus vaccine.