Louisiana vaccine providers paused their use of the single-dose Johnson & Johnson vaccine this morning, following a joint recommendation from the CDC and FDA. The recommendation was based on a handful of blood clots diagnosed in women who had recently received the COVID vaccine.
In a follow-up briefing, FDA officials said that the pause would likely last only a few days. However, the move is likely to introduce a new barrier to vaccine outreach, as vaccine uptake slows and the city steps up outreach to people who are hesitant about taking the vaccine.
In a Tuesday morning committee meeting with members of the New Orleans City Council, Dr. Jennifer Avegno, the city health director, said that the New Orleans Health Department had paused its use of Johnson & Johnson in city-run vaccination sites. .
“What we will do is shift any events that were planning to use J&J to Pfizer and Moderna,” she said. “It’s just a little more logistically challenging.”
The extremely rare blood clotting events have been seen so far in women between the ages of 18 and 48, within two weeks of receiving a Johnson & Johnson shot.
Symptoms listed by the FDA and CDC are: severe headache, abdominal pain, leg pain, or shortness of breath. According to the FDA and CDC, “people who have received the J&J who develop [these symptoms] within three weeks after vaccination should contact their health care provider.”
Shortly after the meeting, the Louisiana Department of Health released a statement reporting that it had told all providers in the state to pause their administration of Johnson & Johnson vaccines, pending further guidance. Representatives for healthcare networks LCMC Health and Ochsner Health said that their systems had already halted use of the vaccines.
The symptoms documented by the CDC and FDA closely resemble those that prompted several countries in Europe to pause their use of the AstraZeneca vaccine, which has not been approved in the United States. Several countries have resumed using the vaccine, although some have restricted its use. The AstraZeneca vaccine has not yet been submitted for emergency approval in the United States following a media debacle over inaccurate efficacy numbers in a press release.
Alex Spyropoulos, an expert on blood clotting and professor at the Feinstein Institutes in New York, told the Lens that the similarity “gives me pause, for sure.” But he’s not sure that there’s a causal link between the vaccines and blood clots.
“I’m not going to call it a complication yet,” he said.
Deliveries of the Johnson & Johnson vaccine had dropped sharply this week before the pause, after a manufacturing error at a Baltimore factory led the company to throw out 15 million doses. Avegno estimated that the vaccine made up about 10 percent of the city’s total supply.
‘I fear this is just going to lengthen the amount of time to get people vaccinated’
The pause comes at a particularly sensitive time for the city, as vaccine uptake slows, and outreach becomes more important.
“Everybody that was rushing out to get it as soon as it was available has largely gotten their vaccine,” Avegno told the City Council. “Now we’ve got about 30 percent of our population that needs more time, needs more education, needs us to come to them.”
Currently, just over 40 percent of the city has received a first dose. Avegno has said before that the city is aiming for 70 to 75 percent vaccinated to reach herd immunity.
State vaccination data shows that while vaccination rates among those over 65 are approaching those levels in Orleans Parish, young people lag behind. Survey data from the Louisiana Public Health Institute suggests that young people, particularly young women, are more cautious about the vaccines. Many express concerns about side effects.
Avegno and medical providers were looking to the Johnson & Johnson vaccines, which is easy to store and requires only a single dose, to fill that gap, partly through events at bars and clubs.
“What we learned at the Dragon’s Den,” Avegno said, referring to a “Shots for Shots” event held by the clinic CrescentCare and the club Dragon’s Den over the weekend that distributed Johnson & Johnson vaccines, “is that young people who were rolling up to hear DJ RQ Away would say, ‘Hey I’m here, I’ll take it.’ They can have conversations on the spot.”
Providers can run those events with the two-dose Pfizer or Moderna vaccines, but the logistics, especially getting people to return for a second shot, are more difficult. However, at the Dragon’s Den, Dr. Jason Halperin, the lead infectious disease doctor at CrescentCare, told The Lens that he’d already begun considering the option. It would involve giving people a first shot at the bar, and then scheduling them to come into the clinic later on, he said.
The more complicated challenge, however, is public trust. According to the LPHI study, more than a third of respondents said that they were still cautious about taking the vaccine. In Europe, concerns over the AstraZeneca vaccine turned into rising rates of vaccine refusal.
“Our young folks, and young folks of color,” Avegno acknowledged, “have a lot more questions, and need a lot more information in different ways.”
“I fear this is just going to lengthen the amount of time to get people vaccinated.”
The key to communicating with people about Johnson & Johnson, Avegno said in a Tuesday interview with the Lens, will be more information from the CDC on who is affected by the clots.
“Lots of people are walking around with genes that predispose them to have clotting disorders. Are we going to find that these six people had predispositions to clot?” she said.
If a risk factor becomes clear, Avegno said, it will be possible to say, for example, “You have a known clotting disorder in your family, this is not the right one for you,” just as providers currently screen for allergies.
Until that data becomes available, she said, the emphasis will be on the safety of the Pfizer and Moderna vaccines. She emphasized that most people who are hesitant want more information about the vaccine, and are open to conversations with healthcare providers. “We can say to people, ‘Yes, we’re getting more information about Johnson & Johnson, we’re not using that one, but let’s talk about Pfizer and Moderna: What questions do you have?’ ”
But Avegno and state leaders praised the CDC and FDA for the quick decision.
“While this news is frustrating and concerning, we appreciate the FDA acting with abundant caution and transparency,” Dr. Joseph Kanter, Louisiana’s State Health Officer, said in a statement. “This temporary pause should give the public and providers confidence the system of monitoring and safety checks are working as intended.”
What do we know about the possible reaction?
Clotting has not been connected to the Pfizer or Moderna vaccines. According to the LDH statement, 85,000 Johnson & Johnson doses have been administered in Louisiana without a single case of clotting.
If the complications are found to be connected to the vaccine, the reaction would be exceedingly rare. The FDA and CDC statement describes six documented cases out of 6.8 million people vaccinated. All the cases happened in women between 18 and 48 within two weeks of receiving the vaccine. One person died.
Many drugs have extremely rare side effects, Avegno told the City Council.
“If you’re giving millions and millions of doses, you’re going to see a few cases.” But, she said, the city would be looking for more information on mitigating those chances, like specific risk factors for clotting, before making further decisions.
Spyropoulos noted that women between 18 and 48 are also the most likely to be using oral contraceptives, or to be pregnant, both of which carry a heightened blood clot risk.
“We have a bias. We’re only looking at these events in vaccinated individuals,” he said. “With that kind of rarity, it may be that if we looked at [7 million] Americans who have not been vaccinated, we may have seen the same prevalence of these events.”
It could also be that providers have been on heightened alert for these events given the attention on clotting in Europe.
And COVID itself carries a risk of blood disorders, from clotting to internal bleeding. In a recent study, more than one in a hundred COVID patients experienced a life-threatening blood clot in the three months after they were hospitalized. Studies are ongoing to understand the risk of blood clots in people with milder COVID cases.
The clots are a rare form found in the brain, and come paired with a low platelet count in the blood. Both of those features resemble the events that have been documented in Europe, as well as an extremely rare immune reaction to a type of blood thinner called heparin.
The good news is that that reaction is treatable with other blood thinners, Spyropoulos said. Federal officials have signalled that these blood clots are likely similarly treatable if diagnosed. Avegno said that she is opening conversations with healthcare providers about how to monitor for and treat these events if they do occur.
This story has been updated with additional comments from Dr. Jennifer Avegno.