Sites halt J&J vaccinations

Officials report rare but serious blood clot reaction

FEMA’s massive COVID19 vaccination site at Valencia College’s West Campus, Central Florida health clinics and the Orlando VA Healthcare System abruptly halted their use of the single-dose Johnson & Johnson vaccine Tuesday after federal health officials reported an extremely rare but serious reaction to the shot in a halfdozen recipients nationwide.

In addition, Publix, Walmart and Winn-Dixie said they suspended the administration of the vaccine at all pharmacies following guidance from the Centers for Disease Control and Prevention and Food and Drug Administration. The federal agencies recommended — but did not mandate — a pause in administering the vaccine due to reports of six women ages 18 to 48 developing blood clots 6 to 13 days after vaccination.

The clots were observed in patients who also had low platelet counts, making the usual treatment for blood clots — the blood thinner heparin — potentially “dangerous.” In one case, a patient died, and a second woman was hospitalized in critical condition.

Most sites quickly pivoted to using the Pfizer and Moderna vaccines, which have not been linked to clots. But officials worried the news would undermine the effort to persuade Americans to get vaccinated.

Gov. Ron DeSantis said at a news conference Tuesday that the state will heed the federal government’s recommendation and pause the use of the Johnson & Johnson vaccine. But he also urged Floridians to get the one-dose shot if and when it becomes available again.

“I don’t think people should be freaking out,” said DeSantis, who received the Johnson & Johnson vaccine himself earlier this month. “I think that what they’re doing is out of an abundance of caution. … I got J&J. I think my arm was sore for 45 minutes. And then that was that. So I think the track record thus far in Florida has been good.”

Dr. Peter Marks, director of the Food and Drug Administration’s Center for Biologics Evaluation and Research, said the clotting problem appeared to involve a highly unusual immune response to the vaccine. There was no reason to think it was related to the use of birth control pills, despite the age range of the women involved, he said, and officials hope to have enough information to resume the vaccine’s use — at least in some populations — in a matter of days.

The vaccine already has been used to inoculate 6.8 million Americans against COVID-19, though it accounts for less than 5% of the recorded vaccine shots so far in the United States, said Jeff Zients, the White House COVID-19 response coordinator.

Lakeland-based Publix said customers can still schedule appointments for the Moderna vaccine, where available, at publix.com/covidvaccine. The retailer administered Johnson & Johnson through its pharmacies on Saturdays and Sundays.

Similarly, Walmart and WinnDixie said they would pause their use of the Johnson & Johnson vaccine but try to meet demand through Pfizer and Moderna where possible. A Winn-Dixie spokesman said customers who already have confirmed appointments for the Johnson & Johnson shot will receive a text message notifying them of their appointment cancellation and invite them to reschedule online for another vaccine.

Vaccinations also were canceled Tuesday at the Blanchard Park YMCA in east Orange County, where the Y had been scheduled to offer a one-day clinic for staff, members and the public. Other vaccination efforts were forced to pivot to the Pfizer and Moderna formulas, including Orlando VA clinics in Orange, Volusia and Brevard counties and a mobile clinic that inoculated homebound individuals in Central Florida.

“What we’ve had to do is just let our patients know that we will still be able to provide the vaccine, but it would be the Pfizer vaccine,” said Orlando City Commissioner Bakari Burns, the longtime CEO of the Health Care Center for the Homeless, which serves both low-income and homeless patients.

“My main concern is the erosion of trust. This was just truly a blow to all of us who’ve been trying to increase vaccine confidence.”

State officials are awaiting word from the CDC and FDA before resuming use of the Johnson & Johnson shots at federal vaccine sites, mobile pop-up locations and homebound efforts, said Samantha Bequer, a spokeswoman for the Florida Division of Emergency Management.

“The state is reviewing current vaccine supply to determine how to supplement these operations with Pfizer or Moderna allocations,” she said.

Some 195 people received the Johnson & Johnson vaccine at the Valencia site Tuesday morning before those shots were halted, she said.

For now, the Johnson & Johnson doses are being transported to county departments of health for storage.

At True Health, a Sanfordbased nonprofit organization that operates seven community health centers in Orange and Seminole counties, plans to continue vaccinating people with the Johnson & Johnson product in Casselberry were scrapped Tuesday morning as workers scrambled to reach about 30 people with appointments.

“We did offer those individuals the ability to receive the Moderna vaccine, however, a lot of them really wanted to do the Johnson & Johnson,” said Deana Montella, True Health’s chief nursing officer. “This doesn’t help the vaccine numbers at all because now some individuals may opt to not get anything.”

Given shortages of the Johnson & Johnson vaccine following news last month that 15 million doses at a Baltimore factory had been contaminated, the decision to pause its use will have less of an immediate impact than it might otherwise.

But some public health officials are worried about the potential for larger fallout — distrust in a vaccination rollout that has already spawned more than its share of conspiracy theories.

“For some people who are very adamant against not getting the vaccine … it’s probably just going to be another example of why you shouldn’t,” said Dr. Vincent Hsu, an epidemiologist and AdventHealth’s infection control officer. “Our message is really for patients who are on the fence — there are still obviously very safe and effective vaccines that have been distributed and given to millions of Floridians with the Moderna and Pfizer. Even the Johnson & Johnson vaccine, the risks that are being evaluated now — and I’m not minimizing them — but they are very rare. We’re talking about less than one in a million.”

Most immediately, AdventHealth is working on educating the public, especially those recently vaccinated with the Johnson & Johnson vaccine, and their physicians, Hsu said.

“Number one is any persons who were vaccinated within the past three weeks, if they were to develop severe headaches, leg pain, shortness of breath, abdominal pain, those persons should contact their physicians and be evaluated,” Hsu said. “We’re also in the process of sending a letter to our physicians to make sure they can diagnose and manage these potential cases,” including asking anyone with such symptoms about their vaccination history.

For 64-year-old Kim Liberty in DeLand, the news prompted only a brief moment of concern.

“I took a quick look at the back on my legs once I heard about the clots, just in case I could see anything developing,” she said. “But I got the vaccine March 17, so I don’t think I have to worry. And, you know, six [adverse cases] out of 6 million — I’m OK.”

Jessica Townsend, 30, of Orlando, said she received the Johnson & Johnson vaccine March 24 along with her entire household. They had been cautious throughout the past year, only going out for essential trips for groceries, and were eager to get vaccinated to go out to eat and see friends again.

She said Tuesday’s news didn’t worry her.

“The risk of blood clots with things like birth control is already high,” she said. “I might have been more worried if news broke a week ago.”

Bradley Sessions, 40, received the shot on April 6, and said he wasn’t concerned for himself, as the blood clots so far have only been reported in women. But he was awaiting information on other factors that might make recipients more vulnerable.

“I’m not concerned for myself, but I guess I’ll know for sure in a few weeks,” he said. “I’m still glad I opted for the J&J vaccine.”

Orange County Mayor Jerry Demings acknowledged the pause would likely slow vaccination efforts.

On Monday, Demings said his staff was developing a plan to gradually ease restrictions on social distancing, occupancy and wearing facial coverings. He said such a plan could be announced this week unless anything changed drastically involving vaccination and infection rates.

“It potentially could impact some of our efforts to get people vaccinated, but the CDC hopefully will make some quick adjustments there,” Demings said at a Board of County Commissioners meeting Tuesday. “At some point we will hopefully get some clarity on the use of the J&J.”

The Johnson & Johnson vaccine had been expected to play a bigger role in the months to come because it involves only a single dose and doesn’t require extremely cold storage.