No ‘significant effects’ from Johnson & Johnson shots in Florida

Florida has seen no “significant effects” related to the coronavirus vaccine produced by Johnson & Johnson, Gov. Ron DeSantis said at a news conference Tuesday.

Administration of the single-dose vaccine has been halted in the state and elsewhere at the direction of the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention, which jointly recommended a “pause” on the shots after reports of blood clots in six women who received them.

So far, nearly 7 million people have received the Johnson & Johnson vaccines, according to the CDC. As of Monday, 473,416 of those had been inoculated in Florida, including 75,530 in Tampa Bay’s four core counties, state data shows.

To date, Floridians have reported 285 “adverse events” to the federal Vaccine Adverse Events Reporting System after receiving a Johnson & Johnson COVID-19 vaccine, data shows. Reported medical issues included expected side effects, such as headaches, fatigue or fevers, as well as more significant issues. The reports are unconfirmed and don’t necessarily mean the vaccine caused or contributed to any of the reported issues.

Tampa Bay’s largest vaccination site, Tampa Greyhound Track, which is state run but federally supported, started offering the Johnson & Johnson vaccine almost exclusively on April 6. It was operating as normal Tuesday morning, but stopped shots at about 7:45 a.m., said Carole Covey, the site’s incident commander. The site gave out 70 Johnson & Johnson doses during that time, according to a spokeswoman with the state Division of Emergency Management.

By 9 a.m., site workers were changing electronic message boards along Waters Avenue, where vehicles were lined up for vaccines, and directing some people to other sites in the area. Covey said the site has not seen any life-threatening or serious side effects from the shots.

Samantha Bequer, a spokeswoman for the state Division of Emergency Management, said Florida is following the recommendation “out of an abundance of caution.” She did not immediately answer whether any of the cases identified by the CDC happened in Florida.

Bequer said the state is reviewing current vaccine supply to determine how to supplement efforts at federally supported sites, mobile vaccination sites and homebound vaccination programs that had been using Johnson & Johnson vaccines.

She said all Johnson & Johnson vaccines will be transported to the nearest county health department and kept in storage as the state awaits further guidance.

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Meanwhile, DeSantis urged the public not to worry.

“There’s a lot of medications that people take every day that have risk of blood clotting and other stuff,” the governor said, adding that he took the Johnson & Johnson vaccine himself and “my arm was sore for 45 minutes and that was that.”

DeSantis noted that the number of people experiencing side effects from the drug represent a “very small number” of the millions who have received it.

“You also have to balance that against how many people are alive today because they had the J&J vaccine,” he said. “There’s no question that it’s saved lives already.”

Joni Johnson, a 39-year-old in St. Petersburg, got her shot at the Tampa Greyhound Track on Thursday, and she said she’d do it again, even in light of Tuesday’s news. She’s seen the effects of COVID-19 in her own life, saying a young family member living out of state is currently in a medically induced coma with the virus.

“The numbers appear to reflect (that) this reaction is very rare,” she said. “I am glad the vaccine is being scrutinized for further investigation. But I hope people who still want to get vaccinated do.”

Michael Kaplan, a 34-year-old in Bradenton who got his vaccine Monday, said he doesn’t have regrets about it either. The news seemed like an overreaction at first, given that so few people reported issues, but he’s glad federal regulators are investigating.

“The FDA knows what it’s doing and they wouldn’t do this for no reason,” Kaplan said. “It seems they need to pause to gather more data to make sure it isn’t a much bigger problem. I’m good with that.”

Kevin Sneed, dean of the University of South Florida College of Pharmacy, called the reported issues with Johnson & Johnson “exceptionally low,” but cautioned that more information could come to light in the coming days.

It’s unclear why only women are reported to have experienced clots related to the vaccine, he said. But investigations into their cases should help regulators identify a profile of the type of person who might be most susceptible to adverse effects.

“One person per 1 million people is extremely rare, but it’s something we have to be aware of and monitor,” he said, adding that the fact that regulators are looking into the cases shows the country’s oversight process is working.

Some other drugs can cause clotting, but it’s rare, Sneed added. Hormone replacement therapies, including birth control, present the most risk by far.

Florida should have plenty of coronavirus vaccines from Moderna and Pfizer-BioNtech in the coming weeks, giving residents “very robust availability of the vaccine” despite the pause of Johnson & Johnson shots, DeSantis said.

A similar message came from the White House COVID-19 Response Team, in a tweet by member Ben Wakana that said less than 5 percent of coronavirus vaccines administered in the U.S. have been from Johnson & Johnson.

“Pause will NOT have a significant impact on our vaccination plan,” he wrote. “We’re pushing out 25 (million) Pfizer and Moderna doses each week.”

State and federal leaders had already expected a significant decline in supplies of Johnson & Johnson vaccines due to a quality control issue at a Baltimore manufacturing plant. The New York Times reported Friday that allocations were projected to drop by about 86 percent.

Officials were supposed to bring 400 Johnson & Johnson doses to a homeless outreach event Tuesday at Bell Shoals Church in unincorporated Hillsborough County, said sheriff’s Deputy Stephanie Krager, one of the organizers of the event. But Krager said those shots “went out the door” following news of the federal government’s recommendation. Instead, the site was able to offer about 50 doses of the Pfizer-BioNTech vaccine.

Covey, the Tampa Greyhound Track site commander, said anyone who has received a Johnson & Johnson vaccine and is experiencing any side effects should report them to the Vaccine Adverse Event Reporting System, a national tracking database.

Staff writers Zachary T. Sampson and Natalie Weber contributed to this report.

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