The Johnson & Johnson COVID-19 vaccine is being pulled from administration sites around Florida after Tuesday’s federal recommendation to pause the single-dose shots to investigate reports of potentially dangerous blood clots.
In a joint statement, the Centers for Disease Control and Prevention and the Food and Drug Administration announced they were investigating clots in six women in the days after vaccination, in combination with reduced platelet counts.
"Right now, these adverse events appear to be extremely rare," the statement said.
Federal distribution channels, including mass vaccination sites, will pause the use of the J&J shot, and states and other providers were expected to follow.
In Florida, that included all FEMA-supported sites and hubs, as well as mobile allocations scheduled to visit underserved communities.
“We are following the recommendation of the CDC on this all in an abundance of caution,” said Samantha Bequer, spokeswoman for the Florida Department of Emergency Management.
Federally supported sites in Tampa, Orlando, Jacksonville and Miami will not be offering first doses of any vaccines on Tuesday, Bequer said.
The sites will still offer the Pfizer vaccine, but only for people who need their second dose. Those who need a first dose can visit one of several county-run sites. Retail partners also may carry the two-dose vaccines.
The FEMA sites had been offering up to 3,000 doses a day of the Johnson & Johnson vaccine.
Asked whether the state will redirect some Pfizer or Moderna vaccines to federally supported sites, Bequer said officials were still looking at current allocations and determining what they have on hand.
Today FDA and @CDCgov issued a statement regarding the Johnson & Johnson #COVID19 vaccine. We are recommending a pause in the use of this vaccine out of an abundance of caution.
— U.S. FDA (@US_FDA) April 13, 2021
More than 6.8 million doses of the J&J vaccine have been administered in the U.S., including more than 473,000 in Florida.
Gov. Ron DeSantis called the pause a "speed bump," while acknowledging the state would follow the federal recommendation.
"I don't think people should be freaking out," DeSantis said at a news conference in Manatee County.
DeSantis said the state still has "a lot" of Pfizer and Moderna vaccines and that the deliveries of Johnson & Johnson doses were scheduled to decrease this week.
No one in Florida experienced significant side effects from the shot, DeSantis said. He received the Johnson and Johnson vaccine and only had some soreness in his arm, he said.
"I don't think people should be worried who've already had it, who haven't had any effects, I think it's likely going to be very effective for you," DeSantis said.
Federal and state authorities recommend that people who were given the J&J vaccine who are experiencing severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after the shot contact their health care provider.
The CDC and FDA said they want to “ensure that the health care provider community is aware of the potential for these adverse events and can plan due to the unique treatment required with this type of blood clot."
The CDC said that on Wednesday it will convene a meeting of the Advisory Committee on Immunization Practices to review the cases and assess their significance. The FDA will review that analysis as it also investigates the cases of rare blood clots.
"In these cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia)," said Dr. Anne Schuchat, principal deputy director of the CDC and Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. "All six cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination."
Johnson & Johnson said it was aware of the reports of “thromboembolic events,” or blood clots, but that no link to its vaccine had been established.
Concerns over rare blood clots have been raised over the Oxford-AstraZeneca vaccine, which has been widely administered in the U.K., European Union and many other countries. Last week, the European Union's drug regulator said the benefits of the vaccine outweigh its risks.
WUSF staff writer Rick Mayer, and information from the Associated Press and NPR was used in this report.
