The U.S. on Tuesday recommended a pause in using the single-dose Johnson & Johnson COVID-19 vaccine to investigate reports of rare but potentially dangerous blood clots.
The acting Food and Drug Administration commissioner said she expected the pause to last “a matter of days.”
The Centers for Disease Control and Prevention and the FDA announced that they were investigating unusual clots that occurred 6 to 13 days after vaccination.
The clots occurred in veins that drain blood from the brain and occurred together with low platelets, the fragments in blood that normally form clots. All six cases were in women between the ages of 18 and 48. One person died, and all of the cases remain under investigation.
Since the J&J vaccine rolled out in the United States, there have been more than 6.8 million doses administered.
On a joint media briefing Tuesday with the CDC and the FDA, doctors reiterated that right now there’s no indication that more people have been affected by the clots and that this is just out of an abundance of caution.
“I’d like to stress these events appear to be extremely rare. However COVID-19 vaccine safety is a top priority,” said acting FDA Commissioner Janet Woodcock.
FDA officials emphasized that Tuesday’s action was not a mandate.
While the federally-supported vaccination site at the Gateway Mall in Jacksonville halted J&J shots and Gov. Ron DeSantis announced Florida is temporarily suspending J&J shots, that doesn’t mean that all doctors are following the guidance.
Doctors and patients could still use J&J’s vaccine if they decide its benefits outweigh its risks for individual cases, said Dr. Peter Marks.
Doctors also pointed out that there are just too few cases to determine if there are any patterns in the people affected -- only that they’re all women. Authorities have not seen similar clots after use of the Pfizer or Moderna vaccines, the CDC’s Dr. Anne Schuchat said.
“We are committed to vaccination. We feel that is a very important tool to get this pandemic under control. We’re also committed to patient safety. Our message is, in doing this, we feel we’re taking the route that will provide the most safety for the patients by enabling health care professionals to recognize, to properly treat and to properly report any events that might happen,” said Woodcock.
The doctors are hoping to ensure people that they’re doing everything they can to make sure the shots are safe, and if there’s any doubt, they’ll take a step back.
The agencies recommend that people who were given the J&J vaccine should contact their doctor if they experience severe headache, abdominal pain, leg pain or shortness of breath within three weeks.
Until now concern about the unusual blood clots has centered on the vaccine from AstraZeneca, which has not yet received authorization in the U.S. Last week, European regulators said they found a possible link between the shots and a very rare type of blood clot that occurs together with low blood platelets, one that seems to occur more in younger people.
The AstraZeneca vaccine uses the same type of technology as the J&J vaccine.