U.S. and Georgia officials recommended a “pause” Tuesday, April 13, in administration of the single-dose Johnson & Johnson COVID-19 vaccine to investigate reports of potentially dangerous blood clots.
In a joint statement Tuesday, the Centers for Disease Control and Prevention and the Food and Drug Administration said they were investigating unusual clots in six women that occurred six to 13 days after vaccination. The clots occurred in veins that drain blood from the brain and occurred together with low platelets. All six cases were in women between the ages of 18 and 48.
The reports appear similar to a rare, unusual type of clotting disorder that European authorities say is possibly linked to another COVID-19 vaccine not yet cleared in the U.S., from AstraZeneca.
The Georgia Department of Public Health announced Tuesday morning there would be a pause on vaccinations using the Johnson & Johnson vaccine.
DPH said none of the six cases were vaccinated in Georgia, and these cases are not connected to the reactions reported April 9 at the Cumming Fairgrounds.
Eight recipients reported adverse reactions, and DPH officials said they would pause administering the Johnson & Johnson vaccine.
“DPH and District Health Departments are working to provide Pfizer or Moderna vaccines for individuals with previously scheduled appointments for the J&J vaccine,” DPH said in a news release. “In some cases, this may require rescheduling, and we ask for patience while scheduling arrangements and adjustments are made. Right now, these adverse events appear to be extremely rare, but out of an abundance of caution DPH will temporarily stop the administration of the (Johnson & Johnson) vaccine while scientists review the data around these cases.”
More than 6.8 million doses of the J&J vaccine have been administered in the U.S., the vast majority with no or mild side effects. Georgia DPH said more than 124,000 doses of the vaccine have been administered in Georgia.
According to Georgia DPH data, thousands of doses of the Johnson & Johnson vaccine have been allocated to Hall County pharmacies and other health care entities.
The Hall County Health Department has received 6,600 doses of the Johnson & Johnson vaccine and administered 1,734 of those doses.
District 2 Public Health spokesman Dave Palmer said any patient at risk will be notified.
“Patients who received the (Johnson & Johnson) vaccine more than three weeks ago are no longer at risk,” Palmer wrote in an email.
Vaccination clinics using the Johnson & Johnson version were held in early March for both the Gainesville City School System and Hall County Schools, but both were more than three weeks ago.
Palmer said anyone scheduled to receive the Johnson & Johnson vaccine will be offered the Pfizer version.
Northeast Georgia Health System has received 2,200 Johnson & Johnson doses so far but has only administered 27 doses at Northeast Georgia Physicians Group’s location in Wauka Mountain last week.
“We are working today to contact each of those patients to advise them to watch for severe headache, leg pain, abdominal pain or shortness of breath up to three weeks after receiving the Johnson & Johnson vaccine,” said Bobby Norris, vice president of operations for Northeast Georgia Physicians Group, in a statement.
Norris said only two NGPG locations have the Johnson & Johnson vaccine doses on hand, and people with appointments will now receive Moderna or Pfizer options.
Though it has received 500 Johnson & Johnson doses roughly two weeks ago, Longstreet Clinic has only administered one vial, which contains five doses.
“These doses went to internal personnel who had requested the (Johnson & Johnson) shot,” the clinic said in a statement. “The remainder of our initial Johnson & Johnson inventory was intended for use at one of our vaccine clinics. Instead, we will now use Moderna or Pfizer for all Longstreet Clinic vaccine clinics as we await further guidance (from the) state.”
The Longstreet Clinic said no adverse reactions were reported or observed on site.
“We will continue to administer either the Moderna or the Pfizer vaccine at our upcoming clinics,” said Mimi Collins, Longstreet Clinic CEO, in a statement. “Fortunately we feel good about our inventory of those two vaccines and we are hopeful that trend will continue.”
U.S. health authorities cautioned doctors against using a typical clot treatment, the blood-thinner heparin, in patients who received the Johnson & Johnson vaccine. “In this setting, administration of heparin may be dangerous and alternative treatments need to be given,” the FDA and CDC said.
Officials say they also want to educate vaccine providers and health professionals about the “unique treatment” required for this type of clot.