SC lifts pause on Johnson & Johnson COVID-19 vaccine
South Carolina’s health department has lifted its 10-day pause on the use of Johnson & Johnson’s COVID-19 vaccine, which had been on ice following reports that it caused dangerous blood clots in extremely rare cases.
The move comes after federal health officials determined the benefits of vaccination against the deadly coronavirus outweighed the risks of developing the clots, which have developed in just 15 of the nearly 8 million people who have received a Johnson & Johnson (Janssen) dose.
“Safety is our top priority. This pause was an example of our extensive safety monitoring working as they were designed to work—identifying even these small number of cases,” Acting U.S. Food and Drug Administration Commissioner Janet Woodcock said in a statement announcing that federal officials had lifted the pause on the vaccine. “We’ve lifted the pause based on the FDA and CDC’s review of all available data and in consultation with medical experts and based on recommendations from the CDC’s Advisory Committee on Immunization Practices. We have concluded that the known and potential benefits of the Janssen COVID-19 Vaccine outweigh its known and potential risks in individuals 18 years of age and older.”
In statement released Friday evening, the S.C. Department of Health and Environmental Control said it had notified all state vaccine providers that they could resume administering the single-shot vaccine to the public.
DHEC suspended use of the Johnson & Johnson vaccine April 13 at the recommendation of the U.S. Centers for Disease Control and Prevention and FDA, and instructed vaccine providers to “quarantine” and label their existing doses “Do Not Use” until instructed otherwise.
The federal agencies had strongly recommended states pause administration of the single-shot vaccine after six women developed an extremely rare condition called cerebral venous sinus thrombosis, or CVST, that is characterized by blood clots, often in the brain, and low blood platelet counts.
Initial symptoms, starting with headaches, typically develop six to 13 days after vaccination, and progress to include nausea, vomiting, abdominal pain and eventually may result in speech difficulties, loss of consciousness and seizures.
Fifteen cases of CVST have been identified in Johnson & Johnson vaccine recipients to date, federal health officials said.
All of the cases affected women, the vast majority of whom were between 18 and 49 years old.
Three of the women have died and seven are hospitalized, including four in intensive care units, CDC officials said.
Some South Carolina vaccine providers were forced to cancel or reschedule appointments due to the Johnson & Johnson pause, but because the one-shot vaccine comprises only a small percentage of the state’s overall vaccine supply, its suspension didn’t have a major impact on vaccine availability in the state, health officials said.
It’s not yet clear what effect the pause will have on demand for the single-shot vaccine, which the state was shipping mostly to independent rural pharmacies or using with vulnerable or hard-to-reach populations that may struggle to return for a second dose.
South Carolina’s public health director Brannon Traxler said Friday she suspects demand for the Johnson & Johnson product still exists.
“Many people either don’t want to have to worry about scheduling and going back for a second dose or are in a situation or circumstance where that may be more challenging, so there still is a role where a single-dose vaccine could benefit the population,” she said.
As of Friday, nearly 90,000 South Carolinians, or almost 8% of the state’s fully vaccinated population, had received the Johnson & Johnson vaccine, according to DHEC data.